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).

Restart icon

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

Improvement icon

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

Resume icon

If tolerated for at least 1 week:
Resume once-daily
application of VALCHLOR gel

Reference:

  1. VALCHLOR [package insert]. Iselin, NJ: Helsinn Therapeutics US, Inc.; November 2018.