Australia - English - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - venetoclax, quantity: 100 mg - tablet, film coated - excipient ingredients: sodium stearylfumarate; colloidal anhydrous silica; copovidone; calcium hydrogen phosphate; polysorbate 80; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - acute myeloid leukaemia,venclexta, as part of combination therapy, is indicated for the treatment of newly diagnosed adult patients with acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.,this medicine has provisional approval in australia for the treatment of newly diagnosed patients with aml who are ineligible for intensive chemotherapy. the decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). continued approval of this indication depends on verification and description of benefit in confirmatory trials. chronic lymphocytic leukaemia/small lymphocytic lymphoma,venclexta in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll) who are considered unfit or unsuitable for chemo-immunotherapy.,venclexta in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.,venclexta monotherapy is indicated for the treatment of:,? patients with relapsed or refractory cll with 17p deletion, or,? patients with relapsed or refractory cll for whom there are no other suitable treatment options.,acute myeloid leukaemia,venclexta, in combination with azacitidine or low-dose cytarabine, is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - venetoclax, quantity: 50 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; sodium stearylfumarate; copovidone; colloidal anhydrous silica; polysorbate 80; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - chronic lymphocytic leukaemia/small lymphocytic lymphoma,venclexta in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll) who are considered unfit or unsuitable for chemo-immunotherapy.,venclexta in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.,venclexta monotherapy is indicated for the treatment of:,? patients with relapsed or refractory cll with 17p deletion, or,? patients with relapsed or refractory cll for whom there are no other suitable treatment options.,acute myeloid leukaemia,venclexta, in combination with azacitidine or low-dose cytarabine, is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy. acute myeloid leukaemia,venclexta, as part of combination therapy, is indicated for the treatment of newly diagnosed adult patients with acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.,this medicine has provisional approval in australia for the treatment of newly diagnosed patients with aml who are ineligible for intensive chemotherapy. the decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). continued approval of this indication depends on verification and description of benefit in confirmatory trials.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - venetoclax, quantity: 50 mg - tablet, film coated - excipient ingredients: sodium stearylfumarate; copovidone; polysorbate 80; colloidal anhydrous silica; calcium hydrogen phosphate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - acute myeloid leukaemia,venclexta, as part of combination therapy, is indicated for the treatment of newly diagnosed adult patients with acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.,this medicine has provisional approval in australia for the treatment of newly diagnosed patients with aml who are ineligible for intensive chemotherapy. the decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). continued approval of this indication depends on verification and description of benefit in confirmatory trials. chronic lymphocytic leukaemia/small lymphocytic lymphoma,venclexta in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll) who are considered unfit or unsuitable for chemo-immunotherapy.,venclexta in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.,venclexta monotherapy is indicated for the treatment of:,? patients with relapsed or refractory cll with 17p deletion, or,? patients with relapsed or refractory cll for whom there are no other suitable treatment options.,acute myeloid leukaemia,venclexta, in combination with azacitidine or low-dose cytarabine, is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - venetoclax, quantity: 100 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; sodium stearylfumarate; copovidone; polysorbate 80; calcium hydrogen phosphate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - acute myeloid leukaemia,venclexta, as part of combination therapy, is indicated for the treatment of newly diagnosed adult patients with acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.,this medicine has provisional approval in australia for the treatment of newly diagnosed patients with aml who are ineligible for intensive chemotherapy. the decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). continued approval of this indication depends on verification and description of benefit in confirmatory trials. chronic lymphocytic leukaemia/small lymphocytic lymphoma,venclexta in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll) who are considered unfit or unsuitable for chemo-immunotherapy.,venclexta in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.,venclexta monotherapy is indicated for the treatment of:,? patients with relapsed or refractory cll with 17p deletion, or,? patients with relapsed or refractory cll for whom there are no other suitable treatment options.,acute myeloid leukaemia,venclexta, in combination with azacitidine or low-dose cytarabine, is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl).imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5.1).imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy.imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

