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IMPORTANT SAFETY INFORMATION AND USE

What is SKYTROFA^® used for?

SKYTROFA is a prescription medication for the replacement of growth hormone in children 1 year old or older who weigh at least 26 pounds (11.5 kilograms) with growth hormone deficiency (GHD).

You should not use SKYTROFA if you have:
- Critical illness immediately after open heart surgery, abdominal surgery, or accidental trauma, or those with severe breathing problems known as respiratory failure;
- Had a reaction to SKYTROFA or any of its ingredients;

IMPORTANT SAFETY INFORMATION AND USE

What is SKYTROFA^® used for?

SKYTROFA is a prescription medication for the replacement of growth hormone in children 1 year old or older who weigh at least 26 pounds (11.5 kilograms) with growth hormone deficiency (GHD).
What Warnings should I know about SKYTROFA?

There have been reports of death when using treatments like SKYTROFA in patients with critical illness due to complications following certain surgeries, severe injury, or in people with respiratory failure.

Severe hypersensitivity reactions including anaphylactic reactions and swelling underneath the skin, have been reported during use with treatments like SKYTROFA. Seek medical help right away if the following happen after administering SKYTROFA: hives, trouble breathing, and swelling of the face, eyes, lips, or mouth. Do not use if there is any history of hypersensitivity reactions to any ingredients in SKYTROFA.

Childhood cancer survivors treated with brain/head radiation are at increased risk of secondary cancers and, as a precaution, need to be monitored for recurrence. Changes in behavior, new headaches, vision disturbances or changes in skin color or changes in birthmarks or moles should be discussed with the healthcare provider.

Children with certain rare genetic causes of short stature have an increased risk of developing cancer. Talk with the healthcare provider about risks and benefits of starting SKYTROFA.

Patients may develop impaired glucose tolerance or Type 2 diabetes or have a worsening of diabetes when using SKYTROFA. Dosage of diabetes medicines may need to be adjusted during growth hormone treatment.

Increased pressure in the brain has been reported in a small number of patients taking treatments like SKYTROFA, which can cause changes in vision, headache, nausea or vomiting. Treatment may be reduced or stopped if any of these conditions occur.

SKYTROFA can cause the body to retain fluid which may cause swelling, joint pain, or muscle pain, and usually goes away after treatment is stopped or dose is reduced.

Patients taking SKYTROFA who have or are at risk for pituitary hormone deficiencies may be at risk for reduced serum cortisol levels and/or unmasking of central hypoadrenalism. Patients should be checked regularly for low serum cortisol levels and/or the need to increase the dose of the glucocorticoids they are taking.

Thyroid function should be monitored as low thyroid levels can cause SKYTROFA to not work. Low thyroid hormone levels may become apparent or worsen during SKYTROFA treatment.

In children experiencing rapid growth, limping or hip or knee pain may occur. If a child being treated with SKYTROFA starts to limp or gets hip or knee pain, the child’s doctor should be notified and the child should be examined. Children and caregivers should be aware that decreased blood flow to bones may occur with human growth hormone products.

In children experiencing rapid growth, curvature of the spine may worsen, known as scoliosis. Patients with scoliosis should be checked regularly to make sure their scoliosis does not get worse during treatment with SKYTROFA.

SKYTROFA can cause inflammation of the pancreas which may cause pain in the area of the stomach.

SKYTROFA can cause loss of fat tissue around the injection site with continued use. Injection sites should be different each time SKYTROFA is administered to prevent this risk.

SKYTROFA should not be used in patients with Prader-Willi syndrome who are very overweight or who have severe breathing problems due to risk of death. SKYTROFA is not indicated for treatment of Prader-Willi syndrome.
You should not use SKYTROFA if you have:
- Critical illness immediately after open heart surgery, abdominal surgery, or accidental trauma, or those with severe breathing problems known as respiratory failure;
- Had a reaction to SKYTROFA or any of its ingredients;
- Bones that have stopped growing;
- Cancer;
- Eye vision problems due to diabetes;
- A condition known as Prader-Willi syndrome and are overweight; have a history of upper airway breathing problems, have sleep apnea, or have severe breathing problems, due to the risk of sudden death
What are the side effects of SKYTROFA?

The most common side effects include viral infection, fever, cough, nausea and vomiting, bleeding, diarrhea, stomach area pain, and joint pain and arthritis.
What other medication might interact with SKYTROFA?

Make certain to tell your healthcare provider about all medicines you take including corticosteroids, estrogen containing products, including certain birth control medications, or medicine for diabetes. These are not all of the drugs that may interact with SKYTROFA.

These are not all of the possible side effects of SKYTROFA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1-844-442-7236.

Please click here for full Prescribing Information for SKYTROFA.

The product information provided in this site is intended only for residents of the US. The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider.

hEIghT TRIAL

A 52-week, randomized, open-label, active-controlled, parallel-group phase 3 study of 161 treatment-naïve, prepubertal (Tanner stage 1) pediatric patients with GHD aged 3 years and older. Patients were randomized in a 2:1 ratio to receive either SKYTROFA^® 0.24 mg/kg/week (n = 105) or a daily somatropin 0.24 mg/kg/week (n = 56). The primary endpoint was to evaluate and compare the LS mean AHV of prepubertal children with growth failure due to GHD treated with weekly SKYTROFA with that of somatropin at 52 weeks.^1,3

fliGHt TRIAL

Once-weekly SKYTROFA^® was studied in a multicenter, phase 3, open-label, 26-week trial investigating the safety, tolerability, and efficacy of SKYTROFA administered once weekly in children with GHD. The trial included 3 treatment-naïve and 143 treatment-experienced patients previously treated with daily hGH (≥ 0.20 mg hGH/kg/week) for ≤ 130 weeks. Children with open epiphyses aged 3 to 17 years must have been treated with daily hGH (≥ 0.20 mg hGH/kg/week) for 13 to 130 weeks. Safety and tolerability were the primary endpoints.

enliGHten TRIAL

SKYTROFA^® is being studied in an ongoing open-label extension study of pediatric patients with GHD who previously participated in phase 3 SKYTROFA trials. The study enrolled a total of 298 patients: 103 patients on SKYTROFA and 55 patients on a daily somatropin from the heiGHt trial, and 140 patients on SKYTROFA from the fliGHt trial. The mean age at baseline was 9.54 years (range: 4.4 to 14.1 years) for SKYTROFA-treated patients from the heiGHt trial, 9.56 years (range: 4.2 to 13.9 years) for daily somatropin-treated patients from the heiGHt trial, and 11.11 years (range: 1.7 to 17.8 years) for patients from the fliGHt trial.⁵