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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-pigmentation	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

How to
prescribe
VALCHLOR

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Reference:

VALCHLOR [package insert]. Iselin, NJ: Helsinn Therapeutics US, Inc.; January 2020.

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Important Safety Information

Contraindications

VALCHLOR is contraindicated in patients with known severe hypersensitivity to mechlorethamine. Hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine.

Warnings And Precautions

Mucosal or eye injury: Exposure of mucous membranes to mechlorethamine such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, which may be severe. Exposure of the eyes causes pain, burns, inflammation, photophobia, and blurred vision. Blindness and severe irreversible anterior eye injury may occur. Should eye exposure or mucosal contact occur, immediately irrigate for at least 15 minutes with copious amounts of water, followed by immediate medical consultation
Secondary exposure: Avoid direct skin contact with VALCHLOR in individuals other than the patients due to risk of dermatitis, mucosal injury, and secondary cancers
Dermatitis: Dermatitis may be moderately severe or severe. Monitor patients for redness, swelling, inflammation, itchiness, blisters, ulceration, and secondary skin infections. Stop treatment with VALCHLOR or reduce dose frequency
Non-melanoma skin cancer: Monitor patients during and after treatment with VALCHLOR
Embryo-fetal toxicity: May cause fetal harm. Women should avoid becoming pregnant while using VALCHLOR due to the potential hazard to the fetus. For nursing mothers, do not breastfeed during treatment with VALCHLOR
Flammable gel: VALCHLOR is an alcohol-based gel. Avoid fire, flame, and smoking until the gel has dried

Adverse Reactions

The most common adverse reactions (≥5%) were dermatitis (56%), pruritus (20%), bacterial skin infection (11%), skin ulceration or blistering (6%), and hyperpigmentation (5%). These reactions may be moderately severe or severe. Elderly patients aged 65 and older may be more susceptible. Depending on severity, treatment reduction, suspension, or discontinuation may be required.

Use In Specific Populations

Contraception: Females who are able to become pregnant, and males with female partners who are able to become pregnant, should use a barrier method of contraception to avoid direct exposure of reproductive organs to VALCHLOR
Infertility: The reproductive effects of VALCHLOR have not been studied: however systemically administered mechlorethamine may impair fertility. The reversibility of the effect on fertility is unknown.

Dosing and Application

VALCHLOR is for topical dermatologic use only. Apply a thin film of gel once daily to affected areas of the skin. VALCHLOR is a cytotoxic drug and special handling and disposal procedures should be followed during use. Caregivers must wear disposable nitrile gloves when applying VALCHLOR. Patients and caregivers must thoroughly wash hands after handling or applying VALCHLOR.

To report SUSPECTED ADVERSE REACTIONS, contact Helsinn Therapeutics (U.S.), Inc. at 1-855-482-5245 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see the VALCHLOR full Prescribing Information and Medication Guide.