IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML

CATALENT INDIANA, LLC - UNITED STATESVETTER PHARMA-FERTIGUNG GMBH & CO. KG - GERMANYASTRAZENECA AB (SWEDEN)🇸🇬 Health Sciences Authority

Approval Date: Oct 29, 2018
Approval ID: 76f297c27e2ac8b2
Company: CATALENT INDIANA, LLC - UNITED STATESVETTER PHARMA-FERTIGUNG GMBH & CO. KG - GERMANYASTRAZENECA AB (SWEDEN)
Type: Therapeutic

Approval Details

Approval Id: 76f297c27e2ac8b2
Drug Name: IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML
Product Name: IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML
Approval Number: SIN15569P
Approval Date: 2018-10-29
Registrant: ASTRAZENECA SINGAPORE PTE LTD
Licence Holder: ASTRAZENECA SINGAPORE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INFUSION, SOLUTION CONCENTRATE
Dosage: 4.2 Posology and method of administration The recommended dose of IMFINZI depends on the indication as presented in Table 1. IMFINZI is administered as an intravenous infusion over 1 hour. When IMFINZI is administered in combination with other therapeutic agents, refer to the Prescribing Information of the therapeutic agents for further information. <img src="/TGIF/Imfinzi-Table1_190925.png" alt="Imfinzi Dosage Table 1" /> No dose reduction or escalation for IMFINZI is recommended. In general, withhold IMFINZI for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue IMFINZI for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating corticosteroids. Immune-mediated adverse reactions requiring specific management are summarized in Table 2. Refer to section 4.4 for further management recommendations, monitoring and evaluation information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. <img src="/TGIF/Imfinzi-Table2_190925.png" alt="Imfinzi Dosage Table 2" /> For non-immune-mediated adverse reactions, withhold IMFINZI for Grade 2 and 3 adverse reactions until ≤ Grade 1 or baseline. IMFINZI should be discontinued for Grade 4 adverse reactions (with the exception of Grade 4 laboratory abnormalities, about which the decision to discontinue should be based on accompanying clinical signs/symptoms and clinical judgment). Special patient populations Based on a population pharmacokinetic analysis, no dose adjustment of IMFINZI is recommended based on patient age, body weight, gender and race (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric and adolescents The safety and effectiveness of IMFINZI have not been established in children and adolescents aged less than 18 years. Elderly (≥ 65 years) No dose adjustment is required for elderly patients (≥ 65 years of age) (see sections 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal impairment No dose adjustment of IMFINZI is recommended in patients with mild or moderate renal impairment. Data from patients with severe renal impairment are too limited to draw conclusions on this population (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment Based on a population pharmacokinetic analysis, no dose adjustment of IMFINZI is recommended for patients with mild or moderate hepatic impairment. IMFINZI has not been studied in patients with severe hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Method of administration For intravenous administration. For instructions on dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. IMFINZI in combination with chemotherapy For resectable NSCLC, ES-SCLC,BTC and endometrial cancer, when IMFINZI is administered in combination with chemotherapy, administer IMFINZI prior to chemotherapy on the same day. IMFINZI in combination with tremelimumab For uHCC, when IMFINZI is administered in combination with tremelimumab, administer tremelimumab prior to IMFINZI on the same day. IMFINZI and tremelimumab are administered as separate intravenous infusions.
Route Of Administration: INTRAVENOUS
Indication Info: 4.1 Therapeutic indications Locally Advanced Non-small Cell Lung Cancer (NSCLC) IMFINZI in combination with chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, is indicated for the treatment of patients with resectable NSCLC at high risk of recurrence and who have no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). IMFINZI is indicated for the treatment of patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy (CRT). Small Cell Lung Cancer (SCLC) IMFINZI is indicated for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). 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 cisplatin and gemcitabine, 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 patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior systemic therapy. Urothelial Carcinoma IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of patients with resectable muscle invasive bladder cancer (MIBC). Endometrial Cancer IMFINZI in combination with carboplatin and paclitaxel is indicated for the first-line treatment of patients with advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by treatment with <ul> <li>IMFINZI as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR).</li> <li>IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).</li> </ul>
Contraindications: 4.3 Contraindications Hypersensitivity to the active ingredient or to any of the excipients.
Atc Code: L01XC28
Atc Item Name: xl 01 xc 28
Pharma Manufacturer Name: ASTRAZENECA SINGAPORE PTE LTD

Active Ingredients

Durvalumab

50 mg/ml

Durvalumab

50 mg/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 29, 2018

Approval ID

76f297c27e2ac8b2

Type

Therapeutic

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