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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Advise patients to contact their healthcare provider for a new onset fever or symptoms of infection. We only can refer you to a foundation that supports your disease state. Liposomal doxorubicin is administered intravenously into a veinand the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient.

Please inform your doctor about your history of allergic reactions to medications or other substances.

The pharmacokinetic parameters for total doxorubicin following a single dose of Doxil infused over 30 minutes are presented in Table 8. Two analyses of tumor response were used: This may lead to tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet.

A hazard ratio less than 1 indicates an advantage for Doxil. Because many drugs, including anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Doxil, discontinue breastfeeding during treatment with Doxil. HFS or other skin toxicity required discontinuation of Doxil in 4. Patients were randomized 1: Advise patients to notify their healthcare provider if they develop painful redness, swelling, or sores in the mouth symptoms of stomatitis.

Efficacy results are as shown in Table 13 and Figure 1. Do not administer as an undiluted suspension or as an intravenous bolus [see Warnings and Precautions 5.

Please take me back. Premature menopause can occur with doxorubicin HCl.

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. We encourage you to read the Privacy Policy of every website you visit.

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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. Recovery of menses and ovulation is related to age at treatment. If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. Erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter Delay dosing up to 2 weeks or until resolved to Grade 0—1.

By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug.

The following adverse reactions are discussed in more detail in other sections of the labeling. These malignancies were diagnosed both during treatment with Doxil and up to 6 years after the last dose.

Each mL also contains ammonium sulfate, approximately 0.

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. Some patients may experience other side effects that are not listed here. The following programs are not affiliated with Janssen. Mild erythema, swelling, or desquamation not interfering with daily activities.

IMPORTANT SAFETY INFORMATION

po Advise patients about the symptoms of infusion related reactions and to seek immediate medical attention if they develop any of these symptoms [see Warnings doxjl Precautions 5. Discontinue Doxil infusion for serious or life-threatening infusion-related reactions. Painful erythema, edema, or ulcers, and cannot eat Delay dosing up to 2 weeks or until resolved to Grade 0—1. Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions 5.

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The following additional adverse reactions have been identified during post approval use of Doxil. Mutagenicity or carcinogenicity studies have not been conducted with Doxil, however doxorubicin was shown to be mutagenic in the in vitro Ames assay, and clastogenic in multiple in vitro assays CHO cell, V79 hamster cell, human lymphoblast, and SCE assays and the in vivo mouse micronucleus assay.

The possible adverse effects on fertility in animals have not been adequately evaluated. In this trial, patients received Doxil for a median number of 3. Manage confirmed or suspected extravasation as follows:.

The background risk of major birth defects and miscarriage for the indicated populations doxi unknown. If after 2 weeks there is no resolution, discontinue Doxil. ;i

The combination arm demonstrated significant improvement in TTP. The foundations on this list are not the only ones that might be able to help you. If you are pregnant, planning to become pregnant, or nursing, inform your doctor. Results are dixil in Table The primary outcome measure was time to progression TTP.

Doxil – FDA prescribing information, side effects and uses

At the current time, patient affordability programs for the selected insurance option are not available for this product. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Although patients will be closely monitored for a reaction, patients should tell their healthcare provider immediately if they are experiencing difficulty breathing, swelling of facial features, back pain, fever, chills, redness of face, tightness of chest, swelling of throat, headache, lightheadedness, dizziness, itching, rash, or noticeable changes in heart rate. SGPT increase, weight loss, hyperbilirubinemia.

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