Alitretinoin

What is Alitretinoin?

• Alitretinoin (Panretin) is a naturally-occurring endogenous retinoid is used for topical treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma.

Alitretinoin Structure

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Alitretinoin2DACS

What are the uses of this medicine?

• Alitretinoin (Panretin) is used for topical treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma.

Limitations of use:

• Panretin® gel is not indicated when systemic anti-KS therapy is required (e.g., more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement).

How does this medicine work?

• Alitretinoin (9-cis-retinoic acid) is a naturally-occurring endogenous retinoid that binds to and activates all known intracellular retinoid receptor subtypes (RARα, RARβ, RARγ, RXRα, RXRβ and RXRγ).
• Once activated these receptors function as transcription factors that regulate the expression of genes that control the process of cellular differentiation and proliferation in both normal and neoplastic cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with a known hypersensitivity to retinoids or to any of the ingredients of the product.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Do not use insect repellants that contain DEET while using alitretinoin.

Is this medicine FDA approved?

• Food and Drug Administration (FDA) approved alitretinoin in February 1999.

How should this medicine be used?

Recommended dosage:

• Panretin® gel should initially be applied two times a day to cutaneous KS lesions.
• The application frequency can be gradually increased to three or four times a day according to individual lesion tolerance.

Administration:

• Alitretinoin comes in topical gel.
• Alitretinoin is usually used twice a day.
• Your doctor may tell you to use alitretinoin more or less frequently depending on your response to it.
• Wash your hands and affected skin area thoroughly with mild soap (not medicated or abrasive soap or soap that dries the skin) and water.
• Use clean fingertips, a gauze pad, or a cotton swab to apply the medication.
• Apply enough gel to cover the lesion with a generous coating.
• Apply the medication to the affected skin area only. Do not apply to unaffected areas; do not apply on or near mucus membranes.
• Allow the gel to dry for 3-5 minutes before covering with clothing.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a gel 0.1% contains alitretinoin and is intended for topical application only.

This medicine is available in fallowing brand namesː

• Panretin

What side effects can this medication cause?

The most common side effects of this medicine include:

• Rash
• Pain
• Pruritus
• Exfoliative dermatitis
• Skin disorder
• Paresthesia
• Edema

What special precautions should I follow?

• Retinoids as a class have been associated with photosensitivity. Patients should be advised to minimize exposure of treated areas to sunlight and sunlamps during the use of Panretin® gel.
• Patients who are applying Panretin® gel should not concurrently use products that contain DEET (N,N-diethyl-m-toluamide), a common component of insect repellent products.
• Panretin® gel could cause fetal harm if significant absorption were to occur in a pregnant woman.
• Tell your doctor if you have or have ever had a type of skin cancer known as T-cell lymphoma.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There has been no experience with acute overdose of Panretin® gel in humans.

Management of overdosage:

• There is no specific antidote for overdosage.
• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category D.
• There are no adequate and well-controlled studies in pregnant women.
• Panretin® gel could cause fetal harm if significant absorption were to occur in a pregnant woman.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• alitretinoin

Inactive Ingredients:

• Dehydrated alcohol
• Polyethylene Glycol
• Hydroxypropyl Cellulose
• Butylated Hydroxytoluene

Who manufactures and distributes this medicine?

Manufactured for:

• Ligand Pharmaceuticals Incorporated
• San Diego, CA

Manufactured by:

• Bristol-Myers Squibb Company
• Princeton, NJ USA

What should I know about storage and disposal of this medication?

• Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F).

• Dailymed label info on Alitretinoin
• FDA Alitretinoin

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