Zuellig Pharma
Concise Prescribing Info
Newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) in childn & adult. Adult & paed patients w/ Ph+ CML in chronic phase after failure of interferon-α therapy, or in blast crisis, accelerated phase. Kit (CD117) positive unresectable &/or metastatic malignant GI stromal tumours (GIST) in adult. Adjuvant treatment of adult patient following resection of GIST w/ a tumor size ≥3 cm. Newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) acute lymphoblastic leukaemaia (ALL) integrated chemotherapy in adult & ped. Adult patients w/ relapsed or refractory Ph+ ALL. Adult patients w/ myelodysplastic/myeloproliferation disease (MDS/MPD) associated w/ platelet-derived growth factor receptor (PDGFR) gene re-arrangements. Adult patients w/ systemic mastocytosis (SM) w/o the D816V c-Kit mutation or w/ c-Kit mutational status unknown. Adult patients w/ hypereosinophilic syndrome (HES) &/or chronic eosinophilic leukemia (CEL). Adult patients w/ unresectable, recurrent &/or metastatic dermatofibrosarcoma protuberans (DFSP).
Dosage/Direction for Use
Chronic myeloid leukemia (blast crisis) Adult 600 mg/day. Max: 800 mg (given as 400 mg bid). Chronic & advanced phase CML Childn 340 mg/m2 daily. Max: 600 mg/day. Treatment can be given as a once daily dose or alternatively the dose may be split into 2 administrations (morning & evening). Unresectable &/or metastatic malignant GI stromal tumour 400 mg/day, may be increased up to 600-800 mg. Non-haematological AR Adult Reduce dose from 600 to 400 mg, or from 800 to 600 mg. Childn Reduce dose from 340 to 260 mg/m2/day. Mild, moderate or severe liver dysfunction 400 mg/day. Ph+ ALL Adult 600 mg/day. Childn 340 mg/m2 daily.
Should be taken with food: Take w/ meals & a full glass of water to minimise GI discomfort. For patients unable to swallow, disperse tab in a glass of water or apple juice. Place the required number of tab in the appropriate vol of beverage (approx 50 mL for a 100-mg tab & 200 mL for a 400-mg tab) & stir w/ a spoon. Drink immediately after tab completely disintegrates.
Special Precautions
Concomitant use w/ CYP3A4 inducers [eg, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarb or Hypericum perforatum (St. John's wort)]. Monitor closely TSH levels in thyroidectomy patients. Carefully monitor peripheral blood counts & liver enzymes in patients w/ hepatic dysfunction. Regularly weigh patients. Cardiac dysfunction. Patients w/ cardiac disease or risk factors for cardiac failure. May affect ability to drive or use machines. Pregnancy & lactation. Childn <2 yr.
Adverse Reactions
Neutropenia, thrombocytopenia, anaemia; headache; nausea, diarrhoea, vomiting, dyspepsia, abdominal pain, ascites; periorbital oedema, dermatitis, eczema, rash; muscle spasm & cramps, musculoskeletal pain including myalgia, arthralgia; fluid retention, oedema, fatigue; increased wt. Pancytopenia, febrile neutropenia; anorexia; insomnia; dizziness, paraesthesia, taste disturbance, hypoaesthesia; eyelid oedema, increased lacrimation, conjunctival & retinal haemorrhage, dry eye, blurred vision; flushing, haemorrhage; dyspnoea, epistaxis, cough; flatulence, abdominal distension, gastro-oesophageal reflux, constipation, gastritis, mouth ulceration; increased hepatic enzymes; pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction; joint swelling; weakness, pyrexia, anasarca, chills, rigors; decreased wt.
Drug Interactions
Increased plasma conc w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole, erythromycin, clarithromycin). Decreased plasma conc w/ CYP3A4 inducers [eg, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarb, fosphenytoin, primidone or Hypericum perforatum (St. John’s wort)]. Increase mean Cmax & AUC of simvastatin. May increase plasma conc of triazolo-benzodiazepines, dihydropyridine Ca channel blockers, certain HMG-CoA reductase inhibitors, eg, statins. Increase plasma exposure of levothyroxine. Cyclosporine, pimozide, warfarin, paracetamol.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EA01 - imatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
Alvotinib FC tab 100 mg
Alvotinib FC tab 400 mg
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