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LILLY HUMATROPE in 4 UNIT VIALS
HGH must be prescribed by a licensed physician. Before beginning treatment,
your blood levels of somatomedin-C (also called IGF-1) will be measured.
Benefits occur slowly over several months, and full benefits take six months
to one year. The lower your initial somatomedin-C levels, the faster you
will notice improvements.
HGH is more effective when used together with DHEA replacement therapy.
Estrogen/progesterone replacement (for women) or testosterone replacement
(for men) may also add to the benefits from hormone replacement therapy.
These hormones all decline with age. The goal of hormone replacement therapy
is to restore levels to those normally present during early adulthood. Safe
levels produced by the pituitary gland at age 30 will remain safe when
replaced to that same level later in life. Adverse effects from hormone
replacement result only from excessive doses or the use of unnatural and
synthetic hormone analogs.
After an evaluation has been completed, and if HGH is prescribed, your vials
of injectable HGH can be either:
Dispensed in person at the Clinic, premixed with diluent; or
Shipped overnight via Federal Express or UPS Red Label to your home or
office, either
weekly, premixed, ready to inject; or
In dry powder form, needing the addition of liquid diluent by you before
use.
Patients of the Clinic may purchase up to several months’ supply of dry,
undiluted HGH at one time, or receive a single vial of premixed HGH each
week. In order to receive more than a one-week supply, it is necessary to
dispense the HGH in powder form (freeze-dried). In that case, you must add
diluent (saline solution shipped with your powder HGH) to the vial of
freeze-dried HGH before use.
Undiluted, freeze-dried HGH powder in sterile vials may be safely kept in a
refrigerator for up to 18 months (as dated on each vial). It will also
remain stable at room temperature for approximately two months, if the
temperature does not exceed 90 degrees Fahrenheit. Once the diluent is
added, however, the resulting liquid HGH must be kept refrigerated and used
within two weeks or potency slowly deteriorates.
Diluent is composed of a weak salt solution formulated to maintain
sterility. Sterile sodium chloride (ordinary salt) is dissolved in sterile
water at the exact concentrations normally present in blood and plasma.
Diluent for LILLY HUMATROPE is provided by the clinic in a separate
multi-dose 30-ml vial. The HGH vial contains a dry, white, powdery pellet of
sterile, purified HGH. The diluent is a clear, colorless fluid, which looks
like water. The diluent vial and HGH vial are both clearly identified on
their labels. Diluent is labeled "Bacteriostatic 0.9% Sodium Chloride for
Inj. USP." In addition to the HGH syringes, you will also be provided with a
supply of 3-ml syringes with 23 gauge needles attached. These are used to
transfer diluent into the HGH vial. Please notify us if you need more
diluent or syringes.
The following procedures will be demonstrated for you by Clinic staff until
you feel confident to do them yourselves. Alternatively, you may have a
nurse, friend, or relative near you who can help you become proficient at
doing this. Please feel free to telephone a nurse or the doctor if you have
questions.
Mixing Instructions:
Before the vials are first used, they will have a plastic cap over the top
of the rubber stopper. It is first necessary to remove that cap. This can be
done by simply pushing up on the cap and breaking the seal. Beneath the cap
will be a rubber stopper. In the center is a smaller circle through which
the needle is inserted. It is important to keep the rubber stopper clean and
sterile. Before each use, wipe the area where the needle goes carefully with
an alcohol swab on both the diluent and HGH vials. Then do not allow
anything to touch those sterile areas except the sterile needle.
If you add diluent yourself before use, first remove the 3-ml diluent
syringe from its paper wrapper. Before removing the plastic guard from the
needle, twist it firmly clockwise to insure that the needle is tight on the
syringe. Then hold the syringe with the needle pointing upwards and
carefully remove the plastic guard from the needle. Do not touch the needle
and do not allow the needle to come in contact with anything, which might
contaminate it. Pull back the plunger to draw 2 ml of air into the syringe.
Then, with your other hand, hold the vial of diluent upside down over the
tip of the needle and slowly insert the needle straight up through the
center of the stopper into the vial. Push the plunger up so that all the air
goes into the vial, and then pull the plunger back until slightly more than
2 ml of saline is in the syringe. Move the plunger in and out slightly until
all air is out of the syringe and 2.2 (two and two-tenths) ml of diluent
remains in the syringe. Graduations in ml and fractions of ml are clearly
marked on the barrel of each syringe. When the diluent vial is close to
empty, it will be necessary to keep the tip of the needle below the level of
the liquid, only slightly inside the rubber stopper, so that diluent and not
air is drawn into the syringe. We will send more diluent on request when it
gets low.
Slowly inject diluent into the HGH vial as follows: Hold the HGH vial
stopper side up and point the needle of the syringe downward. Insert the
needle through the very center of the HGH vial, but angle the tip of the
needle toward the glass wall. Slowly push in the plunger, releasing the
diluent into the HGH powder. Inject diluent slowly so that it runs down the
inside wall of the vial onto the HGH powder at the bottom. Do not inject
forcefully, as the HGH will foam if agitated. For the same reason, do not
shake the HGH vial when mixing. Instead, slowly roll or turn the HGH in
solution until dissolved. This will result in a concentration of 1 unit of
HGH in each 1/2-ml of solution.
If desired, you may elect to have clinic staff add diluent, as described
above, and then ship premixed vials weekly.
Storage, Handling, and Traveling:
After the HGH is fully dissolved, keep it refrigerated whenever possible. Do
not allow it to freeze. If out of the refrigerator for a day or so when
traveling, after the diluent has been added, be sure that it does not get
any warmer than 80 degrees Fahrenheit.
Do not allow the HGH solution to get hot. DO NOT SHAKE the vial, as the
solution will foam, causing some to stick to the glass walls of the vial,
making it impossible to extract the entire amount.
The HGH solution for injection is stable for several days at room
temperature and for approximately 2 weeks if refrigerated. Potency is lost
more rapidly if not refrigerated. The higher the temperature, the shorter
the life. HGH in solution can remain stable for 48 hours out of the
refrigerator, but only if the temperature does not exceed 80 degrees
Fahrenheit. If used within the time specified and stored properly, full
potency is assured. A small, insulated CoolPack can be used to store your
vial of HGH during travel, and may be ordered through this office
If you travel and will not be home to receive your regular shipment, please
advise us in advance of the proper shipping instructions and address. If you
plan to travel and wish to order more than your usual number of vials in
advance, please notify us. In addition, if you are leaving the country, we
can provide a letter certifying that the injectables and syringes are
lawfully prescribed by a licensed physician. This can avoid embarrassment if
your luggage is searched by customs officials.
Shipping Schedule:
We will ship your supply of HGH via overnight courier (UPS Red Label). You
will be notified of the shipment day so that you can look for delivery. You
will receive your vials of HGH, diluent, disposable syringes, and alcohol
swabs on the following morning. Put the vials into the refrigerator on
receipt.
Cost:
The cost for HGH is $120.00 for each 4-unit vial, plus actual shipping
cost—which will vary from approximately $20 to $60 per order, depending on
size of the order and destination. You will be charged at the time of each
shipment to your credit card, or paid in advance, as instructed by you.
