Bexarotene (Targretin)

Trade Name : Targretin

Bausch Health US LLC

CAPSULE, LIQUID FILLED

Strength 75 mg/1

BEXAROTENE Retinoid [EPC],Retinoids [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Bexarotene (Targretin) which is also known as Targretin and Manufactured by Bausch Health US LLC. It is available in strength of 75 mg/1 per ml. Read more

Bexarotene (Targretin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • TARGRETIN is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats. TARGRETIN must not be administered to a pregnant woman. ()
  • WARNING: BIRTH DEFECTS
  • See full prescribing information for complete boxed warning.
  • TARGRETIN is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats. TARGRETIN must not be administered to a pregnant woman. ()
  • 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.
  • TARGRETIN (bexarotene) is a retinoid 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 TARGRETIN is 300 mg/m/day (see Table 1). TARGRETIN 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 [n
  • Dose Modification Guidelines: The 300 mg/m/day dose level of TARGRETIN 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, TARGRETIN was administered for up to 97 weeks.
  • TARGRETIN should be continued as long as the patient is deriving benefit.
  • 2n- 2
  • Capsules: 75 mg, off-white, oblong soft gelatin capsules, imprinted with black ink u201cTargretinu201d.
  • Capsules: 75 mg ()
  • No data
  • No data
  • 5.1n- 5.11
  • The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • The safety of TARGRETIN has been evaluated in two clinical trials of 152 patients with CTCL who received TARGRETIN for up to 97 weeks and in 352 patients in other trials. The mean duration of therapy for the 152 patients with CTCL was 166 days. The most common adverse events reported with an incidence of at least 10% in patients with CTCL treated at an initial dose of 300 mg/m/day of TARGRETIN are shown in Table 2. The events at least possibly related to treatment are lipid abnormalities (elevated triglycerides, elevated total and LDL cholesterol and decreased HDL cholesterol), hypothyroidism, headache, asthenia, rash, leukopenia, anemia, nausea, infection, peripheral edema, abdominal pain, and dry skin. Most adverse events occurred at a greater incidence in patients treated at starting doses of greater than 300 mg/m/day (see Table 2).
  • Adverse reactions leading to TARGRETIN dose reduction or discontinuation in at least two patients were hyperlipemia, neutropenia/leukopenia, diarrhea, fatigue/lethargy, hypothyroidism, headache, liver function test abnormalities, rash, pancreatitis, nausea, anemia, allergic reaction, muscle spasm, pneumonia, and confusion.
  • The NCI Grade 3 and NCI Grade 4 adverse reactions reported in two or more patients with CTCL treated at an initial dose of 300 mg/m/day of TARGRETIN (see Table 3) were hypertriglyceridemia, pruritus, headache, peripheral edema, leukopenia, rash, and hypercholesteremia. Most of these moderately severe or severe adverse events occurred at a higher rate in patients treated at starting doses of greater than 300 mg/m/day than in patients treated at a starting dose of 300 mg/m/day.
  • In patients with CTCL receiving an initial dose of 300 mg/m/day, the incidence of NCI Grade 3 or 4 elevations in triglycerides and total cholesterol was 28% and 25%, respectively (Table 4). In contrast, in patients with CTCL receiving greater than 300 mg/m/day, the incidence of NCI Grade 3 or 4 elevated triglycerides and total cholesterol was 45% and 45%, respectively. Other Grade 3 and 4 laboratory abnormalities are shown in Table 3.
  • In addition to the 152 patients enrolled in the two CTCL trials, 352 patients received TARGRETIN as monotherapy for various advanced malignancies at doses from 5 mg/m/day to 1000 mg/m/day. The common adverse reactions (incidence greater than 10%) were similar to those seen in patients with CTCL.
  • In the 504 patients (CTCL and non-CTCL) who received TARGRETIN as monotherapy, drug-related serious adverse reactions that were fatal, in one patient each, were acute pancreatitis, subdural hematoma, and liver failure.
  • In the patients with CTCL receiving an initial dose of 300 mg/m/day of TARGRETIN, adverse reactions reported at an incidence of less than 10% and not included in Tables 2-4 or discussed in other parts of labeling and possibly related to treatment were as follows:
  • Body as a Whole:
  • Cardiovascular:
  • Digestive:
  • Hemic and Lymphatic:
  • Metabolic and Nutritional:
  • Musculoskeletal:
  • Nervous:
  • Respiratory
  • Skin and Appendages:
  • Special Senses:
  • Urogenital:
  • Table : Incidence of Moderately Severe and Severe Adverse Events Reported in at Least Two Patients (CTCL Trials)
