Adriamycin must not be given by the intramuscular or subcutaneous route. Dacarbazine may also inhibit dna and rna synthesis by acting as a purine analogue and by interacting with sulfhydryl groups. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Temozolamide is an oral analogue of dacarbazine and crosses the bloodbrain barrier but is more expensive and has no improvement in. Dacarbazine medac 500 mg mg is supplied as a sterile powder for solution for infusion in singledose vials made of amber glass type i, ph. Dacarbazine is a cell cycle nonspecific antineoplastic agent that functions as an alkylating agent after activation in the liver. Fatal infusionrelated reactions within 24 hours of rituxan infusion. Extravasation of the drug subcutaneously during intravenous administration may result in tissue. Dacarbazine 100 mg powder for solution for injection. Dacarbazine dacarbazine this product information is intended only for residents of the united states. Dacarbazine is available as an injectable solution in 100, 200, and 500mg vials fda 2009. Bystolic may be used alone or in combination with other antihypertensive agents see drug interactions 7. Monitor patients and discontinue rituxan infusion for severe reactions 5. The median time to the first appearance of cuscc was 7 to 8 weeks.
This is based on results in animals with other known arteriolar irritants. Dbl dacarbazine for injection is a sterile parenteral dosage form for. Each vial also contains anhydrous citric acid and mannitol. Dacarbazine dacarbazine dose, indications, adverse. Dacarbazine was teratogenic in rats at doses 20times the daily human dose on day 12 of gestation.
Dacarbazine is a triazene derivative with antineoplastic activity. This emedtv page covers some warnings on how to safely use dacarbazine, with precautions for people with who may have a high risk for complications. Melanoma that has metastasized spread to other parts of the body. Ndc 5539033910 200 mgvial of sterile dacarbazine in boxes of 10. Ixempra as monotherapy is indicated for the treatment of metastatic or locally.
Melanoma is a leading cause of skin cancer mortality in the united states. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. Serious irreversible myocardial toxicity with delayed congestive. Doxorubicin and dacarbazine may be mixed in the same container and administered as a single infusion. Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Doxorubicin hydrochloride for injection, usp for intravenous use only rx only warnings 1. The mechanism of action of vinblastine sulfate has been related to the inhibition of microtubule formation in the mitotic spindle, resulting in an arrest of dividing cells at the metaphase stage. Dacarbazine for injection is a colorless to an ivory colored solid which is light sensitive. Clinical pharmacology after intravenous administration of dacarbazine for injection, the volume of distribution exceeds total body water content suggesting localization in some body tissue, probably the liver. Dailymed dacarbazine injection, powder, for solution. Nexavar tablets are round, biconvex, red filmcoated tablets, debossed with the bayer cross on one side and 200 on the other side.
Hodgkin lymphoma in patients whose disease has not gotten better with other chemotherapy. Dacarbazine is also being studied in the treatment of other types of cancer. Stage iii or iv chl, in combination with doxorubicin, vinblastine, and dacarbazine. Doxorubicin hydrochloride for injection, usp patient. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020. Severe mucocutaneous reactions, some with fatal outcomes 5. Dacarbazine may cause fetal harm when used during pregnancy, based on its mechanism of action and data from animal studies. Other studies indicate that vinblastine sulfate has an effect on cellenergy production required for mitosis and interferes with nucleic acid synthesis. Geriatric patients and women have a higher risk of developing myelosuppression. Across clinical trials of tafinlar n 586, the 39 incidence of cuscc was 11%.
See full prescribing information for complete boxed warning. Dacarbazine medac 200 mg powder for solution for injectioninfusion. Dacarbazine injection, powder, for solution dailymed. Dacarbazine fda prescribing information, side effects.
Review the prescribing information for nivolumab for full dosing and schedule information. When reconstituted as directed each ml of the solution in the 200 milligram vial contains dacarbazine 10 milligrams, citric acid 10 milligrams and mannitol 3. Of those patients who developed a cuscc, approximately 33% developed one or more 41 cuscc with continued tafinlar. Each carton of dacarbazine medac 500 mg mg contains one vial. Dacarbazine for injection usp is supplied as follows lyophilized powder.
Camptosar injection must be diluted prior to infusion. Dacarbazine is cell cycle phasenonspecific and is mildly immunosuppressive. Dacarbazine may cause potentially fatal allergic reactions or other serious problems in some people. Both dacarbazine and temozolomide are prodrugs of mtic. Halaven arm and at a higher incidence than in the dacarbazine arm between. Dbl dacarbazine for injection is a sterile parenteral dosage form for reconstitution.
Dacarbazine alkylates and crosslinks dna during all phases of the cell cycle, resulting in disruption. Vinp03 vinblastine sulfate for injection usp warning caution this preparation should be administered by individuals experienced in the administration of vinblastine sulfate. Sections or subsections omitted from the full prescribing information are not. Each vial contains 100 mg of dacarbazine, or 200 mg of dacarbazine the active ingredient, anhydrous citric acid and mannitol. Dacarbazine is the standard intravenous chemotherapy drug for metastatic melanoma with a response rate of 1020% and a median duration of response of 36 months. Dailymed dacarbazine dacarbazine injection, powder, for. Dacarbazine for injection bp is a potent drug and should be used only by.
It is given 34 weekly at doses of 850 mgm 2 with nausea as the main side effect. The package insert states that there is no proven successful management of extravasation after it occurs, although sympathetic block and heparinization are commonly employed during acute management. Highlights of prescribing information these highlights do not include all the information needed to use cubicin safely and effectively. Doxorubicin and dacarbazine ad regimen for soft tissue. Treatment for melanoma had been limited to very few agents, including chemotherapy, with older treatment options such as. Alodhaib, in profiles of drug substances, excipients and related methodology, 2016. Camptosar injection 20 mgml is intended for single use only and any unused portion should be discarded. Cytarabine injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mgml mg50 ml pharmacy bulk package. Dacarbazine for injection, usp is a colorless to an ivory colored solid which is light sensitive. Dacarbazine for injection is reconstituted and administered intravenously ph 34. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. Highlights of prescribing information these highlights do not include all the information needed to use dacogensafely and effectively. Since dacarbazine is light sensitive, the solution should be protected from light immediately following preparation.
Severe local tissue necrosis will occur if there is extravasation during administration. Dacarbazine is an anticancer agent designated chemically. Full prescribing information 1 indications and usage zaltrap, in combination with. Cyclophosphamide for injection, usp rx only description cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide monohydrate.
In patients treated with tafinlar, the median time to initial onset of fever any 60 severity was 11 days range. The drug is used in the treatment of metastatic malignant melanoma. Previously untreated stage iiiiv chl adult patients with previously untreated stage iiiiv classical hodgkin lymphoma chl in combination with doxorubicin, vinblastine, and dacarbazine. Medicinal forms there can be variation in the licensing of different medicines containing the same drug.
Camptosar should be diluted in 5% dextrose injection, usp, preferred or 0. Dacarbazine is approved to be used alone or with other drugs to treat. As the drug is excreted 50% unchanged in the urine by tubular secretion. Highlights of prescribing information recurrent or. Highlights of prescribing information these highlights do not include all the information needed to use votrient safely and effectively. Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. Tablets containing sorafenib tosylate 274 mg equivalent to 200 mg of sorafenib. Dacarbazine for injection, usp is reconstituted and administered intravenously ph 3 to 4. Pdf dacarbazine is a cellcycle nonspecific antineoplastic alkylating agent used in the treatment of metastatic malignant melanoma.