Syringes with needles attached, diluent, and alcohol swabs are included at
no additional cost. If you need more, please call.
Dosage:
The usual dose is one unit of HGH taken daily for four successive days in
the evening, close to bedtime. Some doctors recommend morning injections,
and the timing may not be important; however, HGH is normally produced by
the pituitary gland during the early hours of sleep and, therefore, evening
dosing may be preferable. This is followed by a three-day rest (no
injections). Based on several years of experience, this dosing schedule has
been found safe and most cost-effective. If cost was not so high, twice that
dose could safely be taken with added benefit. Some patients prefer to take
one unit of HGH every day. That is safe and increases the benefit, but it
also increases the cost.
The abbreviations "cc" for cubic centimeter and "ml" for milliliter are used
interchangeably and both mean the same thing. Some syringes are labeled "cc"
and others are labeled "ml". Diluent syringes hold a total of 3 ml and the
syringes used for injection hold 1 ml.
To administer your daily dose, first draw up slightly more than 1 unit of
HGH into the 1cc syringe. After the solution has been drawn into the
syringe, hold the needle upright and tap on the syringe with your fingernail
to dislodge any large air bubbles in the solution. After any bubbles present
have risen to the top, just beneath the base of the needle, the air can be
expelled back into the vial by pushing on the plunger very slightly, leaving
exactly 1 unit of HGH solution in the syringe. It is best to do this with
the needle still in the inverted vial so that any HGH solution, which
accidentally comes out with the air, will not be lost. If a tiny amount of
air remains in the syringe, it will not cause any problem. It is often not
possible to get every last speck of air or foam out of the injection.
Between your fingers pinch up a layer of skin and subcutaneous fat anywhere
on the body. Insert the tiny needle, and press the plunger in all the way to
inject the dose. The abdomen, near the navel, is one convenient location.
The proper procedure will be demonstrated by the doctor or nurse in the
clinic when HGH is first prescribed.
ALTERNATE DOSING OPTION:
Recently some patients have chosen to administer half the daily dose (½ unit
of HGH) at bedtime and half on arising in the morning. There have been
reports of increased benefit with the same total daily dose. The number of
injections is doubled, however, which is less convenient. In addition, if
HGH is every day, the monthly cost increases.
If you decide to split your daily doses, taking half at night and half in
the morning, you should fill each syringe with only ½ unit of HGH (1/4 or
0.25 ml). You will therefore need eight syringes per 4-unit vial of HGH. If
you plan to use this twice-daily dosing option, please let us know and we
will ship the extra syringes as needed at be no additional charge.
GETTING EVERY LAST DROP:
The rubber stopper has a crosswise notch or slit on the inside of the
bottle. It is necessary to turn the vial until you can sight across that
notch to get all of the HGH into the last syringe. If care is not taken, you
might miss the last few drops. In order to get 100% of the last dose from
the vial, take the following steps:
Remove the protective needle cover from the needle attached to the
disposable syringe, being careful not to touch the needle to preserve
sterility. Insert the needle straight into the vial, holding the vial and
syringe perfectly in line. Be sure that the needle enters straight through
the very center of the rubber stopper. There is a small circle on the top of
the stopper, which marks the center. This is most easily done by placing the
vial upright on a tabletop and directing the syringe and needle straight
downward into the very center of the stopper.
After the needle has been inserted, hold the vial in your hand and turn the
vial vertically, upside down, so that the HGH solution runs into the
depression and notch just inside the stopper.
Rotate the vial continuing to hold it straight upside down until you can see
through the vertical notch in the rubber stopper, inside the vial. You
should be able to see into the bottom of the depression in the stopper,
where the needle first enters the vial, where HGH has pooled. The tip of the
needle will be seen protruding into the pool of HGH solution.
The tip of the needle must be in the solution to get the last drop. Slowly
pull the needle back until just the very tip is visible coming through the
stopper
Taking care to hold the tip of the needle in that same position (barely
penetrating the inside surface of the stopper), draw back on the plunger of
the syringe until all the HGH solution has been drawn up. It may be a little
more or a little less than one-half ml, depending on the amount withdrawn in
prior doses and the amount that adheres to the glass walls.
Carefully inject any air back into the vial. It will not hurt to inject a
little foam with the HGH.
QUESTIONS AND FOLLOW-UP:
If any questions occur or if you believe you are having any problems with
treatment, please call this office.
SYRINGE DISPOSAL:
Used syringes are considered to be "bio-hazard waste", and it is against the
law to dispose of them with your other garbage and waste. They should be
incinerated at high temperature to insure that no environmental
contamination from blood could occur. If you cannot dispose of the used
syringes safely, you may return them to our clinic. We have a licensed
biohazard disposal service that makes regular pickups.
REPORTED BENEFITS OF HGH
Benefits of HGH replacement by injection reported in the medical literature
are described below. Benefits are gradually achieved over four to six months
by restoring growth hormone levels in older patients to normal levels for a
healthy young adult. Benefits may continue to increase for up to 18 months
or more after beginning therapy.
It is scientifically well proven that secretion of growth hormone by the
pituitary gland decreases progressively with age. Starting after
adolescence, secretion of growth hormone steadily declines until the amount
present in older people is a small fraction of younger levels, often less
than 10%. This is one cause of many adverse effects of aging, including the
following:
5% increase in fat with each decade of life.
Decreases in muscle strength, skin thickness, bone density, physical
endurance, mental ability, and immune defenses.
Osteoporosis
Alzheimer’s disease
Senility
Obesity
Fatigue
Muscle and organ atrophy
And other age-related conditions, which have, been reported to improve with
HGH replacement therapy.
Benefits reported in published studies include:
15% average decrease in fat.
8% average increase in muscle and lean body structures.
Improved skin texture resulting in a more youthful appearance.
Fewer skin wrinkles.
Increased bone density, reversal of osteoporosis.
Faster healing of any type of injury, fracture, or wound.
Greatly enhanced immunity and resistance to infection.
Enhanced brain function, retention of intellect with aging.
Improvement in Alzheimer’s and Parkinson’s syndromes.
Improved sex drive.
Improved fertility, sperm production, and ovulation.
Improvement in overall physical and mental well being.
Improvement in sleep disorders, better quality of sleep.
Improved exercise tolerance.
Improved mineral balance.
Improved mood, with less depression and fatigue.
Improved heart and kidney function.
LILLY HUMATROPE in 4 UNIT VIALS
HGH must be prescribed by a licensed physician. Before beginning treatment,
your blood levels of somatomedin-C (also called IGF-1) will be measured.
Benefits occur slowly over several months, and full benefits take six months
to one year. The lower your initial somatomedin-C levels, the faster you
will notice improvements.
HGH is more effective when used together with DHEA replacement therapy.
Estrogen/progesterone replacement (for women) or testosterone replacement
(for men) may also add to the benefits from hormone replacement therapy.
These hormones all decline with age. The goal of hormone replacement therapy
is to restore levels to those normally present during early adulthood. Safe
levels produced by the pituitary gland at age 30 will remain safe when
replaced to that same level later in life. Adverse effects from hormone
replacement result only from excessive doses or the use of unnatural and
synthetic hormone analogs.
