Chlormethine Other names: HN2 Mustine Embikhin Mechlorethamine

There are limited data from the use of chlormethine in pregnant women. Studies in animals have shown reproductive toxicity after systemic administration. Chlormethine is not recommended during pregnancy.

It is unknown whether chlormethine is excreted in human milk. A risk to newborns/infants cannot be excluded due to the potential for topical or systemic exposure of the breast-feeding child to chlormethine through contact with the mother’s skin.

A decision must be made whether to discontinue breast-feeding or to discontinue chlormethine therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the breast-feeding mother.

Women of childbearing potential

Chlormethine is not recommended in women of childbearing potential not using contraception.

Fertility

In animals, adverse effects of chlormethine on male fertility after systemic administration have been documented. The relevance to humans receiving topical chlormethine is unknown.

Chlormethine has no or negligible influence on the ability to drive or use machines.

Summary of the safety profile

In a randomised-controlled trial (n=128 exposed to chlormethine for a median duration of 52 weeks), the most frequent adverse reactions to chlormethine were skin related: dermatitis (54.7%; e.g., skin irritation, erythema, rash, urticaria, skin-burning sensation, pain of the skin), pruritus (20.3%), skin infections (11.7%), skin ulceration and blistering (6.3%), and skin hyperpigmentation (5.5%). Cutaneous hypersensitivity reactions were reported in 2.3% of the treated patients.

Tabulated list of adverse reactions

Adverse reactions reported with chlormethine in an active-controlled trial in patients with MF-type CTCL are shown below. Frequencies were defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing severity.

Elderly population

In the controlled clinical trial, 31% (79/255) of the study population were aged 65 years or older. The safety profile observed in elderly patients was consistent with that in the overall patient population.