Bexarotene (Targretin)

Trade Name : Targretin

Valeant Pharmaceuticals North America LLC

GEL

Strength 1 g/100g

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 Valeant Pharmaceuticals North America LLC. It is available in strength of 1 g/100g 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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About GNH

No data

Targretin (bexarotene) gel 1% contains bexarotene and is intended for topical application only. Bexarotene is 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 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.
Targretin gel is a clear gelled solution containing 1.0% (w/w) bexarotene in a base of dehydrated alcohol,u00a0USP, polyethylene glycol 400,u00a0NF, hydroxypropyl cellulose,u00a0NF, and butylated hydroxytoluene,u00a0NF.

No data

Targretin (bexarotene) gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies.

Targretin gel 1% is contraindicated in patients with a known hypersensitivity to bexarotene or other components of the product.
Targretin gel 1% may cause fetal harm when administered to a pregnant woman.
Targretin gel must not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking Targretin gel, Targretin gel must be stopped immediately and the woman given appropriate counseling.
Bexarotene caused malformations when administered orally to pregnant rats during days 7-17 of gestation. Developmental abnormalities included incomplete ossification at 4u00a0mg/kg/day and cleft palate, depressed eye bulge/microphthalmia, and small ears at 16u00a0mg/kg/day. At doses greater than 10u00a0mg/kg/day, bexarotene caused developmental mortality. The no-effect oral dose in rats was 1u00a0mg/kg/day. Plasma bexarotene concentrations in patients with CTCL applying Targretin gel 1% were generally less than one hundredth the Cassociated with dysmorphogenesis in rats, although some patients had Cmax levels that were approximately one eighth the concentration associated with dysmorphogenesis in rats.
Women of child-bearing potential should be advised to avoid becoming pregnant when Targretin gel is used. The possibility that a woman of child-bearing potential is pregnant at the time therapy is instituted should be considered. A negative pregnancy test (e.g., serum beta-human chorionic gonadotropin, beta-HCG) with a sensitivity of at least 50u00a0mIU/L should be obtained within oneu00a0week prior to Targretin gel therapy, and the pregnancy test must be repeated at monthly intervals while the patient remains on Targretin gel. Effective contraception must be used for oneu00a0month prior to the initiation of therapy, during therapy and for at least oneu00a0month following discontinuation of therapy; it is recommended that two reliable forms of contraception be used simultaneously unless abstinence is the chosen method. Male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must use condoms during sexual intercourse while applying Targretin gel and for at least oneu00a0month after the last dose of drug. Targretin gel therapy should be initiated on the second or third day of a normal menstrual period. No more than a oneu00a0month supply of Targretin gel should be given to the patient so that the results of pregnancy testing can be assessed and counseling regarding avoidance of pregnancy and birth defects can be reinforced.

No data

The safety of Targretin gel has been assessed in clinical studies of 117u00a0patients with CTCL who received Targretin gel for up to 172u00a0weeks. In the multicenter open-label study, 50u00a0patients with CTCL received Targretin gel for up to 98u00a0weeks. The mean duration of therapy for these 50u00a0patients was 199u00a0days. The most common adverse events reported with an incidence at the application site of at least 10% in patients with CTCL were rash, pruritus, skin disorder, and pain.
Adverse events leading to dose reduction or study drug discontinuation in at least twou00a0patients were rash, contact dermatitis, and pruritus.
Of the 49u00a0patients (98%) who experienced any adverse event, most experienced events categorized as mild (9u00a0patients, 18%) or moderate (27u00a0patients, 54%). There were 12u00a0patients (24%) who experienced at least one moderately severe adverse event. The most common moderately severe events were rash (7u00a0patients, 14%) and pruritus (3u00a0patients, 6%). Only oneu00a0patient (2%) experienced a severe adverse event (rash).
In the patients with CTCL receiving Targretin gel, adverse events reported regardless of relationship to study drug at an incidence of u22655% are presented in Table 1.
A similar safety profile for Targretingel was demonstrated in the Phaseu00a0I-II program. For the 67u00a0patients enrolled in the Phaseu00a0I-II program, the mean duration of treatment was 436u00a0days (range 12-1203u00a0days). As in the multicenter study, the most common adverse events regardless of relationship to study drug in the Phaseu00a0I-II program were rash (78%), pain (40%), and pruritus (40%).

Systemic toxicity following acute overdosage with topical application of Targretin gel is unlikely because of low systemic plasma levels observed with normal therapeutic doses. There is no specific antidote for overdosage.
There has been no experience with acute overdose of Targretin gel in humans. Any overdose with Targretin gel should be treated with supportive care for the signs and symptoms exhibited by the patient.

Targretin gel should be initially applied once every other day for the first week. The application frequency should be increased at weekly intervals to once daily, then twice daily, then three times daily and finally four times daily according to individual lesion tolerance. Generally, patients were able to maintain a dosing frequency of two to four times per day. Most responses were seen at dosing frequencies of two times per day and higher. If application site toxicity occurs, the application frequency can be reduced. Should severe irritation occur, application of drug can be temporarily discontinued for a few days until the symptoms subside. See n
Sufficient gel should be applied to cover the lesion with a generous coating. The gel should be allowed to dry before covering with clothing. Because unaffected skin may become irritated, application of the gel to normal skin surrounding the lesions should be avoided. In addition, do not apply the gel near mucosal surfaces of the body.
A response may be seen as soon as four weeks after initiation of therapy but most patients require longer application. With continued application, further benefit may be attained. The longest onset time for the first response among the responders was 392u00a0days based on the Composite Assessment of Index Lesion Severity in the multicenter study. In clinical trials, Targretin gel was applied for up to 172u00a0weeks.
Targretin gel should be continued as long as the patient is deriving benefit.
Occlusive dressings should not be used with Targretin gel.
Targretinu00ae gel is a topical therapy and is not intended for systemic use.Targretin gel has not been studied in combination with other CTCL therapies.

