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Indications

REMS


Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

No adverse reactions reported in prescribing information.

Interactions

Drug-drug:

Availability

  • Capsules (Vyndaqel): 20 mg
  • Capsules (Vyndamax): 61 mg

Route/Dosage

Vyndaqel

  • PO (Adults ): 80 mg once daily.

Vyndamax

  • PO (Adults ): 61 mg once daily.

US Brand Names

Vyndamax, Vyndaqel

Action

  • Acts as a transthyretin (TTR) stabilizer by selectively binding to TTR at the thyroxine binding sites and stabilizing the tetramer of the TTR transport protein by slowing its dissociation into monomers, which is the rate-limiting step in the amyloidogenic process.
Therapeutic effects:
  • Reduction in mortality and cardiovascular hospitalizations.

Classifications

Therapeutic Classification: none assigned

Pharmacologic Classification:

Pharmacokinetics

Absorption: Unknown.

Distribution: Well distributed to tissues.

Protein Binding: >99%.

Metabolism/Excretion: Metabolic pathway not fully known (may undergo glucuronidation). 59% excreted in feces (primarily as unchanged drug); 22% excreted in urine (primarily as metabolites).

Half-Life: 49 hr.

Time/Action Profile

(plasma concentrations)

ROUTEONSETPEAKDURATION
POUnknown4 hr24 hr



Patient/Family Teaching

  • Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy. If a dose is missed, instruct patient to take as soon as remembered or omit and take the next scheduled dose. Do not double doses.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
  • Rep: Advise women of reproductive potential of potential risk to fetus and to avoid breastfeeding during therapy. Notify health care professional if pregnancy is planned or suspected or if breastfeeding. Consider reporting pregnancy to Pfizer at 1-800-438-1985.

Pronunciation

ta-FAM-id-is