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Imfinzi

Imfinzi

Manufacturer:

AstraZeneca

Distributor:

DKSH
Concise Prescribing Info
Contents
Durvalumab
Indications/Uses
As monotherapy for locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following definitive platinum-based chemoradiation therapy. In combination w/ etoposide & either carboplatin or cisplatin for 1st-line treatment in adults w/ extensive-stage small cell lung cancer (ES-SCLC).
Dosage/Direction for Use
Locally advanced NSCLC 10 mg/kg as IV infusion over 60 min every 2 wk until disease progression, unacceptable toxicity, or a max of 12 mth. ES-SCLC 1,500 mg as IV infusion over 60 min in combination w/ chemotherapy every 3 wk (21 days) for 4 cycles, followed by 1,500 mg every 4 wk as single agent until disease progression or unacceptable toxicity. Patients weighing ≤30 kg Wt based-dosing equiv to 20 mg/kg in combination w/ chemotherapy every 3 wk (21 days) for 4 cycles, followed by 20 mg/kg every 4 wk as single agent until wt increases to >30 kg.
Contraindications
Special Precautions
Monitor for signs & symptoms of pneumonitis or radiation pneumonitis, colitis or diarrhoea, adrenal insufficiency, type 1 DM, hypophysitis, rash or dermatitis, immune-mediated adverse reactions, infusion-related reactions. Monitor for abnormal liver, thyroid function & renal function tests prior to, & periodically during treatment. Patients treated w/ PD-1/PD-L1 inhibitors. Withhold dose if Grade 2 pneumonitis/interstitial lung disease, Grade 2 hepatitis (ALT or AST >3-5 x ULN &/or total bilirubin >1.5-3 x ULN), Grade 3 hepatitis (AST or ALT >5 to ≤8 x ULN or total bilirubin >3 to ≤5 x ULN), Grade 2 colitis or diarrhea, Grade 2 nephritis (serum creatinine >1.5-3 x ULN or baseline), Grade 2 rash or dermatitis for >1 wk, Grade 3 rash or dermatitis (including pemphigoid), Grade 2 myocarditis, Grade 2 or 3 myositis/polymyositis, Grade 3 or 4 infection until clinically stable, or other Grade 3 immune-mediated adverse reactions occur, & initiate prednisone or equiv followed by a taper. Permanently discontinue if Grade 3 or 4 pneumonitis/interstitial lung disease, Grade 3 hepatitis (AST or ALT >8 x ULN or total bilirubin >5 x ULN), hepatitis w/ concurrent ALT or AST >3 x ULN & total bilirubin >2 x ULN w/ no other cause, Grade 3 or 4 colitis or diarrhoea, Grade 3 nephritis (serum creatinine 3 x baseline or >3-6 x ULN), Grade 4 nephritis (serum creatinine >6 x ULN), Grade 4 rash or dermatitis (including pemphigoid), Grade 3 or 4 myocarditis or any grade w/ positive biopsy, Grade 4 myositis/polymyositis, Grade 3 or 4 infusion-related reactions, or other Grade 4 adverse reactions occur, & initiate prednisone or equiv followed by a taper. Withhold dose until clinically stable if Grade 2-4 hyperthyroidism, thyroiditis occurs, & institute symptomatic treatment. Initiate thyroid hormone replacement as clinically indicated if Grade 2-4 hypothyroidism occurs. Withhold dose until clinically stable if Grade 2-4 adrenal insufficiency or hypophysitis/hypopituitarism occurs, & initiate prednisone or equiv followed by a taper & hormone replacement as clinically indicated. Initiate treatment w/ insulin as clinically indicated if Grade 2-4 type 1 DM occurs. Interrupt or slow the rate of infusion if Grade 1 or 2 infusion-related reactions occur, & consider pre-medications for prophylaxis of subsequent infusion reactions. Caution when driving or operating machinery. Women of childbearing potential should use effective contraception during treatment & for at least 3 mth after last dose. Do not breastfeed during treatment & for at least 3 mth after last dose.
Adverse Reactions
Upper resp tract infections; 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; infusion-related reaction, peripheral oedema.
Drug Interactions
Potential interference w/ the pharmacodynamics activity & efficacy w/ systemic corticosteroids or immunosuppressants.
ATC Classification
L01XC28 - durvalumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Imfinzi soln for infusion 120 mg/2.4 mL
Packing/Price
1's
Form
Imfinzi soln for infusion 500 mg/10 mL
Packing/Price
1's
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