Targretin gel is supplied in tubes containing 60u00a0g (600u00a0mg active bexarotene).
60 g tubeNDC 0187-5525-60
Store at 25u00b0C (77u00b0F); with excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Avoid exposing to high temperatures and humidity after the tube is opened. Protect from light.
Manufactured for:
By
TARGRETIN is a trademark of Valeant Pharmaceuticals International Inc., or its affiliats.
u00a9Valeant Pharmaceuticals North America LLCRev. 10/2016 9553900

Targretin (bexarotene) 1% geln- Patient's Instructions for Usen- (For Topical Use Only)
To help you get the full benefits from this medicine, you should read this leaflet carefully and ask your doctor to explain anything you do not understand.
What are the most important things I should know about Targretin gel?
What is Targretin gel?
Targretin (tar-GRET-in) gel contains bexarotene (beks-AIR-oh-teen). Targretin gel belongs to a class of medicines known as retinoids.
What are the uses for Targretin gel?
This medicine is used to treat the skin problems arising from a disease called cutaneous T-cell lymphoma, or CTCL. Your health care provider has prescribed Targretin for the topical treatment of the cutaneous T-cell lymphoma (CTCL), or mycosis fungoides (MF), lesions (sometimes referred to as patches or plaques) on your skin. Your doctor must instruct you on the proper use of Targretin gel. The following instructions will help you successfully begin and continue your treatment.
Do not use Targretin gel if you are allergic to this medicine.
Do not use Targretin gel if you are pregnant or believe you may be pregnant.
If you have any of the following conditions, make sure you have discussed them with your doctor before you start to take this medicine.
When should you be extra careful while using Targretin gel?
WARNINGS
For external use only.
DO NOT apply the gel on or near mucosal surfaces of the body such as eyes, nostrils, mouth, lips, vagina, tip of the penis, rectum, or anus.
DO NOT use insect repellents containing DEET (-diethyl--toluamide) or other products containing DEET while using Targretin gel.
Keep out of reach of children.
Product contains alcohol and should be kept away from open flame.
DO NOT use Targretin gel if you are pregnant or breastfeeding. Speak to your health care provider if you have any questions or need more information.
HOW TO APPLY
Apply Targretin gel to your CTCL lesions using a clean washed finger. Place a of gel over the entire surface of each lesion. You should not apply gel to the healthy skin around the lesion. The extra effort you take in carefully applying the gel only to the area of the CTCL lesion will help to lessen any irritation or redness that may occur. Proper application should leave some gel visible on the surface of the lesion when you are finished with the application.
Immediately following application, wipe the finger(s) you have used to apply the gel with a disposable tissue and wash your hands using soap and water.
Allow five (5) to ten (10) minutes for the gel to dry before covering a treated area with clothing.
A mild non-deodorant soap is recommended when bathing or showering. If you apply Targretin gel after your shower or bath, you should wait 20u00a0minutes before application.
WHEN TO APPLY
Targretin gel should be applied at an initial frequency of once every other day for the first week. The frequency of application should then be increased as tolerated at weekly intervals to once daily, then twice daily, then three times daily, and finally four times daily. Your health care provider may instruct you to apply Targretin gel at a different frequency.
YOU SHOULD AVOID...
You should avoid
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WHAT SIDE EFFECTS DOES TARGRETIN GEL HAVE?
While using Targretin gel, you may experience some local effects such as redness, itching, burning, irritation, and scaling at the area of application. In clinical trials, the majority of these effects were mild or moderate, but some patients did experience more severe rash, itching, irritation, and inflammation. A few patients discontinued treatment due to these types of effects. Should these or other effects become troublesome to you, consult your health care provider. He or she can provide information on how to manage these effects.
All medications have side effects. You should call your physician regarding any questions or concerns you may have when using Targretin gel.
HOW QUICKLY CAN I EXPECT TARGRETIN GEL TO WORK?
Be patient. Targretin gel takes time to work. In clinical trials, some patients began to respond as early as 4u00a0weeks, but most patients did not experience their best response until 48 to 62u00a0weeks of treatment. Do not stop treatment at the first sign of improvement. Continue to use Targretin gel as instructed by your health care provider.
OTHER INFORMATION
The opening of the Targretin gel tube is covered by a metal safety seal. If this seal has been punctured or is not visible when you first open the package, this tube and promptly return the product to your pharmacy or place of purchase.
To open, use the pointed portion of the cap to puncture the metal safety seal.
Always use the cap to close the tube tightly after each use.
Store at room temperature. Keep away from heat or flame.
The gel should not be used after the expiration date printed on the tube.
Keep this medicine out of the reach and sight of children.
IF YOU HAVE QUESTIONS....
If you have questions about your treatment, talk with your health care provider.
Valeant
All other product/brand names are trademarks of their respective owners.
Targretin is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.
u00a9Valeant Pharmaceuticals North America LLC

PRINCIPAL DISPLAY PANEL - Carton 60 grams
Arrayn- (bexarotene)n- gel
Net Wt. 60u00a0grams
VALEANT
u00a0

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Bexarotene (Targretin)

Trade Name : Targretin

GEL

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Bexarotene (Targretin)

Trade Name : Targretin

GEL

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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