United States - English - NLM (National Library of Medicine)

beigene usa, inc. - zanubrutinib (unii: ag9mhg098z) (zanubrutinib - unii:ag9mhg098z) - brukinsa is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy. this indication is approved under accelerated approval based on overall response rate [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. brukinsa is indicated for the treatment of adult patients with waldenström's macroglobulinemia (wm) [see clinical studies (14.2)] . brukinsa is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (mzl) who have received at least one anti–cd20-based regimen. this indication is approved under accelerated approval based on overall response rate [see clinical studies (14.3)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. brukinsa is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) [see clinical studies (14.4)] . brukinsa is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl), in combination with obinutuzumab, after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate and durability of response [see clinical studies (14.5)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. none. risk summary based on findings in animals, brukinsa can cause fetal harm when administered to pregnant women. there are no available data on brukinsa use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of zanubrutinib to pregnant rats during the period of organogenesis was associated with fetal heart malformation at approximately 5-fold human exposures (see data) . women should be advised to avoid pregnancy while taking brukinsa. if brukinsa is used during pregnancy, or if the patient becomes pregnant while taking brukinsa, the patient should be apprised of the potential hazard to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data embryo-fetal development toxicity studies were conducted in both rats and rabbits. zanubrutinib was administered orally to pregnant rats during the period of organogenesis at doses of 30, 75, and 150 mg/kg/day. malformations in the heart (2 or 3-chambered hearts) were noted at all dose levels in the absence of maternal toxicity. the dose of 30 mg/kg/day is approximately 5 times the exposure (auc) in patients receiving the recommended dose of 160 mg twice daily. administration of zanubrutinib to pregnant rabbits during the period of organogenesis at 30, 70, and 150 mg/kg/day resulted in postimplantation loss at the highest dose. the dose of 150 mg/kg is approximately 32 times the exposure (auc) in patients at the recommended dose and was associated with maternal toxicity. in a pre and postnatal developmental toxicity study, zanubrutinib was administered orally to rats at doses of 30, 75, and 150 mg/kg/day from implantation through weaning. the offspring from the middle and high dose groups had decreased body weights preweaning, and all dose groups had adverse ocular findings (e.g., cataract, protruding eye). the dose of 30 mg/kg/day is approximately 5 times the auc in patients receiving the recommended dose. risk summary there are no data on the presence of zanubrutinib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions from brukinsa in a breastfed child, advise lactating women not to breastfeed during treatment with brukinsa and for two weeks following the last dose. brukinsa can cause embryo-fetal harm when administered to pregnant women [see use in specific populations (8.1)] . pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiating brukinsa therapy. contraception females advise female patients of reproductive potential to use effective contraception during treatment with brukinsa and for 1 week following the last dose of brukinsa. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus. males advise men to avoid fathering a child while receiving brukinsa and for 1 week following the last dose of brukinsa. safety and effectiveness of brukinsa in pediatric patients have not been established. of the 1729 patients with mcl, mzl, wm, cll/sll, and fl in clinical studies with brukinsa, 59% were ≥65 years of age, and 21% were ≥75 years of age. patients ≥65 years of age had numerically higher rates of grade 3 or higher adverse reactions and serious adverse reactions (57% and 38%, respectively) than patients <65 years of age (51% and 29%, respectively). no overall differences in effectiveness were observed between younger and older patients. no dosage modification is recommended in patients with mild, moderate, or severe renal impairment (clcr ≥15 ml/min, estimated by cockcroft-gault). monitor for brukinsa adverse reactions in patients on dialysis [see clinical pharmacology (12.3)] . dosage modification of brukinsa is recommended in patients with severe hepatic impairment [see dosage and administration (2.2)] . the safety of brukinsa has not been evaluated in patients with severe hepatic impairment. no dosage modification is recommended in patients with mild to moderate hepatic impairment. monitor for brukinsa adverse reactions in patients with hepatic impairment [see clinical pharmacology (12.3)] .

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - capsules - ibrutinib 140 mg - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.

United States - English - NLM (National Library of Medicine)

abbvie inc. - venetoclax (unii: n54aic43pw) (venetoclax - unii:n54aic43pw) - venetoclax 10 mg - venclexta is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll). venclexta is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (aml) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. concomitant use of venclexta with strong cyp3a inhibitors at initiation and during the ramp-up phase is contraindicated in patients with cll/sll due to the potential for increased risk of tumor lysis syndrome [see dosage and administration ( 2.6 ) and drug interactions ( 7.1 )] . risk summary based on findings in animals and its mechanism of action [see clinical pharmacology ( 12.1 )] , venclexta may cause embryo-fetal harm when administered to a pregnant woman. there are no available data on venclexta use in pregnant women to inform a drug-associated risk. administration of venetoclax to pregnant mice during

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn bhd - ibrutinib -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn. bhd. - ibrutinib -