Vyndamax
Pronunciation: VIN-dah-max
Generic name: tafamidis
Dosage form: oral capsule
Drug class: Transthyretin stabilizers
What is Vyndamax?
Vyndamax is an oral prescription medicine that may be used to reduce death or hospitalization related to heart problems in adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). Vyndamax is a transthyretin stabilizer.
Vyndamax works by stabilizing abnormal transthyretin, a protein associated with ATTR-CM. This mechanism of action of Vyndamax prevents the formation of harmful amyloid protein deposits in the heart, slowing disease progression.
Vyndamax was FDA approved on May 3, 2019. There is no Vyndamax generic.
Vyndaqel Vs Vyndamax
The difference between Vyndaqel and Vyndamax is the form of the active ingredient they both contain, tafamidis. Vyndaqel has the micronized tafamidis meglumine salt, while Vyndamax has the free acid form of tafamidis.
Both forms work the same way in the body, but Vyndaqel contains a smaller amount of tafamidis, and needs to be taken 4 times a day. Vyndamax only needs to be taken 1 time per day.
Vyndamax side effects
There are no side effects of Vyndamax listed in the Vyndamax Package Insert, but the most common side effect reported post-marketing has been diarrhea.
- No additional lab testing or monitoring is required in people taking Vyndamax.
- As with any medicine, hypersensitivity reactions are possible. Get emergency medical help if you have signs of an allergic reaction, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Warnings
There are no warnings, serious side effects, or contraindications for Vyndamax.
Before taking
Before taking Vyndamax, tell your healthcare provider about all your medical conditions, including if you:
- have liver problems
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
Vyndamax may harm your unborn baby. You may need to take a pregnancy test before starting treatment and use effective contraception throughout treatment. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Vyndamax. You may also report your pregnancy by calling the Pfizer reporting line at 1-800-438-1985.
Breastfeeding
It is not known if Vyndamax passes into your breast milk. You should not breastfeed during treatment with Vyndamax. Talk to your healthcare provider about the best way to feed your baby during treatment.
How do I take Vyndamax?
Take Vyndamax exactly as your healthcare provider tells you to take it.
Take Vyndamax 1 time a day. Try to take it at around the same time each day.
- The usual dosage is 61 mg (1 capsule) once a day.
- You cannot substitute Vyndamax for Vyndaqel on a mg-to-mg basis.
Swallow the capsule whole. Do not crush or cut.
Related/similar drugs
Amvuttra, Vyndaqel, Onpattro, Tegsedi, Wainua, tafamidis, Attruby, inotersen, patisiran
What happens if I miss a dose?
If you miss a dose of Vyndamax, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regularly scheduled time. Do not take 2 doses at the same time.
What other drugs will affect Vyndamax?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect the way Vyndamax works, and Vyndamax may affect how some medicines work. Especially tell your healthcare provider if you take:
- Medications that are BCRP substrates such as methotrexate, rosuvastatin, or imatinib. Monitor for signs of BCRP substrate-related toxicities and modify the dosage of the substrate if appropriate.
Know the medicines you take. Keep a list of all your medicines. Show them to your healthcare provider or pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.
Storage
Store Vyndamax capsules at room temperature between 68°F to 77°F (20°C to 25°C).
Keep out of the reach of children.
Vyndamax ingredients
Active ingredient: tafamidis 61 mg
Inactive ingredients: ammonium hydroxide 28%, butylated hydroxytoluene, gelatin, glycerin, iron oxide (red), polyethylene glycol 400, polysorbate 20, povidone (K-value 90), polyvinyl acetate phthalate, propylene glycol, sorbitol, and titanium dioxide
Who makes Vyndamax?
Pfizer Inc. manufactures Vyndamax.
Popular FAQ
What’s the difference between Vyndaqel and Vyndamax?
The difference between Vyndaqel and Vyndamax lies in the form of tafamidis, their active ingredient, that they contain.
Vyndaqel contains the micronized meglumine salt of tafamidis, while Vyndamax contains the free acid form of tafamidis.
Vyndamax was developed for patient convenience and this formulation allows patients to take just one capsule once per day. Patients taking Vyndaqel, on the other hand, need to take four capsules once a day. Continue reading
How long does it take Vyndamax to work?
Vyndamax, when compared to a placebo, was shown to improve the survival rates (71% vs. 57%, respectively) for patients with wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) over a 30-month long clinical study. Quality-of-life measurements improved as early as 6 months. Continue reading
How long does it take for Vyndaqel to start working?
It takes at least 6 months for Vyndaqel to start working and it may take up to 18 months for the full effects to be seen, but these persist for at least 30 months. There was significantly less decline in functional capacity (as measured by a 6-minute walk test [6MWT]) and health status (as measured by the Kansas City Cardiomyopathy Questionnaire-Overall Summary [KCCQ-OS]) with Vyndaqel at 6 months than placebo. It may take at least 18 months before Vyndaqel makes a difference in all cause mortality compared to placebo, but this difference persists and trials have reported a survival rate of 71% in those taking Vyndaqel compared to 57% taking placebo. Those receiving Vyndaqel had 32% less hospitalizations due to heart problems, also statistically significant. Continue reading
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