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TARGRETIN Soft capsule (2019)

Active ingredients: Bexarotene

Therapeutic indications

Targretin is indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) in adult 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.

Posology

The recommended initial dose is 300 mg/m²/day. Initial dose calculations according to body surface area are as follows:

Table 1. Recommended initial dose:

Initial dose level (300 mg/m²/ημέρα)Number of 75 mg Targretin capsules
Body Surface Area (m²)Total daily dose (mg/ημέρα)0.88–1.123004
1.13-1.373755
1.38-1.624506
1.63-1.875257
1.88-2.126008
2.13-2.376759
2.38-2.6275010

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.

Paediatric population

The safety and efficacy of bexarotene in children (aged below 18 years) have not been established. No data are available.

Elderly patients

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.

Patients with renal impairment

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.

Method of administration

For oral use.

Targretin capsules should be taken as a single oral daily dose with a meal. The capsule should not be chewed.

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 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.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C.

Keep the bottle tightly closed.

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 for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.