After an evaluation has been completed, and if HGH is prescribed, your vials
of injectable HGH can be either:
Dispensed in person at the Clinic, premixed with diluent; or
Shipped overnight via Federal Express or UPS Red Label to your home or
office, either
weekly, premixed, ready to inject; or
In dry powder form, needing the addition of liquid diluent by you before
use.
Patients of the Clinic may purchase up to several months’ supply of dry,
undiluted HGH at one time, or receive a single vial of premixed HGH each
week. In order to receive more than a one-week supply, it is necessary to
dispense the HGH in powder form (freeze-dried). In that case, you must add
diluent (saline solution shipped with your powder HGH) to the vial of
freeze-dried HGH before use.
Undiluted, freeze-dried HGH powder in sterile vials may be safely kept in a
refrigerator for up to 18 months (as dated on each vial). It will also
remain stable at room temperature for approximately two months, if the
temperature does not exceed 90 degrees Fahrenheit. Once the diluent is
added, however, the resulting liquid HGH must be kept refrigerated and used
within two weeks or potency slowly deteriorates.
Diluent is composed of a weak salt solution formulated to maintain
sterility. Sterile sodium chloride (ordinary salt) is dissolved in sterile
water at the exact concentrations normally present in blood and plasma.
Diluent for LILLY HUMATROPE is provided by the clinic in a separate
multi-dose 30-ml vial. The HGH vial contains a dry, white, powdery pellet of
sterile, purified HGH. The diluent is a clear, colorless fluid, which looks
like water. The diluent vial and HGH vial are both clearly identified on
their labels. Diluent is labeled "Bacteriostatic 0.9% Sodium Chloride for
Inj. USP." In addition to the HGH syringes, you will also be provided with a
supply of 3-ml syringes with 23 gauge needles attached. These are used to
transfer diluent into the HGH vial. Please notify us if you need more
diluent or syringes.
The following procedures will be demonstrated for you by Clinic staff until
you feel confident to do them yourselves. Alternatively, you may have a
nurse, friend, or relative near you who can help you become proficient at
doing this. Please feel free to telephone a nurse or the doctor if you have
questions.
Mixing Instructions:
Before the vials are first used, they will have a plastic cap over the top
of the rubber stopper. It is first necessary to remove that cap. This can be
done by simply pushing up on the cap and breaking the seal. Beneath the cap
will be a rubber stopper. In the center is a smaller circle through which
the needle is inserted. It is important to keep the rubber stopper clean and
sterile. Before each use, wipe the area where the needle goes carefully with
an alcohol swab on both the diluent and HGH vials. Then do not allow
anything to touch those sterile areas except the sterile needle.
If you add diluent yourself before use, first remove the 3-ml diluent
syringe from its paper wrapper. Before removing the plastic guard from the
needle, twist it firmly clockwise to insure that the needle is tight on the
syringe. Then hold the syringe with the needle pointing upwards and
carefully remove the plastic guard from the needle. Do not touch the needle
and do not allow the needle to come in contact with anything, which might
contaminate it. Pull back the plunger to draw 2 ml of air into the syringe.
Then, with your other hand, hold the vial of diluent upside down over the
tip of the needle and slowly insert the needle straight up through the
center of the stopper into the vial. Push the plunger up so that all the air
goes into the vial, and then pull the plunger back until slightly more than
2 ml of saline is in the syringe. Move the plunger in and out slightly until
all air is out of the syringe and 2.2 (two and two-tenths) ml of diluent
remains in the syringe. Graduations in ml and fractions of ml are clearly
marked on the barrel of each syringe. When the diluent vial is close to
empty, it will be necessary to keep the tip of the needle below the level of
the liquid, only slightly inside the rubber stopper, so that diluent and not
air is drawn into the syringe. We will send more diluent on request when it
gets low.
Slowly inject diluent into the HGH vial as follows: Hold the HGH vial
stopper side up and point the needle of the syringe downward. Insert the
needle through the very center of the HGH vial, but angle the tip of the
needle toward the glass wall. Slowly push in the plunger, releasing the
diluent into the HGH powder. Inject diluent slowly so that it runs down the
inside wall of the vial onto the HGH powder at the bottom. Do not inject
forcefully, as the HGH will foam if agitated. For the same reason, do not
shake the HGH vial when mixing. Instead, slowly roll or turn the HGH in
solution until dissolved. This will result in a concentration of 1 unit of
HGH in each 1/2-ml of solution.
If desired, you may elect to have clinic staff add diluent, as described
above, and then ship premixed vials weekly.
Storage, Handling, and Traveling:
After the HGH is fully dissolved, keep it refrigerated whenever possible. Do
not allow it to freeze. If out of the refrigerator for a day or so when
traveling, after the diluent has been added, be sure that it does not get
any warmer than 80 degrees Fahrenheit.
Do not allow the HGH solution to get hot. DO NOT SHAKE the vial, as the
solution will foam, causing some to stick to the glass walls of the vial,
making it impossible to extract the entire amount.
The HGH solution for injection is stable for several days at room
temperature and for approximately 2 weeks if refrigerated. Potency is lost
more rapidly if not refrigerated. The higher the temperature, the shorter
the life. HGH in solution can remain stable for 48 hours out of the
refrigerator, but only if the temperature does not exceed 80 degrees
Fahrenheit. If used within the time specified and stored properly, full
potency is assured. A small, insulated CoolPack can be used to store your
vial of HGH during travel, and may be ordered through this office
If you travel and will not be home to receive your regular shipment, please
advise us in advance of the proper shipping instructions and address. If you
plan to travel and wish to order more than your usual number of vials in
advance, please notify us. In addition, if you are leaving the country, we
can provide a letter certifying that the injectables and syringes are
lawfully prescribed by a licensed physician. This can avoid embarrassment if
your luggage is searched by customs officials.
Shipping Schedule:
We will ship your supply of HGH via overnight courier (UPS Red Label). You
will be notified of the shipment day so that you can look for delivery. You
will receive your vials of HGH, diluent, disposable syringes, and alcohol
swabs on the following morning. Put the vials into the refrigerator on
receipt.
Cost:
The cost for HGH is $120.00 for each 4-unit vial, plus actual shipping
cost—which will vary from approximately $20 to $60 per order, depending on
size of the order and destination. You will be charged at the time of each
shipment to your credit card, or paid in advance, as instructed by you.
Syringes with needles attached, diluent, and alcohol swabs are included at
no additional cost. If you need more, please call.
Dosage:
The usual dose is one unit of HGH taken daily for four successive days in
the evening, close to bedtime. Some doctors recommend morning injections,
and the timing may not be important; however, HGH is normally produced by
the pituitary gland during the early hours of sleep and, therefore, evening
dosing may be preferable. This is followed by a three-day rest (no
injections). Based on several years of experience, this dosing schedule has
been found safe and most cost-effective. If cost was not so high, twice that
dose could safely be taken with added benefit. Some patients prefer to take
one unit of HGH every day. That is safe and increases the benefit, but it
also increases the cost.
