Imfinzi

Imfinzi

Manufacturer:

AstraZeneca
Concise Prescribing Info
Contents
Durvalumab
Indications/Uses
Patients w/ locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. In combination w/ etoposide & either carboplatin or cisplatin for 1st-line treatment of patients w/ extensive-stage small cell lung cancer (ES-SCLC).
Dosage/Direction for Use
IV Locally advanced NSCLC 10 mg/kg infusion over 1 hr every 2 wk until disease progression, unacceptable toxicity, or max of 12 mth. ES-SCLC 1,500 mg in combination w/ chemotherapy every 3 wk (21 days) for 4 cycles, followed by 1,500 mg every 4 wk as monotherapy until disease progression or unacceptable toxicity. Patient weighing ≤30 kg 20 mg/kg in combination w/ chemotherapy every 3 wk (21 days) for 4 cycles, followed by 20 mg/kg every 4 wk as monotherapy until wt increases to >30 kg. Administer Imfinzi prior to chemotherapy on the same day.
Contraindications
Special Precautions
Monitor for signs & symptoms of pneumonitis, colitis or diarrhoea, adrenal insufficiency, type 1 DM, hypophysitis, rash or dermatitis (including pemphigoid), immune-mediated AR (eg, myasthenia gravis, myocarditis, myositis, polymyositis, meningitis, Guillain-Barré syndrome, immune thrombocytopenia), infusion-related reactions. Monitor for abnormal liver, thyroid & renal function tests prior to, & periodically during treatment. Patients w/ baseline ECOG performance score ≥2; active or prior documented autoimmune disease w/in 2 yr of initiation of the study; history of immunodeficiency, & severe immune-mediated AR; medical conditions requiring systemic immunosuppression, except physiological dose of systemic corticosteroids (≤10 mg daily prednisone or equivalent); uncontrolled intercurrent illnesses; active TB or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine w/in 30 days before or after the start of Imfinzi. Caution when driving or operating machinery. Not recommended during pregnancy. Women of childbearing potential should use effective contraception during treatment & for at least 3 mth after the last dose. Do not breastfeed during treatment & for at least 3 mth after the last dose. Childn <18 yr.
Adverse Reactions
Cough/productive cough, radiation pneumonitis, diarrhoea, pruritus, pyrexia, URTI, pneumonia, dental & oral infections, abdominal pain, myalgia, night sweats, dysuria, increased ALT, AST & creatinine, elevated TSH >ULN & above baseline, decreased TSH <LLN & below baseline, infusion related reactions. Immune-mediated & autoimmune encephalitis. Immune-mediated myocarditis; hepatitis; colitis; hypothyroidism, hyperthyroidism, thyroiditis; adrenal insufficiency; type 1 DM; hypophysitis/hypopituitarism; nephritis; rash. NSCLC: Pemphigoid, immune thrombocytopenia, diabetes insipidus, myositis. SCLC: Neutropenia, anaemia, nausea, fatigue, vomiting, constipation, alopecia, thrombocytopenia, leukopenia, decreased appetite.
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 concentrated soln for infusion 120 mg/2.4 mL
Packing/Price
(vial) 1's (Rp19,749,120/boks)
Form
Imfinzi concentrated soln for infusion 500 mg/10 mL
Packing/Price
(vial) 1's (Rp82,288,000/boks)
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in