genotropin
Genotropin (Somatropin) is a recombinant human growth hormone used to treat Cachexia, Dwarfism, Heart Failure, Noonan Syndrome.
Somatropin · by Pharmacia
Key facts
- Active ingredient
- Somatropin
- Drug class
- Recombinant Human Growth Hormone
- Form
- Kit
- Strength
- Somatropin 13.8MG/VIAL · Somatropin 5.8MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- cachexia, dwarfism, heart failure
- Manufacturer
- Pharmacia
- Half-life
- about 3 hours (after subcutaneous injection) (how long it stays in your system)
- FDA application
- BLA020280
What is Genotropin?
From the FDA label:Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. 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. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. 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…
How to use
The weekly dose should be divided into 6 or 7 subcutaneous injections. GENOTROPIN must not be injected intravenously. Therapy with GENOTROPIN should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD), Prader-Willi syndrome (PWS), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD. GENOTROPIN should be administered subcutaneously ( 2 ) • Pediatric GHD: 0.16 to 0.24 mg/kg/week ( 2.1 ) • Prader-Willi Syndrome: 0.24 mg/kg/week ( 2.1 ) • Small for Gestational Age: Up to 0.48 mg/kg/week ( 2.1 ) • Turner Syndrome: 0.33 mg/kg/week ( 2.1 ) • Idiopathic Short Stature: up to 0.47 mg/kg/week ( 2.1 ) • Adult GHD: Either a non-weight based or a weight based dosing regimen may be followed, with doses adjusted based on treatment response and IGF-I concentrations ( 2.2 ) • Non-weight based dosing: A starting dose of approximately 0.2 mg/day (range, 0.15–0.30 mg/day) may be used without consideration of body weight, and increased gradually every 1–2 months by increments of approximately 0.1–0.2 mg/day. ( 2.2 ) • Weight based dosing: The recommended initial dose is not more than 0.04 mg/kg/week; the dose may be increased as tolerated to not more than 0.08…
Side effects
The following important adverse reactions are also described elsewhere in the labeling: • Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1) ] • Fatalities in children with Prader-Willi syndrome [see Warnings and Precautions (5.2) ] • Neoplasms [see Warnings and Precautions (5.3) ] • Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4) ] • Intracranial hypertension [see Warnings and Precautions (5.5) ] • Severe hypersensitivity [see Warnings and Precautions (5.6) ] • Fluid retention [see Warnings and Precautions (5.7) ] • Hypoadrenalism [see Warnings and Precautions (5.8) ] • Hypothyroidism [see Warnings and Precautions (5.9) ] • Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.10) ] • Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.11) ] • Otitis media and cardiovascular disorders in patients with Turner syndrome [see Warnings and Precautions (5.12) ] • Lipoatrophy [see Warnings and Precautions (5.13) ] • Pancreatitis [see Warnings and Precautions (5.15) ] Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy ( 6.1 ) and headaches ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1…
Warnings
Important safety information
Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential risk ( 5.1 ) • Prader-Willi Syndrome in Children: Evaluate for signs of upper airway obstruction and sleep apnea before initiation of treatment Discontinue treatment if these signs occur ( 5.2 ) • Neoplasm: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin in particular meningiomas in patients treated with radiation to the head for their first neoplasm ( 5.3 ) • Impaired Glucose Tolerance and Diabetes Mellitus: May be unmasked Periodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment ( 5.4 ) • Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction ( 5.5 ) • Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention ( 5.6 ) • Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome – especially in adults): May occur frequently. Reduce dose as necessary ( 5.7 ) • Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism ( 5.8 ) • Hypothyroidism: May first become evident or worsen. Monitor thyroid function periodically ( 5.9 ) • Slipped Capital Femoral Epiphysis: May develop. Evaluate children with the onset of a limp or hip/knee pain ( 5.10 ) • Progression of Preexisting Scoliosis: Monitor any child with scoliosis for progression of the curve ( 5.11 ) • Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain ( 5.15 ) 5.1 Acute Critical Illness Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin [see Contraindications (4) ]. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3–8 mg/day) compared to those receiving placebo. The safety of continuing somatropin 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 somatropin in patients having acute critical illnesses should be weighed against the potential risk. 5.2 Prader-Willi Syndrome in Children There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. If during treatment with somatropin, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with somatropin should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively [see Contraindications (4) ]. 5.3 Neoplasms In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence [see Contraindications (4) ] . Monitor all patients with a history of GHD secondary to an intracranial neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor. Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, practitioners should thoroughly consider the risks and benefits of starting somatropin in these patients. If treatment with somatropin is initiated, these patients should be carefully monitored for development of neoplasms. Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi. 5.4 Impaired Glucose Tolerance and Diabetes Mellitus 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. New-onset Type 2 diabetes mellitus has been reported. 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. 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. 5.5 Intracranial Hypertension Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients treated with somatropins. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Fundoscopic examination should be performed routinely before initiating treatment with somatropin to exclude preexisting papilledema, and periodically during the course of somatropin therapy. If papilledema is observed by fundoscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with somatropin can be restarted at a lower dose after IH-associated signs and symptoms have resolved. Patients with Turner syndrome and Prader-Willi syndrome may be at increased risk for the development of IH. 5.6 Severe Hypersensitivity 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) ]. 5.7 Fluid Retention Fluid retention during somatropin replacement therapy in adults may occur. Clinical manifestations of fluid retention (e.g., edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent. 5.8 Hypoadrenalism Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment [see Drug Interactions (7.1) ]. 5.9 Hypothyroidism Undiagnosed/untreated hypothyroidism may prevent…
Who should not take Genotropin
Acute Critical Illness ( 4 ) • Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death ( 4 ) • Active Malignancy ( 4 ) • Hypersensitivity to somatropin or excipients ( 4 ) • Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy ( 4 ) • Children with closed epiphyses ( 4 ) GENOTROPIN is contraindicated in patients with: • Acute Critical Illness Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure [see Warnings and Precautions (5.1) ]. • Prader-Willi Syndrome in Children Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients [see Warnings and Precautions (5.2) ]. • Active Malignancy In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. 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. • Hypersensitivity GENOTROPIN is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. The 5 mg and 12 mg presentations of GENOTROPIN lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins [see Warnings and Precautions (5.6) ] . • Diabetic Retinopathy Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy. • Closed Epiphyses Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses.
