Dacarbazine 200 mg/20mL
Dacarbazine · INJECTION, POWDER, FOR SOLUTION · Meitheal Pharmaceuticals Inc.
Dacarbazine is a injection, powder, for solution containing dacarbazine at 200 mg/20mL, taken intravenous. Manufactured by Meitheal Pharmaceuticals Inc..
Key Facts
- Brand Name
- Dacarbazine
- Generic Name
- Dacarbazine
- NDC Code (Product)
71288-174- Manufacturer
- Meitheal Pharmaceuticals Inc.
- Strength
- 200 mg/20mL
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA075259
- Drug Class
- Alkylating Drug [EPC]
- Marketing Start
- 04/22/2024
Recall History
Teva Pharmaceuticals USA
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Infusion Options, Inc.
Lack of Assurance of Sterility
Hospira Inc.
Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Dacarbazine for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, dacarbazine is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 I.V. for 5 days. Treatment may be repeated every 3 weeks. Hodgkin's Disease The recommended dosage of dacarbazine 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 200 mg/vial is reconstituted with 19.7 mL of Sterile Water for Injection. 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, or sodium chloride injection, 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 a…
Warnings
WARNINGS Hemopoietic depression is the most common toxicity with dacarbazine and involves primarily the leukocytes and platelets, although, anemia may sometimes occur. Leukopenia and thrombocytopenia may be severe enough to cause death. The possible bone marrow depression requires careful monitoring of white blood cells, red blood cells, and platelet levels. Hemopoietic toxicity may warrant temporary suspension or cessation of therapy with dacarbazine. Hepatic toxicity accompanied by hepatic vein thrombosis and hepatocellular necrosis resulting in death, has been reported. The incidence of such reactions has been low; approximately 0.01% of patients treated. This toxicity has been observed mostly when dacarbazine has been administered concomitantly with other anti-neoplastic drugs; however, it has also been reported in some patients treated with dacarbazine alone. Anaphylaxis can occur following the administration of dacarbazine.
Contraindications
CONTRAINDICATIONS Dacarbazine is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.
Adverse Reactions
ADVERSE REACTIONS 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 to 12 hours and is incompletely and unpredictably palliated with phenobarbital and/or prochlorperazine. Rarely, intractable nausea and vomiting have necessitated discontinuance of therapy with dacarbazine. Rarely, dacarbazine has caused diarrhea. Some helpful suggestions include restricting the patient’s oral intake of food for 4 to 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 …
Frequently Asked Questions
What is Dacarbazine used for?
Dacarbazine contains Dacarbazine. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.
Is Dacarbazine a controlled substance?
Dacarbazine is not classified as a controlled substance by the DEA.
What is the generic name for Dacarbazine?
The generic name for Dacarbazine is Dacarbazine. There are no other listed brand versions of Dacarbazine.
What is the NDC code for Dacarbazine 200 mg/20mL?
The NDC (National Drug Code) for Dacarbazine 200 mg/20mL is 71288-174, listed by Meitheal Pharmaceuticals Inc..
Other Dacarbazine Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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