Somatropin — uses, dosing, side effects & the brands that sell it · pharmaranks
Somatropin: uses, dosing, side effects & brands
Somatropin is a recombinant human growth hormone sold in the U.S. under 16 brand and generic names, for cachexia, dwarfism and heart failure. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Recombinant Human Growth Hormone
Treats
Cachexia, Dwarfism and Heart Failure
Available as
Injectable · Kit
Sold as
16 products — Nutropin, Nutropin Aq and Nutropin Aq Nuspin, and others
Prescription?
Prescription only
Generic available?
Not in our catalog
How somatropin is dosed
From the FDA label for Nutropin (application BLA020168). Other somatropin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
SEROSTIM is administered by subcutaneous injection. SEROSTIM therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of HIV infection. The recommended dose of SEROSTIM is 0.1 mg/kg subcutaneously (SC) daily (up to 6 mg) at bedtime for HIV patients with wasting or cachexia ( 2.1 ) Injection sites, which may be located on thigh, upper arm, abdomen or buttock, should be rotated to avoid local irritation ( 2.2 ) 2.1 HIV-associated wasting or cachexia The usual starting dose of SEROSTIM is 0.1 mg/kg subcutaneously once daily (up to a total dose of 6 mg). SEROSTIM should be administered subcutaneously once daily at bedtime according to the following body weight-based dosage recommendations: Weight Range Dose >55kg (>121 lb) 6 mg Based on an approximate daily dosage of 0.1 mg/kg. SC daily 45-55 kg (99-121 lb) 5 mg SC daily 35-45 kg (75-99 lb) 4 mg SC daily <35 kg (<75 lb) 0.1 mg/kg SC daily Treatment with SEROSTIM 0.1 mg/kg every other day was associated with fewer side effects, and resulted in a similar improvement in work output, as compared with SEROSTIM 0.1 mg/kg daily. Therefore, a starting dose of SEROSTIM 0.1 mg/kg every other day should be considered in patients at increased risk for adverse effects related to recombinant human growth hormone therapy (i.e., glucose intolerance). In…
Somatropin side effects
The following important adverse reactions are also described elsewhere in the labeling: Acute Critical Illness [see Warnings and Precautions (5.1) ] Neoplasms [see Warnings and Precautions (5.3) ] Impaired glucose tolerance 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/Carpal tunnel syndrome [see Warnings and Precautions (5.7) ] Lipoatrophy [see Warnings and Precautions (5.8) ] Pancreatitis [see Warnings and Precautions (5.9) ] Most common adverse reactions include (incidence >10%) tissue turgor (edema, myalgia, hypoesthesia) and musculoskeletal discomfort (arthralgia, pain in extremities) ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088 ext 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical trials in HIV-associated wasting or cachexia: In the 12-week, placebo-controlled Clinical Trial 2, 510 patients were treated with SEROSTIM. The most common adverse reactions judged to be…
Every somatropin product we track (16)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
SEROSTIM is a human growth hormone (hGH) produced by recombinant DNA technology. SEROSTIM has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. SEROSTIM is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the hGH gene. SEROSTIM is secreted directly through the cell membrane into the cell-culture medium for collection and purification. SEROSTIM is a sterile lyophilized powder intended for subcutaneous injection after reconstitution to its liquid form. Vials of SEROSTIM contain either 4 mg, 5 mg, or 6 mg. Each vial contains the following: Vials 4 mg 5 mg 6 mg Component Somatropin 4 mg 5 mg 6 mg Sucrose 27.3 mg 34.2 mg 41 mg Phosphoric acid 0.9 mg 1.2 mg 1.4 mg Each 4 mg multi-vial is supplied in a combination package with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The pH is adjusted with sodium hydroxide of phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution. Each 5 mg single-use vial is supplied in a combination package with Sterile Water for Injection, USP. The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 6.5 to 8.5 after reconstitution. Each 6 mg single-use vial is supplied in a combination package with Sterile Water for Injection, USP. The…
What kind of drug is somatropin?
The FDA classifies somatropin as 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. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take somatropin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run somatropin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take somatropin
Acute Critical Illness Growth hormone therapy should not be initiated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure [see Warnings and Precautions (5.1) ]. 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 [see Warnings and Precautions (5.3) ] . Hypersensitivity SEROSTIM is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products [see Warnings and Precautions (5.6) ]. Diabetic Retinopathy Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy. Acute Critical Illness ( 4 ) Active Malignancy ( 4 ) Diabetic Retinopathy ( 4 ) Hypersensitivity to somatropin or excipients ( 4 )
Somatropin drug interactions
Formal drug interaction studies have not been conducted. No data are available on drug interactions between SEROSTIM and HIV protease inhibitors or the non-nucleoside reverse transcriptase inhibitors. Inhibition of 11β-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 ) Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin ( 7.2 ) Oral Estrogen: Larger doses of somatropin may be required in women ( 7.3 ) Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment ( 7.4 ) 7.1 11β-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. Somatropin inhibits 11βHSD-1. 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. 7.2 Cytochrome P450-metabolized…
We track 16 somatropin-containing products in the U.S.: Nutropin, Nutropin Aq, Nutropin Aq Nuspin, Nutropin Aq Pen, Bio-Tropin, Norditropin, Norditropin Flexpro and Norditropin Nordiflex, and 8 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does somatropin come in?
Across the brands we track, somatropin is currently marketed as injectable and kit, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic somatropin?
We do not currently list a generic-labelled somatropin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.