Zuellig Pharma
Concise Prescribing Info
Adult patients w/ relapsed or refractory mantle cell lymphoma (MCL), previously untreated chronic lymphocytic leukaemia (CLL) & lymphocytic leukaemia who have received at least 1 prior therapy.
Dosage/Direction for Use
MCL Recommended dose: 560 mg once daily. CLL Recommended dose: 420 mg once daily. Continue treatment until disease progression or no longer tolerated by patient. Mild hepatic impairment 280 mg daily. Moderate hepatic impairment 140 mg daily.
May be taken with or without food: Take at the same time each day. Swallow whole w/ water, do not open/break/chew. Do not take w/ grapefruit juice or Seville oranges.
Hypersensitivity. Concomitant use w/ St. John's wort-containing prep.
Special Precautions
Bleeding-related events; congenital bleeding diathesis; infections; treatment-emergent grade 3-4 cytopenias; new or worsening neurological, cognitive or behavioral signs or symptoms; interstitial lung disease; atrial fibrillation & flutter in patients w/ cardiac risk factors, HTN, acute infections & previous history of atrial fibrillation; tumour lysis syndrome; non-melanoma skin cancer; viral reactivation. Temporarily withhold therapy in patients w/ leukostasis; if signs & symptoms of ventricular tachyarrhythmia develops. Withheld therapy at least 3-7 days pre- & post-surgery. Monitor complete blood count mthly. Not to be concomitantly administered w/ warfarin or other vit K antagonists. Avoid supplements eg, fish oil & vit E prep; concomitant use w/ CYP3A4 inhibitors & inducers. May affect ability to drive & use machines. Not recommended in severe hepatic impairment (Child-Pugh C). Severe renal impairment (CrCl <30 mL/min) or on dialysis. Women of childbearing potential should use effective contraception during & for 3 mth after treatment. Not to be used during pregnancy & lactation. Childn ≤18 yr.
Adverse Reactions
Pneumonia, upper resp tract infection, sinusitis, skin infection; neutropenia, thrombocytopenia; headache; haemorrhage, bruising; diarrhoea, vomiting, stomatitis, nausea, constipation; rash; arthralgia, muscle spasms, musculoskeletal pain; pyrexia, peripheral oedema. Sepsis, UTI; non-melanoma skin cancer, basal & squamous cell carcinoma; febrile neutropenia, leukocytosis, lymphocytosis; interstitial lung disease; tumour lysis syndrome, hyperuricaemia; peripheral neuropathy, dizziness; blurred vision; atrial fibrillation, ventricular tachyarrhythmia; subdural haematoma, epistaxis, petechiae, HTN; urticaria, erythema, onychoclasis.
Drug Interactions
Increased exposure w/ strong, moderate or mild CYP3A4 inhibitors. Decreased plasma conc w/ CYP3A4 inducers eg, carbamazepine, rifampicin, phenytoin. Reduced efficacy w/ St. John's wort-containing prep. Drugs w/ narrow therapeutic range eg, dihydroergotamine, ergotamine, fentanyl, cyclosporine, sirolimus, tacrolimus; P-gp or BCRP substrates eg, digoxin or methotrexate. Reduced exposure to CYP2B6 substrates eg, efavirenz, bupropion.
ATC Classification
L01XE27 - ibrutinib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Imbruvica hard cap 140 mg
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