Dacivo Injection

Dactinomycin for Injection is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion. Wilms Tumor Dactinomycin for Injection is indicated for the treatment of adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. Rhabdomyosarcoma Dactinomycin for Injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. Ewing Sarcoma Dactinomycin for Injection is indicated for the treatment of adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. Metastatic Nonseminomatous Testicular Cancer Dactinomycin for Injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. Gestational Trophoblastic Neoplasia Dactinomycin for Injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. Regional Perfusion in Locally Recurrent and Locoregional Solid Malignancies Dactinomycin for Injection is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Secondary Malignancy or Leukemia: Increased risk of secondary malignancies following treatment. Veno-occlusive Disease: Can cause severe or fatal VOD. Monitor for elevations in AST, ALT, total bilirubin, hepatomegaly, weight gain, or ascites. Consider delaying next dose. Extravasation: Immediately interrupt the injection or infusion and apply ice. Myelosuppression: Monitor blood cell counts before each cycle. Delay next dose if severe myelosuppression has not improved. Immunizations: Vaccination with live viral vaccines is not recommended before or during treatment. Severe Mucocutaneous Reactions: Discontinue treatment Renal Toxicity: Monitor creatinine and electrolytes frequently. Hepatotoxicity: Monitor transaminases, alkaline phosphatase and bilirubin prior to and during treatment. Potentiation of Radiation Toxicity and Radiation Recall: Reduce dose by 50% during concomitant radiation. Use caution when administering within two months of radiation. Embryo-fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. Secondary Malignancy or Leukemia The risk of developing secondary malignancies, including leukemia, is increased following treatment with Dactinomycin. Veno-occlusive Disease Severe and fatal hepatic veno-occlusive disease (VOD) can occur with Dactinomycin. Risk factors for the development of VOD include age younger than 4 years or concomitant radiotherapy. After treatment with Dactinomycin, monitor frequently for signs and symptoms of VOD; these include elevations in AST, ALT, total bilirubin, hepatomegaly, weight gain, or ascites. If patients develop VOD, considering delaying next dose of Dactinomycin. Resume, reduce dose or permanently discontinue based on severity of reaction and disease being treated. Extravasation of Dactinomycin can result in severe local tissue injury manifesting as blistering, ulcerations and persistent pain requiring wide excision surgery followed by split-thickness skin grafting. If any signs or symptoms of extravasation occur, immediately interrupt the injection or infusion. Apply ice to the site intermittently for 15 minutes, 4 times a day for 3 days. Observe closely and consult plastic surgery if necessary based on severity of reaction. Myelosuppression Severe and fatal myelosuppression, which may include neutropenia, thrombocytopenia and anemia, can occur with Dactinomycin. The nadir in neutrophil counts generally occurs 14 to 21 days after administration. Obtain complete blood counts prior to each treatment cycle. Delay next dose of Dactinomycin if severe myelosuppression has not improved. Consider dose reduction for patients with prolonged myelosuppression based on severity of reaction and disease being treated. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following serious adverse reactions are described elsewhere in the labeling: Secondary Malignancy and Leukemia Veno-occlusive Disease Extravasation Myelosuppression Immunizations Severe Mucocutaneous Reactions Renal Toxicity Hepatotoxicity Potentiation of Radiation Toxicity and Radiation Recall Common adverse reactions are: infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, and hepatotoxicity. The following adverse reactions have been identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections: infections including sepsis with fatal outcome Hematologic: anemia, leukopenia, thrombocytopenia, pancytopenia, reticulocytopenia, neutropenia, febrile neutropenia, disseminated intravascular coagulation Immune system: hypersensitivity Metabolism and nutrition: anorexia, hypocalcemia, tumor lysis syndrome Nervous system: peripheral neuropathy Ocular: optic neuropathy Vascular: thrombophlebitis, hemorrhage Respiratory, thoracic and mediastinal: pneumonitis, pneumothorax Gastrointestinal: nausea, vomiting, abdominal pain, diarrhea, constipation, gastrointestinal ulceration, cheilitis, dysphagia, esophagitis, ulcerative stomatitis, ascites, proctitis, mucositis Hepatobiliary: liver function test abnormalities, hepatomegaly, hepatitis, hepatic failure with reports of death, hepatic veno-occlusive disease Dermatologic: alopecia, rash, dermatitis, acne, erythema multiforme, Stevens Johnson Syndrome, radiation recall, toxic epidermal necrolysis Musculoskeletal and connective tissue: myalgia, growth retardation Renal and urinary: renal impairment, renal failure General: fatigue, fever, malaise Common adverse reactions are: infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, and hepatotoxicity

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.