Forzinity
Pronunciation: For-zin-it-tee
Generic name: elamipretide
Dosage form: Injection for subcutaneous use (280 mg/3.5 mL multi-dose vial, single-patient use)
What is Forzinity? Barth Syndrome Medication
Forzinity is used to improve muscle strength in adults and children with Barth syndrome who weigh at least 30kg. Forzinity injection received accelerated approval based on clinical trials showing significant improvement in knee extensor muscle strength.
Key Facts About Forzinity
- Generic name: Elamipretide
- Drug class: Mitochondrial cardiolipin binder
- FDA approval: Accelerated approval for Barth syndrome, 19 September 2025
- Patient eligibility: Adults and children ≥30kg with Barth syndrome
- Administration: Daily subcutaneous injection.
Note: Continued approval depends on the results of confirmatory clinical trials demonstrating long-term benefits.
How Does Forzinity Work? Mechanism of Action
Forzinity works through a unique mitochondrial targeting mechanism:
- Cardiolipin binding: Binds to cardiolipin, a critical lipid in mitochondria
- Mitochondrial repair: Targets the inner mitochondrial membrane
- Energy restoration: Improves mitochondrial structure and function
- Muscle strength: Enhances cellular energy production in muscle cells
This targeted approach addresses the root cause of muscle weakness in Barth syndrome patients by restoring mitochondrial function.
Forzinity Side Effects & Safety Information
Common Side Effects
The most common side effects of Forzinity are injection site reactions, with symptoms such as:
- Redness and pain
- Swelling (induration)
- Itching (pruritus)
- Bruising
- Hives (urticaria).
Treatment for mild skin reactions: Consider applying topical corticosteroids or taking oral antihistamines for mild injection site reactions. Talk to your healthcare provider if these reactions are persistent or severe.
Serious Warnings & Contraindications
Allergic Reactions:
- These can occur within minutes to months of Forzinity use.
- Symptoms include a skin rash, breathing problems, or a persistent cough.
- Emergency action: Stop Forzinity immediately, seek medical help.
- Treatment: Epinephrine, antihistamines, corticosteroids as needed.
- For serious allergic reactions, do not restart Forzinity.
Benzyl Alcohol Warning:
Forzinity contains benzyl alcohol as a preservative.
- Never use in newborns or premature babies.
- Benzyl alcohol can cause serious breathing problems in infants.
- Forzinity is only approved for subcutaneous injection (not IV).
Before Using
Absolute Contraindications:
- Known hypersensitivity to elamipretide or any of the ingredients in Forzinity.
- Neonates and premature babies.
Pregnancy & Breastfeeding Information
Pregnancy Considerations
Barth Syndrome mainly affects males (X-linked genetic condition), so pregnancy use is unlikely, and there is no pregnancy data available for Forzinity.
Animal studies showed no developmental problems at any dose tested.
Benzyl alcohol (preservative) breaks down quickly in pregnant women, so minimal fetal exposure is expected.
Breastfeeding Safety
Barth Syndrome mainly affects males (X-linked genetic condition), so breastfeeding use is unlikely, and there is no breastfeeding data available for Forzinity.
Benzyl alcohol (preservative) breaks down quickly in nursing mothers, so minimal infant exposure is expected.
How do I administer Forzinity?
Administer Forzinity once a day by subcutaneous injection (an injection under the skin).
- Administer at the same time each day
- Your healthcare provider will train you on safe preparation and injection of Forzinity. You should also read the Instructions for Use
- Forzinity comes as a multi-dose vial that contains several doses
- Use a new disposable syringe/needle each time
- Forzinity is injected in the abdomen (at least 2 inches from the navel) or outer thigh.
- Rotate the injection site daily, according to the Instructions for Use.
- Do not inject where the skin is tender, bruised, red, or hard. Avoid injecting into scars or stretch marks.
Before First Use:
- Let vial reach room temperature (10+ minutes).
- Write the discard date on the vial (8 days from opening).
- Check the tamper seal is intact.
Missed Dose
If a dose is missed, skip the dose and take the next dose of Forzinity at the scheduled time. Do not take a double dose of Forzinity.
Forzinity Storage:
- Unopened: Refrigerate 36-46°F (2-8°C)
- Opened: Refrigerate or room temperature 68-77°F (20-25°C)
- Discard 8 days after opening
- Don't freeze.
Safety:
- Don't mix with other medicines
- Use only prescribed syringes (wrong syringe = wrong dose)
- Never reuse/share needles
- Keep away from children.
Patient Monitoring
Healthcare providers should monitor for:
- Hypersensitivity reaction signs
- Injection site reactions
- Treatment response
- Kidney function (if impaired).
Forzinity Dosing Information
Standard Dosing for Barth Syndrome
- Adults and children ≥30kg: 40mg subcutaneously once daily
- Kidney impairment (eGFR <30 mL/min, not on dialysis): 20mg once daily
- Dialysis patients: Insufficient data, consult a physician.
Manufacturer & Prescription Information
Manufacturer: Stealth BioTherapeutics Inc., Needham, MA 02494
Frequently Asked Questions (FAQs)
How quickly does Forzinity work?
Clinical improvement in muscle strength was demonstrated in clinical trials, but individual response times vary. Discuss expectations with your healthcare provider.
Can Forzinity be used in children under 30kg?
No, Forzinity is only approved for patients weighing 30kg or more due to limited safety and efficacy data in smaller children.
What should I do if I experience injection site reactions?
Mild reactions can be treated with antihistamines or topical corticosteroids. Contact your healthcare provider if reactions are severe or persistent.
Does Insurance cover Forzinity?
Coverage varies by insurance plan. Contact your insurance provider or the manufacturer's patient assistance program for coverage information.
References
More about Forzinity (elamipretide)
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.