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Safety and Prescribing Information for Norditropin^® 

Norditropin^® cartridges (somatropin [rDNA origin] injection) are indicated for the long-term treatment of children who have growth failure and adults who are experiencing Adult Onset Growth Hormone Deficiency Syndrome. 

Growth hormone should not be used in patients with closed epiphyses (bone growth plates). Growth hormone should not be used in hypopituitary patients who have evidence of actively growing intracranial tumors. Therapy with somatropin should be discontinued if there is evidence of recurrent tumor growth. 

Norditropin^® cartridges should not be used or should be discontinued when there is any evidence of active malignancy. Anti-malignancy treatment must be complete with evidence of remission prior to institution of growth hormone therapy. 

Norditropin^® cartridges should not be used in any patients with known hypersensitivity to any of the constituents of the preparation. 

Norditropin^® cartridges should be given to pregnant women only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Norditropin^® is administered to a nursing woman. 

Because growth hormone may induce a state of insulin resistance, patients should be observed for evidence of glucose intolerance. 

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients treated with growth hormone products.

Symptoms usually occurred within the first 8 weeks of the initiation of growth hormone therapy. In all reported cases, IH-associated signs and symptoms resolved after termination of therapy or a reduction of the growth hormone dose. 

Growth hormone should not be initiated to treat patients with acute critical illness due to complications of open heart or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure.

The safety of continuing growth hormone replacement therapy for approved uses in patients who develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with growth hormone in patients having acute critical illnesses should be weighed against the potential risk.