Tafamidis meglumine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of tafamidis meglumine.
Drugs List
Therapeutic Indications
Uses
Treatment of TTR-FAP in adults with stage 1 symptomatic polyneuropathy
Treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Dosage
Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis.
Adults
The recommended dose is 20mg of tafamidis meglumine once daily.
Additional Dosage Information
If vomiting occurs after dosing and the capsule is identified and intact, then an additional dose should be administered. If no capsule is identified, then no additional dose is necessary. Resume with next day dosing as usual.
Contraindications
Children under 18 years
Breastfeeding
Hereditary fructose intolerance
Liver transplant
Pregnancy
Precautions and Warnings
Females of childbearing potential
Renal impairment - creatinine clearance below or equal to 30ml/minute
Severe hepatic impairment
Treatment to be initiated and supervised by a specialist
Presentations with sorbitol unsuitable in hereditary fructose intolerance
May affect results of some laboratory tests
Discontinue if patient undergoes liver transplant
Female: Contraception required during and for 1 month after treatment
Patients should be monitored continually to assess the need for other therapy, including the need for liver transplantation.
Pregnancy and Lactation
Pregnancy
Tafamidis meglumine is contraindicated during pregnancy.
The manufacturer does not recommend using tafamidis meglumine during pregnancy and in women of childbearing potential not using contraception. Animal studies have shown developmental toxicity. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Tafamidis meglumine is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking tafamidis meglumine. Animal studies indicate tafamidis is expressed in the breast milk, but the quantity is unknown.
Side Effects
Diarrhoea
Upper abdominal pain
Urinary tract infections
Vulvovaginal infections
Effects on Laboratory Tests
A decrease in total thyroxine with no accompanying change to free thyroxine (T4) or thyroid stimulating hormone (TSH) may occur during treatment with tafamidis meglumine.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2020
Reference Sources
Summary of Product Characteristics: Vyndaqel 20mg soft capsules. Pfizer Ltd. Revised February 2020.
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