General

High Alert Medication: This medication bears a heightened risk of causing significant patient harm when it is used in error.

Pronunciation:
me-klor-eth-a-meen

Trade Name(s)

• Ledaga 
• Valchlor

Ther. Class.

antineoplastics

Pharm. Class.

alkylating agents

Indications

Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have already received skin-directed treatment.

Action

Interferes with DNA and RNA synthesis by cross-linking strands (cell-cycle phase-nonspecific).

Therapeutic Effect(s):

Death of rapidly replicating cells, particularly malignant ones.

Pharmacokinetics

Absorption: Systemic absorption is not detectable following topical administration.

Distribution: Unknown.

Metabolism and Excretion: Systemically administered mechlorethamine is rapidly degraded in body tissues and fluids.

Half-life: Unknown.

TIME/ACTION PROFILE (improvement in lesions)

Contraindication/Precautions

Contraindicated in:

• Severe hypersensitivity;
• OB:  Pregnancy (safety of topical formulation not established; systemic exposure causes fetal harm);
• Lactation: Lactation.

Use Cautiously in:

• Rep:  Women of reproductive potential and men with female partners of reproductive potential;
• Pedi:  Safety and effectiveness in children not established.

Adverse Reactions/Side Effects

Derm: dermatitis, bacterial skin infection, hyperpigmentation, non-melanoma skin cancer, pruritus, skin blistering/ulceration

GU: ↓ fertility

Misc: HYPERSENSITIVITY REACTIONS (including anaphylaxis)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

None reported.

Route/Dosage

Topical (Adults): Apply a thin film once daily to affected area.

Availability

Topical gel: 0.016% (equivalent to 0.02% mechlorethamine)

Assessment

• Assess skin lesions therapy before and check for any new lesions periodically during therapy.
• Monitor for skin reactions and secondary skin infections. If skin ulceration, blistering, or moderately severe or severe dermatitis (marked skin redness with edema, inflammation, itchiness) occurs, discontinue therapy. Face, genitalia, anus, and intertriginous skin are at ↑ risk of dermatitis. Restart therapy at ↓ frequency of once every 3 days upon improvement. If tolerated for ≥1 wk, ↑ frequency to every other day for ≥1 wk, then daily if tolerated.
• Assess for hypersensitivity reactions (e.g., anaphylaxis); if they occur, discontinue immediately and initiate appropriate medical treatment (epinephrine).

Implementation

• High Alert: Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution specific policies/procedures.
• Topical 

  Apply thin film of gel to completely dry skin once daily to affected areas within 30 min of removal from refrigerator; return to refrigerator immediately after use. Apply ≥4 hr before or 30 min after showering or washing. Allow treated areas to dry for 5–10 min after application before covering with clothing. Discard unused gel after 60 days in household trash in a manner that prevents accidental application or ingestion by others, including children and pets.

  • Emollients (moisturizers) may be applied to treated areas 2 hr before or after application.
  • Do not cover areas of application with occlusive dressing.
  • Avoid fire, flame, and smoking until topical gel has dried. Gel is alcohol-based and flammable.
  • If oral or nasal mucous membranes are exposed to gel, may cause severe pain, redness, and ulceration. Immediately irrigate with copious amounts of water for ≥15 min and notify health care professional.

Patient/Family Teaching

• Explain purpose and side effects of medication to patient. Advise patient to read Patient Information  before starting therapy and with each Rx refill in case of changes.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Instruct patient and caregiver on correct technique for application. Advise patients to wash hands thoroughly with soap and water after application. Caregivers must wear disposable nitrile gloves during application and wash hands thoroughly with soap and water after removal of gloves. If accidental skin exposure occurs, caregivers must immediately wash exposed area thoroughly with soap and water for 15 min and remove contaminated clothing. Secondary exposure may cause dermatitis, mucosal injury, and secondary cancers.
• Advise patient to assess for new skin lesions and hypersensitivity reactions. If they occur, notify a health care professional.
• Rep:  May cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during therapy. Use a barrier method of contraception to avoid direct exposure of reproductive organs to mechlorethamine. Advise patient to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy. May impair fertility in males and females.

Evaluation/Desired Outcomes

Death of rapidly replicating cells, particularly malignant ones.