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.
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.
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.
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.