Immediately discontinue use, promptly treat per standard of care & monitor until signs & symptoms resolve if serious systemic hypersensitivity reaction (eg, anaphylaxis, angioedema) occurs. Possible increased mortality in patients w/ acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or those w/ acute resp failure. Monitor patients for reduced serum cortisol levels &/or need for glucocorticoid dose increases in those w/ known hypoadrenalism. Consider pancreatitis in patients who develop abdominal pain during treatment. Carefully monitor patients for increased growth or potential malignant changes of pre-existing nevi. Advise patients/caregivers to report marked behavior changes, headache onset, vision disturbances &/or changes in skin pigmentation or pre-existing nevi appearance. Temporarily discontinue use in patients w/ clinical or fundoscopic evidence of intracranial HTN; monitor for signs & symptoms if Ngenla is restarted. Consider additional monitoring in patients who have glucose intolerance or additional risk factors for diabetes. Monitor signs of development or progression of scoliosis during treatment. Patients w/ GH deficiency & central (secondary) hypothyroidism may become evident or worsen; monitor thyroid function during treatment. Consider myositis in case of myalgia or disproportionate pain at inj site; use other GH products w/o metacresol if confirmed. Pregnancy & lactation. Not recommended for growth promotion in childn w/ closed epiphyses. Not indicated for long-term treatment of ped patients who have growth failure due to genetically confirmed Prader-Willi syndrome unless diagnosed w/ GH deficiency. Carefully evaluate ped patients w/ onset of limp or complaints of hip or knee pain during treatment.
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