The abbreviations "cc" for cubic centimeter and "ml" for milliliter are used
interchangeably and both mean the same thing. Some syringes are labeled "cc"
and others are labeled "ml". Diluent syringes hold a total of 3 ml and the
syringes used for injection hold 1 ml.
To administer your daily dose, first draw up slightly more than 1 unit of
HGH into the 1cc syringe. After the solution has been drawn into the
syringe, hold the needle upright and tap on the syringe with your fingernail
to dislodge any large air bubbles in the solution. After any bubbles present
have risen to the top, just beneath the base of the needle, the air can be
expelled back into the vial by pushing on the plunger very slightly, leaving
exactly 1 unit of HGH solution in the syringe. It is best to do this with
the needle still in the inverted vial so that any HGH solution, which
accidentally comes out with the air, will not be lost. If a tiny amount of
air remains in the syringe, it will not cause any problem. It is often not
possible to get every last speck of air or foam out of the injection.
Between your fingers pinch up a layer of skin and subcutaneous fat anywhere
on the body. Insert the tiny needle, and press the plunger in all the way to
inject the dose. The abdomen, near the navel, is one convenient location.
The proper procedure will be demonstrated by the doctor or nurse in the
clinic when HGH is first prescribed.
ALTERNATE DOSING OPTION:
Recently some patients have chosen to administer half the daily dose (½ unit
of HGH) at bedtime and half on arising in the morning. There have been
reports of increased benefit with the same total daily dose. The number of
injections is doubled, however, which is less convenient. In addition, if
HGH is every day, the monthly cost increases.
If you decide to split your daily doses, taking half at night and half in
the morning, you should fill each syringe with only ½ unit of HGH (1/4 or
0.25 ml). You will therefore need eight syringes per 4-unit vial of HGH. If
you plan to use this twice-daily dosing option, please let us know and we
will ship the extra syringes as needed at be no additional charge.
GETTING EVERY LAST DROP:
The rubber stopper has a crosswise notch or slit on the inside of the
bottle. It is necessary to turn the vial until you can sight across that
notch to get all of the HGH into the last syringe. If care is not taken, you
might miss the last few drops. In order to get 100% of the last dose from
the vial, take the following steps:
Remove the protective needle cover from the needle attached to the
disposable syringe, being careful not to touch the needle to preserve
sterility. Insert the needle straight into the vial, holding the vial and
syringe perfectly in line. Be sure that the needle enters straight through
the very center of the rubber stopper. There is a small circle on the top of
the stopper, which marks the center. This is most easily done by placing the
vial upright on a tabletop and directing the syringe and needle straight
downward into the very center of the stopper.
After the needle has been inserted, hold the vial in your hand and turn the
vial vertically, upside down, so that the HGH solution runs into the
depression and notch just inside the stopper.
Rotate the vial continuing to hold it straight upside down until you can see
through the vertical notch in the rubber stopper, inside the vial. You
should be able to see into the bottom of the depression in the stopper,
where the needle first enters the vial, where HGH has pooled. The tip of the
needle will be seen protruding into the pool of HGH solution.
The tip of the needle must be in the solution to get the last drop. Slowly
pull the needle back until just the very tip is visible coming through the
stopper
Taking care to hold the tip of the needle in that same position (barely
penetrating the inside surface of the stopper), draw back on the plunger of
the syringe until all the HGH solution has been drawn up. It may be a little
more or a little less than one-half ml, depending on the amount withdrawn in
prior doses and the amount that adheres to the glass walls.
Carefully inject any air back into the vial. It will not hurt to inject a
little foam with the HGH.
QUESTIONS AND FOLLOW-UP:
If any questions occur or if you believe you are having any problems with
treatment, please call this office.
SYRINGE DISPOSAL:
Used syringes are considered to be "bio-hazard waste", and it is against the
law to dispose of them with your other garbage and waste. They should be
incinerated at high temperature to insure that no environmental
contamination from blood could occur. If you cannot dispose of the used
syringes safely, you may return them to our clinic. We have a licensed
biohazard disposal service that makes regular pickups.
REPORTED BENEFITS OF HGH
Benefits of HGH replacement by injection reported in the medical literature
are described below. Benefits are gradually achieved over four to six months
by restoring growth hormone levels in older patients to normal levels for a
healthy young adult. Benefits may continue to increase for up to 18 months
or more after beginning therapy.
It is scientifically well proven that secretion of growth hormone by the
pituitary gland decreases progressively with age. Starting after
adolescence, secretion of growth hormone steadily declines until the amount
present in older people is a small fraction of younger levels, often less
than 10%. This is one cause of many adverse effects of aging, including the
following:
5% increase in fat with each decade of life.
Decreases in muscle strength, skin thickness, bone density, physical
endurance, mental ability, and immune defenses.
Osteoporosis
Alzheimer’s disease
Senility
Obesity
Fatigue
Muscle and organ atrophy
And other age-related conditions, which have, been reported to improve with
HGH replacement therapy.
Benefits reported in published studies include:
15% average decrease in fat.
8% average increase in muscle and lean body structures.
Improved skin texture resulting in a more youthful appearance.
Fewer skin wrinkles.
Increased bone density, reversal of osteoporosis.
Faster healing of any type of injury, fracture, or wound.
Greatly enhanced immunity and resistance to infection.
Enhanced brain function, retention of intellect with aging.
Improvement in Alzheimer’s and Parkinson’s syndromes.
Improved sex drive.
Improved fertility, sperm production, and ovulation.
Improvement in overall physical and mental well being.
Improvement in sleep disorders, better quality of sleep.
Improved exercise tolerance.
Improved mineral balance.
Improved mood, with less depression and fatigue.
Improved heart and kidney function.
More info.
Growth Hormone
The use of exogenous sources of Growth Hormone has been popular in the United States for almost 8 years now. Originally, pituitary glands of cadavers. Ascellacrin and Crescormon were the two most popular brand names on this original GH. While production was under way on the synthetic, recombinant DNA versions of this drug, it was discovered that the biologically active form was associated with the formation of a rare brain virus called Creutzveldt Jacob Disease. This was a fatal virus that afflicted a very small number of GH users, none of whom were athletes. In light of this discovery, the FDA removed all of these natural GH versions from the market in the United States. Luckily, the synthetic recombinant versions were approved by the FDA a short time afterwards. These versions were developed after years of experiments with amino acid chains. The first of these versions was patented and produced by Genentech Labs with the brand name Protropin. A short time later, another form of synthetic growth Hormone gained FDA approval. It was produced by Eli Lilly Labs and brand named Humatrope. This product was allowed to be patented because it was shown to be unique in that it contained a slightly different amino acid chain than the Protropin. The difference was that Humatrope had 191 amino acid chains in sequence and Protropin had 192. For some very complicated reasons, the 191 amino acid configuration has been shown to be more effective. It had been speculated that these synthetic versions of GH would greatly improve the cost effectiveness of using GH, yet that has not been the case. An athlete who wants to do a cycle of GH can still expect to be out as much as $4000 a month. There are numerous versions of Growth Hormone available in Europe, the majority of which are made up of the 191 amino acid sequence. There is even a form of the original human extract Growth Hormone, called Grorm which is available in a few countries. Although this drug is indicated for the treatment of pituitary deficient dwarfism, it has been used extensively by athletes who are attempting to alter their body composition. Growth Hormone itself, is an endogenous hormone produced by the pituitary gland. It exists at especially high levels during the teen years when it promotes growth of almost all tissues. It also contributes to the deposition of protein and promotes the breakdown of fat for use as energy. As the body reaches full maturation, the endogenous levelsof GH are substantially deminished. After this, GH is still present in the body but at a substantially lower level where it continues to aid in protein synthesis, RNA and DNA reactions and the conversion of body fat to energy. By introducing an exogenous source of this hormone, athletes are hoping to promote these effects, causing the body to deposit more muscle tissue while at the same time reducing body fat stores.
