Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Eisai Ltd. European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom
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.
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/m2/day. Targretin capsules should be taken as a single oral daily dose with a meal (see section 4.5). Initial dose calculations according to body surface area are as follows:
| Initial dose level (300 mg/m2/day) | Number of 75 mg Targretin capsules | |
|---|---|---|
| Body Surface Area (m²) | Total daily dose (mg/day) | |
| 0.88 – 1.12 | 300 | 4 |
| 1.13 – 1.37 | 375 | 5 |
| 1.38 – 1.62 | 450 | 6 |
| 1.63 – 1.87 | 525 | 7 |
| 1.88 – 2.12 | 600 | 8 |
| 2.13 – 2.37 | 675 | 9 |
| 2.38 – 2.62 | 750 | 10 |
Dose modification guidelines: the 300 mg/m2/day dose level may be adjusted to 200 mg/m2/day then to 100 mg/m2/day, or temporarily suspended, if necessitated by toxicity. When toxicity is controlled, doses may be carefully readjusted upward. With appropriate clinical monitoring, individual patients may benefit from doses above 300 mg/m2/day. Doses greater than 650 mg/m²/day have not been evaluated in patients with CTCL. In clinical trials, bexarotene was administered for up to 118 weeks to patients with CTCL. Treatment should be continued as long as the patient is deriving benefit.
Use in children and adolescents: the clinical safety and effectiveness of bexarotene in the paediatric population (below 18 years of age) have not been studied and this product should not be used in a paediatric population until further data become available.
Use in the elderly: of the total number of patients with CTCL in clinical studies, 61% were 60 years or older, while 30% were 70 years or older. No overall differences in safety were observed between patients 70 years or older and younger patients, but greater sensitivity of some older individuals to bexarotene cannot be ruled out. The standard dose should be used in the elderly.
Renal insufficiency: no formal studies have been conducted in patients with renal insufficiency. Clinical pharmacokinetic data indicate that urinary elimination of bexarotene and its metabolites is a minor excretory pathway for bexarotene. In all evaluated patients, the estimated renal clearance of bexarotene was less than 1 ml/minute. In view of the limited data, patients with renal insufficiency should be monitored carefully while on bexarotene therapy.
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 of bexarotene have been administered in clinical studies with no acute toxic effects. Single doses of 1500 mg/kg (9000 mg/m²) and 720 mg/kg (14,400 mg/m²) were tolerated without significant toxicity in rats and dogs, respectively.
3 years.
High-density polyethylene bottles with child-resistant closures containing 100 capsules.
No special requirements.
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