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Molecule

Mechlorethamine

Alkylating Drug
Available on requestOrphanCold chainOncology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Mechlorethamine is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. It is available as gel for topical use. MedsAcross supplies Mechlorethamine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Alkylating Drug, Alkylating Activity
ATC classification
L01AA05 Mechlorethamine · Nitrogen mustard
US FDA first approval
15 March 1949
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Topical
Dosage forms
Gel
Identifiers
UNII 50D9XSG0VRRxCUI 6674CAS 51-75-2DrugBank DB00888Q418011

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.

Source: US FDA prescribing information

How it works

Mechlorethamine, also known as nitrogen mustard, is an alkylating agent which inhibits rapidly proliferating cells.

Source: US FDA prescribing information

Dosing overview

For topical dermatological use only. Apply a thin film once daily to affected areas of the skin. Dosing and Dose Modification For Topical Dermatological Use Only Apply a thin film of VALCHLOR gel once daily to affected areas of the skin. Stop treatment with VALCHLOR for any grade of skin ulceration, blistering, or moderately-severe or severe dermatitis (i.e., marked skin redness with edema). Upon improvement, treatment with VALCHLOR can be restarted at a reduced frequency of once every 3 days. If reintroduction of treatment is tolerated for at least one week, the frequency of application can be increased to every other day for at least one week and then to once daily application if tolerated.

Source: US FDA prescribing information

Contraindications

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

Source: US FDA prescribing information

Warnings and precautions

Mucosal or eye injury: VALCHLOR exposure to mucous membranes, especially of the eyes, can cause mucosal injury which may be severe. Eye injury may lead to blindness. Immediately irrigate for at least 15 minutes followed by immediate medical consultation. Secondary exposure to VALCHLOR: individuals other than the patient must avoid skin contact with VALCHLOR. Dermatitis: Monitor patients for redness, swelling, inflammation, itchiness, blisters, ulceration, and secondary skin infections. Stop treatment or reduce dose frequency. Non-melanoma skin cancer: Monitor patients during and after treatment. Embryo-fetal toxicity: May cause fetal harm. Flammable gel: VALCHLOR is an alcohol-based gel. Avoid fire, flame, and smoking until the gel has dried.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information: Mucosal or eye injury Secondary exposure to VALCHLOR Dermatitis Non-melanoma skin cancer The most common adverse reactions (≥5%) are dermatitis, pruritus, bacterial skin infection, skin ulceration or blistering, and hyperpigmentation.

Source: US FDA prescribing information

Interactions

No drug interaction studies have been performed with VALCHLOR. Systemic exposure has not been observed with topical administration of VALCHLOR, therefore, systemic drug interactions are not likely.

Source: US FDA prescribing information

Storage

Prior to dispensing, store in the freezer at -13°F to 5°F (-25°C to -15°C). Advise patients that refrigerated storage is required once dispensed.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Mechlorethamine, sorted by availability.

MedicineManufacturerRegisterAvailability
Valchlor 0.02% gelTopical Cold chainHelsinn TherapeuticsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 15 March 1949Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Mechlorethamine in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Mechlorethamine available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Mechlorethamine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Mechlorethamine have?

The catalogue lists 1 brand names for Mechlorethamine, including Valchlor.

Is Mechlorethamine approved by the US FDA?

Yes. The US FDA first approved Mechlorethamine on 15 March 1949, according to Drugs@FDA.

Is Mechlorethamine authorised in the European Union?

Yes. Mechlorethamine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Mechlorethamine need cold chain shipping?

At least one listed presentation of Mechlorethamine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Mechlorethamine in?

Mechlorethamine is classified under ATC code L01AA05 (Mechlorethamine).

References

  1. VALCHLOR prescribing information (Helsinn Therapeutics). U.S. National Library of Medicine, DailyMed. Retrieved 20 November 2024
  2. Ledaga: European public assessment report (EPAR). European Medicines Agency. Retrieved 12 December 2024

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