VALCHLOR® (mechlorethamine) gel is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides–type cutaneous T-cell lymphoma (MF-CTCL) in patients who have received prior skin-directed therapy
VALCHLOR demonstrated safety profile
Local skin reactions were the most common (≥5%) adverse reaction (AR) in the clinical study1
VALCHLOR® (mechlorethamine) gel (n=128) | Compounded mechlorethamine HCI (n=127) | |||
---|---|---|---|---|
Any grade | Moderately-severe or severe | Any grade | Moderately-severe or severe |
|
Dermatitis | 56% | 23% | 58% | 17% |
Pruritus | 20% | 4% | 16% | 2% |
Bacterial skin infection | 11% | 2% | 9% | 2% |
Skin ulceration or blistering | 6% | 3% | 5% | 2% |
Skin hyper |
5% | 0% | 7% | 0% |
Informing patients about potential side effects prior to treatment can support effective management
- In the pivotal trial, moderately severe or severe skin-related adverse reactions were managed with treatment reduction, suspension, or discontinuation1
- Similar rates of AR-related treatment discontinuations were observed (22% with VALCHLOR and 18% with compounded mechlorethamine HCl)1
- Concomitant use of topical corticosteroids was not permitted during the trial1
In the pivotal trial, no evidence of systemic exposure was observed after topical administration
of VALCHLOR in a pharmacokinetic analysis.1
Proactive dose modifications may help patients avoid treatment discontinuations1
Temporarily suspend VALCHLOR gel if patient develops:
Any grade of skin ulceration, blistering, or moderately severe or severe dermatitis (ie, marked skin redness with edema).

When patient improves:
Restart VALCHLOR gel
(applied once every 3 days)

If tolerated after 1 week with
improvement: Increase VALCHLOR gel
(applied once every other day)

If tolerated for at least 1 week:
Resume once-daily
application of VALCHLOR gel
Reference:
- VALCHLOR [package insert]. Iselin, NJ: Helsinn Therapeutics US, Inc.; January 2020.