Ngenla Special Precautions

Acute critical illness: There is no clinical experience with NGENLA in patients with acute critical illness.
Treatment with pharmacologic amounts of daily growth hormone products has been associated with increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure (see Contraindications).
Based on experience with daily growth hormone products, if patients who are receiving NGENLA therapy become acutely critically ill, the potential benefit of continued treatment should be weighed against the potential risk (see Contraindications).
Hypersensitivity reactions: Serious systemic hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with daily growth hormone products. If a serious hypersensitivity reaction occurs, immediately discontinue use of NGENLA; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with previous hypersensitivity to NGENLA (see Contraindications).
Hypoadrenalism: Based on published data, patients receiving daily growth hormone therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NGENLA treatment (see Interactions). Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism (see Interactions).
Pancreatitis: Although rare, pancreatitis has been reported in somatropin-treated patients. Consider pancreatitis in patients who develop abdominal pain during treatment.
Neoplasm: In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm. Intracranial tumors, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms. Monitor patients on NGENLA therapy carefully for increased growth or potential malignant changes of pre-existing nevi. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of pre-existing nevi.
Benign intracranial hypertension: No evidence of benign intracranial hypertension was reported in clinical trials with NGENLA.
Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with daily growth hormone products. Symptoms usually occurred within the first 8 weeks after the initiation of daily growth hormone therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the daily growth hormone dose. NGENLA should be temporarily discontinued in patients with clinical or fundoscopic evidence of IH. If treatment with NGENLA is restarted, monitoring for signs and symptoms of IH is recommended.
Glucose metabolism impairment: No clinically meaningful changes in glucose metabolism, including insulin sensitivity, were observed in clinical trials with NGENLA.
Treatment with daily growth hormone products may induce a state of insulin resistance and hyperglycemia. Additional monitoring should be considered in patients treated with NGENLA who have glucose intolerance, or additional risk factors for diabetes. In patients treated with NGENLA who have diabetes mellitus, anti-diabetic therapy may require adjustment (see Interactions).
Scoliosis: Because NGENLA increases growth rate, signs of development or progression of scoliosis should be monitored during treatment.
Closed epiphyses: In children with closed epiphyses, NGENLA is not recommended to be used for growth promotion.
Thyroid function impairment: In general, peripheral thyroid hormone levels remain within the normal reference range during treatment with somatropin. However, there is an enhanced conversion of T4 to T3 that may result in a reduction in serum T4 and an increase in serum T3 concentrations. This effect may be of clinical relevance for patients with central subclinical hypothyroidism in whom hypothyroidism may theoretically develop. Based on experience with daily growth hormone products, undiagnosed/untreated hypothyroidism may prevent an optimal response to NGENLA therapy. In patients with growth hormone deficiency (GHD), central (secondary) hypothyroidism may first become evident or worsen during treatment. During NGENLA therapy, thyroid function should be monitored as indicated based on clinical evaluation.
Prader-Willi syndrome: NGENLA has not been studied in patients with Prader-Willi syndrome. NGENLA is not indicated for the long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome unless they also have a diagnosis of GHD. There have been reports of sudden death after initiating therapy with growth hormone in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection.
Epiphyseal disorders: No epiphyseal disorders were reported with the administration of NGENLA in clinical trials. Epiphyseal disorders, including slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during treatment should be carefully evaluated.
Myositis: Myositis is a very rare adverse event that may be related to the preservative metacresol. In the case of myalgia or disproportionate pain at injection site, myositis should be considered and if confirmed, other growth hormone products without metacresol should be used.
Effects on ability to drive and use machines: No effects on the ability to drive and use machines have been observed.