Scoliosis is also commonly seen in untreated patients with Prader-Willi syndrome. Physicians should be alert to these abnormalities, which may manifest during somatropin therapy. A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen.
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Elderly patients may be more likely to have side effects with growth hormone therapy. Turner syndrome patients taking growth hormone therapy may be more likely to get ear infections. In studies of GENOTROPIN in children with PWS, side effects included fluid retention, aggressiveness, joint and muscle pain, hair loss, headache, and increased pressure in the brain. In children experiencing rapid growth, limping or hip or knee pain may occur. If a child getting growth hormone therapy starts to limp or gets hip or knee pain, the child’s doctor should be notified and the child should be examined. In children experiencing rapid growth, curvature of the spine may develop or worsen.
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Mean Cmax levels were 12.4 ng/mL (first injection) and 12.2 ng/mL (second injection), achieved at approximately six hours after dosing. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection.
5 Insulin and/or Oral/Injectable Hypoglycemic Agents
The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. In patients with diabetes mellitus requiring drug therapy, the dose of insulin and/or oral/injectable agent may require adjustment when somatropin therapy is initiated [see Warnings and Precautions (5.4)]. Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth‑promoting effects of somatropin in children. Therefore, glucocorticoid replacement dosing should be carefully adjusted in children receiving concomitant somatropin and glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS).
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All of the bodily functions governed by GH are the areas that begin to suffer as you age. As GH levels drop, your skin tone deadens, wrinkles appear, and skin slackens. That is a direct result of shifting hormone levels, plus changes in blood pressure and skin sensitivity; all of which are governed by GH. This is due to decreased cell production and a reduced metabolic rate. This is due to the slower rejuvenation of cells, this time in your brain. Put the used GENOTROPIN MINIQUICK and needles in a FDA-cleared sharps disposal container right away after use.
DOSAGE FORMS AND STRENGTHS
This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display.
Instructions for Use
The mean volume of distribution of GENOTROPIN following administration to GHD adults was estimated to be 1.3 (± 0.8) L/kg. The estimated background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy. Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
ADVERSE REACTIONS
Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults. Published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children. Pancreatitis should be considered in any somatropin–treated patient, especially a child, who develops persistent severe abdominal pain. The safety and effectiveness of GENOTROPIN in patients aged 65 and over have not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of GENOTROPIN, and therefore may be more prone to develop adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.2)].
Full Patient Information
- This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged.
- Pfizer does not foresee any long-term supply disruption and we are working to resolve the situation as quickly as possible.
- These events were reported early during therapy and tended to be transient and/or responsive to dosage reduction.
- To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display.
- GENOTROPIN is supplied in a two-chamber cartridge, with the lyophilized powder in the front chamber and a diluent in the rear chamber.
- Patients and caregivers who will administer GENOTROPIN should receive appropriate training and instruction on the proper use of GENOTROPIN from the physician or other suitably qualified health care professional.
All patients with Prader-Willi syndrome should be examined for these problems. In studies of GENOTROPIN in children with GHD, side effects included injection site reactions, such as pain, redness/swelling, inflammation, bleeding, scarring, lumps, or rash. Other side effects were fat loss, headache, blood in the urine, low thyroid activity, and mildly increased blood sugar. GENOTROPIN is a prescription product for the replacement of growth hormone in adults with growth hormone deficiency (GHD) that started either in childhood or as an adult. Your doctor should do tests to be sure you have GHD, as appropriate.
1 Pediatric Patients
Somatropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor. Some cases of pancreatitis (inflamed pancreas) have been reported rarely in children and adults receiving growth hormone. There is some evidence that there is a greater risk of this in children than in adults. Literature suggests that girls who have Turner syndrome may have a greater risk of pancreatitis than other children taking growth hormone.
