Tafamidis

Tafamidis is a prescription medication used for the treatment of Transthyretin Amyloid Cardiomyopathy. 

• Tafamidis is available under the following different brand names: Vyndamax

Common side effects of Tafamidis include:

• None

Serious side effects of Tafamidis include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Rash,
• Itching, and
• Severe dizziness

Rare side effects of Tafamidis include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 61 mg

Transthyretin Amyloid Cardiomyopathy

Adult dosage

• 61 mg orally once a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tafamidis has severe interactions with no other drugs.
• Tafamidis has serious interactions with the following drugs
  • alpelisib
  • ozanimod
  • rimegepant
• Tafamidis has moderate interactions with at least 33 other drugs.
• Tafamidis has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tafamidis?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tafamidis?”

Cautions

• Drug interactions overview
  • Breast cancer-resistant protein (BCRP) inhibitor
  • BCRP substrates
  • Monitor for signs of BCRP substrate-related toxicities and modify the dosage of the substrate if appropriate
  • Tafamadis increases exposure and risk of toxicities of BCRP substrates

Pregnancy and Lactation

• Based on animal studies, fetal harm may occur when administered to a pregnant woman
• Limited available human data with tafamidis meglumine use in pregnant women (at a dose of 20 mg/day) have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Consider pregnancy planning and prevention for females of reproductive potential
• Report pregnancies to the Pfizer reporting line at 1-800-438-1985
• Lactation
  • No data available on the presence of tafamidis in human milk, its effect on the breastfed infant, or the effect on milk production
  • Tafamidis is present in rat milk; the drug may likely be present in human milk
  • Based on animal studies, which suggest the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment