VyndamaxTM 61 mg (tafamidis) Abbreviated Prescribing Information:
PRESENTATION: Tafamidis 61-mg soft gelatin capsule for oral use.
INDICATIONS: VYNDAMAX is indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
DOSAGE AND ADMINISTRATION: The recommended dosage of Vyndamax is 61 mg (one 61-mg tafamidis capsule) orally once daily. The capsules should be swallowed whole and not crushed or cut. If a dose is missed, instruct patients to take the dose as soon as remembered or to skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose. No clinically significant differences in the pharmacokinetics of tafamidis were observed following administration of a high fat, high calorie meal.
SPECIAL POPULATION: Pregnancy: VYNDAMAX may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. Lactation: There are no available data on the presence of tafamidis in human milk, the effect on the breastfed infant, or the effect on milk production. Advise patients that breastfeeding is not recommended during treatment with VYNDAMAX. VYNDAMAX may cause fetal harm when administered to a pregnant woman. Consider pregnancy planning and prevention for females of reproductive potential. Pediatric Use: The safety and effectiveness of VYNDAMAX have not been established in pediatric patients. Geriatric Use: No dosage adjustment is required for elderly patients (≥65 years).
CONTRAINDICATIONS: None.
WARNING AND PRECAUTIONS: None.
DRUG INTERACTIONS: BCRP Substrates: Tafamidis inhibits breast cancer resistant protein (BCRP) in humans. Coadministration of tafamidis and drugs that are BCRP substrates may increase the exposure of substrates of this transporter and the risk of the substrate-related toxicities. Monitor for signs of BCRP substrate-related toxicities and modify dosage of the substrate if appropriate.
OVERDOSE: There is minimal clinical experience with overdose.
ADVERSE REACTION: Adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
PHARMACEUTICAL PRECAUTIONS: Store at controlled room temperature 20°C to 25°C; excursions permitted to 15°C to 30°C.
REFERENCE: VYNDAMAX™ (Tafamidis) Egyptian Drug Authority leaflet approval date 26/7/2021. Revision date: June 2021
DATE OF THIS DOCUMENT: 27-Oct-21
-Healthcare professionals should report any suspected adverse reactions to the Egyptian pharmacovigilance center (EPVC hotline:15301) & pharmacovigilance department of Pfizer ([email protected])
-Approved by Egyptian Drug Authority HF0098OA171/082022 invalidation date: 11/08/2024
-Kindly report any violated online promotional ,educational and awareness material not having this message to the general administration for regulation of marketing and advertising materials at : www.edaegypt.gov.eg(link is external)
MOA: mechanism of action; MOD: mechanism of disease.
MOH Approval No. : HF0098OA171/082022
Invalidation Date : 11/08/2024
PP-VDM-EGY-0011
