Version May 2024
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.
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.
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.
|
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 | |
Refer to adult dosing.
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%)
Known hypersensitivity to alitretinoin, other retinoids, or any component of the formulation.
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Gel, External:
Panretin: 0.1% (60 g [DSC])
Panretin: 0.1% (60 g) [contains alcohol, usp]
No
Gel (Panretin External)
0.1% (per gram): $115.96
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.
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 agent (NIOSH 2016 [group 3]).
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 2016; 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.
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.
Alitretinoin (topical) may be confused with tretinoin (topical).
Panretin may be confused with pancreatin.
None known.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Patients who could become pregnant should avoid becoming pregnant during treatment with topical alitretinoin.
In utero exposure to alitretinoin (topical) may cause fetal harm if significant absorption occurs.
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.
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
Absorption: Not extensive
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