On paper, GH should work exceptionally well; however, it does not seem to be delivering up to its potential. Most athletes who have experimented with this product end up being disappointed. There is some evidence that exogenous sources of GH are being destroyed by antibodies which appear after the introduction of the synthetic compound. Although the 191 amino acid sequence versions have been shown to produce less of an antibody reaction, they are still not yielding consistent results. I have speculated as to whether the introduction of exogenous GH would yield an appreciable degree of efficacy simply due to the fact that the body does not have sufficient receptor affinity to GH in the post-teen years. A number of athletes claim that GH is not that effective on its own, but in a stack with steroids it can do remarkable things. Perhaps there is some type of actual synegism created by the concomitant use of these two agents. Empirical data suggests that the efficacy of GH is dose related and that the majority of users may not have been taking enough of it to get positive results.
Despite speculation concerning its efficacy, syntheric GH is being used by thousands of elite athletes. These include men and women bodybuilders, strength athletes, as well as a multitude of Olympic competitors. Although Growth Hormone is banned by athletic committees, there is no method for the detection of it which allows drug tested competitors to use this product freely without any ramifications. Adverse reactions to GH use are rare but technically could involve acromegaly (elongation of the feet, forehead and hands). Other possible side effects involve overgrowth of the elbows or jaw, thickening of the skin and a type of diabetes.
There are numerous counterfeit versions of this product which are merely cashing in on the drug's mystique and high price tag. The legitimate versions must be refrigerated at all times, before and after they are reconstituted.
Growth Hormone
The use of exogenous sources of Growth Hormone has been popular in the United States for almost 8 years now. Originally, pituitary glands of cadavers. Ascellacrin and Crescormon were the two most popular brand names on this original GH. While production was under way on the synthetic, recombinant DNA versions of this drug, it was discovered that the biologically active form was associated with the formation of a rare brain virus called Creutzveldt Jacob Disease. This was a fatal virus that afflicted a very small number of GH users, none of whom were athletes. In light of this discovery, the FDA removed all of these natural GH versions from the market in the United States. Luckily, the synthetic recombinant versions were approved by the FDA a short time afterwards. These versions were developed after years of experiments with amino acid chains. The first of these versions was patented and produced by Genentech Labs with the brand name Protropin. A short time later, another form of synthetic growth Hormone gained FDA approval. It was produced by Eli Lilly Labs and brand named Humatrope. This product was allowed to be patented because it was shown to be unique in that it contained a slightly different amino acid chain than the Protropin. The difference was that Humatrope had 191 amino acid chains in sequence and Protropin had 192. For some very complicated reasons, the 191 amino acid configuration has been shown to be more effective. It had been speculated that these synthetic versions of GH would greatly improve the cost effectiveness of using GH, yet that has not been the case. An athlete who wants to do a cycle of GH can still expect to be out as much as $4000 a month. There are numerous versions of Growth Hormone available in Europe, the majority of which are made up of the 191 amino acid sequence. There is even a form of the original human extract Growth Hormone, called Grorm which is available in a few countries. Although this drug is indicated for the treatment of pituitary deficient dwarfism, it has been used extensively by athletes who are attempting to alter their body composition. Growth Hormone itself, is an endogenous hormone produced by the pituitary gland. It exists at especially high levels during the teen years when it promotes growth of almost all tissues. It also contributes to the deposition of protein and promotes the breakdown of fat for use as energy. As the body reaches full maturation, the endogenous levelsof GH are substantially deminished. After this, GH is still present in the body but at a substantially lower level where it continues to aid in protein synthesis, RNA and DNA reactions and the conversion of body fat to energy. By introducing an exogenous source of this hormone, athletes are hoping to promote these effects, causing the body to deposit more muscle tissue while at the same time reducing body fat stores.
On paper, GH should work exceptionally well; however, it does not seem to be delivering up to its potential. Most athletes who have experimented with this product end up being disappointed. There is some evidence that exogenous sources of GH are being destroyed by antibodies which appear after the introduction of the synthetic compound. Although the 191 amino acid sequence versions have been shown to produce less of an antibody reaction, they are still not yielding consistent results. I have speculated as to whether the introduction of exogenous GH would yield an appreciable degree of efficacy simply due to the fact that the body does not have sufficient receptor affinity to GH in the post-teen years. A number of athletes claim that GH is not that effective on its own, but in a stack with steroids it can do remarkable things. Perhaps there is some type of actual synegism created by the concomitant use of these two agents. Empirical data suggests that the efficacy of GH is dose related and that the majority of users may not have been taking enough of it to get positive results.
Despite speculation concerning its efficacy, syntheric GH is being used by thousands of elite athletes. These include men and women bodybuilders, strength athletes, as well as a multitude of Olympic competitors. Although Growth Hormone is banned by athletic committees, there is no method for the detection of it which allows drug tested competitors to use this product freely without any ramifications. Adverse reactions to GH use are rare but technically could involve acromegaly (elongation of the feet, forehead and hands). Other possible side effects involve overgrowth of the elbows or jaw, thickening of the skin and a type of diabetes.
There are numerous counterfeit versions of this product which are merely cashing in on the drug's mystique and high price tag. The legitimate versions must be refrigerated at all times, before and after they are reconstituted.
These are all from my personal library.
Serostim ®
BRIEF SUMMARY. SEE FULL PRESCRIBING INFORMATION BEFORE PRESCRIBING.
INDICATIONS AND USAGE:
Serostim ® [somatropin (rDNA origin) for injection] is indicated for the treatment of AIDS wasting or cachexia. This indication is based on analyses of surrogate endpoints in studies of up to 12 weeks in duration. Concomitant anti-viral therapy is necessary (see PRECAUTIONS: General). The continued use of Serostim treatment should be reevaluated in patients who continue to lose weight in the first two weeks of treatment.
CONTRAINDICATIONS:
Growth hormone should not be initiated to treat patients with acute critical illness due to com-plications following open heart or abdominal surgery, multiple accidental trauma or to patients having acute respiratory fail-ure. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions revealed a significant increase in mortality (41.9% vs 19.3%) among somatropin treated patients (doses 5.3-8 mg/day) compared to those receiving placebo (see WARNINGS). Serostim ® [somatropin (rDNA origin) for injection] is contraindicated in patients with a known hypersensitivity to growth hormone.
WARNINGS:
See CONTRAINDICATIONS for information on increased mortality in patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. The safety of continuing growth hormone treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with growth hormone in patients having acute critical illnesses should be weighed against the potential risk.