GENOTROPIN lyophilized powder was compared with placebo in six randomized clinical trials involving a total of 172 adult GHD patients. GENOTROPIN was administered as a daily SC injection at a dose of 0.04 mg/kg/week for the first month of treatment and 0.08 mg/kg/week for subsequent months. The only treatment-related adverse event that occurred in more than 1 patient was joint pain. Beneficial changes in body composition were observed at the end of the 6-month treatment period for the patients receiving GENOTROPIN as compared with the placebo patients. Lean body mass, total body water, and lean/fat ratio increased while total body fat mass and waist circumference decreased.
Important Safety Information & Indications
If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away. Battery charge is low and will be empty in 1 month.Afterwards the dose can be set and your pen can be used correctly. A dose is not set.The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose. Attach the Needle Guard (Optional)The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. Treatment with GENOTROPIN for short stature should be discontinued when the epiphyses are fused.
- Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth‑promoting effects of somatropin in children.
- Beneficial changes in body composition were observed at the end of the 6-month treatment period for the patients receiving GENOTROPIN as compared with the placebo patients.
- The GENOTROPIN 5 and 12 mg cartridges are color-coded to help ensure proper use with the GENOTROPIN PEN delivery device.
- During the second year, the control group received GENOTROPIN at a dose of 0.48 mg/kg/week.
- Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy (6.1) and headaches (6.2).
- Limited published data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone.
- The GENOTROPIN dosage and administration schedule should be individualized based on the growth response of each patient.
Pfizer Genotropin 12MG 36IU Pen
Patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin therapy. The doses of antihyperglycemic drugs (i.e., insulin or oral/injectable agents) may require adjustment when somatropin therapy is instituted in these patients. Non-weight based — based on published consensus guidelines, a starting dose of approximately 0.2 mg/day (range, 0.15–0.30 mg/day) may be used without consideration of body weight. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-I concentrations above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person, and between male and female patients. Two randomized, open-label, clinical trials were conducted that evaluated the efficacy and safety of GENOTROPIN in Turner syndrome patients with short stature.
GENOTROPIN PEN 12 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period. INSTRUCTIONS FOR USEGENOTROPIN 12 (JEEN-o-tro-pin 12)GENOTROPIN PEN 12 is a medical device used to mix and inject doses of reconstituted GENOTROPIN (somatropin) for injection. GENOTROPIN PEN 5 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.
- In studies of GENOTROPIN in adults with GHD, side effects included fluid retention, joint or muscle pain, stiffness, and changes in sensation.
- Growth hormone should not be used to increase height in children after the growth plates have closed.
- Turner syndrome patients taking growth hormone therapy may be more likely to get ear infections.
- Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia.
- Patients who received any dose of GENOTROPIN showed significant increases in growth during the first 24 months of study, compared with patients who received no treatment (see Table 5).
- A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.2)].
If your cartridge is nearly empty you can also dial the injection button until it cannot go any further. The dose display will then show the maximum dose that can be delivered. GENOTROPIN is supplied in a two-chamber cartridge, with the lyophilized powder in the front chamber and a diluent in the rear chamber. The metabolic fate of GENOTROPIN involves classical protein catabolism in both the liver and kidneys.
Report Adverse Event
Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions. Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi. In studies of GENOTROPIN in adults with GHD, side effects included fluid retention, joint or muscle pain, stiffness, and changes in sensation. Usually these side effects did not last long and depended on the dose of GENOTROPIN being taken.
3 Cytochrome P450-Metabolized Drugs
Generally, a dose of 0.16 to 0.24 mg/kg body weight/week is recommended. Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy (6.1) and headaches (6.2). You are no longer growing, so you no longer need to generate as many new cells on a regular basis. GH directly influences the growth and development of cells, bones, cartilage, muscles, skin, blood vessels, nerves, liver and kidneys.
Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses in susceptible patients. As a result, previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment. genopharm hgh Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus.
