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

astrazeneca pharmaceuticals lp - durvalumab (unii: 28x28x9okv) (durvalumab - unii:28x28x9okv) - durvalumab 120 mg in 2.4 ml - imfinzi, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc). imfinzi, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (btc). none. risk summary based on findings from animal studies and its mechanism of action, imfinzi can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of imfinzi in pregnant women. in animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at the clinical dose of 10 mg/kg based on area under the curve (auc), resulted in an increase in premature delivery, fetal loss, and premature neonatal death (see data). human immunoglobulin g1 (igg1) is known to cross the placental barrier; therefore, durvalumab has the potential to be transmitted from the mother to the developing fetus. apprise pregnant women of the potential risk to a fetus. 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 as reported in the literature, the pd-1/pd-l1 pathway plays a central role in preserving pregnancy by maintaining maternal immune tolerance to the fetus. in mouse allogeneic pregnancy models, disruption of pd-l1 signaling was shown to result in an increase in fetal loss. the effects of durvalumab on prenatal and postnatal development were evaluated in reproduction studies in cynomolgus monkeys. durvalumab was administered from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at a clinical dose of 10 mg/kg (based on auc). administration of durvalumab resulted in premature delivery, fetal loss (abortion and stillbirth), and increase in neonatal deaths. durvalumab was detected in infant serum on postpartum day 1, indicating the presence of placental transfer of durvalumab. based on its mechanism of action, fetal exposure to durvalumab may increase the risk of developing immune-mediated disorders or altering the normal immune response and immune-mediated disorders have been reported in pd-1 knockout mice. risk summary there are no data on the presence of durvalumab in human milk, its effects on the breastfed child, or the effects on milk production. maternal igg is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to imfinzi are unknown. durvalumab was present in the milk of lactating cynomolgus monkeys and was associated with premature neonatal death (see data ). because of the potential for adverse reactions in a breastfed child, advise women not to breastfeed during treatment with imfinzi and for 3 months after the last dose. refer to the prescribing information for the agents administered in combination with imfinzi for recommended duration to not breastfeed, as appropriate. data in lactating cynomolgus monkeys, durvalumab was present in breast milk at about 0.15% of maternal serum concentrations after administration of durvalumab from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at the recommended clinical dose of 10 mg/kg (based on auc). administration of durvalumab resulted in premature neonatal death. pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating treatment with imfinzi. contraception females imfinzi can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with imfinzi and for 3 months following the last dose of imfinzi. refer to the prescribing information for the agents administered in combination with imfinzi for recommended contraception duration, as appropriate. the safety and effectiveness of imfinzi have not been established in pediatric patients. of the 476 patients treated with imfinzi in the pacific study, 45% were 65 years or older, while 7.6% were 75 years or older. no overall differences in safety or effectiveness were observed between patients 65 years or older and younger patients. the pacific study did not include sufficient numbers of patients aged 75 years and over to determine whether they respond differently from younger patients. of the 265 patients with es-sclc treated with imfinzi in combination with chemotherapy 101 (38%) patients were 65 years or older and 19 (7.2%) patients were 75 years or older. there were no clinically meaningful differences in safety or efficacy between patients 65 years or older and younger patients. of the 330 patients with metastatic nsclc treated with imfinzi in combination with tremelimumab-actl and platinum-based chemotherapy, 143 (43%) patients were 65 years or older and 35 (11%) patients were 75 years or older. there were no clinically meaningful differences in safety or efficacy between patients 65 years or older and younger patients. of the 338 patients with btc treated with imfinzi in combination with chemotherapy in the topaz-1 study, 158 (47%) patients were 65 years or older and 38 (11%) patients were 75 years or older. no overall differences in safety or effectiveness of imfinzi have been observed between patients 65 years of age and older and younger adult patients. of the 393 patients with uhcc treated with imfinzi in combination with tremelimumab-actl, 50% of patients were 65 years of age or older and 13% of patients were 75 years of age or older. no overall differences in safety or effectiveness of imfinzi have been observed between patients 65 years of age and older and younger adult patients.

