Lonapegsomatropin

What is Lonapegsomatropin?

• Lonapegsomatropin (Skytrofa) is a human growth hormone used to treat short stature due to inadequate secretion of endogenous growth hormone.

What are the uses of this medicine?

• Lonapegsomatropin (Skytrofa) used 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).

How does this medicine work?

• Lonapegsomatropin (Skytrofa) is a pegylated human growth hormone (somatropin) for once-weekly subcutaneous injection.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Acute critical illness
• Hypersensitivity to somatropin or any of the excipients in Skytrofa
• Children with closed epiphyses
• Active malignancy
• Active proliferative or severe non-proliferative diabetic retinopathy
• Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment due to risk of sudden death

What drug interactions can this medicine cause?

• Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Skytrofa.
• Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.
• Careful monitoring is advisable when Skytrofa is administered in combination with drugs metabolized by CYP450 liver enzymes.
• Patients receiving oral estrogen replacement may require higher Skytrofa dosages.
• Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.

Is this medicine FDA approved?

• Lonapegsomatropin was approved for medical use in the United States in August 2021.

How should this medicine be used?

Recommended dosage:

• The recommended dose is 0.24 mg/kg body weight once-weekly.

Administration:

• Skytrofa should be administered subcutaneously into the abdomen, buttock, or thigh with regular rotation of the injection sites.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 3 mg, 3.6 mg, 4.3 mg, 5.2 mg, 6.3 mg, 7.6 mg, 9.1 mg, 11 mg and 13.3 mg.

This medicine is available in fallowing brand namesː

• Skytrofa

What side effects can this medication cause?

The most common side effects of this medicine include:

• viral infection
• pyrexia
• cough
• nausea and vomiting
• hemorrhage
• diarrhea
• abdominal pain
• arthralgia
• arthritis

What special precautions should I follow?

• Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported. In the event of an allergic reaction, seek prompt medical attention.
• There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy. Monitor patients with preexisting tumors for progressions 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.
• Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. Previously undiagnosed impaired glucose tolerance and overt type 2 diabetes mellitus may be unmasked. Periodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment.
• Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropin. Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction.
• Fluid retention during somatropin therapy may occur. Reduce dose as necessary.
• Patients receiving somatropin 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. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.
• Undiagnosed or untreated hypothyroidism may prevent optimal response to Skytrofa. In patients with GHD, central (secondary) hypothyroidism may first become evident or worsen during Skytrofa treatment. Perform periodic thyroid function tests in patients and initiate or appropriately adjust thyroid hormone replacement therapy when indicated.
• Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain.
• Somatropin increases growth rate, and progression of existing scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression.
• Pancreatitis has been reported in pediatric patients receiving somatropin. The risk may be greater in pediatric patients than adults. Consider pancreatitis in patients who develop persistent severe abdominal pain.
• When Skytrofa is administered subcutaneously at the same site over a long period of time, lipoatrophy may result. Rotate injection sites when administering Skytrofa to reduce this risk.
• Serum levels of phosphate, alkaline phosphatase, and parathyroid hormone may increase after somatropin treatment. If a patient is found to have abnormal laboratory tests, monitor as appropriate.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypoglycemia and subsequently to hyperglycemia
• fluid retention

• Long-term overdosage may result in signs and symptoms of gigantism.

Management of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• There are no available data on lonapegsomatropin-tcgd use in pregnant patients to evaluate a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
• Available published data over several decades for somatropin, the active component of lonapegsomatropin-tcgd, have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Skytrofa in children less than 1 year of age have not been established.
• Use of somatropin in pediatric patients with Prader-Willi syndrome has been associated with reports of sudden death.
• Skytrofa is not indicated for the treatment of pediatric patients with growth failure due to genetically confirmed Prader-Willi syndrome.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Lonapegsomatropin

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured by:

• Ascendis Pharma Endocrinology Division A/S
• Tuborg Boulevard 12 Hellerup Denmark DK

What should I know about storage and disposal of this medication?

• 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).

• Dailymed label info on Lonapegsomatropin
• FDA Lonapegsomatropin

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