Targretin (Bexarotene) - Indications and Dosage

INDICATIONS AND USAGE

Targretin^® (bexarotene) capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.

DOSAGE AND ADMINISTRATION

The recommended initial dose of Targretin^® capsules is 300 mg/m²/day. (See Table 4.) Targretin^® capsules should be taken as a single oral daily dose with a meal. See CONTRAINDICATIONS: Pregnancy: Category X section for precautions to prevent pregnancy and birth defects in women of child-bearing potential.

Table 4.    Targretin^® Capsule Initial Dose Calculation According to Body Surface Area

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 of Targretin^® capsules 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. If there is no tumor response after eight weeks of treatment and if the initial dose of 300 mg/m²/day is well tolerated, the dose may be escalated to 400 mg/m²/day with careful monitoring.

Duration of Therapy: In clinical trials in CTCL, Targretin^® capsules were administered for up to 97 weeks.

Targretin^® capsules should be continued as long as the patient is deriving benefit.

HOW SUPPLIED

Targretin^® capsules are supplied as 75 mg off-white, oblong soft gelatin capsules, imprinted with“Targretin”, in high density polyethylene bottles with child-resistant closures.

Bottles of 100 capsules........................................................................ NDC 64365-502-01

Store at 2^°-25^°C (36^°-77^°F). Avoid exposing to high temperatures and humidity after the bottle is opened. Protect from light.

Manufactured for:
Ligand Pharmaceuticals Incorporated
San Diego, CA 92121

Medical Information Telephone Number: (800) 964-5836

Manufactured by:
Cardinal Health
St. Petersburg, FL 33716

“Ligand”, the Ligand logo and Targretin^® are registered trademarks of Ligand Pharmaceuticals, Inc.

U.S. Patent Nos. 5,466,861, 5,780,676, and 5,962,731

Ligand Part #3000207        (Rev. 0403)
Anderson Part #5422101-03