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Alkeran愛克蘭

Alkeran

melphalan

Manufacturer:

Aspen Pharmacare Asia

Distributor:

DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Melphalan
Indications/Uses
Tab Multiple myeloma. Advanced ovarian adenocarcinoma. Breast carcinoma, either alone or in combination w/ other drugs. Polycythaemia rubra vera. Inj Multiple myeloma. Ovarian adenocarcinoma. Malignant melanoma. Soft tissue sarcoma. Advanced neuroblastoma.
Dosage/Direction for Use
Tab Multiple myeloma 0.15 mg/kg/day in divided doses for 4 days repeated at intervals of 6 wk. Advanced ovarian adenocarcinoma 0.2 mg/kg/day in divided doses for 5 days. Repeated every 4-8 wk or as soon as bone marrow has recovered. Breast carcinoma 0.15 mg/kg or 6 mg/m2 BSA/day for 5 days & repeated every 6 wk. Polycythaemia rubra vera Remission induction: 6-10 mg daily for 5-7 days, then 2-4 mg daily until satisfactory disease control achieved. Maintenance: 2-6 mg once/wk. Inj Multiple myeloma 0.4 mg/kg body wt repeated at appropriate intervals. Ovarian adenocarcinoma 1 mg/kg body wt given at 4 wk intervals. Malignant melanoma Upper extremity perfusion: 0.6-1 mg/kg body wt. Lower extremity perfusion: 0.8-1.5 mg/kg body wt. Soft tissue sarcoma Upper extremity perfusion: 0.6-1 mg/kg body wt. Lower extremity perfusion: 1-1.4 mg/kg body wt. Advanced neuroblastoma 100-240 mg/m2 BSA.
Administration
Should be taken on an empty stomach.
Contraindications
Special Precautions
Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised host. Monitor blood counts; should not be given to patients who have recently undergone radio- or chemotherapy. Renal impairment. Ensure adequate contraceptive precautions. Tab Increase risk of DVT & pulmonary embolism in combination w/ lenalidomide & prednisone or thalidomide & prednisone or dexamethasone during the 1st 5 mth especially in patients w/ additional thrombotic risk factors (eg, smoking, HTN, hyperlipidaemia & history of thrombosis). Immediately discontinue treatment w/ any thromboembolic events. May restart original dose upon benefit-risk assessment once thromboembolic event has been managed. Increase rate of haematological toxicities (eg, neutropenia & thrombocytopenia) & solid second primary malignancy (SPM) in newly diagnosed elderly multiple myeloma in patients treated w/ Alkeran in combination w/ lenalidomide & prednisone or thalidomide & prednisone or dexamethasone. Reports of mutagenicity, carcinogenicity (SPM) & leukaemogenicity (eg, AML & myelodysplastic syndromes); acute leukaemia occurring after treatment for diseases (eg, amyloidosis, malignant melanoma, multiple myeloma, macroglobulinaemia, cold agglutinin syndrome & increase w/ ovarian cancer). Temporary significant elevation of blood urea in early stages of therapy in myeloma patients w/ renal damage. May cause temporary or permanent sterility in male patients. Men receiving treatment should not father a child during treatment & up to 6 mth afterwards. Ovarian function suppression in premenopausal women resulting in amenorrhoea. Combined OC pills are not recommended. Risk of venous thromboembolism continues for 4-6 wk after discontinuing combined OC. Not to be used during pregnancy, particularly during 1st trimester, unless considered absolutely essential. Dosage guidelines on paed population cannot be provided.
Adverse Reactions
Bone marrow depression, thrombocytopenia, anaemia; nausea, vomiting, diarrhea, stomatitis; alopecia; elevated blood urea. Tab Neutropenia. Pyrexia. Inj Muscle atrophy & fibrosis, myalgia, increased blood creatinine phosphokinase, compartment syndrome; subjective & transient sensation of warmth &/or tingling.
Drug Interactions
Live organism vaccines, nalidixic acid, cyclosporin. Nalidixic acid w/ high-dose IV Alkeran may cause deaths in paed population due to haemorrhagic enterocolitis. May influence development of toxicities upon Alkeran administration <24 hr after the last oral busulfan administration in paed population.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01AA03 - melphalan ; Belongs to the class of alkylating agents, nitrogen mustard analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Alkeran film-coated tab 2 mg
Packing/Price
25's ($711/pack)
Form
Alkeran inj 50 mg
Packing/Price
1's ($3,224/vial)
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