NGENLA® (somatrogon-ghla) for HCPs

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INDICATION

Ngenla is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Ngenla is contraindicated in patients with:

Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or acute respiratory failure due to the risk of increased mortality with somatropin
Hypersensitivity to somatrogon-ghla or any of the excipients in Ngenla
Closed epiphyses
Active malignancy due to the risk of malignancy progression
Active proliferative or severe non-proliferative diabetic retinopathy
Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to the sudden risk of death

WARNINGS AND PRECAUTIONS
Increased Mortality in Patients with Acute Critical Illness: 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 has been reported with somatropin.

Severe Hypersensitivity: Severe systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with somatropin. Inform patients and/or caregivers that such reactions are possible, and to seek prompt medical attention if allergic reaction occurs.

Increased Risk of Neoplasms: There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy. Any preexisting malignancy should be inactive, and its treatment should be completed, prior to instituting therapy. In childhood cancer survivors treated with radiation to the brain/head for their first neoplasm and developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Monitor patients with a history of GHD secondary to an intracranial neoplasm for progression or recurrence of the tumor. Children with certain rare genetic causes of short stature have an increased risk of developing malignancies. Monitor for development of neoplasms. Monitor patients for increased growth or potential malignant changes of preexisting nevi. Advise patients and/or caregivers to report marked changes in behavior, onset of headaches, vision disturbances, and/or changes in skin pigmentation or changes in the appearance of preexisting nevi.

Glucose Intolerance and Diabetes Mellitus: Treatment with growth hormone may decrease insulin sensitivity, particularly at higher doses. New-onset type 2 diabetes mellitus has been reported. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic. Monitor glucose levels periodically in all patients receiving Ngenla, especially in those with risk factors for diabetes mellitus. The doses of antidiabetic agents may require adjustment when Ngenla is initiated.

Intracranial Hypertension (IH): Has been reported in patients treated with somatropin, usually within 8 weeks of treatment initiation. Perform fundoscopic examination prior to initiation of treatment and periodically thereafter. If papilledema is identified, evaluate the etiology, and treat the underlying cause before initiating Ngenla. Temporarily discontinue Ngenla in patients with evidence of IH. If IH is confirmed, restart Ngenla at a lower dose after IH signs and symptoms have resolved.

Fluid Retention: May occur during Ngenla therapy. Clinical manifestations of fluid retention are usually transient and dose dependent.

Hypoadrenalism: Patients receiving growth hormone therapy who have or are at risk for pituitary hormone deficiencies may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Ngenla. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases.

Hypothyroidism: Undiagnosed/untreated hypothyroidism may prevent an optimal response to Ngenla. Central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy. Monitor thyroid function periodically and appropriately initiate or adjust thyroid hormone replacement therapy.

Slipped Capital Femoral Epiphysis: Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly.

Progression of Preexisting Scoliosis: Monitor patients with a history of scoliosis for disease progression.

Pancreatitis: Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared with adults. Consider pancreatitis in patients who develop persistent severe abdominal pain.

Lipoatrophy: May occur if Ngenla is administered at the same site over a long period of time. Rotate injection sites to reduce this risk.

Sudden Death in Pediatric Patients with Prader-Willi Syndrome: There have been reports of sudden death after initiating therapy with somatropin 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. Male patients with one or more of these factors may be at greater risk. Ngenla is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader‑Willi syndrome.

Laboratory Tests: Serum levels of phosphorus, alkaline phosphatase, and parathyroid hormone may increase with NGENLA therapy. Monitor as appropriate.

ADVERSE REACTIONS
Adverse reactions reported in ≥5% of patients treated with Ngenla are injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain. Health care providers should supervise the first injection and provide appropriate training and instruction for the proper use of all NGENLA devices.

DRUG INTERACTIONS
Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses.

Cytochrome P450-Metabolized Drugs: Ngenla may alter the clearance. Monitor carefully.

Oral Estrogen: Patients receiving oral estrogen replacement may require higher Ngenla dosages.

Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin and/or antihyperglycemic agent may be required.

INDICATION

Ngenla is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.