Alitretinoin

Alitretinoin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Alitretinoin is a Dermatological Agent that is FDA approved for the treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma. Common adverse reactions include Rash, Application site pain, Pruritus, Exfoliative dermatitis, Skin disorder, Edema, Paresthesia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Panretin® gel is indicated for topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma. 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). There is no experience to date using Panretin® gel with systemic anti-KS treatment.

Dosage

• Panretin® gel should initially be applied two (2) times a day to cutaneous KS lesions. The application frequency can be gradually increased to three (3) or four (4) times a day according to individual lesion tolerance. 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.

Sufficient gel should be applied to cover the lesion with a generous coating. The gel should be allowed to dry for three to five minutes 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 on or near mucosal surfaces of the body.

A response of KS lesions may be seen as soon as two weeks after initiation of therapy but most patients require longer application. With continued application, further benefit may be attained. Some patients have required over 14 weeks to respond. In clinical trials, Panretin® gel was applied for up to 96 weeks. Panretin® gel should be continued as long as the patient is deriving benefit.

Occlusive dressings should not be used with Panretin® gel.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Alitretinoin in adult patients.

Non–Guideline-Supported Use

• Hand eczema, chronic (Moderate to Severe), Refractory to treatment

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Alitretinoin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Alitretinoin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Alitretinoin in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Alitretinoin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Alitretinoin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Alitretinoin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Alitretinoin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Alitretinoin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Alitretinoin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Alitretinoin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Alitretinoin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Alitretinoin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Alitretinoin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Alitretinoin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Alitretinoin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Alitretinoin in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Alitretinoin in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Alitretinoin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Alitretinoin in the drug label.

Pharmacology

There is limited information regarding Alitretinoin Pharmacology in the drug label.

Mechanism of Action

Structure

File:Alitretinoin01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Alitretinoin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Alitretinoin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Alitretinoin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Alitretinoin in the drug label.

How Supplied

Storage

There is limited information regarding Alitretinoin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Alitretinoin in the drug label.

Precautions with Alcohol

• Alcohol-Alitretinoin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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