"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
As with all protein pharmaceuticals, patients may develop antibodies to the protein. GH antibody-binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases when binding capacity exceeds 2 mg/L, growth attenuation has been observed. In clinical studies of pediatric patients who were treated with Nutropin Depot (somatropin (rdna origin) for inj) , 0/138 patients with GHD screened for antibody production developed antibodies with binding capacities ≥ 2 mg/L at any time during a treatment period of up to 17.4 months.
In addition to an evaluation of compliance with the prescribed treatment program and thyroid status, testing for antibodies to GH should be carried out in any patient who fails to respond to therapy.
In studies involving 138 pediatric patients treated with Nutropin Depot (somatropin (rdna origin) for inj) , the most frequent adverse reactions were injection-site reactions, which occurred in nearly all patients. On average, 2 to 3 injection-site adverse reactions were reported per injection. These reactions included nodules (61% of injections), erythema (53%), pain post-injection (47%), pain during injection (43%), bruising (20%), itching (13%), lipoatrophy (13%), and swelling or puffiness (8%). The intensity of these reactions was generally rated mild to moderate, with pain during injection occasionally rated as severe (7%).
Adverse reactions observed less frequently in the Nutropin Depot (somatropin (rdna origin) for inj) studies which were considered possibly, probably, or definitely related to the drug by the treating physician (usually occurring 1–3 days postdose) included: headache (13% of subjects), nausea (8%), lower extremity pain (7%), fever (7%), and vomiting (5%). These symptoms were generally self-limited and well-tolerated. One patient experienced a generalized body rash that was most likely an allergic reaction to Nutropin Depot (somatropin (rdna origin) for inj) .
Leukemia has been reported in a small number of GHD patients treated with GH. It is uncertain whether this increased risk is related to the pathology of GH deficiency itself, GH therapy, or other associated treatments such as radiation therapy for intracranial tumors. On the basis of current evidence, experts cannot conclude that GH therapy is responsible for these occurrences.
Other adverse drug reactions that have been reported in GH-treated patients include the following: 1) Metabolic: mild, transient peripheral edema; 2) Musculoskeletal: arthralgia, carpal tunnel syndrome; 3) Skin: rare increased growth of pre-existing nevi; patients should be monitored for malignant transformation; 4) Endocrine: gynecomastia; and 5) Rare pancreatitis. Of these reactions, only edema ( < 1% of patients) and arthralgia (4%) were reported as related to drug in the Nutropin Depot (somatropin (rdna origin) for inj) studies.
Read the Nutropin Depot (somatropin (rdna origin) for inj) Side Effects Center for a complete guide to possible side effects
Excessive glucocorticoid therapy will inhibit the growth-promoting effect of human GH. Patients with ACTH deficiency should have their glucocorticoid-replacement dose carefully adjusted to avoid an inhibitory effect on growth.
Limited published data indicate that GH treatment increases cytochrome P450 (CP450) mediated antipyrine clearance in humans. These data suggest that GH administration may alter the clearance of compounds known to be metabolized by CP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporin). Careful monitoring is advisable when GH is administered in combination with other drugs known to be metabolized by CP450 liver enzymes.
Read the Nutropin Depot Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Nutropin Depot Information
- Nutropin Depot Drug Interactions Center: somatropin subq
- Nutropin Depot Side Effects Center
- Nutropin Depot Overview including Precautions
- Nutropin Depot FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.