PRECAUTIONS:
General: Serostim therapy should be carried out under the regular guidance of a physician who is expe-rienced in the diagnosis and management of AIDS. Inadequate nutritional intake, malabsorption and hypogonadism, which are common in individuals with AIDS and which may contribute to catabolism and weight loss, should also be monitored and treated.
HIV and Growth Hormone Considerations: In some experimental systems, recombinant human Growth Hormone (r-hGH) has been shown to potentiate HIV replication in vitro at concentrations ranging from 50-250 ng/ml. There was no increase in virus production when the antiretroviral agents, zidovudine, didanosine or lamivudine were added to the culture medium. Additional in vitro studies have shown that r-hGH does not interfere with the antiviral activity of zalcitabine or stavudine. In the controlled clinical trials, no sig-nificant growth hormone-associated increase in viral burden was observed. However, the protocol required all participants to be on concomitant nucleoside analogue therapy for the duration of the study. In view of the potential for acceleration of virus replication, it is recommended that HIV+ patients be maintained on nucleoside analogue therapy for the duration of Serostim treatment.
Increased tissue turgor (swelling, particularly in the hands and feet) and musculoskeletal discomfort (pain, swelling and/or stiffness) may occur during treatment with Serostim, but may resolve spontaneously, with analgesic therapy, or after reduc-ing the frequency of dosing (see DOSAGE AND ADMINISTRATION). Carpal tunnel syndrome may occur during treatment with Serostim. If the symptoms of carpal tunnel syndrome do not resolve by decreasing the weekly number of doses of Serostim, it is recommended that treatment be discontinued.
Patients should be informed that allergic reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs. None of the 188 study participants with AIDS wasting who were evaluable for antibody assessments and who were treated with Serostim for the first time developed detectable antibodies to growth hormone (> 4 pg binding).
Patients were not rechallenged.
Recombinant Human Growth Hormone (r-hGH) has been associated with acute pancreatitis.
Hyperglycemia may occur in HIV-infected individuals due to a variety of reasons. Serostim use was associated with a min-imal increase of mean blood glucose concentration. Patients with other risk factors for glucose intolerance should be mon-itored closely during Serostim therapy.
No cases of intracranial hypertension (IH) have been observed among patients with AIDS wasting treated with Serostim. The syndrome of IH, with papilledema, visual changes, headache, and nausea and/or vomiting has been reported in a small number of children with growth failure treated with growth hormone products. Nevertheless, funduscopic evaluation of patients is recommended at the initiation and periodically during the course of Serostim therapy.
Kaposi’s sarcoma, lymphoma, and other malignancies are common in HIV+ individuals. There was no increase in the incidence of Kaposi’s sarcoma, lymphoma, or in the progression of cutaneous Kaposi’s sarcoma in clinical studies of Serostim.
Patients with internal KS lesions were excluded from the studies. Potential effects on other malignancies are unknown.
Information For Patients:
Patients being treated with Serostim should be informed of the potential benefits and risks asso-ciated with treatment. Patients should be instructed to contact their physician should they experience any side effects or discomfort during treatment with Serostim. It is recommended that Serostim be administered using sterile, disposable syringes and needles. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of needles and syringes. An appropriate container for the disposal of used syringes and needles should be employed.
Patients should be instructed to rotate injection sites to avoid lipodystrophy.
Drug Interactions:
Formal in vitro drug interaction studies have not been conducted. No data are available on drug inter-actions between Serostim and HIV protease inhibitors or the non-nucleoside reverse transcriptase inhibitors.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies for carcinogenicity have not been per-formed with Serostim. There is no evidence from animal studies to date of Serostim-induced mutagenicity or impairment of fertility.
Pregnancy: Pregnancy Category B. Reproduction studies have been performed in rats and rabbits. Doses up to 5 to 10 times the human dose, based on body surface area, have revealed no evidence of impaired fertility or harm to the fetus due to Serostim. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Women: It is not known whether Serostim is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Serostim is administered to a nursing woman.
Pediatric Use: In two small studies, 11 children with HIV associated failure to thrive were treated subcutaneously with human growth hormone. In one study, five children (age range, 6 to 17 years) were treated with 0.04 mg/kg/day for 26 weeks. In a second study, six children (age range, 8 to 14 years) were treated with 0.07 mg/kg/day for 4 weeks. Treatment appeared to be well tolerated in both studies. These preliminary data collected in a limited number of patients with HIV associated fail-ure to thrive appear to be consistent with safety observations in growth hormone treated adults with AIDS wasting.
ADVERSE REACTIONS:
In two placebo-controlled clinical trials in which 205 patients were treated with Serostim the most common adverse reactions judged to be associated with Serostim were musculoskeletal discomfort and increased tissue turgor (swelling, particularly of the hands or feet) (see PRECAUTIONS: General). These symptoms were generally rated by investigators as mild to moderate in severity and usually subsided with continued treatment. Discontinuations as a result of these events were rare.
Because of the diverse clinical manifestations of AIDS, and the frequent occurrence of adverse events associated with underlying disease process, it was often difficult to distinguish adverse events possibly associated with the administration of Serostim from underlying signs or symptoms of AIDS or associated intercurrent illnesses.
Clinical adverse events which occurred during the first 12 weeks of study in at least 10% of those who received Serostim during the two placebo-controlled trials are listed below by treatment group, without regard to causality assessment.
For Table see PDF
Adverse events that occurred in 1% to less than 10% of study participants receiving Serostim in the two placebo-controlled clinical efficacy studies are listed below by body system. The list of adverse events has been compiled regardless of causal relationship to Serostim.
Body as a Whole: rigors, flu-like symptoms, back pain, malaise, asthenia, carpal tunnel syndrome (see PRECAUTIONS: General), chest pain, hot flashes, allergic reaction. Gastrointestinal System: oral leukoplakia, flatulence, dyspepsia, dry mouth, constipation, ulcerative stomatitis, increased amylase, dysphagia, esophagitis, colitis, pancreatitis, rectal disorder, gastritis, tongue ulceration, gingivitis. Musculoskeletal System: muscle weakness. Central and Peripheral Nervous System: dizziness, convulsions, hypertonia, neuralgia, tremor, encephalopathy, nystagmus, meningism. Respiratory System: dyspnea, coughing, sinusitis, upper respiratory tract infection, pharyngitis, rhinitis, pneumonia, bronchitis, increased sputum, respiratory disorder, bronchospasm, pneumonitis, pleurisy. White Blood Cell and Reticuloendothelial System Disorders: cervical lym-phadenopathy, eosinophilia. Skin and Appendages: skin disorder, folliculitis, rash, alopecia, photosensitivity reaction, erythematous rash, pruritus, abnormal pigmentation, seborrhea, dermatitis, skin ulceration, acne, skin discoloration, verruca.
Psychiatric: depression, anxiety, somnolence, nervousness, appetite increased, amnesia, abnormal thinking. Metabolic and
Nutritional: hypertriglyceridemia, increased alkaline phosphatase, dehydration, increased creatinine phosphokinase, increased LDH, glycosuria, hypokalemia, cachexia, thirst, acidosis. Immune System Dysfunction: moniliasis, bacterial infection, Pneumocystis carinii infection, viral infection, infection, Herpes simplex, sepsis, abscess, fungal infection, Herpes zoster.