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

astrazeneca pty ltd - durvalumab, quantity: 500 mg - injection, concentrated - excipient ingredients: histidine hydrochloride monohydrate; trehalose dihydrate; water for injections; polysorbate 80; histidine - locally advanced non-small cell lung cancer (nsclc),imfinzi is indicated for the treatment of patients with locally advanced, unresectable nsclc whose disease has not progressed following platinum-based chemoradiation therapy.,small cell lung cancer (sclc),imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,biliary tract cancer (btc),imfinzi in combination with gemcitabine and cisplatin is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (btc).,hepatocellular carcinoma (hcc),imfinzi in combination with tremelimumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uhcc) who have not received prior treatment with a pd-1/pd-l1 inhibitor. malignant pleural mesothelioma (mpm),imfinzi in combination with pemetrexed and either cisplatin or carboplatin has provisional approval for the first-line treatment of patients with unresectable mpm with epithelioid histology.,the decision to approve this indication has been made on the basis of two phase 2 single arm studies. continued approval of this indication depends on verification and description of clinical benefit in a confirmatory trial.

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

astrazeneca pty ltd - durvalumab, quantity: 120 mg - injection, concentrated - excipient ingredients: histidine; water for injections; trehalose dihydrate; histidine hydrochloride monohydrate; polysorbate 80 - locally advanced non-small cell lung cancer (nsclc),imfinzi is indicated for the treatment of patients with locally advanced, unresectable nsclc whose disease has not progressed following platinum-based chemoradiation therapy.,small cell lung cancer (sclc),imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,biliary tract cancer (btc),imfinzi in combination with gemcitabine and cisplatin is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (btc).,hepatocellular carcinoma (hcc),imfinzi in combination with tremelimumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uhcc) who have not received prior treatment with a pd-1/pd-l1 inhibitor. malignant pleural mesothelioma (mpm),imfinzi in combination with pemetrexed and either cisplatin or carboplatin has provisional approval for the first-line treatment of patients with unresectable mpm with epithelioid histology.,the decision to approve this indication has been made on the basis of two phase 2 single arm studies. continued approval of this indication depends on verification and description of clinical benefit in a confirmatory trial.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - durvalumab - solution for infusion - durvalumab 50 mg/ml - durvalumab - urothelial carcinoma imfinzi is indicated for the treatment of patients with pd-l1 high (tumor cell ≥25% or ic ≥25%) locally advanced or metastatic urothelial carcinoma who: - have disease progression during or following platinum-containing chemotherapy. - have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. non-small cell lung cancer - imfinzi is indicated for the treatment of patients with unresectable stage iii non-small cell lung cancer (nsclc) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.- imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations.small cell lung cancer imfinzi, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc).biliary tract cancersimfinzi in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (btc).hepatocellular carcinomaimfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Israel - English - Ministry of Health

astrazeneca (israel) ltd - durvalumab - solution for infusion - durvalumab 50 mg/ml - durvalumab - urothelial carcinoma imfinzi is indicated for the treatment of patients with pd-l1 high (tumor cell ≥25% or ic ≥25%) locally advanced or metastatic urothelial carcinoma who: - have disease progression during or following platinum-containing chemotherapy. - have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. non-small cell lung cancer - imfinzi is indicated for the treatment of patients with unresectable stage iii non-small cell lung cancer (nsclc) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.- imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations.small cell lung cancer imfinzi, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc).biliary tract cancersimfinzi in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (btc).hepatocellular carcinomaimfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - carcinoma, non-small-cell lung - antineoplastic agents - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations.small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc).biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc).hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Canada - English - Health Canada

astrazeneca canada inc - durvalumab - solution - 50mg - durvalumab 50mg - antineoplastic agents

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - durvalumab 120mg;   - concentrate for infusion - active: durvalumab 120mg   excipient: histidine histidine hydrochloride monohydrate polysorbate 80 trehalose dihydrate water for injection - imfinzi (durvalumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: · have disease progression during or following platinum-containing chemotherapy · have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy this indication is approved based on objective response rate and duration of response in a single arm study. an improvement in survival or disease-related symptoms has not been established.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - durvalumab 500mg;   - concentrate for infusion - active: durvalumab 500mg   excipient: histidine histidine hydrochloride monohydrate polysorbate 80 trehalose dihydrate water for injection - imfinzi (durvalumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: · have disease progression during or following platinum-containing chemotherapy · have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy this indication is approved based on objective response rate and duration of response in a single arm study. an improvement in survival or disease-related symptoms has not been established.

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

astrazeneca uk limited - durvalumab - durvalumab....120 mg/2,4ml / durvalumab....500 mg/10ml