This information is not for clinical use. These highlights do not include all the information needed to use Lipodox safely and effectively. Before taking Lipodox please consult with your doctor. See full prescribing information for Lipodox.

Indications And Usage

Indications: Lipodox 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. Lipodox is indicated as monotherapy for the treatment of metastatic breast cancer, where there is an increased cardiac risk. Lipodox is also indicated for the treatment of AIDS related Kaposi’s Sarcoma in patients with extensive mucocutaneous or visceral disease that has progressed on prior combination therapy (consisting of two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin or another anthracycline) or in patients who are intolerant to such therapy.

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Dosage And Administration

PALMAR- PLANTAR ERYTHRODYSESTHESIA
Toxicity Grade Dose Adjustment
1-(Mild erythema, swelling or desquamation not interfering with daily activities). Redose unless patient has experienced previous grade 3 or 4 toxicity. If so, delay upto 2 weeks and decrease dose by 25%. Return to original dose interval.
2- (Erythema, desquamation or swelling interfering with but not precluding normal physical activities, small blisters or ulceration less than 2 cm in diameter). Delay dosing upto 2 weeks or until resolved to grade 0-1. If after 2 weeks there is no resolution, Lipodox should be discontinued.
3- (Blistering, ulceration or swelling interfering with walking or normal daily activities; cannot wear regular clothing). Delay dosing upto 2 weeks or until resolved to grade 0-1. Decrease dose by 25% and return to original dose interval. If after 2 weeks there is no resolution, Lipodox should be discontinued.
4- (Diffuse or local process causing infectious complications, or a bed ridden state or hospitalization). Delay dosing upto 2 weeks or until resolved to grade 0-1. Decrease dose by 25% and return to original dose interval. If after 2 weeks there is no resolution, Lipodox should be discontinued

Contraindications

Contraindications: History of hypersensitivity reactions to the conventional formulation of doxorubicin or to any other components of this formulation. Nursing mothers.

Adverse Reactions

Side effects: Ovarian cancer patients/Breast cancer patients: Adverse effects reported in 5% of patients include hematological adverse events such as leucopenia, neutropenia, anemia, thrombocytopenia and the non hematological adverse events such as palmar-plantar erythrodysesthesia (all grades), stomatitis (all grades), nausea (all grades), asthenia, vomiting, rash, alopecia, constipation, anorexia, mucous membrane disorder, diarrhea, abdominal pain, paresthesia, pain, fever, pharyngitis, dry skin, headache, dyspepsia, somnolence and skin discolouration. The adverse effects reported in 1-5% of ovarian cancer patients are allergic reaction, chills, infection, chest pain, back pain, enlarged abdomen, malaise, oral moniliasis, mouth ulceration, esophagitis, dysphagia, peripheral edema, dehydration, myalgia, dizziness, depression, insomnia, anxiety, dyspnea, increased cough, rhinitis, pruritus, skin disorder, exfoliative dermatitis, herpes zoster, sweating, conjunctivitis and taste perversion. The adverse effects reported in 1-5% of breast cancer patients are breast pain, leg cramps, edema, leg edema, peripheral neuropathy, oral pain, ventricular arrhythmia, folliculitis, bone pain, musculoskeletal pain, cold sores (non herpetic), fungal infection, epistaxis, upper respiratory tract infection, bullous eruption, dermatitis, erythematous rash, nail disorder, scaly skin, lacrimation and blurred vision. AIDS-KS patients: Adverse effects associated with the discontinuation of treatment are bone marrow suppression, cardiac adverse events, infusion related reactions, toxoplasmosis, palmar-plantar erythrodysesthesia, pneumonia, cough/dyspnea, fatigue, optic neuritis, progression of a non-KS tumour and allergy to penicillins. Adverse reactions reported in ≥ 5% of patients include hematological side effects such as neutropenia, anemia, thrombocytopenia and non hematological side events such as nausea, asthenia, fever, alopecia, increased alkaline phosphatase, vomiting, hypochromic anemia, diarrhea, stomatitis and oral moniliasis. Side effects reported in 1-5% of patients which may be possibly drug related are headache, back pain, infection, allergic reaction, chills, chest pain, hypotension, tachycardia, herpes simplex, rash, itching, mouth ulceration, glossitis, constipation, aphthous stomatitis, anorexia, dysphagia, abdominal pain, hemolysis, increased prothrombin time, increased SGPT, weight loss, hypocalcemia, hyperbilirubinemia, hyperglycemia, dyspnea, albuminuria, pneumonia, retinitis, emotional lability, dizziness and somnolence.