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Bexarotene
Overview
What is Bexarotene?
Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs).
The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follow:
Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of CHO. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP.
Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: polyethylene glycol 400, NF, polysorbate 20, NF, povidone, USP, and butylated hydroxyanisole, NF. The capsule shell contains gelatin, NF, water, sorbitol sorbitan solution, NF, glycerin, USP and titanium dioxide, USP. The imprinting ink contains hypromellose, USP, iron oxide black, and polyethylene glycol, USP.
What does Bexarotene look like?
What are the available doses of Bexarotene?
Capsules: 75 mg ()
What should I talk to my health care provider before I take Bexarotene?
How should I use Bexarotene?
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.
The recommended initial dose of bexarotene capsules is 300 mg/m/day (see Table 1). Bexarotene capsules should be taken as a single oral daily dose with a meal. For precautions to prevent pregnancy and birth defects in women of child-bearing potential [].
Dose Modification Guidelines: The 300 mg/m/day dose level of bexarotene capsules may be adjusted to 200 mg/m/day then to 100 mg/m/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/m/day is well tolerated, the dose may be escalated to 400 mg/m/day with careful monitoring.
Duration of Therapy: In clinical trials in CTCL, bexarotene was administered for up to 97 weeks.
Bexarotene capsules should be continued as long as the patient is deriving benefit.
What interacts with Bexarotene?
Sorry No Records found
What are the warnings of Bexarotene?
Sorry No Records found
What are the precautions of Bexarotene?
Sorry No Records found
What are the side effects of Bexarotene?
Sorry No records found
What should I look out for while using Bexarotene?
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4.2
What might happen if I take too much Bexarotene?
Doses up to 1,000 mg/m/day of bexarotene have been administered in short-term trials in patients with advanced cancer without acute toxic effects. Single doses of 1,500 mg/kg and 720 mg/kg were tolerated without significant toxicity in rats and dogs, respectively. These doses are approximately 30 and 50 times, respectively, the recommended human dose on a mg/m basis.
How should I store and handle Bexarotene?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Bexarotene capsules are supplied as 75 mg white to off-white, oblong soft gelatin capsules printed with in black ink, in high density polyethylene bottles with child-resistant closures.Bottles of 100 capsules: NDC 0378-6955-01Store at 2° to 25°C (36° to 77°F). Avoid exposing to high temperatures and humidity after the bottle is opened. Protect from light.Bexarotene capsules are supplied as 75 mg white to off-white, oblong soft gelatin capsules printed with in black ink, in high density polyethylene bottles with child-resistant closures.Bottles of 100 capsules: NDC 0378-6955-01Store at 2° to 25°C (36° to 77°F). Avoid exposing to high temperatures and humidity after the bottle is opened. Protect from light.Bexarotene capsules are supplied as 75 mg white to off-white, oblong soft gelatin capsules printed with in black ink, in high density polyethylene bottles with child-resistant closures.Bottles of 100 capsules: NDC 0378-6955-01Store at 2° to 25°C (36° to 77°F). Avoid exposing to high temperatures and humidity after the bottle is opened. Protect from light.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Bexarotene selectively binds and activates retinoid X receptor subtypes (RXRα, RXRβ, RXRγ). RXRs can form heterodimers with various receptor partners such as retinoic acid receptors (RARs), vitamin D receptor, thyroid receptor, and peroxisome proliferator activator receptors (PPARs). Once activated, these receptors function as transcription factors that regulate the expression of genes that control cellular differentiation and proliferation. Bexarotene inhibits the growth of some tumor cell lines of hematopoietic and squamous cell origin. It also induces tumor regression in some animal models. The exact mechanism of action of bexarotene in the treatment of cutaneous T-cell lymphoma (CTCL) is unknown.
Non-Clinical Toxicology
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4.2
See WARNINGS section.
No cross-resistance with other chemotherapeutic agents, radiotherapy or steroids has been demonstrated.
Bexarotene induces substantial elevations in lipids in most patients. About 70% of patients with CTCL who received an initial dose of ≥300 mg/m/day of bexarotene had fasting triglyceride levels greater than 2.5 times the upper limit of normal. About 55% had values over 800 mg/dL with a median of about 1,200 mg/dL in those patients. Cholesterol elevations above 300 mg/dL occurred in approximately 60% and 75% of patients with CTCL who received an initial dose of 300 mg/m/day or greater than 300 mg/m/day, respectively. Decreases in high density lipoprotein (HDL) cholesterol to less than 25 mg/dL were seen in about 55% and 90% of patients receiving an initial dose of 300 mg/m/day or greater than 300 mg/m/day, respectively, of bexarotene. Monitor lipid changes and treat abnormalities during therapy. The effects on triglycerides, HDL cholesterol, and total cholesterol were reversible with cessation of therapy, and could generally be mitigated by dose reduction and/or concomitant antilipemic therapy.
Perform fasting blood lipid determinations before bexarotene therapy is initiated and weekly until the lipid response to bexarotene is established, which usually occurs within two to four weeks, and monitor at eight week intervals thereafter. Fasting triglycerides should be normal or normalized with appropriate intervention prior to initiating bexarotene therapy. Maintain triglyceride levels below 400 mg/dL to reduce the risk of clinical sequelae []. If fasting triglycerides are elevated or become elevated during treatment, institute antilipemic therapy, and if necessary, reduce or interrupt the dose of bexarotene. In the 300 mg/m/day initial dose group, 60% of patients were given lipid lowering drugs. Atorvastatin was used in 48% (73/152) of patients with CTCL. Because of a potential drug-drug interaction, avoid gemfibrozil use with bexarotene [].
The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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