Version May 2024
Amyloid cardiomyopathy: Oral:
Note: Tafamidis (Vyndamax) and tafamidis meglumine (Vyndaqel) are not substitutable on a per mg basis.
Tafamidis (Vyndamax): 61 mg once daily.
Tafamidis meglumine (Vyndaqel): 80 mg once daily.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
There are no adverse reactions listed in the manufacturer's labeling.
There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Additional contraindications not in the US labeling: Hypersensitivity to tafamidis or any component of the formulation.
Other warnings/precautions:
• Appropriate use: Equivalency: Tafamidis (Vyndamax) and tafamidis meglumine (Vyndaqel) are not substitutable on a per mg basis.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Vyndamax: 61 mg
Capsule, Oral, as meglumine:
Vyndaqel: 20 mg [contains fd&c blue #1 (brilliant blue)]
No
Capsules (Vyndamax Oral)
61 mg (per each): $893.29
Capsules (Vyndaqel Oral)
20 mg (per each): $223.32
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Vyndamax: 61 mg
Capsule, Oral, as meglumine:
Vyndaqel: 20 mg [contains carmine, fd&c blue #1 (brilliant blue)]
Oral: Swallow capsules whole; do not crush or cut.
Amyloid cardiomyopathy: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
Inhibits BCRP/ABCG2
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alpelisib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Alpelisib. Management: Avoid coadministration of BCRP/ABCG2 inhibitors and alpelisib due to the potential for increased alpelisib concentrations and toxicities. If coadministration cannot be avoided, closely monitor for increased alpelisib adverse reactions. Risk D: Consider therapy modification
BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors): Tafamidis may increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Berotralstat: BCRP/ABCG2 Inhibitors may increase the serum concentration of Berotralstat. Management: Decrease the berotralstat dose to 110 mg daily when combined with BCRP inhibitors. Risk D: Consider therapy modification
Cladribine: BCRP/ABCG2 Inhibitors may increase the serum concentration of Cladribine. Management: Avoid concomitant use of BCRP inhibitors during the 4 to 5 day oral cladribine treatment cycles whenever possible. If combined, consider dose reduction of the BCRP inhibitor and separation in the timing of administration. Risk D: Consider therapy modification
Imatinib: Tafamidis may increase the serum concentration of Imatinib. Risk C: Monitor therapy
Methotrexate: Tafamidis may increase the serum concentration of Methotrexate. Risk C: Monitor therapy
PAZOPanib: BCRP/ABCG2 Inhibitors may increase the serum concentration of PAZOPanib. Risk X: Avoid combination
Rosuvastatin: Tafamidis may enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Tafamidis may increase the serum concentration of Rosuvastatin. Management: Avoid this combination if possible. If combined, initiate rosuvastatin at a dose of 5 mg once daily and do not exceed a dose of rosuvastatin 20 mg daily. Monitor for signs of myopathy and rhabdomyolysis. Risk D: Consider therapy modification
Talazoparib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Talazoparib. Risk C: Monitor therapy
Topotecan: BCRP/ABCG2 Inhibitors may increase the serum concentration of Topotecan. Risk X: Avoid combination
Ubrogepant: BCRP/ABCG2 Inhibitors may increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a BCRP inhibitor. Risk D: Consider therapy modification
Based on adverse events observed in animal reproduction studies, the manufacturer recommends pregnancy planning and pregnancy prevention in females of reproductive potential.
Information related to tafamidis use in pregnancy is limited and based on doses of 20 mg/day.
It is not known if tafamidis is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.
Tafamidis is a transthyretin (TTR) stabilizer that selectively binds to TTR at the thyroxine binding sites and stabilizes the tetramer of the TTR transport protein, slowing dissociation into monomers which is the rate-limiting step in the amyloidogenic process. Tafamidis stabilizes both wild-type TTR tetramers and the tetramers of 14 TTR variants when tested clinically as well as 25 TTR variants tested ex vivo.
Distribution: Tafamidis: Vdss: 18.5 L
Protein binding: Tafamidis: >99%, primarily TTR
Metabolism: Tafamidis: Not fully established; glucuronidation has been observed
Half-life elimination: Tafamidis: ~49 hours
Time to peak: Tafamidis: 4 hours
Excretion: Tafamidis meglumine: Feces: ~59% (unchanged); Urine: ~22% (glucuronide metabolite)
Tafamidis: Clearance: 0.236 L/hour
Hepatic function impairment: In moderate hepatic impairment (Child-Pugh class B), tafamidis systemic exposure decreased (~40%) and clearance increased (~68%) compared to healthy subjects. Since TTR levels are lower with moderate hepatic impairment, exposure of tafamidis relative to the amount of TTR is sufficient to maintain stabilization of the TTR tetramer in these patients.
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