Vyndaqel and Vyndamax
- Generic Name: tafamidis and tafamidis meglumine capsules
- Brand Name: Vyndaqel and Vyndamax
Vyndaqel and Vyndamax (Tafamidis and Tafamidis Meglumine Capsules) side effects drug center
Vyndaqel and Vyndamax Side Effects Center
What Is Vyndaqel and Vyndamax?
Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) are transthyretin stabilizers indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
What Are Side Effects of Vyndaqel and Vyndamax?
There were no known side effects that happened during treatment with Vyndaqel or Vyndamax in people with cardiomyopathy of transthyretin-mediated amyloidosis. Tell your doctor if you experience any side effects.
Dosage for Vyndaqel and Vyndamax
The recommended dosage is either Vyndaqel 80 mg orally once daily, or Vyndamax 61 mg orally once daily.
What Drugs, Substances, or Supplements Interact with Vyndaqel and Vyndamax?
Vyndaqel and Vyndamax may interact with methotrexate, rosuvastatin, and imatinib. Tell your doctor all medications and supplements you use.
Vyndaqel and Vyndamax During Pregnancy or Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Vyndaqel or Vyndamax; they may harm a fetus. It is unknown if Vyndaqel and Vyndamax pass into breast milk. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended while using Vyndaqel or Vyndamax.
Additional Information
Our Vyndaqel (tafamidis meglumine) Capsules, for Oral Administration and Vyndamax (tafamidis) Capsules, for Oral Administration Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Vyndaqel and Vyndamax Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Less serious side effects may be more likely, and you may have none at all.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Vyndaqel and Vyndamax (Tafamidis and Tafamidis Meglumine Capsules)
Vyndaqel and Vyndamax Professional Information
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data reflect exposure of 377 ATTR-CM patients to 20 mg or 80 mg (administered as four 20-mg capsules) of VYNDAQEL administered daily for an average of 24.5 months (ranging from 1 day to 111 months).
Adverse events were assessed from ATTR-CM clinical trials with VYNDAQEL, primarily a 30-month placebo-controlled trial [see Clinical Studies]. The frequency of adverse events in patients treated with VYNDAQEL 20 mg (n=88) or 80 mg (n=176; administered as four 20-mg capsules) was similar to that with placebo (n=177).
In the 30-month placebo-controlled trial, similar proportions of VYNDAQEL-treated patients and placebo-treated patients discontinued the study drug because of an adverse event: 12 (7%), 5 (6%), and 11 (6%) from the VYNDAQEL 80-mg, VYNDAQEL 20-mg, and placebo groups, respectively.
DRUG INTERACTIONS
BCRP Substrates
Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of substrates of this transporter (e.g., methotrexate, rosuvastatin, imatinib) following VYNDAQEL 80 mg or VYNDAMAX 61 mg. Dose adjustment may be needed for these substrates.
Read the entire FDA prescribing information for Vyndaqel and Vyndamax (Tafamidis and Tafamidis Meglumine Capsules)
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&Copy; Vyndaqel and Vyndamax Patient Information is supplied by Cerner Multum, Inc. and Vyndaqel and Vyndamax Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.