Imbruvica億珂

Imbruvica

ibrutinib

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Ibrutinib
Indications/Uses
As a single agent for the treatment of adult patients w/ relapsed or refractory mantle cell lymphoma (MCL); previously untreated chronic lymphocytic leukaemia (CLL); Waldenström's macroglobulinaemia (WM) who have received at least 1 prior therapy, or in 1st line treatment for patients unsuitable for chemo-immunotherapy. As a single agent or in combination w/ bendamustine & rituximab (BR) for treatment of chronic lymphocytic leukaemia (CLL) who have received at least 1 prior therapy.
Dosage/Direction for Use
Mantle cell lymphoma 560 mg (4 cap) once daily. Chronic lymphocytic leukaemia 420 mg (3 cap) once daily, either as a single agent or in combination. Waldenström's macroglobulinaemia 420 mg (3 cap) once daily. Patient w/ mild liver impairment (Child-Pugh class A) 280 mg daily (2 cap); moderate liver impairment (Child-Pugh class B) 140 mg daily (1 cap).
Administration
Should be taken with 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.
Contraindications
Hypersensitivity. Concomitant use w/ St. John's wort-containing prep.
Special Precautions
Haemorrhagic events; leukostasis; infections (including sepsis, neutropenic sepsis, bacterial, viral, or fungal infections); cytopenias; intestitial lung disease; cardiac arrhythmia; tumour lysis syndrome; non-melanoma skin cancer; hepatitis B reactivation. Withhold treatment at least 3-7 days pre- & post-surgery depending upon the type of surgery & the risk of bleeding. Monitor complete blood counts mthly. Monitor patients for infections & cardiac arrhythmia. Concomitant use w/ CYP3A4 inhibitor or inducer. Women of childbearing potential must use highly effective method of contraception while on treatment. Women using hormonal contraceptive should add a barrier method. Patients w/ hepatic impairment & severe renal impairment. May impair ability to drive or operate machinery. Should not be used during pregnancy. Discontinue breast-feeding during treatment. Paed population. Patients w/ severe CV disease.
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, oedema peripheral. Sepsis, UTI; non-melanoma skin cancer, basal cell carcinoma, squamous cell carcinoma; febrile neutropenia, leukocytosis, lymphocytosis; interstitial lung disease; tumour lysis syndrome, hyperuricaemia; dizziness; vision blurred; atrial fibrillation, ventricular tachyarrhythmia; subdural haematoma, epistaxis, petechiae, HTN; urticaria, erythema, onychoclasis.
Drug Interactions
Increased exposure (Cmax & AUC) w/ strong CYP3A4 inhibitors (eg, ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, nefazodone, cobicistat, voriconazole & posaconazole) or moderate CYP3A4 inhibitors (fluconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodarone & dronedarone); grapefruit & seville oranges. Decreased exposure w/ strong or moderate CYP3A4 inducers (eg, carbamazepine, rifampicin, phenytoin). Reduced efficacy w/ prep containing St. John's Wort. May increase exposure of P-gp or BCRP substrates w/ narrow therapeutic range (eg, digoxin, methotrexate); drugs that undergo BCRP-mediated hepatic efflux eg, rosuvastatin; CYP3A4 substrates w/ narrow therapeutic range (eg, dihydroergotamine, ergotamine, fentanyl, cyclosporine, sirolimus and tacrolimus). May reduce exposure of CYP2B6 substrates (eg, efavirenz & bupropion).
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EL01 - ibrutinib ; Belongs to the class of Bruton's tyrosine kinase (BTK) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Imbruvica hard cap 140 mg
Packing/Price
90's
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