IMPORTANT SAFETY INFORMATION

What should I tell my doctor before taking FORZINITY™?

Before taking FORZINITY tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. You should also tell your doctor if you have or had:

• any allergies
• kidney problems

What are the possible side effects of FORZINITY?

Injection site reactions: The most common side-effects or adverse reactions with FORZINITY are redness, swelling, pain, itching, bruising, or hives at the site of injection. These adverse reactions are referred to as injection site reactions.

Allergic reactions. FORZINITY may cause allergic reactions, such as rash, small, raised skin bumps known as papular lesions, inflammation of the skin or eczematous dermatitis, as well as respiratory symptoms including cough. Stop using FORZINITY and get medical help right away if you develop any of the following symptoms of a severe allergic reaction:

swelling of your face, lips, mouth, or tongue

trouble breathing or airway constriction

wheezing

dizziness or fainting

fast heartbeat or pounding in your chest

sweating

These are NOT all of the possible side effects of FORZINITY.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is FORZINITY used for?

FORZINITY is a prescription medicine used to improve muscle strength in adult and pediatric individuals living with Barth syndrome weighing at least 30 kg. The safety and effectiveness of FORZINITY have not been established in pediatric individuals weighing less than 30 kg.

The recommended dosage of FORZINITY in most affected individuals weighing at least 30 kg is 40 mg subcutaneously once daily. For individuals with reduced renal function, please have your doctor refer to the Prescribing Information.

This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The risk information provided here is not comprehensive. To learn more, talk with your doctor and read the full Prescribing Information.