Drugs Details

Drugs Info of Panretin
Drugs Details
  • Drugs Type  : FDA
  • Date : 1st Jan 2015 11:25 pm
  • Brand Name : Panretin
  • Generic Name : alitretinoin topical (Pronunciation: ah lih TREH tin oyn)
Descriptions

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:

 

Panretin® (alitretinoin) Structural Formula Illustration

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 (alitretinoin) ® 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.

What are the possible side effects of alitretinoin topical (Panretin)?

Serious side effects are not likely to occur. Stop using alitretinoin topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

If you experience any of the following less serious side effects at the application site(s), continue to use alitretinoin topical and notify your doctor

  • redness;
  • itching;
  • irritation;
  • warmth;
  • burning, stinging, or pain;
  • rash;
  • peeling;
  • swelling or...

Read All Potential Side Effects and See Pictures of Panretin »

What are the precautions when taking alitretinoin (Panretin)?

Before using alitretinoin, tell your doctor or pharmacist if you are allergic to it; or to other retinoids (e.g., tretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain type of cancer (skin T-cell lymphoma).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this...

Read All Potential Precautions of Panretin »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Panretin® (alitretinoin) gel is indicated for topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma. Panretin® (alitretinoin) 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® (alitretinoin) gel with systemic anti-KS treatment.

Dosage Administration

Panretin® (alitretinoin) 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® (alitretinoin) gel was applied for up to 96 weeks. Panretin® (alitretinoin) gel should be continued as long as the patient is deriving benefit.

Occlusive dressings should not be used with Panretin® (alitretinoin) gel.

How Supplied

Panretin® (alitretinoin) gel is available in tubes containing 60 grams. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

NDC 64365-501-01

Manufactured for: Ligand Pharmaceuticals Incorporated, San Diego, CA 92121. By: Stiefel Laboratories, Inc., Coral Gables, FL 33134. (Rev. 0598). FDA revision date: 11/21/2000


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The safety of Panretin® (alitretinoin) gel has been assessed in clinical studies of 385 patients with AIDS-related KS. Adverse events associated with the use of Panretin® (alitretinoin) gel in patients with AIDS-related KS occurred almost exclusively at the site of application. The dermal toxicity begins as erythema; with continued application of Panretin® (alitretinoin) gel, erythema may increase and edema may develop. Dermal toxicity may become treatment-limiting, with intense erythema, edema, and vesiculation. Usually, however, adverse events are mild to moderate in severity; they led to withdrawal from the study in only 7% of the patients. Severe local (application site) skin adverse events occurred in about 10% of patients in the U.S. study (versus 0% in the vehicle control). Table 2 lists the adverse events that occurred at the application site with an incidence of at least 5% during the double-blind phase in the Panretin® (alitretinoin) gel-treated group and in the vehicle control group in either of the two controlled studies. Adverse events were reported at other sites but generally were similar in the two groups.

TABLE 2: Adverse Events with an Incidence of at Least 5% at the Application Site in Either Controlled Study in Patients Receiving Panretin® (alitretinoin) Gel or Vehicle Control

Adverse Event Term Study 1 Study 2
Panretin® (alitretinoin) Gel
N=134 Pts
.%
Vehicle Gel
N=134 Pts.
%
Panretin® (alitretinoin) Gel
N=36 Pts.
%
Vehicle Gel
N=46 Pts.
%
Rash1 77 11 25 4
Pain2 34 7 0 4
Pruritus3 11 4 8 4
Exfoliative dermatitis4 9 2 3 0
Skin disorder5 8 1 0 0
Paresthesia6 3 0 22 7
Edema7 8 3 3 0
Includes Investigator terms:
1Erythema, scaling, irritation, redness, rash, dermatitis
2Burning, pain
3Itching, pruritis
4Flaking, peeling, desquamation, exfoliation
5Excoriation, cracking, scab, crusting, drainage, eschar, fissure or oozing
6Stinging, tingling
7Edema, swelling, inflammation

Read the Panretin (alitretinoin) Side Effects Center for a complete guide to possible side effects

Interactions

Patients who are applying Panretin® (alitretinoin) gel should not concurrently use products that contain DEET (N,N-diethyl-m-toluamide), a common component of insect repellent products. Animal toxicology studies showed increased DEET toxicity when DEET was included as part of the formulation.

