Somatrogon

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Increased mortality in patients with acute critical illness
• Severe hypersensitivity
• Increased risk of neoplasm
• Glucose intolerance and diabetes mellitus
• Intracranial hypertension
• Fluid retention
• Hypoadrenalism
• Hypothyroidism
• Slipped capital femoral epiphysis
• Progression of preexisting scoliosis
• Pancreatitis
• Lipoatrophy
• Sudden death in pediatric patients with Prader-Willi syndrome [ see Warnings and Precautions ]

Who should not take it

• Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with 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 risk of sudden death.

Other medicines and interactions

Table 2 includes a list of drugs with clinically significant drug interactions when administered concomitantly with NGENLA and instructions for preventing or managing them.

Storing it

Storage and Handling

Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.

After first use: Store the pen refrigerated at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days.

Do not freeze or shake. Do not expose to heat. Do not use if it has been frozen. Store away from direct sunlight.

Always remove and safely discard the needle after each injection and store the NGENLA prefilled pen without an injection needle attached. Always use a new needle for each injection. Replace the cap on your prefilled pen when it is not in use. Write the date of first use in the space provided on the pen label. The prefilled pen should not be used more than 28 days after first use.