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 safety profile1
The most commonly reported adverse reactions (≥5%) in the clinical study were in the local skin1
| VALCHLOR 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 hyperpigmentation | 5% | 0% | 7% | 0% |
- Concomitant use of topical corticosteroids was not permitted during the trial1
- 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
Proactively manage skin reactions with dose modifications1
Dose modifications may help patients continue with their treatment1
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).
Upon improvement, treatment can be gradually reintroduced into patient's treatment plan1:
Restart
VALCHLOR gel once every 3 days when patient improves1
Increase
VALCHLOR gel applied once every other day if tolerated after 1 week with improvement1
Resume
once-daily application of VALCHLOR gel if tolerated for at least 1 week1
Help your patients continue on treatment by setting expectations and establishing a plan to manage potential skin reactions