Important Safety Information: SS-31 (Elamipretide)
What is SS-31?
SS-31, also known as Elamipretide, is a mitochondria-targeting peptide designed to stabilize mitochondrial function and improve energy production. It is currently under investigation for the treatment of mitochondrial diseases, age-related disorders, and conditions associated with oxidative stress.
Warnings and Precautions
- Investigational Use Only
SS-31 is not FDA-approved for therapeutic use in humans. It is available for research purposes and clinical trials. Any use outside of these contexts is experimental and may carry significant risks. - Contraindications
- Do not use if you have a known allergy or hypersensitivity to SS-31 or its components.
- Avoid use during pregnancy, while breastfeeding, or if planning to conceive, as its effects on fetal and maternal health are unknown.
- Patients with active infections, severe metabolic imbalances, or advanced-stage diseases should consult a healthcare provider before use.
- Potential Side Effects
Side effects observed in clinical studies may include:- Injection site reactions, such as pain, redness, or swelling.
- Nausea, headache, or dizziness.
- Transient fatigue or muscle discomfort.
- Mild gastrointestinal symptoms, such as bloating or upset stomach.
- Precautions for Specific Conditions
- Cardiovascular Conditions: Use with caution in patients with a history of heart disease, as SS-31 targets mitochondrial function, which is integral to cardiac health.
- Renal Impairment: Patients with kidney dysfunction should consult their healthcare provider before use, as elimination pathways and effects on renal mitochondria are still being studied.
Drug Interactions
- SS-31 may interact with medications or treatments that influence mitochondrial function or oxidative stress.
- Inform your healthcare provider about all medications, supplements, and therapies you are using to avoid potential interactions.
Usage Instructions
- Administration
- SS-31 is typically administered via intravenous (IV) or subcutaneous injection in research or clinical settings.
- Follow administration protocols established by your healthcare provider or research institution.
- Dosage
- Doses vary widely depending on the study or condition being investigated. Adhere strictly to the prescribed dosage and administration schedule.
- Monitoring
- Periodic monitoring of mitochondrial function, biomarkers of oxidative stress, and overall health markers is essential during use to ensure safety and efficacy.
Storage and Handling
- Store SS-31 in a cool, dry place at 2–8°C (36–46°F).
- Protect from light and moisture.
- Reconstituted solutions should be used promptly or stored as directed.
- Keep out of reach of children and unauthorized personnel.
Disclaimers
- SS-31 is not approved by regulatory authorities such as the FDA for medical use. It is available only for investigational purposes.
- Off-label or unauthorized use may result in significant health risks and complications.
- The safety and efficacy of SS-31 for long-term use have not been fully established.
If you experience adverse effects or have concerns about SS-31, consult a licensed healthcare provider immediately. For more information, contact the product distributor or manufacturer.