Important Safety Information
What is the most important information I should know about VALCHLOR?
VALCHLOR is for use on skin only. 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 VALCHLOR gets in your mouth or nose it can cause pain, redness, and ulcers.
If VALCHLOR 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.
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.
When should I not use VALCHLOR?
Do not use VALCHLOR 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, tell your healthcare provider about all your medical conditions, including if you:
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are pregnant or plan to become pregnant. VALCHLOR may harm your unborn baby. Avoid becoming pregnant during treatment with VALCHLOR. Tell your healthcare provider right away if you think you are or may become pregnant during treatment with VALCHLOR.
- Females who are able to become pregnant should use a barrier method of birth control, such as a male condom or spermicide, during treatment with VALCHLOR.
- Males with female partners who are able to become pregnant should use a barrier method of birth control, such as a male condom or spermicide, during treatment with VALCHLOR.
- are breastfeeding or plan to breastfeed. It is not known if VALCHLOR passes into your breast milk. Do not breastfeed during treatment with VALCHLOR.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while using VALCHLOR?
VALCHLOR is flammable. Avoid fire, flame, and smoking until VALCHLOR has dried.
What are the possible side effects of VALCHLOR?
See "What is the most important information I should know about VALCHLOR?"
VALCHLOR can cause serious side effects, including:
- Risk of secondary exposure to VALCHLOR. 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 VALCHLOR must wash the affected area thoroughly with soap and water right away for at least 15 minutes and remove any contaminated clothing.
Get medical help right away if VALCHLOR 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 VALCHLOR 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.
VALCHLOR may cause fertility problems in females and males. This could affect the ability to become pregnant. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of VALCHLOR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Keep VALCHLOR and all medicines out of the reach of children.
Please see the full Prescribing Information and Medication Guide for VALCHLOR.
VALCHLOR is a topical gel medication that treats patients with Stage IA/IB MF-CTCL who have received previous skin treatment. Ask your doctor if VALCHLOR is right for you.