  • Table : Treatment-Emergent Abnormal Laboratory Values in CTCL Trials
  • The safety profile from the one post-approval trial with 59 subjects was generally comparable to that of the pivotal trials with the exception of serious adverse events hypertriglyceridemia, neutropenia and bone marrow failure which were observed more frequently in the TARGRETIN 300 mg/m/day group than in the TARGRETIN 150 mg/m/day group.
  • Severe hypertriglyceridemia (800 mg/dL) was not seen in any subject in the lower dosage arm.
  • The most common AEs by preferred term in either the TARGRETIN 300 or 150 mg/m/day treatment group were as follows: hypertriglyceridemia (18 subjects [62.1%] and 17 subjects [56.7%], respectively); hypothyroidism (15 subjects [51.7%] and 13 subjects [43.3%], respectively); headache (9 subjects [31.0%] and 7 subjects [23.3%], respectively); hypercholesterolemia (8 subjects [27.6%] and 7 subjects [23.3%], respectively); neutropenia (7 subjects [24.1%] and 2 subjects [6.7%], respectively); and skin exfoliation (5 subjects [17.2%] and 5 subjects [16.7%], respectively).
  • Higher percentage of subjects in the TARGRETIN 300 mg/m/day group than in TARGRETIN 150 mg/m/day group experienced SAEs (13 subjects [44.8%] vs 11 subjects [36.7%], respectively.
  • Of the SAEs of special interest, there were more events in the TARGRETIN 300 mg/m/day group than in the TARGRETIN 150 mg/m/day group of bone marrow failure (3 [10.3%] vs 1 [3.3%, respectively]), neutropenia (3 [10.3%] vs 0 [0%], respectively), and of hypertriglyceridemia (9 [31%] vs 2 [6.7%], respectively).
  • The most common adverse reactions (greater than 10%) include: hyperlipidemia, hypercholesteremia, headache, hypothyroidism, asthenia, leukopenia, rash, nausea, infection, peripheral edema, abdominal pain, and dry skin. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or
  • Arrayn- Effect of Other Drugs on TARGRETIN
  • Gemfibrozil: Concomitant administration of TARGRETIN and gemfibrozil resulted in increases in plasma concentrations of bexarotene. Concomitant administration of gemfibrozil with TARGRETIN is not recommended.
  • Arrayn- Effect of TARGRETIN on Other Drugs
  • TARGRETIN may be an inducer for the CYP3A4 enzymes, and may reduce plasma concentrations of other substrates metabolized by CYP3A4. Drug products which may be affected include oral or other systemic hormonal contraceptives. Thus, if treatment with TARGRETIN is intended for a female with reproductive potential, it is strongly recommended that a non-hormonal contraception be considered. [].
  • Laboratory Test Interference
  • CA125 assay values in patients with ovarian cancer may be increased by TARGRETIN therapy.
  • No data
  • Doses up to 1000 mg/m/day of TARGRETIN have been administered in short-term trials in patients with advanced cancer without acute toxic effects. Single doses of 1500 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.
  • TARGRETIN (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 follows:
  • 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 TARGRETIN 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, sorbitol special-glycerin blend, and titanium dioxide, USP.
  • No data
  • Long-term studies in animals to assess the carcinogenic potential of bexarotene have not been conducted. Bexarotene is not mutagenic to bacteria (Ames assay) or mammalian cells (mouse lymphoma assay). Bexarotene was not clastogenic (micronucleus test in mice).
  • No formal fertility studies were conducted with bexarotene. Bexarotene caused testicular degeneration when oral doses of 1.5 mg/kg/day were given to dogs for 91 days (producing an AUC of approximately one fifth the AUC at the recommended human daily dose).
  • TARGRETIN was evaluated in two clinical trials in 152 patients with advanced and early stage cutaneous T-cell lymphoma (CTCL) in two multicenter, open-label, historically-controlled clinical trials conducted in the U.S., Canada, Europe, and Australia.
  • The advanced disease patients had disease refractory to at least one prior systemic therapy (median of two, range one to six prior systemic therapies) and had been treated with a median of five (range 1 to 11) prior systemic, irradiation, and/or topical therapies. Early disease patients were intolerant to, had disease that was refractory to, or had reached a response plateau of six months on, at least two prior therapies. The patients entered had been treated with a median of 3.5 (range 2 to 12) therapies (systemic, irradiation, and/or topical).
  • The two clinical trials enrolled a total of 152 patients, 102 of whom had disease refractory to at least one prior systemic therapy, 90 with advanced disease and 12 with early disease. This is the patient population for whom TARGRETIN is indicated.
