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Imfinzi

Imfinzi

Manufacturer:

AstraZeneca

Distributor:

DKSH
Concise Prescribing Info
Contents
Durvalumab
Indications/Uses
Monotherapy for locally advanced, unresectable NSCLC whose disease has not progressed following definitive platinum-based chemoradiation therapy. In combination w/ tremelimumab & platinum-based chemotherapy in adults w/ metastatic NSCLC w/ no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. In combination w/ etoposide & either carboplatin or cisplatin for 1st line treatment of adults w/ extensive-stage small cell lung cancer (ES-SCLC). In combination w/ tremelimumab in adults w/ unresectable hepatocellular carcinoma (uHCC). In combination w/ gemcitabine & cisplatin in adults w/ locally advanced or metastatic biliary tract cancer (BTC).
Dosage/Direction for Use
IV Infuse over 60 min. Locally advanced NSCLC Patient weighing ≥30 kg 10 mg/kg every 2 wk, or 1,500 mg every 4 wk, <30 kg 10 mg/kg every 2 wk until disease progression, unacceptable toxicity, or max of 12 mth. In combination w/ tremelimumab & platinum-based chemotherapy Patient w/ non-squamous or squamous tumor histology weighing ≥30 kg 1,500 mg & 75 mg tremelimumab w/ carboplatin & nab-paclitaxel, or carboplatin or cisplatin & pemetrexed, <30 kg 20 mg/kg & 1 mg/kg tremelimumab w/ carboplatin & nab-paclitaxel, or carboplatin or cisplatin & pemetrexed. Dosage schedule: Dosing interval of every 3 wk to every 4 wk starting cycle 5. Continue treatment until disease progression or intolerable toxicity. Give remaining cycles of tremelimumab (up to total of 5) every 4 wk after platinum-based chemotherapy phase in combination w/ Imfinzi, if patient receives fewer than 4 cycles of platinum-based chemotherapy. ES-SCLC Patient weighing ≥30 kg 1,500 mg in combination w/ chemotherapy every 3 wk (21 days) for 4 cycles, followed by 1,500 mg every 4 wk as single agent, <30 kg 20 mg/kg in combination w/ chemotherapy every 3 wk (21 days) for 4 cycles, followed by 10 mg/kg every 2 wk as single agent until disease progression or unacceptable toxicity. uHCC Patient weighing ≥30 kg 1,500 mg following single dose of tremelimumab 300 mg at day 1 of cycle 1. Continue 1,500 mg as single agent every 4 wk, <30 kg 20 mg/kg following single dose of tremelimumab 4 mg/kg at day 1 of cycle 1. Continue 20 mg/kg as single agent every 4 wk until disease progression or unacceptable toxicity. BTC Patient weighing ≥30 kg 1,500 mg in combination w/ gemcitabine & cisplatin every 3 wk (21 days) for 8 cycles, followed by 1,500 mg every 4 wk as single agent, <30 kg 20 mg/kg in combination w/ gemcitabine & cisplatin every 3 wk (21 days) for 8 cycles, followed by 20 mg/kg every 4 wk as single agent until disease progression or unacceptable toxicity.
Contraindications
Special Precautions
Permanently discontinue treatment in life-threatening (Grade 4) & recurrent severe (Grade 3) immune-mediated reactions. Discontinue treatment in Grade 4 non-immune-mediated adverse reactions. Withhold treatment in severe (Grade 3) immune-mediated adverse reactions; Grade 2 & 3 non-immune-mediated adverse reactions. Monitor for signs & symptoms of pneumonitis or radiation pneumonitis, colitis or diarrhoea, adrenal insufficiency, type 1 DM, hypophysitis, rash or dermatitis, immune-mediated myocarditis & other immune-mediated adverse reactions (eg, myasthenia gravis, myositis, polymyositis, immune thrombocytopenia, pancreatitis & encephalitis; SJS, TEN), infusion-related reactions. Monitor for abnormal liver, thyroid & renal function tests prior to, & periodically during treatment. Patients treated w/ PD-1/PD-L1 inhibitors. May affect ability to drive & use machines. Renal & hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 3 mth after last dose. Not to be used during pregnancy. Not to breastfeed during treatment & for at least 3 mth after last dose. Childn & adolescents <18 yr.
Adverse Reactions
URTI; hypothyroidism; cough/productive cough; diarrhoea, abdominal pain; rash, pruritus; pyrexia. Pneumonia, dental & oral soft tissue infections, oral candidiasis, flu; hyperthyroidism; pneumonitis, dysphonia; increased AST or ALT; night sweats; myalgia; increased blood creatinine, dysuria; peripheral oedema.
Drug Interactions
Potential interference w/ pharmacodynamic activity & efficacy w/ systemic corticosteroids or immunosuppressants when used prior to durvalumab.
MIMS Class
Targeted Cancer Therapy / Cancer Immunotherapy
ATC Classification
L01FF03 - durvalumab ; Belongs to the class of PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Imfinzi conc for soln for infusion 120 mg/2.4 mL
Packing/Price
1's
Form
Imfinzi conc for soln for infusion 500 mg/10 mL
Packing/Price
1's
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