In short
This article discusses a clinical trial involving the use of All-Rac-Alpha-Tocopheryl Acetate BP, a form of vitamin E, as part of a multivitamin capsule for patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM). The trial aims to evaluate the long-term safety and efficacy of eplontersen, an investigational drug, in ATTR-CM patients while providing vitamin supplementation, including All-Rac-Alpha-Tocopheryl Acetate BP.
At a glance
- Study Type
- Open-label extension study
- Condition
- Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
- Main Objective
- Evaluate safety and tolerability of extended dosing with eplontersen
- Secondary Objective
- Evaluate efficacy parameters in overall population and subgroups
- Key Inclusion Criteria
- Completion of previous study or satisfactory participation in ISIS 420915CS101 study
- Key Exclusion Criteria
- Permanent discontinuation of Study Drug in previous studies
- Primary Endpoints
- Safety laboratory assessments, adverse events, anti-drug antibody assessments
- Secondary Endpoints
- Biomarkers, clinical tests, imaging tests, quality of life assessments
- Vitamin Supplement
- Concavit Capsules (including All-Rac-Alpha-Tocopheryl Acetate BP)
- Maximum Treatment Period
- 36 months
What is ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP?
ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP is a form of vitamin E that is used in medicinal products. It is one of the active ingredients in a medication called Concavit Capsules. The term "BP" stands for British Pharmacopoeia, which is a collection of quality standards for medicines in the United Kingdom.
Vitamin E is an important nutrient that acts as an antioxidant in the body, helping to protect cells from damage caused by free radicals. It also plays a role in immune function and other metabolic processes.
Uses and Benefits
ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP, as part of Concavit Capsules, is used as a multivitamin supplement. Multivitamins are used to provide essential vitamins and minerals that may be missing from a person's diet. They can help prevent or treat vitamin deficiencies.
The specific benefits of ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP (vitamin E) may include:
- Supporting immune system function
- Acting as an antioxidant to protect cells from damage
- Supporting skin health
- Potentially supporting heart health
However, it's important to note that this ingredient is part of a multivitamin formulation, so its effects are combined with those of other vitamins and minerals.
Formulation and Administration
ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP is included in Concavit Capsules, which are soft capsules taken orally. The medication is designed for oral use, meaning it should be taken by mouth.
Dosage Information
While the exact dosage of ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP in Concavit Capsules is not specified in the provided information, some general dosage details for the medication are available:
- The maximum daily dose is 3000 IU (International Units).
- The maximum total dose amount is 3,285,000 IU.
- The maximum treatment period is 36 months (3 years).
It's crucial to follow the dosage instructions provided by your healthcare provider or as indicated on the product label. Do not exceed the recommended dose without consulting your doctor.
Other Ingredients in Concavit Capsules
Concavit Capsules contain several other active ingredients along with ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP. These include:
- Ergocalciferol BP (Vitamin D2)
- Nicotinamide BP (Vitamin B3)
- Riboflavin BP (Vitamin B2)
- Calcium Pantothenate BP (Vitamin B5)
- Thiamine Nitrate BP (Vitamin B1)
- Vitamin A BP
- Ascorbic Acid BP (Vitamin C)
- Pyridoxine Hydrochloride BP (Vitamin B6)
This combination of vitamins makes Concavit Capsules a multivitamin supplement, classified under the ATC code A11BA for "Multivitamins, plain".
Important Considerations
When taking ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP as part of Concavit Capsules, keep in mind:
- This is a prescription medication and should be taken under the guidance of a healthcare professional.
- Inform your doctor about any other medications or supplements you're taking to avoid potential interactions.
- If you experience any unusual side effects, contact your healthcare provider immediately.
- This medication is not specifically formulated for pediatric use.
- Store the medication as directed on the packaging or by your pharmacist.
Remember, while vitamins are essential for health, more is not always better. Always follow the recommended dosage and consult with your healthcare provider if you have any concerns or questions about taking this supplement.