NGENLA® Highlights

(somatrogon-ghla)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use NGENLA safely and effectively. See full prescribing information for NGENLA.

NGENLA (somatrogon-ghla) injection, for subcutaneous use
Initial U.S. Approval: 2023

INDICATIONS AND USAGE

NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (1).

DOSAGE AND ADMINISTRATION

NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency (2.1).
Administer NGENLA by subcutaneous injection once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms with weekly rotation of injection site (2.1).
The recommended dosage is 0.66 mg/kg based on actual body weight administered once weekly (2.3).
Individualize dosage for each patient based on the growth response (2.3).
Patients switching from daily growth hormone may initiate treatment with once-weekly NGENLA on the day following their last daily injection (2.3).
If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site (2.3).

DOSAGE FORMS AND STRENGTHS

Injection:

24 mg/1.2 mL (20 mg/mL) single-patient-use prefilled pen that delivers a dose in 0.2 mg increments (3).
60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen that delivers a dose in 0.5 mg increments (3).

CONTRAINDICATIONS

Acute critical illness (4).
Hypersensitivity to somatrogon-ghla or excipients (4).
Closed epiphyses (4).
Active malignancy (4).
Active proliferative or severe non-proliferative diabetic retinopathy (4).
Prader-Willi syndrome who are severely obese or have severe respiratory impairment (4).

WARNINGS AND PRECAUTIONS

Severe Hypersensitivity: Severe hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention (5.2).
Increased Risk of Neoplasms: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin – in particular meningiomas in patients treated with radiation to the head for their first neoplasm (5.3).
Glucose Intolerance and Diabetes Mellitus: NGENLA may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving NGENLA, especially in patients with existing diabetes mellitus or at risk for its development (5.4).
Intracranial Hypertension: Perform fundoscopic examinations prior to initiation of treatment with NGENLA and periodically thereafter. If preexisting papilledema is identified, evaluate the etiology and treat the underlying cause before initiating. If papilledema occurs with NGENLA, stop treatment (5.5).
Fluid Retention: May occur and may be dose dependent. Reduce dose as necessary (5.6).
Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism (5.7).
Hypothyroidism: Monitor thyroid function periodically as hypothyroidism may become evident or worsen after initiation with NGENLA (5.8).
Slipped Capital Femoral Epiphysis: May develop. Evaluate patients with the onset of a limp or persistent hip or knee pain (5.9).
Progression of Preexisting Scoliosis: Monitor for development or progression of scoliosis (5.10).
Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain (5.11).
Lipoatrophy: May occur if NGENLA is administered in the same location over a long period of time. Rotate injection sites (5.12).

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 (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Replacement Glucocorticoid Treatment: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress dose following initiation of NGENLA (7).
Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Adjust glucocorticoid dosing in pediatric patients to avoid both hypoadrenalism and an inhibitory effect on growth (7).
Cytochrome P450-Metabolized Drugs: NGENLA may alter the clearance. Monitor carefully if used with NGENLA (7).
Oral Estrogen: Larger doses of NGENLA may be required (7).
Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin or antihyperglycemic agent may be required (5.4, 7).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use NGENLA safely and effectively. See full prescribing information for NGENLA.

NGENLA (somatrogon-ghla) injection, for subcutaneous use
Initial U.S. Approval: 2023

INDICATIONS AND USAGE

NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (1).

DOSAGE AND ADMINISTRATION

NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency (2.1).
Administer NGENLA by subcutaneous injection once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms with weekly rotation of injection site (2.1).
The recommended dosage is 0.66 mg/kg based on actual body weight administered once weekly (2.3).
Individualize dosage for each patient based on the growth response (2.3).
Patients switching from daily growth hormone may initiate treatment with once-weekly NGENLA on the day following their last daily injection (2.3).
If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site (2.3).

DOSAGE FORMS AND STRENGTHS

Injection:

24 mg/1.2 mL (20 mg/mL) single-patient-use prefilled pen that delivers a dose in 0.2 mg increments (3).
60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen that delivers a dose in 0.5 mg increments (3).

CONTRAINDICATIONS

Acute critical illness (4).
Hypersensitivity to somatrogon-ghla or excipients (4).
Closed epiphyses (4).
Active malignancy (4).
Active proliferative or severe non-proliferative diabetic retinopathy (4).
Prader-Willi syndrome who are severely obese or have severe respiratory impairment (4).

WARNINGS AND PRECAUTIONS

Severe Hypersensitivity: Severe hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention (5.2).
Increased Risk of Neoplasms: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin – in particular meningiomas in patients treated with radiation to the head for their first neoplasm (5.3).
Glucose Intolerance and Diabetes Mellitus: NGENLA may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving NGENLA, especially in patients with existing diabetes mellitus or at risk for its development (5.4).
Intracranial Hypertension: Perform fundoscopic examinations prior to initiation of treatment with NGENLA and periodically thereafter. If preexisting papilledema is identified, evaluate the etiology and treat the underlying cause before initiating. If papilledema occurs with NGENLA, stop treatment (5.5).
Fluid Retention: May occur and may be dose dependent. Reduce dose as necessary (5.6).
Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism (5.7).
Hypothyroidism: Monitor thyroid function periodically as hypothyroidism may become evident or worsen after initiation with NGENLA (5.8).
Slipped Capital Femoral Epiphysis: May develop. Evaluate patients with the onset of a limp or persistent hip or knee pain (5.9).
Progression of Preexisting Scoliosis: Monitor for development or progression of scoliosis (5.10).
Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain (5.11).
Lipoatrophy: May occur if NGENLA is administered in the same location over a long period of time. Rotate injection sites (5.12).

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 (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Replacement Glucocorticoid Treatment: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress dose following initiation of NGENLA (7).
Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Adjust glucocorticoid dosing in pediatric patients to avoid both hypoadrenalism and an inhibitory effect on growth (7).
Cytochrome P450-Metabolized Drugs: NGENLA may alter the clearance. Monitor carefully if used with NGENLA (7).
Oral Estrogen: Larger doses of NGENLA may be required (7).
Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin or antihyperglycemic agent may be required (5.4, 7).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2023

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