Serostim/Zorbtive (somatropin [rDNA origin] for injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
- Because malignancies are more common in HIV positive individuals, the risks and benefits of starting somatropin in HIV positive patients should be carefully considered before initiating Serostim treatment and patients should be monitored carefully for the development of neoplasms if treatment with somatropin is initiated.
- Monitor all patients with a history of any neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor..
- Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes of preexisting nevi.
- somatropin inhibits 11β-hydroxysteroid dehydrogenase type 1 in adipose/hepatic tissue that may impact the metabolism of cortisol and cortisone