Although there was no clinical evidence in the vehicle-controlled studies of drug interactions with systemic antiretroviral agents, including protease inhibitors, macrolide antibiotics, and azole antifungals, the effect of Panretin® (alitretinoin) gel on the steady-state concentrations of these drugs is not known. No drug interaction data are available on concomitant administration of Panretin® (alitretinoin) gel and systemic anti-KS agents.

Drug/Laboratory Test Interactions

No interference with laboratory tests has been observed.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Pregnancy

Panretin® (alitretinoin) gel could cause fetal harm if significant absorption were to occur in a pregnant woman. 9-cis-Retinoic acid has been shown to be teratogenic in rabbits and mice. An increased incidence of fused sternebrae and limb and craniofacial defects occurred in rabbits given oral doses of 0.5 mg/kg/day (about five times the estimated daily human topical dose on a mg/m² basis, assuming complete systemic absorption of 9-cis-retinoic acid, when Panretin® (alitretinoin) gel is administered as a 60 g tube over 1 month in a 60 kg human) during the period of organogenesis. Limb and craniofacial defects also occurred in mice given a single oral dose of 50 mg/kg on day eleven of gestation (about 127 times the estimated daily human topical dose on a mg/m² basis). Oral 9-cis-retinoic acid was also embryocidal, as indicated by early resorptions and post-implantation loss when it was given during the period of organogenesis to rabbits at doses of 1.5 mg/kg/day (about 15 times the estimated daily human topical dose on a mg/m² basis) and to rats at doses of 5 mg/kg/day (about 25 times the estimated daily human topical dose on a mg/m²basis). Animal reproduction studies with topical 9-cis-retinoic acid have not been conducted. It is not known whether topical Panretin® (alitretinoin) gel can modulate endogenous 9-cis-retinoic acid levels in a pregnant woman nor whether systemic exposure is increased by application to ulcerated lesions or by duration of treatment. There are no adequate and well-controlled studies in pregnant women. If Panretin® (alitretinoin) gel is used during pregnancy, or if the patient becomes pregnant while taking it, the patient should be apprised of the potential hazard to the fetus. Women of child-bearing potential should be advised to avoid becoming pregnant.

Precautions

Panretin® (alitretinoin) gel is indicated for topical treatment of Kaposi's sarcoma. Patients with cutaneous T-cell lymphoma were less tolerant of topical Panretin® (alitretinoin) gel; five of seven patients had 6 episodes of treatment-limiting toxicities—grade 3 dermal irritation—with Panretin® (alitretinoin) gel (0.01% or 0.05%).

Photosensitivity

Retinoids as a class have been associated with photosensitivity. There were no reports of photosensitivity associated with the use of Panretin® (alitretinoin) gel in the clinical studies. Nonetheless, because in vitro data indicate that 9-cis-retinoic acid may have a weak photosensitizing effect, patients should be advised to minimize exposure of treated areas to sunlight and sunlamps during the use of Panretin® (alitretinoin) gel.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to assess the carcinogenic potential of 9-cis-retinoic acid have not been conducted. 9-cis-Retinoic acid was not mutagenic in vitro (bacterial assays, Chinese hamster ovary cell HGPRT mutation assay) and was not clastogenic in vitro (chromosome aberration test in human lymphocytes) nor in vivo (mouse micronucleus test).

Pregnancy Category D

(see “WARNINGS” section)

Nursing Mothers

It is not known whether alitretinoin or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions from Panretin® (alitretinoin) gel in nursing infants, mothers should discontinue nursing prior to using the drug.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Inadequate information is available to assess safety and efficacy in patients age 65 years or older.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

There has been no experience with acute overdose of Panretin® (alitretinoin) gel in humans. Systemic toxicity following acute overdosage with topical application of Panretin® (alitretinoin) gel is unlikely because of limited systemic plasma levels observed with normal therapeutic doses. There is no specific antidote for overdosage.

