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Valchlor

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Valchlor

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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) [see WARNINGS AND PRECAUTIONS]. 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.

Application Instructions

VALCHLOR is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Patients must wash hands thoroughly with soap and water after handling or applying VALCHLOR.

Caregivers must wear disposable nitrile gloves when applying VALCHLOR to patients and wash hands thoroughly with soap and water after removal of gloves. If there is accidental skin exposure to VALCHLOR, caregivers must immediately wash exposed areas thoroughly with soap and water for at least 15 minutes and remove contaminated clothing [see WARNINGS AND PRECAUTIONS].

Patients or caregivers should follow these instructions when applying VALCHLOR:

  • Apply immediately or within 30 minutes after removal from the refrigerator. Return VALCHLOR to the refrigerator immediately after each use.
  • Apply to completely dry skin at least 4 hours before or 30 minutes after showering or washing. Allow treated areas to dry for 5 to 10 minutes after application before covering with clothing.
  • Emollients (moisturizers) may be applied to the treated areas 2 hours before or 2 hours after application.
  • Do not use occlusive dressings on areas of the skin where VALCHLOR was applied.
  • Avoid fire, flame, and smoking until VALCHLOR has dried [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

The active ingredient in VALCHLOR is mechlorethamine. Each tube of VALCHLOR contains 60g of 0.016% w/w mechlorethamine clear gel (equivalent to 0.02% mechlorethamine HCl).

Storage And Handling

VALCHLOR is supplied in 60g tubes of 0.016% w/w mechlorethamine as a clear gel [NDC 42427-002-60].

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.

VALCHLOR is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

REFERENCES

1 OSHA Hazardous Drugs. OSHA. [Accessed July 3, 2013, from http://www.osha.gov/SLTC/hazardousdrugs]

Manufactured for: Ceptaris Therapeutics, Inc., Malvern, PA 19355. Revised: August 2013

Last reviewed on RxList: 9/6/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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