  • Patients were initially treated with a starting dose of 650 mg/m/day with a subsequent reduction of starting dose to 500 mg/m/day. Neither of these starting doses was tolerated, and the starting dose was then reduced to 300 mg/m/day. If, however, a patient on 300 mg/m/day of TARGRETIN showed no response after eight or more weeks of therapy, the dose could be increased to 400 mg/m/day.
  • Tumor response was assessed in both trials by observation of up to five baseline-defined index lesions using a Composite Assessment of Index Lesion Disease Severity (CA). This endpoint was based on a summation of the grades, for all index lesions, of erythema, scaling, plaque elevation, hypopigmentation or hyperpigmentation, and area of involvement. Also considered in response assessment was the presence or absence of cutaneous tumors and extracutaneous disease manifestations.
  • All tumor responses required confirmation over at least two assessments separated by at least four weeks. A partial response was defined as an improvement of at least 50% in the index lesions without worsening, or development of new cutaneous tumors or non-cutaneous manifestations. A complete clinical response required complete disappearance of all manifestations of disease, but did not require confirmation by biopsy.
  • At the initial dose of 300 mg/m/day, 1/62 (1.6%) of patients had a complete clinical tumor response and 19/62 (30%) of patients had a partial tumor response. The rate of relapse (25% increase in CA or worsening of other aspects of disease) in the 20 patients who had a tumor response was 6/20 (30%) over a median duration of observation of 21 weeks, and the median duration of tumor response had not been reached. Responses were seen as early as 4 weeks and new responses continued to be seen at later visits.
  • In one post-approval clinical trial with a total of 59 subjects (29 in 300 mg/m/day dose group and 30 in the 150 mg/m/day dose), the objective response rate was higher in the TARGRETIN 300 mg/m/day group than in the TARGRETIN 150 mg/m/day group with respect to the CA (34.5% vs 23.3%), Physicians Global Assessment (PGA) (37.9% vs 20.0%), and percent BSA involvement (34.5% vs 23.3%).
  • The median duration of response in the TARGRETIN 300 mg/m/day group based on the CA, PGA, and percent BSA involvement was 86.5 days, 72.0 days and 60.0 days respectively. While in the TARGRETIN 150 mg/m/day group the median duration of response based on the CA, PGA, and percent BSA involvement was 55 days, 119.0 days and 118.0 days respectively.
  • The median time to cutaneous tumor response (the time to cutaneous tumor response for a given subject is defined as the time interval from the first day of TARGRETIN treatment to the time of the first observation when the subject with subsequent confirmation of response meets criteria for CR, CCR or PR) in the TARGRETIN 300 mg/m/day group based on the CA, PGA, and percent BSA involvement was 85 days, 98 days and 117.5 days respectively. While in the TARGRETIN 150 mg/m/day group the median time to cutaneous tumor response based on the CA, PGA, and percent BSA involvement was 87 days, 57 days and 57 days respectively. In the TARGRETIN 300 mg/m/day group, the median time to cutaneous tumor progression based on the CA, PGA, and percent BSA involvement was 77.5, 115.5, and 88.0 days, respectively. In the TARGRETIN 150 mg/m/day group, the median time to cutaneous tumor progression was 203.0 days based on the CA and 86.0 days based on percent BSA involvement; no subject in this treatment group had cutaneous tumor progression based on the PGA.
  • TARGRETIN (bexarotene) Capsules are supplied as 75 mg off-white, oblong soft gelatin capsules, imprinted with u201cTargretinu201d, in high density polyethylene bottles with child-resistant closures.
  • Bottles of 100 capsules: NDC 0187-5526-75
  • Store at 2u00b0 to 25u00b0C (36u00b0 to 77u00b0F). Avoid exposing to high temperatures and humidity after the bottle is opened. Protect from light.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Inform the patient or caregiver about the following:
  • Birth Defects
  • Advise patients that TARGRETIN is contraindicated in pregnancy TARGRETIN is a member of the retinoid class of drugs that is associated with birth defects in humans n
  • Pancreatitis
  • Advise patients of the risk of developing pancreatitis, which may be accompanied by nausea, vomiting, and abdominal or back pain and to immediately contact their healthcare provider if these symptoms occur n
  • Hepatotoxicity
  • Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their healthcare provider if signs of liver failure occur, including jaundice, anorexia, bleeding, or bruising n
  • Neutropenia
  • Advise patients of the possibility of developing neutropenia and to immediately contact their healthcare provider should they develop a fever, particularly in association with any suggestion of infection n
  • Cataracts
  • Advise patients of the possibility of developing new or worsening cataracts and to inform their healthcare provider about any changes in their vision during treatment with TARGRETIN n
  • Vitamin A Supplementation Hazard
  • Advise patients to limit vitamin A intake to 15,000 IU/day to avoid potential additive toxic effects.
  • Hypoglycemia and Diabetes Mellitus
  • Advise patients of the possibility of developing hypoglycemia when using insulin, agents enhancing insulin secretion, or insulin-sensitizers while on TARGRETIN therapy. Instruct patients on these medications to check their blood sugar frequently and to notify their physicians of any changes in blood sugar level n
  • Photosensitivity
  • Advise patients of potential increased skin sensitivity to sunlight while taking TARGRETIN and to minimize exposure to sunlight and artificial ultraviolet light n
  • Laboratory Tests
  • Advise patients of laboratory testing which will occur during therapy to monitor lipids, liver function, thyroid function, and white blood cell counts If applicable, advise patients of monthly pregnancy testing n
  • Administration Instructions
  • Advise patients to take TARGRETIN with a meal n
  • Manufactured for:
  • Valeant Pharmaceuticals North America LLC
  • Bridgewater, NJ 08807 USA
  • By
  • Catalent Pharma Solutions LLC
  • St. Petersburg, FL 33716
  • US Patent Number: 5,962,731
  • Targretinis a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
  • Any other product/brand names are trademarks of their respective owners.
  • u00a9 Valeant Pharmaceuticals International, Inc.
  • 9436600
  • Revised: 10/2015
  • Patient Information
  • TARGRETIN(tar-GRET-in)
  • (bexarotene)
  • Capsules
  • What is the most important information I should know about TARGRETIN?
  • TARGRETIN can cause serious side effects, including major birth defects to an unborn baby, if taken during pregnancy.
  • For females who can become pregnant:
  • For males:
  • What is TARGRETIN?
  • TARGRETIN is a prescription medicine used to treat the skin problems that happen with a type of cancer called cutaneous T-cell lymphoma (CTCL) after treatment with at least one other type of medicine by mouth or injection, did not work or has stopped working.
  • It is not known if TARGRETIN is safe and effective in children.
  • Who should not take TARGRETIN?
  • Do not take TARGRETIN:
  • Before taking TARGRETIN, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all of the medicines you take,
  • How should I take TARGRETIN?
  • Take your dose of TARGRETIN 1 time a day with a meal. Your healthcare provider will do blood tests before you start TARGRETIN and during treatment to check for side effects.
  • What should I avoid while taking TARGRETIN?
  • What are the possible side effects of TARGRETIN?
  • TARGRETIN can cause serious side effects, including:
  • Tell your healthcare provider right
  • The most common side effects of TARGRETIN include:
  • These are not all the possible side effects of TARGRETIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store TARGRETIN?
  • Keep TARGRETIN and all medicines out of the reach of children.
  • General information about the safe and effective use of TARGRETIN
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TARGRETIN for a condition for which it was not prescribed. Do not give TARGRETIN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TARGRETIN that is written for health professionals
  • What are the ingredients in TARGRETIN?
  • Active ingredient: bexarotene
  • Inactive ingredients: polyethylene glycol 400, polysorbate 20, povidone, and butylated hydroxyanisole. The capsule shell contains gelatin, sorbitol special-glycerin blend, and titanium dioxide.
  • Manufactured for:
  • By:
  • US Patent Number: 5,962,731
  • Targretin is a trademark of Valeant Pharmaceuticals International, Inc, or its affiliates.
  • Any other product/brand names are trademarks of their respective owners.
  • u00a9Valeant Pharmaceuticals International, Inc.
  • For more information, call 1-800-321-4576.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Revised: 10/2015
  • NDC 0187-5526-75
  • Targretinu00aen- (bexarotene) capsules
  • 75u00a0mg
  • One (1) bottle of 100u00a0capsules each
  • Each capsule contains 75u00a0mg bexarotene.
  • Rx Only

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