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 Support® provides a full suite of support resources for you and your patients
Comprehensive support and resources are available exclusively through a specialty pharmacy
- Assistance with prior authorizations, insurance verification, and appeals
- Information for patients and caregivers on what to expect with VALCHLOR
- 1:1 patient support via phone call and text message provided by specially trained pharmacists and nurses
- Direct calls from a specialty pharmacy to coordinate prescription refills and delivery
- The specialty pharmacy will call from area codes 844, 955, or 877 to schedule delivery of VALCHLOR. Patients must answer this call
- Financial assistance for eligible patients
VALCHLOR is directly delivered to your patient's doorstep, safely and securely
Available resources for you and your patients
VALCHLOR Patient Brochure
Covers helpful topics such as how to apply and store VALCHLOR and how to address common side effects. To provide to your patients in your office:
Helsinn would like to further support eligible patients by temporarily waiving the $10 fee.
Helps eligible patients pay no more than $10 $0 per prescription fill.
*The VALCHLOR copay program is only available for US and Puerto Rico residents who are 18 or older and have commercial health insurance with copay/coinsurance exceeding $10 $0 per prescription fill. Patients ineligible for the VALCHLOR copay program include those enrolled in Medicare, Medicaid, VA/DoD (Tricare), the Indian Health Service, or any other federal- or state-funded healthcare program, or where prohibited by law. The VALCHLOR copay program is not prescription drug coverage or insurance. Helsinn Therapeutics, Inc. reserves the right to terminate or modify this program at any time or without notice. Other terms and conditions apply.
For more information, call 1-855-4-VALCHLOR (1-855-482-5245)
Additional support information
You can find additional information to help you educate your patients at the following websites:
Cutaneous Lymphoma Foundation: clfoundation.org
Lymphoma Research Foundation: lymphoma.org
Leukemia and Lymphoma Society: lls.org
Helsinn offers links to third-party websites that may assist you in locating other useful information. Helsinn does not control and is not responsible for the content of any linked third-party website, and hereby disclaims any and all liability and responsibility for these resources.
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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 (EN/ES).