ContrainDications

Panretin® (alitretinoin) gel is contraindicated in patients with a known hypersensitivity to retinoids or to any of the ingredients of the product.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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.

Pharmacokinetics

No studies have examined plasma 9-cis-retinoic acid concentrations before and after treatment with Panretin® (alitretinoin) gel. There is, however, indirect evidence that absorption is not extensive. Plasma concentrations of 9-cis-retinoic acid were evaluated during clinical studies in patients with cutaneous lesions of AIDS-related KS after repeated multiple-daily dose application of Panretin® (alitretinoin) gel for up to 60 weeks. The range of 9-cis-retinoic acid plasma concentrations in these patients was similar to the range of circulating, naturally-occurring 9-cis-retinoic acid plasma concentrations in untreated healthy volunteers.

Although there are no detectable plasma concentrations of 9-cis-retinoic acid metabolites after topical application of Panretin® (alitretinoin) gel, in vitro studies indicate that the drug is metabolized to 4-hydroxy-9-cis-retinoic acid and 4-oxo-9-cis-retinoic acid by CYP 2C9, 3A4, 1A1, and 1A2 enzymes. In vivo, 4-oxo-9-cis-retinoic acid is the major circulating metabolite following oral administration of 9-cis-retinoic acid.

No formal pharmacokinetic drug interaction studies between Panretin® (alitretinoin) gel and antiretroviral agents have been conducted.

Clinical Studies

Panretin® (alitretinoin) gel is not a systemic therapy; it therefore cannot treat visceral Kaposi's sarcoma (KS) nor prevent the development of new KS lesions where it has not been applied. Visceral KS disease was not monitored in these trials, and the appearance of new KS lesions was not considered part of the response assessment in clinical trials.

Panretin® (alitretinoin) gel was evaluated in two multicenter, prospective, randomized, double-blind, vehicle-controlled studies in patients with cutaneous lesions of AIDS-related KS. In both studies the primary efficacy endpoint was the patients' cutaneous KS tumor response rate through 12 weeks of study drug treatment which was assessed by evaluating from 3 to 8 KS index lesions according to the modified AIDS Clinical Trials Group (ACTG) response criteria as applied to topical therapy (i.e., evaluation of height and area reductions of the index lesions only; progressive disease in non-index lesions and new lesions were not considered progressive disease; progressive disease was scored only in the treated index lesions). A global evaluation by physicians was also carried out. It considered all of the patient's treated lesions (index and other) compared to baseline. In this evaluation, patients with at least a 50% improvement in the KS lesions were considered responders. In addition, photographs of lesions in patients considered responders by the modified ACTG criteria were examined by the FDA for a cosmetically beneficial response, defined as at least a 50% improvement in appearance compared to baseline, considering both the KS lesions and dermal toxicity at the lesion site, in at least 50% of the index lesions and maintained for at least 3 weeks. Patients were also asked about their satisfaction with the treatment.

In Study 1, a total of 268 patients were entered from centers in the U.S. and Canada. Patients were treated topically three to four times a day with either Panretin® (alitretinoin) gel or a matching vehicle gel for a minimum of 12 weeks, followed by an open-label phase in patients who had not yet progressed on Panretin® (alitretinoin) gel. Responses during the double-blind phase are shown in Table 1. Responses to Panretin® (alitretinoin) gel were seen in both previously untreated patients and in patients with prior systemic and/or topical KS treatment. A total of 72 patients responded to Panretin® (alitretinoin) gel during the randomized or crossover portions of the study. At a median duration of monitoring of 16 weeks, only 15% of the 72 patients had relapsed. Panretin® (alitretinoin) gel would not be expected to affect development of new lesions in untreated areas and these were seen in about 50% of patients, at similar rates in treated and untreated patients, responders and non-responders. The patients' assessment of their overall satisfaction with the drug effect on all treated lesions significantly favored Panretin® (alitretinoin) gel.

