on and sleep apnea before initiation of treatment for GH deficiency. Discontinue treatment if these signs occur.
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.
Impaired Glucose Tolerance (IGT) and Diabetes Mellitus (DM): Periodically monitor glucose levels in all patients, as IGT or DM may be unmasked. Doses of concurrent antihyperglycemic drugs in patients with DM may require adjustment.
Intracranial Hypertension (IH): Exclude preexisting papilledema. IH may develop, but is usually reversible after discontinuation or dose reduction.
Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention.
Fluid Retention (e.g., edema, arthralgia, carpal tunnel syndrome– especially in adults): Reduce dose as necessary if such signs develop.
Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism。
Hypothyroidism: Monitor thyroid function periodically as hypothyroidism may first become evident or worsen after initiation of somatropin. (5.9)
Slipped Capital Femoral Epiphysis (SCFE): eva luate any child with onset of a limp or hip/knee pain for possible SCFE.
Progression of Preexisting Scoliosis: Monitor any child with scoliosis for progression of the curve.
Pancreatitis: Consider pancreatitis in patients with abdominal pain, especially children.
ADVERSE REACTIONS
Common adverse reactions reported in adult and pediatric patients receiving somatropin include injection site reactions, hypersensitivity to the diluent, and hypothyroidism. Additional common adverse reactions in adults include edema, arthralgia, myalgia, carpal tunnel syndrome, paraesthesias, and hyperglycemia.
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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.
Glucocorticoid Replacement: Should be carefully adjusted.
Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin.
Oral Estrogen: Larger doses of somatropin may be required in women.
Insulin and/or Other Hypoglycemic Agents: May require adjustment。 |