The diagnosis of PWS should be confirmed by appropriate genetic testing [see Contraindications (4)]. Due to supply disruptions in the growth hormone market, the Pfizer Bridge Program is experiencing very high call volumes and increased demand for Genotropin pen devices. Long hold times are possible on the phone and patients may have to wait to receive a Genotropin pen. Pfizer does not foresee any long-term supply disruption and we are working to resolve the situation as quickly as possible. Deaths have been reported with the use of growth hormone in children with Prader-Willi syndrome. These children were extremely overweight, had breathing problems, and/or lung infection.
It should be used with caution in nursing mothers because it is not known whether growth hormone is passed into human milk. Growth hormone should not be used in patients who are critically ill because of surgery, trauma, or respiratory failure. Growth hormone should not be used to increase height in children after the growth plates have closed. The display will continue to show until the battery is completely empty. Your pen can still be used correctly, but the dose size will not be displayed. The selected dose size.The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.
In vitro, preclinical, and clinical tests have demonstrated that GENOTROPIN lyophilized powder is therapeutically equivalent to human growth hormone of pituitary origin and achieves similar pharmacokinetic profiles in normal adults. In patients with GHD or PWS, treatment with GENOTROPIN also normalizes concentrations of IGF-I (Insulin-like Growth Factor-I/Somatomedin C). In adults with GHD, treatment with GENOTROPIN results in reduced fat mass, increased lean body mass, metabolic alterations that include beneficial changes in lipid metabolism, and normalization of IGF-I concentrations. The safety and efficacy of GENOTROPIN in the treatment of pediatric patients born small for gestational age (SGA) were evaluated in 4 randomized, open-label, controlled clinical trials. The safety and efficacy of GENOTROPIN in the treatment of pediatric patients with Prader-Willi syndrome (PWS) were evaluated in two randomized, open-label, controlled clinical trials. Patients received either GENOTROPIN or no treatment for the first year of the studies, while all patients received GENOTROPIN during the second year.
Furthermore, overdose with somatropin is likely to cause fluid retention. Preparations of GENOTROPIN contain a small amount of periplasmic Escherichia coli peptides (PECP). Anti-PECP antibodies are found in a small number of patients treated with GENOTROPIN, but these appear to be of no clinical significance. When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site [see Dosage and Administration (2.3)].
Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses. GENOTROPIN cartridges contain m-Cresol and should not be used by patients allergic to it. Growth hormone should only be used during pregnancy if clearly needed.
Children receiving 0.48 mg/kg/week demonstrated a significant improvement in height standard deviation score (SDS) compared with children treated with 0.24 mg/kg/week. Both of these doses resulted in a slower but constant increase in growth between months 24 to 72 (data not shown). Changes in body composition were also observed in the patients receiving GENOTROPIN (see Table 4). These changes included a decrease in the amount of fat mass, and increases in the amount of lean body mass and the ratio of lean-to-fat tissue, while changes in body weight were similar to those seen in patients who received no treatment.
In any child who develops lasting, severe abdominal pain, pancreatitis should be considered. A small number of patients treated with growth hormone have had increased pressure in the brain. Patients with Turner syndrome and Prader-Willi syndrome may be at higher risk of developing increased pressure in the brain.
Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins [see Warnings and Precautions (5.6)]. Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs [see Contraindications (4)]. GENOTROPIN should not be used by patients who have had an allergy or bad reaction to somatropin or any of the other ingredients in GENOTROPIN.
Turner syndrome patients were treated with GENOTROPIN alone or GENOTROPIN plus adjunctive hormonal therapy (ethinylestradiol or oxandrolone). A total of 38 patients were treated with GENOTROPIN alone in the two studies. In Study 055, 22 patients were treated for 12 months, and in Study 092, 16 patients were treated for 12 months. Patients received GENOTROPIN at a dose between 0.13 to 0.33 mg/kg/week. Patients who received any dose of GENOTROPIN showed significant increases in growth during the first 24 months of study, compared with patients who received no treatment (see Table 5).