Urinary System: hematuria, urinary tract infection, nocturia. Liver and Biliary System: abnormal hepatic function,
hepatomegaly, hepatitis. Vision: retinitis, abnormal vision, photophobia. Platelet, Bleeding and Clotting: thrombocytopenia, purpura. Cardiovascular, General: abnormal ECG, heart murmur, hypertension, hypotension. Application Site: injection site pain, injection site reaction. Neoplasms: Kaposi’s sarcoma. Male Reproductive: epididymitis, penis disorder, inguinal hernia.
Hearing and Vestibular: earache, ear disorder, decreasing hearing. Endocrine:gynecomastia, male breast pain. The types and incidences of adverse events reported in an open-label, extension trial and in a single, foreign trial, for up to one year, were not different from, or greater in frequency, than those observed in the primary, placebo-controlled, clinical trials.
OVERDOSAGE
Glucose intolerance can occur with overdosage. Long-term overdosage with growth hormone could result in signs and symptoms of acromegaly.
DOSAGE AND ADMINISTRATION
Serostim® [somatropin (rDNA origin) for injection] should be administered subcutaneously daily at bedtime according to the following dosage recommendations:
For Table see PDF
In patients who weigh less than 35 kg, Serostim should be administered at a dose of 0.1 mg/kg subcutaneously daily at bedtime.
Dose reductions for side effects felt to be related to treatment with Serostim, which are unresponsive to symptomatic treat-ment, may be effected by reducing the total daily dose or the number of doses given per week.
In patients who continue to lose weight at week 2, reevaluate for concurrent opportunistic infections or other clinical events.
\Injection sites should be rotated.
Safety and effectiveness in pediatric patients with AIDS have not been established.
Each vial of Serostim 4 mg, 5 mg or 6 mg is reconstituted with 1 mL sterile water for injection. To reconstitute Serostim, inject the diluent into the vial of Serostim aiming the liquid against the glass vial wall. Swirl the vial with a gentle rotary motion until contents are dissolved completely. The Serostim solution should be clear immediately after reconstitution. DO NOT INJECT Serostim if the reconstituted product is cloudy immediately after reconstitution or refrigeration. Occasionally, after refrigeration, small colorless particles may be present in the Serostim solution. This is not unusual for proteins like Serostim.
STABILITY AND STORAGE
Before reconstitution: Serostim should be stored at room temperature, 59° - 86°F (15° - 30°C). Expiration dates are stated on product labels.
After reconstitution: Use within 24 hours after reconstitution with diluent. The reconstituted solution should be stored under refrigerated conditions (36° - 46°F/2° - 8°C).
Sterile Diluent, 1 mL (Sterile Water for Injection, USP) should be stored at room temperature, 59° - 86°F (15° - 30°C). Avoid freezing vials of Serostim and Sterile Diluent.
------------------
The Cuban
Serostim ®
BRIEF SUMMARY. SEE FULL PRESCRIBING INFORMATION BEFORE PRESCRIBING.
INDICATIONS AND USAGE:
Serostim ® [somatropin (rDNA origin) for injection] is indicated for the treatment of AIDS wasting or cachexia. This indication is based on analyses of surrogate endpoints in studies of up to 12 weeks in duration. Concomitant anti-viral therapy is necessary (see PRECAUTIONS: General). The continued use of Serostim treatment should be reevaluated in patients who continue to lose weight in the first two weeks of treatment.
CONTRAINDICATIONS:
Growth hormone should not be initiated to treat patients with acute critical illness due to com-plications following open heart or abdominal surgery, multiple accidental trauma or to patients having acute respiratory fail-ure. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions revealed a significant increase in mortality (41.9% vs 19.3%) among somatropin treated patients (doses 5.3-8 mg/day) compared to those receiving placebo (see WARNINGS). Serostim ® [somatropin (rDNA origin) for injection] is contraindicated in patients with a known hypersensitivity to growth hormone.
WARNINGS:
See CONTRAINDICATIONS for information on increased mortality in patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. The safety of continuing growth hormone treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with growth hormone in patients having acute critical illnesses should be weighed against the potential risk.
PRECAUTIONS:
General: Serostim therapy should be carried out under the regular guidance of a physician who is expe-rienced in the diagnosis and management of AIDS. Inadequate nutritional intake, malabsorption and hypogonadism, which are common in individuals with AIDS and which may contribute to catabolism and weight loss, should also be monitored and treated.
HIV and Growth Hormone Considerations: In some experimental systems, recombinant human Growth Hormone (r-hGH) has been shown to potentiate HIV replication in vitro at concentrations ranging from 50-250 ng/ml. There was no increase in virus production when the antiretroviral agents, zidovudine, didanosine or lamivudine were added to the culture medium. Additional in vitro studies have shown that r-hGH does not interfere with the antiviral activity of zalcitabine or stavudine. In the controlled clinical trials, no sig-nificant growth hormone-associated increase in viral burden was observed. However, the protocol required all participants to be on concomitant nucleoside analogue therapy for the duration of the study. In view of the potential for acceleration of virus replication, it is recommended that HIV+ patients be maintained on nucleoside analogue therapy for the duration of Serostim treatment.
Increased tissue turgor (swelling, particularly in the hands and feet) and musculoskeletal discomfort (pain, swelling and/or stiffness) may occur during treatment with Serostim, but may resolve spontaneously, with analgesic therapy, or after reduc-ing the frequency of dosing (see DOSAGE AND ADMINISTRATION). Carpal tunnel syndrome may occur during treatment with Serostim. If the symptoms of carpal tunnel syndrome do not resolve by decreasing the weekly number of doses of Serostim, it is recommended that treatment be discontinued.
Patients should be informed that allergic reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs. None of the 188 study participants with AIDS wasting who were evaluable for antibody assessments and who were treated with Serostim for the first time developed detectable antibodies to growth hormone (> 4 pg binding).
Patients were not rechallenged.
Recombinant Human Growth Hormone (r-hGH) has been associated with acute pancreatitis.
Hyperglycemia may occur in HIV-infected individuals due to a variety of reasons. Serostim use was associated with a min-imal increase of mean blood glucose concentration. Patients with other risk factors for glucose intolerance should be mon-itored closely during Serostim therapy.
No cases of intracranial hypertension (IH) have been observed among patients with AIDS wasting treated with Serostim. The syndrome of IH, with papilledema, visual changes, headache, and nausea and/or vomiting has been reported in a small number of children with growth failure treated with growth hormone products. Nevertheless, funduscopic evaluation of patients is recommended at the initiation and periodically during the course of Serostim therapy.
Kaposi’s sarcoma, lymphoma, and other malignancies are common in HIV+ individuals. There was no increase in the incidence of Kaposi’s sarcoma, lymphoma, or in the progression of cutaneous Kaposi’s sarcoma in clinical studies of Serostim.
Patients with internal KS lesions were excluded from the studies. Potential effects on other malignancies are unknown.
