Is Somapacitan approved by the FDA?
Yes, somapacitan (Sogroya) is an FDA-approved growth hormone therapy for treating growth hormone deficiency in both adults and children over 2.5 years old. Approved on August 28, 2020, it offers a convenient once-weekly injection, improving adherence and quality of life for patients.
What is Somapacitan?
Somapacitan is a growth hormone used to treat growth hormone deficiency in both adults and children aged 2.5 years and older. It belongs to the drug class of growth hormones and is administered as a subcutaneous injection.
How Somapacitan Works
Somapacitan works by mimicking the effects of natural growth hormone in the body, which is crucial for growth, metabolism, and muscle development. It helps increase height in children and improve body composition, muscle mass, and overall energy levels in both children and adults with growth hormone deficiency.
Administration and Dosage
Somapacitan is administered as an injection under the skin (subcutaneous). The typical dosage is once a week, and the exact dose is determined by a healthcare provider based on the patient’s specific needs. Important administration guidelines include:
- Your healthcare provider will show you how to inject somapacitan and rotate injection sites to avoid skin problems.
- Do not reuse needles or syringes; dispose of them properly in a puncture-proof container.
- Store the medication as instructed, usually at room temperature away from moisture and heat.
Potential Side Effects
Somapacitan can cause a range of side effects, from common to serious:
Common Side Effects:
- Back and joint pain
- Vomiting, heartburn
- Dizziness
- Weight gain
- Sleep problems
- Abnormal blood tests
- Pain in hands and feet
- Fever, chills, flu symptoms
- Pain, bruising, or swelling at the injection site
Serious Side Effects:
- Changes in behavior, moles, birthmarks, or skin color
- Headaches, vision problems, nausea, or vomiting
- Fluid retention causing shortness of breath, swelling, rapid weight gain
- Decreased adrenal gland hormones leading to nausea, vomiting, loss of appetite
- Pancreatitis with severe upper stomach pain spreading to the back
If you experience any serious side effects, you should contact your doctor immediately.
Warnings and Precautions
- Allergies: Do not use if you are allergic to somapacitan.
- Health Conditions: Inform your doctor if you have cancer, diabetes, adrenal or thyroid problems, or if you are a child with specific conditions like Prader-Willi syndrome.
- Pregnancy and Breastfeeding: Consult your doctor if you are pregnant or breastfeeding.
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