Targretin Capsules (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης | Eisai Ltd |
---|---|
Διεύθυνση | Teva UK Limited, Field House, Station Approach, Harlow, Essex, CM20 2FB |
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Δωρεάν εγγραφή
Name of the medicinal product
Targretin 75 mg soft capsules.
Qualitative and quantitative composition
Each capsule contains 75 mg of bexarotene. For a full list of excipients, see section 6.1.
Pharmaceutical form
Soft capsule. Off-white capsule, containing a liquid suspension and imprinted with Targretin.
Therapeutic indications
Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.
Posology and method of administration
Bexarotene therapy should only be initiated and maintained by physicians experienced in the treatment of patients with CTCL. The recommended initial dose is 300 mg/m<sup>2</sup>/day. Targretin capsules ...
Contraindications
Known hypersensitivity to bexarotene or to any of the excipients of the product. Pregnancy and lactation. Women of child-bearing potential without effective birth-control measures. History of pancreatitis. ...
Special warnings and precautions for use
General: Targretin capsules should be used with caution in patients with a known hypersensitivity to retinoids. No clinical instances of cross-reactivity have been noted. Patients receiving bexarotene ...
Special warnings and precautions for use
Do not store above 30°C. Keep the bottle tightly closed.
Interaction with other medicinal products and other forms of interaction
Effects of other substances on bexarotene: no formal studies to evaluate interactions with bexarotene have been conducted. On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 ...
Pregnancy and lactation
Pregnancy There are no adequate data from the use of bexarotene in pregnant women. Studies in animals have shown reproductive toxicity. Based on the comparison of animal and patient exposures to bexarotene, ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, dizziness and visual difficulties have been reported in patients taking Targretin. Patients who experience ...
Undesirable effects
The safety of bexarotene has been examined in clinical studies of 193 patients with CTCL who received bexarotene for up to 118 weeks and in 420 non-CTCL cancer patients in other studies. In 109 patients ...
Overdose
No clinical experience with an overdose of Targretin has been reported. Any overdose should be treated with supportive care for the signs and symptoms exhibited by the patient. Doses up to 1000 mg/m²/day ...
Pharmacodynamic properties
Pharmacotherapeutic Group: other antineoplastic agents ATC code: L01XX25 Bexarotene is a synthetic compound that exerts its biological action through selective binding and activation of the three RXRs: ...
Pharmacokinetic properties
Absorption/dose proportionality: pharmacokinetics were linear up to a dose of 650 mg/m². Terminal elimination half-life values were generally between one and three hours. Following repeat once daily dose ...
Preclinical safety data
Carcinogenesis, mutagenesis, impairment of fertility Bexarotene is not genotoxic. Carcinogenicity studies have not been conducted. Fertility studies have not been conducted; however, in sexually immature ...
List of excipients
Capsule content: Macrogol Polysorbate Povidone Butylated hydroxyanisole Capsule shell: Gelatin Sorbitol special-glycerin blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol and water) ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Nature and contents of container
High-density polyethylene bottles with child-resistant closures containing 100 capsules.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Eisai Ltd. European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom
Marketing authorization number(s)
EU/1/01/178/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 March 2001 Date of latest renewal: 29 March 2006
Date of revision of the text
6th Apr 2009