Information For Patients:
Patients being treated with Serostim should be informed of the potential benefits and risks asso-ciated with treatment. Patients should be instructed to contact their physician should they experience any side effects or discomfort during treatment with Serostim. It is recommended that Serostim be administered using sterile, disposable syringes and needles. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of needles and syringes. An appropriate container for the disposal of used syringes and needles should be employed.
Patients should be instructed to rotate injection sites to avoid lipodystrophy.
Drug Interactions:
Formal in vitro drug interaction studies have not been conducted. No data are available on drug inter-actions between Serostim and HIV protease inhibitors or the non-nucleoside reverse transcriptase inhibitors.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies for carcinogenicity have not been per-formed with Serostim. There is no evidence from animal studies to date of Serostim-induced mutagenicity or impairment of fertility.
Pregnancy: Pregnancy Category B. Reproduction studies have been performed in rats and rabbits. Doses up to 5 to 10 times the human dose, based on body surface area, have revealed no evidence of impaired fertility or harm to the fetus due to Serostim. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Women: It is not known whether Serostim is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Serostim is administered to a nursing woman.
Pediatric Use: In two small studies, 11 children with HIV associated failure to thrive were treated subcutaneously with human growth hormone. In one study, five children (age range, 6 to 17 years) were treated with 0.04 mg/kg/day for 26 weeks. In a second study, six children (age range, 8 to 14 years) were treated with 0.07 mg/kg/day for 4 weeks. Treatment appeared to be well tolerated in both studies. These preliminary data collected in a limited number of patients with HIV associated fail-ure to thrive appear to be consistent with safety observations in growth hormone treated adults with AIDS wasting.
ADVERSE REACTIONS:
In two placebo-controlled clinical trials in which 205 patients were treated with Serostim the most common adverse reactions judged to be associated with Serostim were musculoskeletal discomfort and increased tissue turgor (swelling, particularly of the hands or feet) (see PRECAUTIONS: General). These symptoms were generally rated by investigators as mild to moderate in severity and usually subsided with continued treatment. Discontinuations as a result of these events were rare.
Because of the diverse clinical manifestations of AIDS, and the frequent occurrence of adverse events associated with underlying disease process, it was often difficult to distinguish adverse events possibly associated with the administration of Serostim from underlying signs or symptoms of AIDS or associated intercurrent illnesses.
Clinical adverse events which occurred during the first 12 weeks of study in at least 10% of those who received Serostim during the two placebo-controlled trials are listed below by treatment group, without regard to causality assessment.
For Table see PDF
Adverse events that occurred in 1% to less than 10% of study participants receiving Serostim in the two placebo-controlled clinical efficacy studies are listed below by body system. The list of adverse events has been compiled regardless of causal relationship to Serostim.
Body as a Whole: rigors, flu-like symptoms, back pain, malaise, asthenia, carpal tunnel syndrome (see PRECAUTIONS: General), chest pain, hot flashes, allergic reaction. Gastrointestinal System: oral leukoplakia, flatulence, dyspepsia, dry mouth, constipation, ulcerative stomatitis, increased amylase, dysphagia, esophagitis, colitis, pancreatitis, rectal disorder, gastritis, tongue ulceration, gingivitis. Musculoskeletal System: muscle weakness. Central and Peripheral Nervous System: dizziness, convulsions, hypertonia, neuralgia, tremor, encephalopathy, nystagmus, meningism. Respiratory System: dyspnea, coughing, sinusitis, upper respiratory tract infection, pharyngitis, rhinitis, pneumonia, bronchitis, increased sputum, respiratory disorder, bronchospasm, pneumonitis, pleurisy. White Blood Cell and Reticuloendothelial System Disorders: cervical lym-phadenopathy, eosinophilia. Skin and Appendages: skin disorder, folliculitis, rash, alopecia, photosensitivity reaction, erythematous rash, pruritus, abnormal pigmentation, seborrhea, dermatitis, skin ulceration, acne, skin discoloration, verruca.
Psychiatric: depression, anxiety, somnolence, nervousness, appetite increased, amnesia, abnormal thinking. Metabolic and
Nutritional: hypertriglyceridemia, increased alkaline phosphatase, dehydration, increased creatinine phosphokinase, increased LDH, glycosuria, hypokalemia, cachexia, thirst, acidosis. Immune System Dysfunction: moniliasis, bacterial infection, Pneumocystis carinii infection, viral infection, infection, Herpes simplex, sepsis, abscess, fungal infection, Herpes zoster.
Urinary System: hematuria, urinary tract infection, nocturia. Liver and Biliary System: abnormal hepatic function,
hepatomegaly, hepatitis. Vision: retinitis, abnormal vision, photophobia. Platelet, Bleeding and Clotting: thrombocytopenia, purpura. Cardiovascular, General: abnormal ECG, heart murmur, hypertension, hypotension. Application Site: injection site pain, injection site reaction. Neoplasms: Kaposi’s sarcoma. Male Reproductive: epididymitis, penis disorder, inguinal hernia.
Hearing and Vestibular: earache, ear disorder, decreasing hearing. Endocrine:gynecomastia, male breast pain. The types and incidences of adverse events reported in an open-label, extension trial and in a single, foreign trial, for up to one year, were not different from, or greater in frequency, than those observed in the primary, placebo-controlled, clinical trials.
OVERDOSAGE
Glucose intolerance can occur with overdosage. Long-term overdosage with growth hormone could result in signs and symptoms of acromegaly.
DOSAGE AND ADMINISTRATION
Serostim® [somatropin (rDNA origin) for injection] should be administered subcutaneously daily at bedtime according to the following dosage recommendations:
For Table see PDF
In patients who weigh less than 35 kg, Serostim should be administered at a dose of 0.1 mg/kg subcutaneously daily at bedtime.
Dose reductions for side effects felt to be related to treatment with Serostim, which are unresponsive to symptomatic treat-ment, may be effected by reducing the total daily dose or the number of doses given per week.
In patients who continue to lose weight at week 2, reevaluate for concurrent opportunistic infections or other clinical events.
\Injection sites should be rotated.
Safety and effectiveness in pediatric patients with AIDS have not been established.
Each vial of Serostim 4 mg, 5 mg or 6 mg is reconstituted with 1 mL sterile water for injection. To reconstitute Serostim, inject the diluent into the vial of Serostim aiming the liquid against the glass vial wall. Swirl the vial with a gentle rotary motion until contents are dissolved completely. The Serostim solution should be clear immediately after reconstitution. DO NOT INJECT Serostim if the reconstituted product is cloudy immediately after reconstitution or refrigeration. Occasionally, after refrigeration, small colorless particles may be present in the Serostim solution. This is not unusual for proteins like Serostim.
STABILITY AND STORAGE
Before reconstitution: Serostim should be stored at room temperature, 59° - 86°F (15° - 30°C). Expiration dates are stated on product labels.
After reconstitution: Use within 24 hours after reconstitution with diluent. The reconstituted solution should be stored under refrigerated conditions (36° - 46°F/2° - 8°C).
Sterile Diluent, 1 mL (Sterile Water for Injection, USP) should be stored at room temperature, 59° - 86°F (15° - 30°C). Avoid freezing vials of Serostim and Sterile Diluent.
------------------
The Cuban
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