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Brand Name: Adriamycin Trade Name: doxorubicin
FDA Approved For: Doxil (doxorubicin HCl liposome injection) is indicated for: The treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens. Refractory disease is defined as disease that has progressed while on treatment, or within 6 months of completing treatment. The treatment of AIDS-related Kaposiís sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy. These indications are based on objective tumor response rates. No results are available from controlled trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in disease-related symptoms or increased survival. Pediatric Use: The safety and effectiveness of Doxil in pediatric patients have not been established.
Carcinogen: Secondary acute myelogenous leukemia has been reported in patients treated with topoisomerase II inhibitors, including anthracyclines. Although no studies have been conducted with Doxil , doxorubicin HCl and related compounds have been shown to have mutagenic and carcinogenic properties when tested in experimental models. Mutagen: STEALTH liposomes without drug were negative when tested in Ames, mouse lymphoma and chromosomal aberration assays in vitro, and mammalian micronucleus assay in vivo.
Manufacturer and/or Distributor: Pharmacia & Upjohn Company    

Adverse Reactions:
Ovarian Cancer Patients Safety data are available from 373 ovarian cancer patients treated with Doxil in 4 clinical studies. The patient population was predominantly white (93.6%) with a median age of 60 years. Patients received a median cycle dose of 50 mg/m2 administered with a median cycle length of 29.5 days. They remained on study drug for a median of 56 days and received a median cumulative dose of 137.5 mg/m2. Patients received a median of 3-cycles of Doxil , although some patients remained on study drug for a prolonged period, with 46 patients (12.3%) receiving more than 10 cycles of treatment. Adverse events (AEs) were reported in all but 2 of the 361 patients who had at least one AE form collected. A total of 3,124 AEs were reported, an average of 8.6 AEs per patient. Most (91.7%) patients had AEs that were considered related to study drug. Drug-Related Adverse Events Reported in ≥ 5% of Ovarian Cancer Patients (See Table) *From concomitant medication or transfusion logs, not reported as AEs. The following additional (not in table) adverse events were observed in ovarian cancer patients with doses administered every four weeks; only events considered at least possibly drug-related by investigators are included. Incidence 1% to 5% Body as a Whole: allergic reaction, chills, infection, chest pain, back pain, abdomen enlarged, malaise. Digestive System: dyspepsia, oral moniliasis, mouth ulceration, esophagitis, dysphagia. Metabolic and Nutritional System: peripheral edema, dehydration. Musculoskeletal System: myalgia. Nervous System: somnolence, dizziness, depression, insomnia, anxiety. Respiratory System: dyspnea, cough increased, rhinitis. Cutaneous: pruritus, skin discoloration, skin disorder, vesiculobullous rash, maculopapular rash, exfoliative dermatitis, herpes zoster, sweating. Special Senses: conjunctivitis, taste perversion. Incidence Less Than 1% Body As A Whole: cellulitis, anaphylactoid reaction, ascites, flu syndrome, neck pain, moniliasis, injection site pain, face edema, chills and fever, pelvic pain, chest pain substernal, injection site inflammation. Cardiovascular System: hypertension, angina pectoris, pericardial effusion, postural hypotension, hypotension, palpitation, syncope, shock, bradycardia, arrhythmia, phlebitis, tachycardia, cardiomegaly, heart failure, hemorrhage. Digestive System: gingivitis, eructation, increased salivation, melena, gastrointestinal hemorrhage, proctitis, jaundice, ileus, periodontal abscess, flatulence, aphthous stomatitis, gastritis, glossitis, gum hemorrhage. Hemic and Lymphatic System: hypochromic anemia, lymphadenopathy, eccymosis, petechia. Metabolic/Nutritional Disorders: SGOT increase, creatinine increase, hypocalcemia, hyperglycemia, hypokalemia, hypermagnesemia, hyponatremia, weight gain, bilirubinemia, generalized edema, cachexia, hypochloremia. Musculoskeletal System: arthralgia, bone pain, myasthenia. Nervous System: peripheral neuritis, incoordination, thinking abnormal, confusion, hypertonia, nervousness, hyperesthesia, hypesthesia, neuropathy, ataxia. Respiratory System: pleural effusion, asthma, hiccup, pneumothorax, laryngitis, sinusitis, voice alteration, epistaxis, pneumonia. Skin and Appendages: skin ulcer, herpes simplex, contact dermatitis, fungal dermatitis, furunculosis, skin nodule, urticaria, acne. Special Senses: amblyopia, blepheritis, parosmia, taste loss. Urogenital System: urinary tract infection, leukorrhea, cystitis, nocturia, dysuria, breast pain, mastitis, oliguria, vaginitis, kidney function abnormal, vaginal hemorrhage, hydronephrosis, vaginal moniliasis. AIDS-KS Patients Information on adverse events is based on the experience reported in 753 patients with AIDS-related KS enrolled in four studies. The majority of patients were treated with 20 mg/m2 of Doxil (doxorubicin HCl liposome injection) every two to