Study 2 was an international study with a planned enrollment of 270 patients. Patients were treated topically twice a day with Panretin® (alitretinoin) gel or a matching vehicle for 12 weeks. The study was stopped early because of positive interim results in the initial 82 patient data set. Results of the study are shown in Table 1. Responses to Panretin® (alitretinoin) gel were seen both in previously untreated patients and in patients with prior systemic and/or topical KS treatment.

TABLE 1: Summary of Tumor Responses

  STUDY 1 STUDY 2
Panretin® Gel
N=134
Vehicle Gel
N=134
Panretin® Gel
N=36
Vehicle Gel
N=46
Modified ACTG Response
(index lesions)
34% PR
1% CR
16% PR
p=0.0012
36% PR 7% PR
Physician's Global/ Subjective Assessment
(all treated lesions)
19% PR 4% PR
p=0.00014
47% PR 11% PR
Beneficial Response Photographs
(index lesions only)
15% 4%
p=0.0026
19% 2%

In the clinical trials, responses were seen as early as two (2) weeks; most patients, however, required four (4) to eight (8) weeks of treatment, and some patients did not experience significant improvement until 14 or more weeks of treatment. The cumulative percentage of patients who achieved a response was less than 1% at 2 weeks, 10% at 4 weeks, and 28% at 8 weeks.

In both studies, responses occurred in patients with a wide range of baseline CD4+ lymphocyte counts, including patients with CD4+ lymphocyte counts less than 50 cells/mm³. Nearly all patients received concomitant combination antiretroviral therapy.

Photographs of patients revealed a substantial erythematous and edematous response in some cases, leading to a cosmetically mixed outcome even in apparent responders. Nonetheless, in Study 1 it appeared that a cosmetically satisfactory result occurred at about the same rate as the Physician's Global response rate and in both studies such a response was more frequent than in the vehicle control.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

ALITRETINOIN GEL - TOPICAL

 

(AL-i-TRET-i-noyn)

 

COMMON BRAND NAME(S): Panretin

 

USES: This medication is used to treat skin sores in patients with a certain type of AIDS-related cancer (Kaposi's sarcoma). Alitretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells.

This medication should not be used when medications taken by mouth are needed to treat the Kaposi's sarcoma (e.g., more than 10 new skin sores in the previous month, disease affects the lungs or other organs).

 

HOW TO USE: Use this medication on the skin only. Wait at least 20 minutes after bathing or showering before applying the medication. Apply enough medication to cover the skin sore(s) well, usually 2 to 4 times daily or as directed by your doctor. It is not necessary to rub the medication into the sore. Allow 3 to 5 minutes for the medication to dry before covering the affected area with clothing.

Do not apply the medication on unaffected skin because doing so may cause increased irritation. Do not apply the medication in or around the eyes, nose, mouth, anus, vagina, or tip of the penis. If you do get the medication in those areas, flush with plenty of water.

Wash your hands after using, unless you are using this medication to treat the hands. Do not bathe, shower, or swim for at least 3 hours after using the medication.

Do not wrap, cover, or bandage the affected area unless directed to do so by your doctor.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.

Do not apply other skin products, except mineral oil, on the treated sores. You may apply mineral oil at least 2 hours before or after applying this medication to help prevent skin dryness/itching.

Tell your doctor if your condition does not improve or if it worsens. You should start to see an improvement in your skin condition in as little as 2 weeks of treatment, but it may take up to 14 weeks of treatment to see the benefit.

Consumer Overview Side Effect

SIDE EFFECTS: Redness, rash, pain, burning, itching, stinging, or tingling at the application site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/crusting/oozing/peeling of the skin, severe burning/stinging of the skin, swelling of the skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Panretin (alitretinoin) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using alitretinoin, tell your doctor or pharmacist if you are allergic to it; or to other retinoids (e.g., tretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain type of cancer (skin T-cell lymphoma).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following products because very serious interactions may occur: products containing DEET (e.g., some insect repellents).

