(somatrogon-ghla)
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Advise patients and caregivers that serious systemic hypersensitivity reactions (anaphylaxis and angioedema) are possible and that prompt medical attention should be sought if an allergic reaction occurs [see Warnings and Precautions (5.2)].
Advise childhood cancer survivors and caregivers that individuals treated with radiation to the head are at increased risk of secondary neoplasms and, as a precaution, need to be monitored for recurrence. Advise patients to report marked changes in skin pigmentation or changes in the appearance of preexisting nevi [see Warnings and Precautions (5.3)].
Advise patients and caregivers that new onset of insulin resistance and hyperglycemia may occur and monitoring of blood glucose during treatment with NGENLA in patients with glucose intolerance or who have risk factors for diabetes, may be needed [see Warnings and Precautions (5.4)].
Advise patients and caregivers to report to their healthcare provider any visual changes, headache, and nausea and/or vomiting [see Warnings and Precautions (5.5)].
Advise patients and caregivers that fluid retention during NGENLA therapy may occur. Inform patients of the clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) and to report to their healthcare provider if any of these signs or symptoms occur during treatment with NGENLA.
Advise patients and caregivers who have or who are at risk for corticotropin deficiency that hypoadrenalism may develop and to report to their healthcare provider if extreme fatigue, dizziness, weakness, vomiting, dehydration or weight loss is experienced during treatment with NGENLA [see Warnings and Precautions (5.7)].
Advise patients and caregivers that undiagnosed/untreated hypothyroidism may prevent an optimal response to NGENLA. Advise patients and caregivers they may require periodic thyroid function tests during treatment with NGENLA [see Warnings and Precautions (5.8)].
Advise patients and caregivers that pancreatitis may develop and to report to their healthcare provider any new onset persistent severe abdominal pain.
Advise patients and caregivers that lipoatrophy may occur if NGENLA is administered subcutaneously at the same site over a long period of time. Advise patients to rotate injection sites when administering NGENLA to reduce this risk.
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