VYNDAQEL 20 mg Soft capsule (2020)
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Περιεχόμενα
Name of the medicinal product
Vyndaqel 20 mg soft capsules.
Qualitative and quantitative composition
Each soft capsule contains 20 mg of micronized tafamidis meglumine equivalent to 12.2 mg tafamidis. Excipient with known effect: Each soft capsule contains no more than 44 mg of sorbitol (E420). For the ...
Pharmaceutical form
Soft capsule. Yellow, opaque, oblong (approximately 21 mm) capsule imprinted with VYN 20 in red.
Therapeutic indications
Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Posology and method of administration
Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with transthyretin amyloid polyneuropathy (ATTR-PN). Posology The recommended dose of tafamidis ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Women of childbearing potential should use appropriate contraception when taking tafamidis meglumine and continue to use appropriate contraception for 1-month after stopping treatment with tafamidis meglumine ...
Interaction with other medicinal products and other forms of interaction
In a clinical study in healthy volunteers, 20 mg tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4. In vitro tafamidis inhibits the efflux transporter BCRP (breast cancer ...
Fertility, pregnancy and lactation
Women of childbearing potential Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis meglumine, and for one month after stopping treatment, due to the ...
Effects on ability to drive and use machines
On the basis of the pharmacodynamic and pharmacokinetic profile, tafamidis meglumine is believed to have no or negligible influence on the ability to drive or use machines.
Undesirable effects
Summary of the safety profile The overall clinical data reflect exposure of 127 patients with ATTR-PN to 20 mg of tafamidis meglumine administered daily for an average of 538 days (ranging from 15 to 994 ...
Overdose
Symptoms There is minimal clinical experience with overdose. During clinical trials, two patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM) accidentally ingested a single tafamidis ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other nervous system drugs ATC code: N07XX08 Mechanism of action Tafamidis is a selective stabiliser of TTR. Tafamidis binds to TTR at the thyroxine binding sites, stabilising ...
Pharmacokinetic properties
Absorption After oral administration of the soft capsule once daily, the maximum peak concentration (C<sub>max</sub>) is achieved within a median time (t<sub>max</sub>) of 4 hours after dosing in the fasted ...
Preclinical safety data
Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, fertility and early embryonic development, genotoxicity and carcinogenic potential. In repeat-dose ...
List of excipients
Capsule shell: Gelatine (E441) Glycerine (E422) Yellow iron oxide (E172) Sorbitan Sorbitol (E420) Mannitol (E421) Titanium dioxide (E171) Purified water Capsule contents: Macrogol 400 (E1521) Sorbitan ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
PVC/PA/alu/PVC-alu/PET/Paper perforated unit dose blisters. Pack sizes: a pack of 30 1 soft capsules and a multipack containing 90 (3 packs of 30 1) soft capsules. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Marketing authorization number(s)
EU/1/11/717/001 EU/1/11/717/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 November 2011 Date of latest renewal: 22 July 2016
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