Mechlorethamine

• Nitrogen Mustard

Serious side effects have been reported with mechlorethamine. See the "Drug Precautions" section.

Common side effects of the mechlorethamine injection include the following:

• nausea
• weakness
• vomiting

Common side effects of the mechlorethamine topical form include the following:

• redness
• swelling
• itching
• skin ulcers or blisters
• skin infection
• darkening of skin areas

This is not a complete list of mechlorethamine side effects.  Ask your doctor or pharmacist for more information.  Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

You should not receive mechlorethamine if you are allergic to it, or if you have any type of infection.

To make sure mechlorethamine is safe for you, tell your doctor if you have:

• weak immune system (caused by disease or by using certain medicines);

• a history of herpes zoster (shingles); or

• if you have recently had radiation or X-ray treatment.

Using mechlorethamine may increase your risk of developing other types of cancer, such as leukemia. Ask your doctor about your specific risk.

Do not receive mechlorethamine if you are pregnant. It could harm the unborn baby. Use effective birth control to avoid pregnancy during your treatment with mechlorethamine. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

This medication may affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether mechlorethamine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while receiving this medicine.

Call your doctor for instructions if you miss a dose of mechlorethamine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Do not receive a "live" vaccine while receiving mechlorethamine Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain, burning, irritation, or skin changes where the injection was given;

• severe vomiting for longer than 24 hours, or coughing up blood;

• fever, chills, weakness, flu symptoms, sores in your mouth and throat;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• hearing problems, ringing in your ears; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• dizziness, spinning sensation;

• nausea, diarrhea; or

• temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to mechlorethamine: intravenous powder for solution

Along with its needed effects, mechlorethamine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way cancer medicines act on the body, there is a chance that they might cause other effects that may not occur until months or years after these medicines are used. These delayed effects may include certain types of cancer. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur while taking mechlorethamine:

• Black, tarry stools
• blood in urine or stools
• cough or hoarseness
• fever or chills
• lower back or side pain
• pain or redness at place of injection
• painful or difficult urination
• pinpoint red spots on skin
• unusual bleeding or bruising

• Shortness of breath, itching, or wheezing

Check with your doctor as soon as possible if any of the following side effects occur while taking mechlorethamine:

• Missing menstrual periods
• painful rash

• Dizziness
• joint pain
• loss of hearing
• ringing in ears
• swelling of feet or lower legs

• Numbness, tingling, or burning of fingers, toes, or face
• sores in mouth and on lips
• yellow eyes or skin

Some side effects of mechlorethamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Nausea and vomiting (usually lasts only 8 to 24 hours)

• Confusion
• diarrhea
• drowsiness
• headache
• loss of appetite
• metallic taste
• weakness

This medicine may cause a temporary loss of hair in some people. After treatment with mechlorethamine has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Black, tarry stools
• blood in urine or stools
• cough or hoarseness
• fever or chills
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on skin
• unusual bleeding or bruising

IV: 0.4 mg/kg either as a single dose or in divided doses of 0.1 to 0.2 mg/kg per day
Intracavitary (intrapleurally, intraperitoneal): 0.4 mg/kg
Intrapericardial: 0.2 mg/kg

Comments:
-The presence of edema or ascites must be considered so dosage will be based on actual weight unaugmented by these conditions.
-The dosage varies with the clinical situation, the therapeutic response and the magnitude of hematologic depression.

Uses:
-Intravenously: Palliative treatment of Hodgkin's disease (Stages III and IV), lymphosarcoma, chronic myelocytic or chronic lymphocytic leukemia, polycythemia vera, mycosis fungoides, and bronchogenic carcinoma.
-Intracavitary and Intrapericardial: Palliative treatment of metastatic carcinoma resulting in pleural, peritoneal, and/or pericardial effusion.

Data not available

US BOXED WARNINGS:
-Should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
-This drug is highly toxic and both powder and solution must be handled and administered with care. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Avoid exposure during pregnancy. Due to the toxic properties of this drug (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently.
-Extravasation of the drug into subcutaneous tissues results in a painful inflammation. The area usually becomes indurated and sloughing may occur. If leakage of drug is obvious, prompt infiltration of the area with sterile isotonic sodium thiosulfate (1/6 molar) and application of an ice compress for 6 to 12 hours may minimize the local reaction. For a 1/6 molar solution of sodium thiosulfate, use 4.14 g of sodium thiosulfate per 100 mL of Sterile Water for Injection or 2.64 g of anhydrous sodium thiosulfate per 100 mL or dilute 4 mL of Sodium Thiosulfate Injection (10%) with 6 mL of Sterile Water for Injection.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.