"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
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® (bexarotene) capsules is 300 mg/m2/day. (See Table 4.) Targretin® (bexarotene) 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® (bexarotene) 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® (bexarotene) 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® (bexarotene) capsules were administered for up to 97 weeks.
Targretin® (bexarotene) capsules should be continued as long as the patient is deriving benefit.
Targretin® (bexarotene) capsules are supplied as 75-mg off-white, oblong soft gelatin capsules, imprinted with "Targretin® (bexarotene) ," 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 by: R.P. Scherer St. Petersburg, FL 33716. FDA rev date: 4/21/2003
Last reviewed on RxList: 9/19/2008
This monograph has been modified to include the generic and brand name in many instances.
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