Vyndaqel (Tafamidis meglumine) - Dose, MOA, Side effects

Vyndaqel (tafamidis meglumine - Pfizer) and Vyndamax (Tafamidis) are oral prescription medicines that selectively bind to the transthyretin and stabilize the transporter protein preventing its dissociation halting the process of amyloidosis.

Vyndaqel (Tafamidis meglumine) Uses:

  • Amyloid cardiomyopathy:

    • It is intended for the treatment of people with inherited transthyretin-mediated amyloidosis or wild-type amyloid cardiomyopathy (ATTR-CM).
    • It reduces cardiovascular mortality and cardio vascular related hospitalization.

Tafamidis (Vyndaqel) Dose in Adults

Tafamidis (Vyndaqel) Dose in the treatment of Amyloid cardiomyopathy:

Note:

Vyndamax (Tafamidis) and Vyndaqel (tafamidis meglumine) are not equivalent on a per mg basis.

  • Tafamidis (Vyndamax) dose:

    • 61 mg orally once a day.
  • Tafamidis meglumine (Vyndaqel):

    • 80 mg orally once a day.

Tafamidis (Vyndaqel) Dose in Children

Tafamidis (Vyndaqel) is not indicated in children.

Pregnancy Risk Category: Not Assigned

  • This information is not available.
  • The manufacturer suggests that pregnant women use effective contraception because of the potential for adverse fetal outcomes in the animals.

Tafamidis use during breastfeeding:

  • It is unknown if the drug will be excreted into breastmilk.
  • The manufacturer suggests that you avoid breastfeeding because of possible adverse effects on the infant.

Tafamidis Dose in Kidney Disease:

The manufacturer has not recommended any adjustment in the dose in patients with kidney disease.

Tafamidis Dose in Liver Disease:

The manufacturer has not recommended any adjustment in the dose in patients with hepatic impairment.

Side effects of Tafamidis (Vyndaqel):

Side effects of the drug have not been listed in the manufacturer's labeling. However, the most common side effects in clinical trials are mentioned here:

  • urinary tract infection
  • vaginal infection,
  • upper abdominal pain and dyspepsia
  • diarrhea.

Contraindication to Tafamidis (Vyndaqel):

The manufacturer's labeling does not contain any contraindications.

Warnings and precautions

  • None mentioned.

  • Vyndaqel, VyndamaxTafamidis meglumine and Tafamidis tartamidis are not the same in terms of mg: mg. When using drugs, it is important to exercise caution.

Monitoring parameters:

Monitor the response to therapy.

How to administer Tafamidis (Vyndaqel)?

  • It is administered orally.
  • The capsules shouldn't be chewed, chopped, or crushed; they should be swallowed whole.

Mechanism of action of Tafamidis (Vyndaqel):

  • Tafamidis stabilises the tetramer TTR transport protein by binding to it at the thyroxine binding sites.
  • Tafamidis slows down the dissociation of transthyretin into monomers by stabilizing it (TTR).
  • The amyloidogenic process' rate-limiting stage is this one. In practise, Tafamidis stabilises both the tetramers from the 14 TTR variations as well as the wildtype TTR Tetramers. It stabilises all 25 TTR mutations ex vivo.

Protein binding: >99% of Tafamidis is bound to plasma proteins primarily TTR

Metabolism: is not known, however, glucuronidation of the drug has been observed

Half-life elimination of Tafamidis is about 49 hours

The time to peak serum concentration of Tafamidis is 4 hours

Excretion of Tafamidis meglumine:

  • Feces: ~59% (unchanged);
  • Urine: ~22% (glucuronide metabolite)

Tafamidis: Clearance: 0.236 L/hour

International Brands of Tafamidis:

  • Vyndaqel (Pfizer)

Tafamidis Price in US:

  • Each Vyndamax 61 mg Oral Capsule costs:  $750.00
  • Each Vyndaqel 20 mg Oral Capsule costs: $187.50

Tafamidis Brand Names in Pakistan:

No Brands Available in Pakistan.