If you are currently using the products listed above, tell your doctor or pharmacist before starting alitretinoin.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. This product is flammable. Keep away from heat and open flame. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Panretin

Generic Name: alitretinoin topical (Pronunciation: ah lih TREH tin oyn)

  • What is alitretinoin topical (Panretin)?
  • What are the possible side effects of alitretinoin topical (Panretin)?
  • What is the most important information I should know about alitretinoin topical (Panretin)?
  • Who should not use alitretinoin topical (Panretin)?
  • How should I use alitretinoin topical (Panretin)?
  • What happens if I miss a dose (Panretin)?
  • What happens if I overdose (Panretin)?
  • What should I avoid while using alitretinoin topical (Panretin)?
  • What other drugs will affect alitretinoin topical (Panretin)?
  • Where can I get more information?

What is alitretinoin topical (Panretin)?

Alitretinoin is a topical retinoid. Alitretinoin affects the growth and development of skin cells.

Alitretinoin topical is used to treat skin lesions caused by AIDS-related Kaposi's sarcoma.

Alitretinoin topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of alitretinoin topical (Panretin)?

Serious side effects are not likely to occur. Stop using alitretinoin topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

If you experience any of the following less serious side effects at the application site(s), continue to use alitretinoin topical and notify your doctor

  • redness;
  • itching;
  • irritation;
  • warmth;
  • burning, stinging, or pain;
  • rash;
  • peeling;
  • swelling or inflammation;
  • numbness or tingling;
  • cracking, crusting, or scabbing; or
  • drainage.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Panretin (alitretinoin) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about alitretinoin topical (Panretin)?

Avoid prolonged exposure to sunlight. Alitretinoin topical may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Do not use products that contain DEET (N, N-diethyl-m-toluamide), a common component of insect repellent products, while using alitretinoin topical. There is an increased risk of harmful effects from DEET when it is used with alitretinoin topical.

Do not cover the treated lesions with any type of occlusive dressing (a dressing that does not allow air to circulate to the area).

Side Effects Centers
  • Panretin

Patient Detailed How Take

Who should not use alitretinoin topical (Panretin)?

Before using alitretinoin topical, tell your doctor if you have cutaneous T-cell lymphoma. You may not be able to use alitretinoin topical, or you may require a dosage adjustment or special monitoring during your treatment.

Alitretinoin topical is the FDA pregnancy category D. This means that alitretinoin topical may be harmful to an unborn baby. Alitretinoin topical has caused birth defects in animal studies. Do not use alitretinoin topical without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether alitretinoin topical passes into breast milk. Do not use alitretinoin topical without first talking to your doctor if you are breast-feeding a baby.

How should I use alitretinoin topical (Panretin)?

Use alitretinoin topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after applying this medication.

Apply enough gel to cover the lesion with a generous coating. Allow the gel to dry for 3 to 5 minutes before covering the area with clothing.

Do not apply alitretinoin topical to normal skin surrounding a lesion. Also, do not apply alitretinoin topical on or near mucosal surfaces of the body such as the inside of the nose or mouth.

Do not cover the treated lesions with any type of occlusive dressing (a dressing that does not allow air to circulate to the area).

Alitretinoin topical is usually applied two to four times a day. Follow your doctor's instructions.

Store alitretinoin topical at room temperature away from moisture and heat.

Side Effects Centers
  • Panretin

Patient Detailed Avoid Taking

What happens if I miss a dose (Panretin)?

Apply the missed dose as soon as you remember.

What happens if I overdose (Panretin)?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, or if alitretinoin topical has been ingested, call an emergency room or poison control center for advice.

What should I avoid while using alitretinoin topical (Panretin)?

Avoid prolonged exposure to sunlight. Alitretinoin topical may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Do not use products that contain DEET (N, N-diethyl-m-toluamide), a common component of insect repellent products, while using alitretinoin topical. There is an increased risk of harmful effects from DEET when it is used with alitretinoin topical.

Do not cover the treated lesions with any type of occlusive dressing (a dressing that does not allow air to circulate to the area).

What other drugs will affect alitretinoin topical (Panretin)?

Do not use products that contain DEET (N, N-diethyl-m-toluamide), a common component of insect repellent products, while using alitretinoin topical. There is an increased risk of harmful effects from DEET when it is used with alitretinoin topical.

Drugs other than those listed here may also interact with alitretinoin topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about alitretinoin topical written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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