Panretin

What is Panretin used for?

Panretin is a prescription medicine that is used to treat skin wounds in patients with AIDS-related Kaposi’s sarcoma.

Description

Panretin® gel 0.1% contains alitretinoin and is intended for topical application only. The chemical name is 9-cis-retinoic acid and the structural formula is as follows:

Chemically, alitretinoin is related to vitamin A. It is a yellow powder with a molecular weight of 300.44 and a molecular formula of C20H28O2. It is slightly soluble in ethanol (7.01 mg/g at 25oC) and insoluble in water. Panretin® gel is a clear, yellow gel containing 0.1% (w/w) alitretinoin in a base of dehydrated alcohol USP, polyethylene glycol 400 NF, hydroxypropyl cellulose NF, and butylated hydroxytoluene NF.

Mechanism of Action

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. Alitretinoin inhibits the growth of Kaposi’s sarcoma (KS) cells in vitro.

Before taking Panretin, tell your doctor:

• If you are allergic to Panretin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding. Do not breast-feed while you take Panretin.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Panretin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Panretin?

• Tell all of your health care providers that you take Panretin. This includes your doctors, nurses, pharmacists, and dentists.
• It may take several weeks to see the full effects.
• Do not use Panretin with insect repellents that have N, N-diethyl-m-toluamide (DEET).
• Talk with your doctor before you use other drugs or products on your skin.
• Do not scratch the affected area.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• This medicine may cause harm if swallowed. If Panretin is swallowed, call a doctor or poison control center right away.
• People using Panretin may get skin reactions where Panretin is used or around the area. These reactions may include burning, crusting, dryness, flaking, itching, oozing, pain, redness, scabbing, scaling, sores or ulcers, or swelling. If these reactions get very bad, a break from using Panretin may be needed as told by the doctor. Talk with the doctor.
• Call your doctor right away if you have a skin reaction that bothers you or if the reaction makes it hard to keep putting Panretin on. Call your doctor right away if you have a skin reaction that causes problems with daily living.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking Panretin.
• If you are pregnant or you get pregnant while taking Panretin, call your doctor right away.

How is Panretin best taken?

Use Panretin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Do not take Panretin by mouth. Use on your skin only.
• Do not put Panretin on or near the eyes, nostrils, mouth, lips, vagina, tip of the penis, rectum, or anus. If you get Panretin in any of these areas, rinse with water right away.
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put on the affected part as you have been told.
• Avoid putting on healthy skin.
• Let gel dry before covering with clothing.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• Put the cap back on after you are done using your dose.
• This medicine may catch on fire. Do not use near an open flame or while smoking.
• Wait 20 minutes after bathing before putting on.
• Do not bathe, shower, or swim for 3 hours after putting on.
• If you are using mineral oil to help prevent dryness or itching, do not put it on within 2 hours before or 2 hours after you put on Panretin.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

What are the side effects of Panretin that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A burning, numbness, or tingling feeling that is not normal.
• Swelling where Panretin is used.

What are some other side effects of Panretin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Panretin?

• Store at room temperature.
• Protect from heat or open flame.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59212-601-22
Panretin® gel
(alitretinoin) 0.1%

SRC: NLM .