Lonapegsomatropin

What it is used for

SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the:

• Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH).
• Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).

Side effects, and when to stop

The following important adverse reactions are described elsewhere in the labeling:

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

Who should not take it

SKYTROFA is contraindicated in patients with:

• 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 use of pharmacologic doses of somatropin.
• Hypersensitivity to somatropin or any of the excipients in SKYTROFA. Severe systemic hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported.
• Pediatric patients with closed epiphyses.
• Active malignancy due to the risk of malignancy progression.
• Active proliferative or severe non-proliferative diabetic retinopathy because treatment with somatropin may worsen this condition.
• Pediatric patients with 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 4 includes a list of drugs with clinically important drug interactions when administered concomitantly with SKYTROFA and instructions for preventing or managing them.

Storing it

Storage and Handling

• For patients: Refrigerate SKYTROFA cartridges at 36°F to 46°F (2°C to 8°C) in the outer carton to protect from light until the expiration date. Do not freeze. Alternatively, SKYTROFA outer carton containing blistered cartridges may be stored at room temperature [up to 86°F (30°C)] for up to 6 months and can be returned to refrigeration within the 6 months. Write the date first removed from the refrigerator in the space provided on the outer carton. Do not use SKYTROFA beyond the expiration date or 6 months after the date it was first removed from refrigeration (whichever is earlier).
• For pharmacy long-term storage: Store SKYTROFA cartridges refrigerated at 36°F to 46°F (2°C to 8°C) in the outer carton to protect from light until the expiration date. Do not freeze.