Dacarbazine

Dacarbazine may be found in some form under the following brand names:

• DTIC-Dome

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Call your doctor for instructions if you miss an appointment for your dacarbazine injection.

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

Do not receive a "live" vaccine while using dacarbazine. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Your doctor or pharmacist can provide more information about dacarbazine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Symptoms of anorexia, nausea, and vomiting are the most frequently noted of all toxic reactions. Over 90% of patients are affected with the initial few doses. The vomiting lasts 1-12 hours and is incompletely and unpredictably palliated with phenobarbital and/or prochlorperazine. Rarely, intractable nausea and vomiting have necessitated discontinuance of therapy with DTlC-Dome. Rarely, DTlC-Dome has caused diarrhea. Some helpful suggestions include restricting the patient's oral intake of food for 4-6 hours prior to treatment. The rapid toleration of these symptoms suggests that a central nervous system mechanism may be involved, and usually these symptoms subside after the first 1 or 2 days.

There are a number of minor toxicities that are infrequently noted. Patients have experienced an influenza-like syndrome of fever to 39�C, myalgias and malaise. These symptoms occur usually after large single doses, may last for several days, and they may occur with successive treatments.

Alopecia has been noted as has facial flushing and facial paresthesia. There have been few reports of significant liver or renal function test abnormalities in man. However, these abnormalities have been observed more frequently in animal studies.

Erythematous and urticarial rashes have been observed infrequently after administration of DTIC-Dome (dacarbazine) . Rarely, photosensitivity reactions may occur.

Read the entire FDA prescribing information for Dtic-Dome (Dacarbazine)

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 using dacarbazine. The vaccine may not work as well during this time, and may not fully protect you from disease. 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:

• severe or continued vomiting;

• fever, chills, body aches, flu symptoms;

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

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

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

Common side effects may include:

• loss of appetite;

• diarrhea;

• temporary hair loss;

• mild skin rash; or

• numbness, warmth, redness, or tingly feeling in your face.

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.

General

• Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.100

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer only by IV injection or infusion.100 b Extremely irritating to tissues; avoid extravasation.100 (See Local Effects under Cautions.)

Reconstitute vial containing 100 or 200 mg of dacarbazine powder with 9.9 or 19.7 mL, respectively, of sterile water for injection to provide a solution containing 10 mg/mL.100 c d

Reconstituted solution may be further diluted with 5% dextrose or 0.9% sodium chloride injection and infused IV.100 c d

IV injection: Administer over 1 minute.100 b

IV infusion: Infuse diluted solution over 15–30 minutes.100 b

Dosage

Optimize results and minimize adverse effects by basing dose on clinical and hematologic response, patient tolerance, and other chemotherapy or irradiation being used.100 b

Consult published protocols for dosages in combination regimens and method and sequence of administration.b

Adults

2–4.5 mg/kg daily for 10 days; may repeat at 4-week intervals.100

Alternatively, 250 mg/m2 daily for 5 days; may repeat at 3-week intervals.100

150 mg/m2 daily for 5 days in combination with other antineoplastic agents; may repeat every 4 weeks.100

Alternatively, 375 mg/m2 on day 1, in combination with other antineoplastic agents; repeat every 15 days.100

Contraindications

• Hypersensitivity to dacarbazine or any ingredient in the formulation.100

Warnings/Precautions

Warnings

Administer only under supervision of a qualified clinician experienced in therapy with antineoplastic agents.100 (See Boxed Warning.)

