PI & CMI Trade Names and Active Ingredients containing doxorubicin. 7 Documents available Doxorubicin Ebewe, PI, Doxorubicin hydrochloride. Doxorubicin. Doxil official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more. Find information on drug affordability programs for DOXIL® (doxorubicin HCl liposome injection). Learn how patients who have been.
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Doxil – FDA prescribing information, side effects and uses
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Of the 77 patients, 34 were evaluable for investigator doxi and 42 were evaluable for indicator lesion assessment; analyses of tumor responses are shown in Table The following additional adverse reactions have been identified during post approval use of Doxil.
Inform patients that following Doxil administration, a reddish-orange color to the urine and other body fluids may be observed.
Discontinue Doxil if no resolution after 2 weeks. Patients should check with their physician about any side effects that continue or are bothersome.
DOXIL® (doxorubicin HCl liposome injection) – Janssen Prescription Assistance
Some side effects may require medical attention. Embryotoxicity was characterized by increased embryo-fetal deaths and reduced live litter sizes. Doxil was studied in three open-label, single-arm, clinical studies of patients with metastatic ovarian cancer Trials 1, 2, and 3. It is also approved for the treatment of coxil cancer that has stopped responding to platinum and paclitaxel-based chemotherapy regimens. In certain cases, this reaction can be more severe leading to serious infections, interfering with walking and other daily activities.
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The safety data reflect exposure to Doxil in patients including: And no previous Grade 3 or 4 HFS: Secondary efficacy parameters were time to response, duration of response, and time to progression.
Receive assistance paying their ddoxil premium Have dosil reduced or no deductible Have reduced or no prescription co-insurance and co-payments Have no gap in coverage. Doxil can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations 8. And previous Grade 3 or 4 toxicity: This information pk intended for the use of patients and caregivers in the United States and Puerto Rico only.
Other side effects do not require medical attention and may go away during treatment. Administer Doxil to patients with a history of cardiovascular disease only when the potential benefit of treatment outweighs the risk.
This is not a complete list of side effects. In the event of an infusion-related reaction, temporarily stop the drug until resolution then resume at a reduced infusion rate. Discontinue Doxil doxl for serious or life-threatening infusion-related reactions.
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By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.
This drug may cause birth defects. Discontinue Doxil if HFS is severe and debilitating. Speak to your doctor if you notice any changes in your health such as a new onset fever or symptoms of infection. What can patients do to help alleviate or prevent discomfort and side effects? TTP was defined as the time from randomization to the first occurrence of progressive disease or death due to progressive disease.
If no infusion-related adverse reactions are observed, increase the infusion rate to complete the administration of the drug over one hour [see Warnings and Precautions 5. HFS was generally observed after 2 or 3 cycles of treatment but may occur earlier. The following tables present adverse reactions from clinical trials of single-agent Doxil in ovarian cancer and AIDS-Related Kaposi’s sarcoma. There was no statistically significant difference in TTP between the two arms.
Painful erythema, edema, or ulcers, but can eat Delay dosing up to 2 weeks or until resolved to Grade 0—1. Doxil may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities.
Based on findings in animals, Doxil can cause fetal harm when administered to a pregnant woman. The pharmacokinetics of Doxil has not been adequately evaluated in patients with doxl impairment. Your doctor will monitor your blood laboratory results.