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USP DI Vol. II - DACARBAZINE (Systemic)

DACARBAZINE (Systemic)


Some commonly used brand names are:

In the U.S.?

  • DTIC-Dome

In Canada?

  • DTIC

Generic name product may be available in the U.S.


Category

  • Antineoplastic

Description

Dacarbazine (da-KAR-ba-zeen) belongs to the group of medicines calledalkylating agents. It is used to treat cancer of the lymph system and malignantmelanoma (a type of skin cancer). It may also be used to treat other kindsof cancer, as determined by your doctor.

Dacarbazine interferes with the growth of cancer cells, which are eventuallydestroyed. Since the growth of normal body cells may also be affected by dacarbazine,other effects will also occur. Some of these may be serious and must be reportedto your doctor. Other effects, like hair loss, may not be serious but maycause concern. Some effects may not occur for months or years after the medicineis used.

Before you begin treatment with dacarbazine, you and your doctor shouldtalk about the good this medicine will do as well as the risks of using it.

Dacarbazine is to be administered only by or under the immediate supervisionof your doctor. It is available in the following dosage form:

    Parenteral
  • Injection (U.S. and Canada)


Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For dacarbazine, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to dacarbazine.

Pregnancy?There is a chance that this medicine may cause birthdefects if either the male or female is taking it at the time of conceptionor if it is taken during pregnancy. In addition, many cancer medicines maycause sterility, which could be permanent. Although sterility has not beenreported with this medicine, the possibility should be kept in mind. Dacarbazinehas caused birth defects and a decrease in successful pregnancies in animalstudies involving rats and rabbits given doses several times the usual humanadult dose.

Be sure that you have discussed this with your doctor before taking thismedicine. It is best to use some kind of birth control while you are receivingdacarbazine. Tell your doctor right away if you think you have become pregnantwhile receiving dacarbazine.

Breast-feeding?It is not known whether dacarbazine passes intobreast milk. However, because this medicine may cause serious side effects,breast-feeding is generally not recommended while you are receiving it.

Children?Studies on this medicine have been done only in adultpatients and there is no specific information comparing use of dacarbazinein children with use in other age groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information about the useof dacarbazine in the elderly.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When receiving dacarbazineit is especially important that your health care professional know if youare taking any of the following:

  • Amphotericin B by injection (e.g., Fungizone) or
  • Antithyroid agents (medicine for overactive thyroid) or
  • Azathioprine (e.g., Imuran) or
  • Chloramphenicol (e.g., Chloromycetin) or
  • Colchicine or
  • Flucytosine (e.g., Ancobon) or
  • Ganciclovir (e.g., Cytovene) or
  • Interferon (e.g., Intron A, Roferon-A) or
  • Plicamycin (e.g., Mithracin) or
  • Zidovudine (e.g., AZT, Retrovir) or
  • If you have ever been treated with radiation or cancer medicines?Dacarbazinemay increase the effects of these medicines or radiation therapy on the blood

Other medical problems?The presence of other medicalproblems may affect the use of dacarbazine. Make sure you tell your doctorif you have any other medical problems, especially:

  • Chickenpox (including recent exposure) or
  • Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body
  • Infection?Dacarbazine can decrease your body's ability to fightinfection
  • Kidney disease or
  • Liver disease?Effects of dacarbazine may be increased becauseof slower removal from the body

Proper Use of This Medicine

Dacarbazineis sometimes given together with certain other medicines. If you are usinga combination of medicines, it is important that you receive each one at theproper time. If you are taking some of these medicines by mouth, ask yourhealth care professional to help you plan a way to remember to take them atthe right times.

This medicine often causes nausea, vomiting, and loss of appetite. Theinjection may also cause a feeling of burning or pain. However, it is veryimportant that you continue to receive the medicine, even if you have discomfortor begin to feel ill. After 1 or 2 days, your stomach upset should lessen.Ask your health care professional for ways to lessen these effects.

Dosing?The dose of dacarbazine will be different fordifferent patients. The dose that is used may depend on a number of things,including what the medicine is being used for, the patient's weight, and whetheror not other medicines are also being taken. If you arereceiving dacarbazine at home, follow your doctor's orders or the directionson the label. If you have any questions about the proper dose of dacarbazine,ask your doctor.


Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check forunwanted effects.

While you are being treated with dacarbazine, and after you stop treatmentwith it, do not have any immunizations (vaccinations)without your doctor's approval. Dacarbazine may lower your body's resistanceand there is a chance you might get the infection the immunization is meantto prevent. In addition, other persons living in your household should nottake oral polio vaccine since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral polio vaccine withinthe last several months. Do not get close to them, and do not stay in thesame room with them for very long. If you cannot take these precautions, youshould consider wearing a protective face mask that covers the nose and mouth.

Dacarbazine can temporarily lower the number of white blood cells in yourblood, increasing the chance of getting an infection. It can also lower thenumber of platelets, which are necessary for proper blood clotting. If thisoccurs, there are certain precautions you can take, especially when your bloodcount is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor if you get a fever or chills, cough or hoarseness, lower back or side pain,or painful or difficult urination.
  • Check with your doctor immediately ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick.Your medical doctor, dentist, or nurse may recommend other ways to clean yourteeth and gums. Check with your medical doctor before having any dental workdone.
  • Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injurycould occur.

If dacarbazine accidentally seeps out of the vein into which it is injected,it may damage some tissues and cause scarring. Tell thedoctor or nurse right away if you notice redness, pain, or swelling at theplace of injection.


Side Effects of This Medicine

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

Also, because of the way these medicines act on the body, there is a chancethat they might cause other unwanted effects that may not occur until monthsor years after the medicine is used. These delayed effects may include certaintypes of cancer, such as leukemia. Discuss these possible effects with yourdoctor.

    Check with your doctoror nurse immediately if any of the following side effects occur:

      More common

        Redness, pain, or swelling at place of injection

      Less common

        Black, tarry stools; blood in urineor stools; cough or hoarseness, accompanied by feveror chills; fever or chills; lower back or side pain, accompanied by fever or chills; painful or difficult urination, accompanied by fever or chills; pinpoint red spots on skin; unusualbleeding or bruising

      Rare

        Shortness of breath; stomach pain; swelling of face; yellow eyes or skin

    Check with your health care professional as soon as possible if the followingside effect occurs:

      Rare

        Sores in mouth and on lips

Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. Also, your health careprofessional may be able to tell you about ways to prevent or reduce someof these side effects. Check with your health care professional if any ofthe following side effects continue or are bothersome or if you have any questionsabout them:

    More common

      Loss of appetite; nausea or vomiting(should lessen after 1 or 2 days)

    Less common

      Feelings of uneasiness; flushing offace; muscle pain; numbnessof face

This medicinemay cause a temporary loss of hair in some people. After treatment with dacarbazinehas ended, normal hair growth should return.

After you stop receiving dacarbazine, it maystill produce some side effects that need attention. During this period oftime check with your doctor if you notice any of the following:

Black, tarry stools; blood in urineor stools; cough or hoarseness, accompanied by feveror chills; fever or chills; lower back or side pain, accompanied by fever or chills; painful or difficult urination, accompanied by fever or chills; pinpoint red spots on skin; unusualbleeding or bruising

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.


Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, dacarbazine is used in certain patients with the following medicalconditions:

  • Cancer of the islet cells (a part of the pancreas)
  • Soft tissue sarcomas (a cancer of the muscles, tendons, vessels thatcarry blood or lymph, joints, and fat)

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.


Revised: 08/14/1998