section name header

Pronunciation ⬇

ta-FAM-id-is

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification:

Indications ⬆ ⬇

REMS

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.

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



Contraind./Precautions ⬆ ⬇

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects ⬆ ⬇

No adverse reactions reported in prescribing information.

Interactions ⬆ ⬇

Drug-drug:

Route/Dosage ⬆ ⬇

Vyndaqel

  • PO (Adults ): 80 mg once daily.

Vyndamax

  • PO (Adults ): 61 mg once daily.

Availability ⬆ ⬇

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

Assessment ⬆ ⬇

  • Monitor cardiovascular status at baseline and as clinically indicated during therapy.

Lab Test Considerations:

  • Test for variant TTR genotype prior to initiation of therapy.

Implementation ⬆ ⬇

  • PO: Administer without regard to food. DNC: Swallow capsules whole. Do not crush, cut, or chew.

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.

Evaluation/Desired Outcomes ⬆ ⬇

  • Reduction in mortality and cardiovascular hospitalizations.

US Brand Names ⬆

Vyndamax, Vyndaqel