Dosing & Uses
Dosage Forms & Strengths
- 0.016% (equivalent to 0.02% mechlorethamine HCl)
Cutaneous T-Cell Lymphoma
Indicated for stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy
Apply a thin film of gel topically to affected areas of the skin once daily
- Stop treatment for any grade of skin ulceration, blistering, or moderately‐severe or severe dermatitis (ie, marked skin redness with edema)
- Upon improvement, may resume at reduced application frequency of once q3days
- After 1 week at q3days, may increase frequency to every other day for at least 1 week, and then to once daily if tolerated
Apply immediately or within 30 minutes after removal from the refrigerator; return gel to the refrigerator immediately after each use
Apply to completely dry skin at least 4 hr before or 30 minutes after showering or washing
Allow treated areas to dry for 5-10 minutes after application before covering with clothing
Emollients (moisturizers) may be applied to the treated areas 2 hr before or 2 hr after application
Do not use occlusive dressings on areas of the skin where gel applied
Avoid fire, flame, and smoking until the gel has dried
- Before dispensing, store in freezer (‐13-5°F (‐25°C to ‐15°C)
- Following dispensing, instruct patient that gel requires refrigeration
- Cytotoxic drug; follow applicable special handling and disposal procedures
- Patients must wash hands thoroughly with soap and water after handling or applying
- Caregivers must wear disposable nitrile gloves when applying gel to patients and wash hands thoroughly with soap and water after removal of gloves
- If there is accidental skin exposure, caregivers must immediately wash exposed areas thoroughly with soap and water for at least 15 minutes and remove contaminated clothing
Safety and efficacy not established
Dermatitis, any grade (56%)
Dermatitis, moderately-severe or severe (23%)
Pruritus, any grade (20%)
Bacterial skin infection, any grade (11%)
Skin ulceration or blistering (3-6%)
Skin hyperpigmentation (5%)
Pruritus, moderately-severe or severe (4%)
Bacterial skin infection, moderately-severe or severe (2%)
Avoid eye exposure; may cause pain, burns, inflammation, photophobia, and blurred vision; blindness and severe irreversible anterior eye injury may occur Avoid direct skin contact with individuals other than the patient; risk of secondary exposure include dermatitis, mucosal injury, and secondary cancers
Dermatitis occurs commonly (see Adverse Effects); modify dose if skin toxicity occurs (see Dosage Modifications)
Nonmelanoma skin cancer reported
Based on its mechanism of action, case reports in humans, and findings in animals, mechlorethamine topical can cause fetal harm when administered pregnant women
Alcohol-based gels are flammable
Pregnancy & Lactation
Pregnancy Category: D; case reports of children born with malformations in pregnant women systemically administered mechlorethamine
Mechlorethamine was teratogenic in animals after a single SC administration
Lactation: Unknown if distributed in human breast milk; a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Alkylating agent which inhibits rapidly proliferating cells
Also known as nitrogen mustard
Systemic exposure was undetectable after topical administration
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|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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