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Forzinity
Resources
Mito Assist® Patient Support Program
Learn about Mito Assist, a no-cost support program available for eligible individuals prescribed FORZINITY that connects them with helpful tools, personalized resources, and guidance throughout treatment.
FORZINITY Enrollment Form
Enroll your patient in Mito Assist to get them started with FORZINITY with support.
FORZINITY Treatment Guide
Support your patient's FORZINITY treatment experience by learning about important administration information with easy-to-follow instructions for preparing and using their subcutaneous injection supplies.
Watch this video for step-by-step guidance detailing how to administer FORZINITY.
INDICATION AND IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
Contraindications
FORZINITY is contraindicated in patients with serious hypersensitivity to elamipretide or any of the excipients in FORZINITY.
Warnings and Precautions
Benzyl Alcohol Toxicity – Do Not Use in Neonates
Serious and fatal reactions (including metabolic acidosis progressing to neurotoxicity and gasping syndrome) have occurred in preterm and low-birth-weight neonates receiving benzyl alcohol (BA)-containing drugs.
FORZINITY contains 20 mg BA/mL and is not approved for use in neonates or for IV administration.
Hypersensitivity
Reported reactions include rash, papular lesions, eczema/dermatitis, cough, and serious allergic reactions requiring emergency medical intervention.
Reactions may occur minutes to months after starting treatment. Monitor patients for signs and symptoms during treatment.
Discontinue FORZINITY permanently if a serious hypersensitivity reaction occurs.
Adverse Reactions
Adverse reactions occurring more commonly with FORZINITY than with placebo included injection site reactions such as injection site erythema, pain, induration, pruritus, bruising, and urticaria.
Eosinophilia
Modest elevations in eosinophil counts (peak ~90 days) occurred but were not associated with clinical symptoms.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Full Prescribing Information for FORZINITY.
INDICATION
FORZINITY is a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.
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).
IMPORTANT SAFETY INFORMATION
Contraindications
FORZINITY is contraindicated in patients with serious hypersensitivity to elamipretide or any of the excipients in FORZINITY.
Warnings and Precautions
Benzyl Alcohol Toxicity – Do Not Use in Neonates
Serious and fatal reactions (including metabolic acidosis progressing to neurotoxicity and gasping syndrome) have occurred in preterm and low-birth-weight neonates receiving benzyl alcohol (BA)-containing drugs.
FORZINITY contains 20 mg BA/mL and is not approved for use in neonates or for IV administration.
Hypersensitivity
Reported reactions include rash, papular lesions, eczema/dermatitis, cough, and serious allergic reactions requiring emergency medical intervention.
Reactions may occur minutes to months after starting treatment. Monitor patients for signs and symptoms during treatment.
Discontinue FORZINITY permanently if a serious hypersensitivity reaction occurs.
Adverse Reactions
Adverse reactions occurring more commonly with FORZINITY than with placebo included injection site reactions such as injection site erythema, pain, induration, pruritus, bruising, and urticaria.
Eosinophilia
Modest elevations in eosinophil counts (peak ~90 days) occurred but were not associated with clinical symptoms.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Full Prescribing Information for FORZINITY.
INDICATION
FORZINITY is a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.
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).