three weeks. The median time on study was 127 days and ranged from 1 to 811 days. The median cumulative dose was 120 mg/m2 and ranged from 3.3 to 798.6 mg/m2 . Twenty-six patients (3.0%) received cumulative doses of greater than 450 mg/m2 . Of these 753 patients, 61.2% were considered p.o. risk for KS tumor burden, 91.5% p.o. for immune system, and 46.9% for systemic illness; 36.2% were p.o. risk for all three categories. Patientsí median CD4 count was 21.0 cells/mm3 , with 50.8% of patients having less than 50 cells/mm3 . The mean absolute neutrophil count at study entry was approximately 3000 cells/mm3 . Patients received a variety of potentially myelotoxic drugs in combination with Doxil. Of the 693 patients with concomitant medication information, 58.7% were on one or more antiretroviral medications; 34.9% patients were on zidovudine (AZT), 20.8% on didanosine (ddI), 16.5% on zalcitabine (ddC), and 9.5% on stavudine (D4T). A total of 85.1% patients were on PCP prophylaxis, most (54.4%) on sulfamethoxazole/ trimethoprim. Eighty-five percent of patients were receiving antifungal medications, primarily fluconazole (75.8%). Seventy-two percent of patients were receiving antivirals, 56.3% acyclovir, 29% ganciclovir, and 16% foscarnet. In addition, 47.8% patients received colony stimulating factors (sargramostim/ filgrastim) sometime during their course of treatment. Of the 753 patients enrolled in the Doxil clinical trials, adverse event information was available for 705 patients. In many instances it was difficult to determine whether adverse events resulted from Doxil, from concomitant therapy, or from the patientsí underlying disease(s). Eighty-three percent of the patients reported adverse events that were considered to be possibly or probably related to the treatment with Doxil. Adverse reactions only infrequently (5%) led to discontinuation of treatment. Those that did so included bone marrow suppression, cardiac adverse events, infusion-related reactions, toxoplasmosis, palmar-plantar erythrodysesthesia, pneumonia, cough/dyspnea, fatigue, optic neuritis, progression of a non-KS tumor, allergy to penicillin, and unspecified reasons. Probably and Possibly Drug-Related Adverse Events Reported in ≥ 5% of AIDS-KS Patients (See Table) The following additional (not in table) adverse events were observed in AIDS-KS patients; only events considered at least possibly drug-related by investigators are included. Incidence 1% to 5% Body as a Whole: headache, back pain, infection, allergic reaction, chills. Cardiovascular: chest pain, hypotension, tachycardia. Cutaneous: Herpes simplex, rash, itching. Digestive System: mouth ulceration, glossitis, constipation, aphthous stomatitis, anorexia, dysphagia, abdominal pain. Hematologic: hemolysis, increased prothrombin time. Metabolic/Nutritional: SGPT increase, weight loss, hypocalcemia, hyperbilirubinemia, hyperglycemia. Other: dyspnea, albuminuria, pneumonia, retinitis, emotional lability, dizziness, somnolence. Incidence Less Than 1% Body As A Whole: face edema, cellulitis, sepsis, abscess, radiation injury, flu syndrome, moniliasis, hypothermia, injection site hemorrhage, injection site pain, cryptococcosis, ascites. Cardiovascular System: thrombophlebitis, cardiomyopathy, pericardial effusion, hemorrhage, palpitation, syncope, bundle branch block, congestive heart failure, cardiomegaly, heart arrest, migraine, thrombosis, ventricular arrhythmia. Digestive System: dyspepsia, cholestatic jaundice, gingivitis, gastritis, ulcerative proctitis, colitis, esophageal ulcer, esophagitis, gastrointestinal hemorrhage, hepatic failure, leukoplakia of mouth, pancreatitis, ulcerative stomatitis, hepatitis, hepatosplenomegaly, increased appetite, jaundice, sclerosing cholangitis, tenesmus, fecal impaction. Endocrine System: diabetes mellitus. Hemic and Lymphatic System: eosinophilia, lymphadenopathy, lymphangitis, lymphedema, petechia, thromboplastin decrease. Metabolic/Nutritional Disorders: lactic dehydrogenase increase, hypernatremia, creatinine increase, BUN increase, dehydration, edema, hypercalcemia, hyperkalemia, hyperlipemia, hyperuricemia, hypoglycemia, hypokalemia, hypolipemia, hypomagnesemia, hyponatremia, hypophosphatemia, hypoproteinemia, ketosis, weight gain. Musculoskeletal System: myalgia, arthralgia, bone pain, myositis. Nervous System: paresthesia, insomnia, peripheral neuritis, depression, neuropathy, anxiety, convulsion, hypotonia, acute brain syndrome, confusion, hemiplegia, hypertonia, hypokinesia, vertigo. Respiratory System: pleural effusion, asthma, bronchitis, cough increase, hyperventilation, pharyngitis, pneumothorax, rhinitis, sinusitis. Skin and Appendages: maculopapular rash, skin ulcer, skin discoloration, herpes zoster, exfoliative dermatitis, cutaneous moniliasis, erythema multiforme, erythema nodosum, furunculosis, psoriasis, pustular rash, skin necrosis, urticaria, vesciculbullous rash. Special Senses: otitis media, taste perversion, abnormal vision, blindness, conjunctivitis, eye pain, optic neuritis, tinnitus, visual field defect. Urogenital System: hematuria, balanitis, cystitis, dysuria, genital edema, glycosuria, kidney failure.


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