Overdose — what happens if you take too much
Short-Term Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Furthermore, overdose with somatropin is likely to cause fluid retention. Long-Term Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone [see Dosage and Administration (2) ].
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Inhibition of 11ß-Hydroxysteroid Dehydrogenase Type 1: May require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses ( 7.1 , 7.2 ). • Glucocorticoid Replacement: Should be carefully adjusted ( 7.2 ) • Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin ( 7.3 ) • Oral Estrogen: Larger doses of somatropin may be required in women ( 7.4 ) • Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment ( 7.5 ) 7.1 11 β-Hydroxysteroid Dehydrogenase Type 1 The microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH and somatropin inhibit 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. As a consequence, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required in patients treated with somatropin. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment; this may be especially true for patients treated with cortisone acetate and prednisone since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1 [see Warnings and Precautions (5.8 )] . 7.2 Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment 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. 7.3 Cytochrome P450-Metabolized Drugs Limited published data indicate that somatropin treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance in man. These data suggest that somatropin administration may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine). Careful monitoring is advisable when somatropin is administered in combination with other drugs known to be metabolized by CYP450 liver enzymes. However, formal drug interaction studies have not been conducted. 7.4 Oral Estrogen In patients on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal [see Dosage and Administration (2.2) ]. 7.5 Insulin and/or Oral/Injectable Hypoglycemic Agents 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) ].
Storing Genotropin, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Discard the cartridge and any unused medication after 28 days.”
How long does Somatropin stay in your body?
The elimination half-life of somatropin is about 3 hours (after subcutaneous injection) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Somatropin is recombinant human growth hormone, given by subcutaneous injection. Its true elimination half-life is very short — the label reports a mean terminal half-life of only 0.4 hours (about 24 minutes) after intravenous dosing. After the usual subcutaneous injection the apparent half-life is longer, about 3.0 hours in growth-hormone-deficient adults, because slow absorption from the injection site (not elimination) becomes rate-limiting. So the drug itself clears quickly, but a subcutaneous dose is released over several hours. This half-life is not a drug-test detection window: growth hormone use is detected by anti-doping tests through downstream biomarkers (e.g., IGF-1) and isoform ratios that stay altered for days, far longer than the hormone's own half-life. Genotropin was not studied in patients with renal or hepatic impairment.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: GENOTROPIN (somatropin) FDA label — DailyMed.
Drug class
How this class works, per Physiology, Growth Hormone - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Genotropin ranks — best-rated recombinant human growth hormone for:
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Genotropin treat?
- Genotropin (Somatropin) may be used to treat cachexia, dwarfism, heart failure, noonan syndrome, prader-willi syndrome, turner syndrome, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Genotropin work?
- Genotropin is a recombinant human growth hormone. Recombinant human growth hormone is a lab-made copy of the body's own growth hormone. It signals the liver and other tissues to make insulin-like growth factor-1 (IGF-1), which drives cells to take up protein and divide, promoting bone, muscle, and tissue growth.
- Is there a coupon or discount for Genotropin?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Genotropin. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Genotropin?
- Genotropin is marketed by Pharmacia. You can see Pharmacia's full profile, rating, and other products on pharmaranks.
- Is Genotropin a brand-name or generic drug?
- Genotropin is a brand-name product with the active ingredient Somatropin.
- Is Genotropin available over the counter?
- No. Genotropin is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Genotropin come in?
- Genotropin is currently marketed as kit, per the FDA's National Drug Code Directory.
- What class of drug is Genotropin?
- Genotropin is classified as recombinant human growth hormone, per the FDA's Established Pharmacologic Class.
- Is Genotropin FDA-registered?
- Genotropin is on record with the U.S. FDA under application number BLA020280. You can verify this on its official FDA label.
- Is Genotropin safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Genotropin. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Genotropin?
- Genotropin's side effects are taken directly from its FDA label. From the label: The following important adverse reactions are also described elsewhere in the labeling: • Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1) ] • Fatalities in children with Prader-Willi syndrome [see Warnings and Precautions (5.2) ] • Neoplasms [see Warni… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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