Myelosuppression (principally severe leukopenia and thrombocytopenia) occurs commonly, generally 2–4 weeks after the last dose;100 b fatal leukopenia and thrombocytopenia reported.100 Anemia can occur.100 b

Carefully monitor hematologic status during therapy; evaluate leukocyte, erythrocyte, and platelet counts at frequent intervals.100

Hematopoietic toxicity (generally leukocyte count <3000/mm3 and platelet count <100,000/mm3) may require temporary withdrawal or discontinuance of the drug.100 b

Hepatotoxicity complicated by hepatic vein thrombosis and hepatocellular necrosis resulting in death has been reported.100 More common with combination regimens but also occurs with dacarbazine alone.100

May cause fetal harm; teratogenicity and embryolethality demonstrated in animals.100

Sensitivity Reactions

Possible hypersensitivity reactions, including anaphylaxis.100

Photosensitivity reactions reported rarely.100

General Precautions

Carcinogenic effects reported in animals; importance in humans not known.100 b

Extravasation may result in tissue damage and severe pain.100

Undiluted solutions administered by IV injection may cause severe pain and phlebitis; some clinicians recommend dilution and infusion.b

Hot packs may relieve local pain, burning sensation, and irritation at the injection site.100

Specific Populations

Category C.100

Not known whether dacarbazine is distributed into milk; discontinue nursing or the drug.100

Common Adverse Effects

Anorexia, nausea, vomiting, leukopenia, thrombocytopenia.100

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Very bad dizziness or passing out.
• Very upset stomach or throwing up.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store dacarbazine at home, talk with your doctor, nurse, or pharmacist about how to store it.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take dacarbazine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to dacarbazine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Give supportive treatment and monitor blood cell counts.

Malignant Melanoma: The recommended dosage is 2 to 4.5 mg/kg/day for 10 days. Treatment may be repeated at 4 week intervals.

An alternate recommended dosage is 250 mg/square meter body surface/day IV for 5 days. Treatment may be repeated every 3 weeks.

Hodgkin's Disease: The recommended dosage of Dacarbazine for Injection in the treatment of Hodgkin's disease is 150 mg/square meter body surface/day for 5 days, in combination with other effective drugs. Treatment may be repeated every 4 weeks. An alternative recommended dosage is 375 mg/square meter body surface on day 1, in combination with other effective drugs, to be repeated every 15 days.

Dacarbazine for Injection 200 mg/vial is reconstituted with 19.7 mL of Sterile Water for Injection, USP. The resulting solution contains 10 mg/mL of Dacarbazine having a pH of 3.0 to 4.0. The calculated dose of the resulting solution is drawn into a syringe and administered only intravenously.

The reconstituted solution may be further diluted with 5% dextrose injection, USP or sodium chloride injection, USP and administered as an intravenous infusion.

After reconstitution and prior to use, the solution in the vial may be stored at 4°C for up to 72 hours or at normal room conditions (temperature and light) for up to 8 hours. If the reconstituted solution is further diluted in 5% dextrose injection, USP or sodium chloride injection, USP, the resulting solution may be stored at 4°C for up to 24 hours or at normal room conditions for up to 8 hours.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published1-7. There is no general agreement that all the procedures recommended in the guidelines are necessary or appropriate.

[US Boxed Warning]: Studies have demonstrated this agent to be carcinogenic and/or teratogenic when used in animals; adverse effects have been observed in animal reproduction studies. Women of reproductive potential should avoid becoming pregnant during treatment. The European Society for Medical Oncology has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy. The guidelines recommend referral to a facility with expertise in cancer during pregnancy and encourage a multidisciplinary team (obstetrician, neonatologist, oncology team). In general, if chemotherapy is indicated, it should be avoided during in the first trimester, there should be a 3-week time period between the last chemotherapy dose and anticipated delivery, and chemotherapy should not be administered beyond week 33 of gestation (Peccatori 2013). An international consensus panel has published guidelines for hematologic malignancies during pregnancy. Dacarbazine is a component of the ABVD regimen, which is used for the treatment of Hodgkin lymphoma. If treatment cannot be deferred until after delivery in patients with early stage Hodgkin lymphoma, ABVD may be administered safely and effectively in the latter phase of pregnancy (based on limited data); for patients with advanced-stage disease, ABVD can be administered in the second and third trimesters (Lishner 2016).

Data not available

Data not available