Buy Skytrofa (lonapegsomatropin-tcgd)

What is Skytrofa (lonapegsomatropin-tcgd) for?

Skytrofa (lonapegsomatropin-tcgd) is a human growth hormone indicated for the treatment of children aged 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH).^[1]

It is available in tablet form each containing 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 lonapegsomatropin-tcgd.^[1]

How does Skytrofa (lonapegsomatropin-tcgd) work?

Somatropin has been a standard of care to treat children with growth hormone deficiency. However, the daily administration is burdensome. Somatropin binds to the growth hormone (GH) receptor in the cell membrane, leading to bone growth, muscle growth and the breakdown of fat.^[2]

The active ingredient in Skytrofa, lonapegsomatropin, is a medicine that consists of three ingredients: the GH somatropin, an inert carrier, and a linker that connects somatropin and the carrier. The carrier has a protecting effect that minimizes excretion via the urine and breakdown of the hormone.^[3]

Skytrofa is designed to release somatropin at a specific rate so it can work similarly to GH that is normally produced by the body and to daily somatropin treatment.^[3]

Where has Skytrofa (lonapegsomatropin-tcgd) been approved?

Skytrofa (lonapegsomatropin-tcgd) was approved for the treatment of children with growth hormone deficiency by:^[4]

• The Food and Drug Administration (FDA), USA on August 25, 2021.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Skytrofa (lonapegsomatropin-tcgd) taken?

The standard dosage for treatment-naïve patients and patients switching from daily somatropin therapy is:^[1]

• 0.24 mg/kg body weight, given once-weekly via under the skin (subcutaneous) injection

​​The dose may be adjusted based on the child’s weight and insulin-like growth factor-1 (IGF-1) levels.^[1]

The injections are given into the abdomen, buttock, or thighs using the Skytrofa Auto-Injector.^[1]

It is important that you inform your doctor about all medicines you take, because Skytrofa (lonapegsomatropin-tcgd) may affect the way other medicines work, including glucocorticoids, oral estrogen, insulin and/or other hypoglycemic agents, and cytochrome P450-metabolized drugs.^[1]

Complete information about Skytrofa (lonapegsomatropin-tcgd) dosage and administration can be found in the official prescribing information listed in our references section.1

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Skytrofa (lonapegsomatropin-tcgd)?

Common adverse reactions

The most common side effects (≥5% of patients) listed in the prescribing information include:^[1]

• Viral infection
• Pyrexia
• Cough
• Nausea and vomiting
• Hemorrhage
• Diarrhea
• Abdominal pain
• Arthralgia and arthritis

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Increased mortality in patients with acute critical illness
• Severe allergic reactions
• Increased risk of malignancy progression
• Decrease insulin sensitivity
• Build-up of pressure around the brain
• Fluid retention
• Underactive adrenal glands
• Underactive thyroid
• Increased risk of a hip condition called slipped capital femoral epiphysis
• Increased risk of scoliosis progression
• Pancreas infection

Use in a specific population

It is not known if Skytrofa (lonapegsomatropin-tcgd) can harm your unborn baby. No adverse effects on breastfed baby’s have been reported with somatropin. Please discuss with the treating doctor.^[1]

Before starting with treatment, tell your doctor about all of your medical conditions, including if you have:^[1]

• Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or if you have acute respiratory failure
• Hypersensitivity to somatropin or any of the ingredients in Skytrofa
• Closed epiphyses for growth promotion
• Active malignancy
• Active proliferative or severe non-proliferative diabetic retinopathy
• Prader-Willi syndrome, have a history of upper airway obstruction or sleep apnea or have severe breathing problems

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Skytrofa (lonapegsomatropin-tcgd) [PDF]
Ascendis Pharma, Aug 2021

2. Weekly Lonapegsomatropin in Treatment-Naïve Children With Growth Hormone Deficiency: The Phase 3 heiGHt Trial
Thornton, PS et al., The Journal of Clinical Endocrinology & Metabolism, Jul 2021

3. Ascendis Pharma (ASND) Investor Presentation – Slideshow
Ascendis Pharma, Aug 2020

4. Ascendis Pharma A/S Announces U.S. Food and Drug Administration Approval of SKYTROFA® (lonapegsomatropin-tcgd), the First Once-weekly Treatment for Pediatric Growth Hormone Deficiency
Ascendis Pharma press release, Aug 2021