Presentation and Status in Health Basket
Presentation | Basket | Yarpa | Pharmasoft |
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Liposome Concentrate for Solution for Infusion (IV) 1×10 ml VIAL |
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Liposome Concentrate for Solution for Infusion (IV) 1×25ml VIAL |
Dosage
Breast cancer/Ovarian cancer:
Administered intravenously at a dose of 50 mg/m2 once every 4 weeks for as long as the disease does not progress and the patient continues to tolerate treatment.
Multiple myeloma:
Administered at 30 mg/m2 on day 4 of the bortezomib 3 week regimen as a 1 hour infusion administered immediately after the bortezomib infusion. The bortezomib regimen consists of 1.3 mg/m2 on days 1, 4, 8, and 11 every 3 weeks. The dose should be repeated as long as patients respond satisfactorily and tolerate treatment. Day 4 dosing of both medicinal products may be delayed up to 48 hours as medically necessary. Doses of bortezomib should be at least 72 hours apart.
AIDS-related KS:
Administered intravenously at 20 mg/m2 every two-to-three weeks. Avoid intervals shorter than 10 days as medicinal product accumulation and increased toxicity cannot be ruled out. Treatment of patients for two-to-three months is recommended to achieve a therapeutic response. Continue treatment as needed to maintain a therapeutic response.
For all patients:
If the patient experiences early symptoms or signs of infusion reaction, immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate.
Guidelines for dose modification
To manage adverse events such as palmar-plantar erythrodysesthesia (PPE), stomatitis or haematological toxicity, the dose may be reduced or delayed.
For guidelines for dose modification secondary to these adverse effects are provided in the tables below. The toxicity grading in these tables is based on the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
Please refer to the license holder for further details.
Indications
First or second line therapy of AIDS related Kaposis sarcoma in patients with low CD 4 counts and extensive mucocutaneous or visceral disease.
Treatment of patients with metastatic carcinoma of the ovary who are refractory to both paclitaxel and platinium-based chemotherapy regimens and who may also be refractory to topotecan. Refractory is defined as a patient having progressive disease while on treatment or within 6 months of completing treatment.
As monotherapy for patients with metastatic breast cancer where there is an increased cardiac risk.
In combination with bortezomib for the treatment of progressive multiplemyeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.
Contra-Indications
Hypersensitivity to the active substance, peanut or soya, or to any of the excipients.
This drug must not be used to treat AIDS-KS that may be effectively treated with local therapy or systemic Alfa-interferon.