Generic Name: mechlorethamine
Date of Approval: August 23, 2013
Company: Ceptaris Therapeutics, Inc.

Treatment for: Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma

FDA Approves Valchlor

The U.S. Food and Drug Administration (FDA) has granted marketing approval for the orphan drug Valchlor (mechlorethamine) gel for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. Valchlor is the first and only FDA-approved topical formulation of mechlorethamine, commonly known as nitrogen mustard. Valchlor is a gel that is applied topically once a day and dries on the skin.

Valchlor Medication Guide

Important information: Valchlor is for use on skin only. Do not get gel near or in your eyes, mouth, or nose.

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What is the most important information I should know about Valchlor?

Keep Valchlor away from your eyes, mouth, and nose.

  • If Valchlor gets in your eyes it can cause eye pain, burning, swelling, redness, sensitivity to light, and blurred vision. It may also cause blindness and permanent injury to your eyes. If the gel gets in your eyes, rinse your eyes right away for at least 15 minutes with a large amount of water, normal saline, or an eye wash solution.
  • If the gel gets in your mouth or nose it can cause pain, redness, and ulcers. Rinse the affected area right away for at least 15 minutes with a large amount of water.

Get medical help right away if Valchlor gets in your eyes, mouth, or nose.

Talk with your healthcare provider before using Valchlor about how to get medical help.

What is Valchlor?

Valchlor is a prescription medicine used on the skin to treat people with Stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma who have received previous skin treatment.

It is not known if it is safe and effective in children.

Who should not use Valchlor?

Do not use if you are severely allergic to mechlorethamine. Tell your healthcare provider if you have had an allergic reaction to mechlorethamine.

What should I tell my healthcare provider before using Valchlor?

Before using this gel, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. Valchlor can harm your unborn baby. You should not become pregnant while using this gel. Tell your healthcare provider right away if you become pregnant while using Valchlor.
  • are breastfeeding or plan to breastfeed. It is not known if mechlorethamine passes into your breast milk. You and your healthcare provider should decide if you will use Valchlor or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Valchlor?

  • Use exactly as your healthcare provider tells you.
  • Caregivers must wear disposable nitrile gloves when applying this gel.
  • Wash your hands with soap and water after touching or applying the gel.
  • Safely throw away used disposable nitrile gloves in household trash.
  • Apply Valchlor right away or within 30 minutes after you take it out of the refrigerator.
  • Return gel to the refrigerator right after each use.
  • Apply a thin layer to completely dry skin at least 4 hours before or 30 minutes after showering or washing.
  • Let the treated areas dry for 5 to 10 minutes after applying before covering with clothing.
  • Moisturizers may be applied to the treated areas 2 hours before or 2 hours after application.
  • You should not use air or water-tight bandages on areas of the skin treated with Valchlor.

What should I avoid?

Valchlor is flammable. Avoid fire, flame, and smoking until gel has dried.

Valchlor side effects

See What is the most important information I should know about Valchlor?

Valchlor can cause serious side effects, including:

  • Risk of Secondary Exposure. You may have a risk of inflammation of your skin (dermatitis), injury to your eyes, mouth, or nose, and certain types of cancers. Caregivers who accidentally come into contact with the gel must wash the affected area with soap and water right away for at least 15 minutes and remove any contaminated clothing. Get medical help right away if the gel gets in your eyes, mouth, or nose.
  • Inflammation of your skin (dermatitis) is common with Valchlor and may sometimes be severe. Your risk for dermatitis is increased if the gel is applied to your face, genital area, anus, or skin folds. Tell your healthcare provider if you develop skin reactions such as redness, swelling, itching, blisters, ulcers, and skin infections.
  • Increased risk of certain types of skin cancers. Certain types of skin cancer can develop on areas of your skin that are treated with Valchlor and areas of your skin that are not treated with Valchlor. Your healthcare provider will check your skin for skin cancers during and after your treatment with Valchlor. Tell your healthcare provider if you get any new skin lesions.

The most common side effects of Valchlor include: redness, swelling, itching, skin ulcers or blisters, skin infection, and darkening of areas of your skin.

These are not all the possible side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

How should I store Valchlor?

  • Store in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Keep away from food in the refrigerator.
  • With clean hands, place Valchlor back in the box it came in and return it to the refrigerator right after each use.
  • Talk with your pharmacist before you use Valchlor that has been out of the refrigerator for more than one hour a day.
  • Safely throw away Valchlor that is not used after 60 days. Unused Valchlor, empty tubes, and used disposable nitrile gloves should be safely thrown away in household trash.
  • Keep Valchlor and all medicines out of the reach of children.

General information about the safe and effective use of Valchlor.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about Valchlor that is written for health professionals. Do not use Valchlor for a condition for which it was not prescribed. Do not give Valchlor to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Valchlor. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Valchlor?

Active ingredient: mechlorethamine

Inactive ingredients: diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerin, lactic acid, hydroxypropylcellulose, sodium chloride, menthol, edetate disodium, butylated hydroxytoluene