VYNDAMAX Tafamidis Application Scope

Indicated for treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

VYNDAMAX Tafamidis Characteristics

Ingredients: tafamidis
Properties: Transthyretin stabilizer; oral soft-gel capsule; capsule is reddish-brown, opaque, and oblong and printed with “VYN 61.”
Packaging Specification: 3 blister cards, each card 10 capsules (total 30 capsules)
Storage: Store below 25°C in a dry place, protected from light and moisture. Use within 30 days after opening
Expiry Date: See product carton/blister for lot-specific expiry
Executive Standard: U.S. FDA Full Prescribing Information
Approval Number: NDA 212161
Date of Revision: 10/2023 (current FDA label referenced).
Manufacturer: Pfizer Inc.

Guidelines for the Use of VYNDAMAX

Dosage and Administration:
- Recommended Dose: VYNDAMAX 61 mg orally once daily.
- Administration: Swallow capsules whole; do not crush or cut. May be taken with or without food.
- Missed Dose: Take as soon as remembered. If missed, take as soon as remembered within 12 hours. If it is more than 12 hours, skip the dose; do not double the next dose.
Adverse Reactions:
- Common Adverse Reactions (≥5% and >3% higher than placebo):
  - Injection site reactions (19%)
  - Decreased platelet count (12%)
  - Arthralgia (9%)
  - Diarrhea (7%).
  - Peripheral edema (6%).
- Serious Adverse Reactions:
  - Hepatic abnormalities (monitor ALT/AST).
  - Hypersensitivity (e.g., bronchospasm, angioedema, urticaria).
Contraindications: Patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA.
Precautions:
- Hypersensitivity Reactions: Monitor patients for signs and symptoms. Discontinue use if reactions occur.
- Platelet Count Monitoring: Monitor platelet counts during treatment.
- Pregnancy and Lactation: Advise patients to inform their healthcare provider if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

VYNDAMAX Interactions

BCRP substrates (e.g., methotrexate): May increase drug levels
Strong CYP3A4 inducers (e.g., rifampin): May reduce effectiveness
Pregnancy & breastfeeding: Not recommended (consult doctor)
Liver/kidney impairment: Use with caution

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.