Imfinzi

Imfinzi

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Durvalumab
Indications/Uses
Unresectable stage III NSCLC whose disease has not progressed following platinum-based chemo- & RT. In combination w/ etoposide & either carboplatin or cisplatin for 1st-line treatment of patients w/ extensive-stage small cell lung cancer (ES-SCLC). In combination w/ gemcitabine & cisplatin for 1st-line treatment of adults w/ unresectable or metastatic biliary tract cancer (BTC).
Dosage/Direction for Use
NSCLC Patient >30 kg 10 mg/kg IV infusion over 60 min every 2 wk or 1,500 mg IV infusion over 60 min every 4 wk until disease progression, unacceptable toxicity or max: 12 mth, patient ≤30 kg 10 mg/kg IV infusion over 60 min every 2 wk until wt increase to >30 kg. ES-SCLC Patient >30 kg 1,500 mg IV infusion over 60 min in combination w/ chemotherapy every 3 wk for 4 cycles, followed by 1,500 mg every 4 wk as monotherapy until disease progression or unacceptable toxicity, patient ≤30 kg 20 mg/kg IV infusion over 60 min in combination w/ chemotherapy every 3 wk for 4 cycles, followed by 20 mg/kg every 4 wk as monotherapy until wt increase to >30 kg. BTC Patient >36 kg 1,500 mg IV infusion over 60 min in combination w/ chemotherapy every 3 wk for 8 cycles, followed by 1,500 mg every 4 wk as monotherapy until disease progression or unacceptable toxicity, patient ≤36 kg 20 mg/kg IV infusion over 60 min in combination w/ chemotherapy every 3 wk for 8 cycles, followed by 20 mg/kg every 4 wk until wt increase to >36 kg.
Special Precautions
Monitor patients for signs & symptoms of pneumonitis, hepatitis, diarrhea or colitis, nephritis, rash or dermatitis, infusion-related reactions. Endocrinopathies eg, thyroid disorders, adrenal insufficiency, type 1 DM & hypophysitis/hypopituitarism; other severe & fatal immune-mediated ARs. Immunogenicity. Monitor abnormal hepatic, renal & thyroid function tests prior to & periodically during treatment. Women of childbearing potential should use effective contraception during & at least 3 mth after last dose. Pregnancy. Not to be used during lactation. Ped patients.
Adverse Reactions
Pneumonitis/radiation pneumonitis, hepatitis, colitis, endocrinopathies, nephritis, rash, other immune-mediated ARs, infusion-related reactions. Fatigue/asthenia. SCLC/BTC: Nausea. NSCLC: Cough, URTI, dyspnea. SCLC: Alopecia. BTC: Constipation, decreased appetite, abdominal pain, rash, pyrexia.
MIMS Class
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 infusion conc (vial) 120 mg/2.4 mL
Packing/Price
1's
Form
Imfinzi infusion conc (vial) 500 mg/10 mL
Packing/Price
1's
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