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Alitretinoin (topical): Drug information

Alitretinoin (topical): Drug information
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For additional information see "Alitretinoin (topical): Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Panretin
Pharmacologic Category
  • Antineoplastic Agent, Retinoic Acid Derivative
Dosing: Adult
Kaposi sarcoma, cutaneous

Kaposi sarcoma, cutaneous: Topical: Initial: Apply gel twice daily to cutaneous lesions; may gradually increase application frequency to 3 or 4 times daily based on lesion tolerance. Continue as long as deriving clinical benefit; response may be observed within 2 weeks of initiation; however, most patients require a longer period, and further benefit may be attained with a longer application period (>14 weeks) in some patients. In clinical trials, therapy lasted up to 96 weeks.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, systemic absorption is not extensive making the need for a dose adjustment appear unlikely.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, systemic absorption is not extensive making the need for a dose adjustment appear unlikely.

Dosing: Adjustment for Toxicity: Adult
Alitretinoin (Topical ) Recommended Dosage Modifications for Adverse Reactions

Adverse reaction

Severity

Alitretinoin (topical) dosage modification

a Walmsley 1999.

b Bodsworth 2001.

Dermal irritation

Any

May reduce the frequency of administration if application site toxicity occurs.

≤ Grade 2

No dosage adjustment necessary.a

Grade 3

Reduce dosing frequency or withhold alitretinoin (topical) for up to 2 weeks; may resume when irritation improves to ≤ grade 1a

or

reduce dosing frequency to once daily.b

Grade 4

Withhold alitretinoin (topical) for up to 2 weeks; may resume at a reduced application frequency (less than once daily) when irritation improves to ≤ grade 1. Continue reduced application frequency for 2 weeks prior to increasing.a

If grade 4 dermal irritation occurs at reduced application frequency (less than once daily), discontinue alitretinoin (topical).a

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Pain (≤34%), paresthesia (3% to 22%)

Dermatologic: Skin rash (25% to 77%), pruritus (8% to 11%)

1% to 10%:

Cardiovascular: Edema (3% to 8%)

Dermatologic: Exfoliative dermatitis (3% to 9%), dermatological disease (≤8%)

Contraindications

Known hypersensitivity to alitretinoin, other retinoids, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Dermal irritation: Application site irritation and pain have been reported, including grade 3 dermal irritation.

• Photosensitivity: Alitretinoin may be photosensitizing (based on experience with other retinoids); minimize sun or other UV exposure of treated areas.

Other warnings/precautions:

• Products containing DEET: Do not use concurrently with topical products containing DEET (eg, insect repellant); an increase in DEET toxicity has been observed.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, External:

Panretin: 0.1% (60 g) [contains alcohol, usp]

Generic Equivalent Available: US

No

Pricing: US

Gel (Panretin External)

0.1% (per gram): $121.74

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical: Apply sufficient gel to cover lesion(s) with a generous coating; allow gel to dry for 3 to 5 minutes after application before covering with clothing. Do not cover alitretinoin application site with occlusive dressings. Avoid applying gel to healthy skin surrounding lesions; do not apply on or near mucosal surfaces. Advise patients to avoid sun or UV light exposure to the treated area. Patients should wait 20 minutes after showering or bathing before applying alitretinoin (topical) and avoid showering, bathing, or swimming for at least 3 hours following application.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 2]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Use: Labeled Indications

Kaposi sarcoma, cutaneous: Topical treatment of cutaneous lesions in AIDS-related Kaposi sarcoma (KS).

Limitations of use: Alitretinoin is not indicated when systemic therapy for KS is necessary (eg, >10 new lesions in previous month, symptomatic visceral involvement, symptomatic pulmonary KS, symptomatic lymphedema). There is no experience in using alitretinoin (topical) in combination with systemic treatment for KS.

Medication Safety Issues
Sound-alike/look-alike issues:

Alitretinoin (topical) may be confused with tretinoin (topical).

Panretin may be confused with pancreatin.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor

Multivitamins/Minerals (with AE, No Iron): May increase adverse/toxic effects of Retinoic Acid Derivatives. Risk X: Avoid

Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Reproductive Considerations

Patients who could become pregnant should avoid becoming pregnant during treatment with topical alitretinoin.

Pregnancy Considerations

In utero exposure to alitretinoin (topical) may cause fetal harm if significant absorption occurs.

Breastfeeding Considerations

It is not known if alitretinoin is present in breast milk.

Due to the potential for adverse reactions in the breastfed infant, the manufacturer recommends discontinuing breastfeeding during alitretinoin (topical) treatment.

Mechanism of Action

Alitretinoin is a naturally occurring endogenous retinoid that binds to and activates intracellular retinoid receptors (RAR and RXR subtypes); this results in altered expression of the genes controlling cellular differentiation and proliferation in normal and neoplastic cells, inhibiting the growth of Kaposi sarcoma

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Not extensive

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Panretin;
  • (DE) Germany: Panretin;
  • (ES) Spain: Panretin;
  • (FR) France: Panretin;
  • (GR) Greece: Panretin;
  • (PR) Puerto Rico: Panretin
  1. Bodsworth NJ, Bloch M, Bower M, et al. Phase III vehicle-controlled, multi-centered study of topical alitretinoin gel 0.1% in cutaneous AIDS-related Kaposi's sarcoma. Am J Clin Dermatol. 2001;2(2):77-87. [PubMed 11705307]
  2. Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
  3. Ovesen JL, Sam­mons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  4. Panretin (alitretinoin) [prescribing information]. Concordia Pharmaceuticals; May 2020.
  5. United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
  6. Walmsley S, Northfelt DW, Melosky B, Conant M, Friedman-Kien AE, Wagner B. Treatment of AIDS-related cutaneous Kaposi's sarcoma with topical alitretinoin (9-cis-retinoic acid) gel. Panretin Gel North American Study Group. J Acquir Immune Defic Syndr. 1999;22(3):235-246. [PubMed 10770343]
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