DOXIL PI PDF

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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Infusion reactions may also occur during administration. Serious reactions, including anaphylaxis, have occurred. The risk of cardiomyopathy may be increased at lower cumulative doses in patients with prior mediastinal irradiation [see Warnings and Precautions 5. The following additional adverse reactions were observed in patients with AIDS-related Kaposi’s sarcoma.

The possible adverse effects on fertility in animals have not been adequately evaluated. In some cases, doxll reactions may be serious and sometimes life-threatening and may be fatal. Available for Android and iOS devices. Painless ulcers, erythema, or mild soreness. There was no statistically significant difference in TTP between the two arms. Painful erythema, edema, or ulcers, but can eat. These malignancies were diagnosed both during treatment with Doxil and up to 6 years after the last dose.

Important Limitations of Use The information provided above docil the ddoxil you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. If previous Grade 3 or 4 HFS: This site is intended for the use of patients and caregivers in the United States. Embryotoxicity was characterized by increased embryo-fetal deaths and reduced live litter sizes. And no previous Grade 3 or 4 stomatitis: And previous Grade 3 or 4 toxicity: The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but po limited to, drugs, regimens, dose, schedule, and any supportive care.

If you are pregnant, planning to become pregnant, or nursing, inform your doctor. Painful erythema, edema, or ulcers, and cannot eat Delay dosing up to 2 weeks or until resolved to Grade 0—1.

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TGA eBS – Product and Consumer Medicine Information

Please inform your doctor about your history of allergic reactions to medications or other substances. Patients should ask their physician about the amount of liquid to consume during a docil. Blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Clinical studies of Doxil conducted in patients with either epithelial ovarian cancer Trial 4 or with AIDS-related Kaposi’s sarcoma Trial 5 did not contain sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects.

Many states have programs for people with limited income and resources that pay some or all of Medicare’s premiums and may pay Medicare deductibles and co-insurance. Some states sponsor prescription financial assistance programs, each with its own eligibility requirements.

IMPORTANT SAFETY INFORMATION

The plasma clearance of total doxorubicin from Doxil was 0. Because many drugs, including anthracyclines, doxi, excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Doxil, discontinue breastfeeding during treatment with Doxil.

Two analyses of tumor response were used: The following tables present adverse reactions from clinical trials of single-agent Doxil in ovarian cancer and AIDS-Related Kaposi’s sarcoma. Some patients may experience reactions during administration of liposomal doxorubicin. Ppi applicable special handling and disposal procedures.

The mechanism of action of doxorubicin HCl is thought to be related to its ability to bind DNA and inhibit nucleic acid synthesis. Some patients may experience other side effects that are not listed here. At doses approximately 0. We have also listed most of the eligibility requirements for each, so you can narrow your focus to those that best suit your circumstances. Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates on other clinical trials and may not reflect the rates observed in clinical practice.

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Of the 77 patients, 34 were evaluable for investigator assessment and 42 were evaluable for indicator lesion assessment; analyses of tumor responses are shown in Table Discontinue Doxil if HFS is severe and debilitating.

Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. How is this drug used?

Need help paying for your DOXIL® (doxorubicin HCl liposome injection) prescription?

There are no available human data informing the drug-associated risk. Based on animal data, Doxil can cause fetal harm when administered to a pregnant woman.

The combination arm demonstrated significant improvement in TTP. Voxil, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing. Your healthcare provider will temporarily stop the infusion to control the symptoms and resume treatment at a reduced rate.

If no previous Grade 3 or 4 toxicity: Mild erythema, swelling, or desquamation not interfering with daily activities.

Los Angeles Cancer Network Doxil® – Los Angeles Cancer Network

Patients were stratified according to platinum sensitivity response to initial platinum-based therapy and a progression-free interval of greater than 6 months off treatment and the presence of bulky disease tumor mass greater than 5 cm in size. Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

No overall differences in safety or efficacy were observed between these patients and younger patients.

This information is intended for the use of patients and caregivers in the United States and Puerto Rico only. Do not rapidly flush the infusion line.