Dtic-Dome (Intravenous, Injection)

Dacarbazine is part of a group of medicines called alkylating agents. It is used to treat cancer in the lymph system and malignant melanoma (a type of skin cancer). It may also be used for other types of cancer, based on your doctor's decision.

Dacarbazine works by interfering with the growth of cancer cells, which are eventually destroyed. It can also affect the growth of normal body cells, leading to other effects. Some of these effects can be serious and should be reported to your doctor. Other effects, like hair loss, may not be serious but could still be concerning. Some effects might not appear for months or years after using the medicine.

Before starting treatment with dacarbazine, you and your doctor should discuss the benefits of this medicine as well as the risks of using it.

Dacarbazine is to be given only by or under the close supervision of your doctor.

It is very important that your doctor check your progress at regular visits to ensure that this medicine is working properly and to look for unwanted effects.

While you are being treated with dacarbazine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Dacarbazine may lower your body's resistance, and there is a chance you might get the infection that the immunization is meant to prevent. Additionally, others in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid close contact with anyone who has taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers your nose and mouth.

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

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or 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 if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine 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 your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

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

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. Here are some things to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

Research on this medicine has only been done in adults, and there is no specific information comparing the use of dacarbazine in children to its use in other age groups.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it is not known if they work the same way in older people as they do in younger adults or if they cause different side effects or issues in older individuals. There is no specific information about the use of dacarbazine in the elderly.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In those situations, your doctor may adjust the dose, or other precautions may be necessary. When taking this medicine, it is particularly important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed below are based on their potential importance and may not include all possibilities.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended but might be necessary in certain situations. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of use for one or both medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Pexidartinib
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of use for one or both medicines.

• Aldesleukin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—there is a risk of severe disease affecting other parts of the body

• Infection—Dacarbazine can lower your body's ability to fight infections

• Kidney disease or
• Liver disease—effects of dacarbazine may be increased due to slower removal from the body

Along with its needed effects, this medicine may cause some unwanted effects. Not all side effects may occur, but if they do, they may need medical attention.

Also, because of how these medicines work in the body, there is a chance that they might cause other unwanted effects that may not show up until months or years after using the medicine. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

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

More common

• Redness, pain, or swelling at the injection site

Less common

• Black, tarry stools
• Blood in urine or stools
• Cough or hoarseness, along with fever or chills
• Fever or chills
• Lower back or side pain, along with fever or chills
• Painful or difficult urination, along with fever or chills
• Pinpoint red spots on skin
• Unusual bleeding or bruising

Rare

• Shortness of breath
• Stomach pain
• Swelling of face
• Yellow eyes or skin

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

Rare

• Sores in mouth and on lips

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

More common

• Loss of appetite
• Nausea or vomiting (should lessen after 1 or 2 days)

Less common

• Feelings of uneasiness
• Flushing of face
• Muscle pain
• Numbness of face

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

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

• Black, tarry stools
• Blood in urine or stools
• Cough or hoarseness, along with fever or chills
• Fever or chills
• Lower back or side pain, along with fever or chills
• Painful or difficult urination, along with fever or chills
• Pinpoint red spots on skin
• Unusual bleeding or bruising

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Dtic-Dome

In Canada

• Dacarbazine

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Imidazole Carboxamide

Dacarbazine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to remember to take them at the right times.

This medicine often causes nausea, vomiting, and loss of appetite. The injection may also cause a feeling of burning or pain. However, it is very important that you continue to receive the medicine, even if you have discomfort or 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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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