Healthcare professionals: Complete the enrollment form Individuals affected by Barth syndrome: Complete your consent form

How to reach your Mito Assist team

1-833-458-9099

Available Monday – Friday,

8 AM – 7 PM CT

When starting treatment, great support can make a difference

From access to treatment support, Mito Assist™ is with you every step of the way

This no-cost support program is available for eligible individuals prescribed FORZINITY™. Mito Assist connects you with helpful tools, personalized resources, and guidance throughout treatment.

Your Mito Assist Support Team

Care Managers

Your Care Manager is your main point of contact who will guide and support you throughout treatment.

Answers questions about your therapy and what to expect about Barth syndrome and FORZINITY
Provides helpful education and resources
Offers ongoing support, including help with refills and staying on track

Insurance Specialists

Navigating insurance can feel overwhelming. Your Insurance Specialist can help.

Explains your coverage and helps you access FORZINITY
Checks eligibility for financial assistance programs, including co-pay and patient assistance.* Terms and conditions apply

Visiting Nurses

If requested by your doctor, a Visiting Nurse can come to your home or set up a telehealth visit to help you get started.

Provides personalized training for your subcutaneous injections
Answers questions about your medication and care plan from your healthcare provider

The Mito Assist team does not offer medical advice or replace discussions with your doctor.

*Terms, conditions, eligibility criteria, program maximums, and restrictions apply. Mito Assist is available only in the United States. Submission of an application or enrollment form does not guarantee participation, coverage, medication, or savings. Eligibility and assistance determinations are made on an individual, case-by-case basis and are subject to verification. Mito Assist does not provide medical or treatment advice and is not insurance and does not replace insurance coverage. No purchase is required for enrollment in Mito Assist; treatment decisions are made solely by patients and their healthcare providers. Programs are administered in accordance with applicable federal and state laws and may be changed, suspended, or canceled at any time without notice.

How to get started with Mito Assist

Complete enrollment

Your doctor will complete the FORZINITY Patient Enrollment Form and submit it to the Mito Assist team, which is managed by our exclusive specialty pharmacy partner, AnovoRx Group, LLC (Anovo).

Note: You or your caregiver must sign and date the Patient Consent and Authorization (Section 10) for your enrollment to be finalized. You or your caregiver can also complete the form here.

Meet your Care Manager

Once your FORZINITY prescription is received by Anovo, your Care Manager will contact you to welcome you into Mito Assist. They will review your information, explain how the process works, and connect you with your Insurance Specialist, who will verify your coverage and help you navigate access to FORZINITY.

Begin treatment

When your prescription is ready, your Care Manager will arrange delivery directly to your home. They will continue to check in, help coordinate refills and deliveries, and answer any questions along the way

The Mito Assist team does not offer medical advice or replace discussions with your doctor.

Connect with Barth syndrome advocacy groups for additional support

Meet the Barth syndrome community

Learn more about mitochondrial diseases

Visit MitoAction

How to reach your Mito Assist team

1-833-458-9099

Available Monday – Friday,

8 AM – 7 PM CT

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.