Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Dacominitib Monohydrate
PFIZER (MALAYSIA) SDN. BHD.
Dacominitib Monohydrate
30 Tablets
Pfizer Manufacturing Deutschland GmbH.
Pfizer Confidential _Consumer Medication Information Leaflet (RiMUP)_ VIZIMPRO ® FILM COATED TABLET Dacomitinib (15mg, 30mg, 45mg) PLD Title : Dacomitinib (VIZIMPRO) PLD Date : 29 18 July February 20192020 Country : Malaysia Reference Document : VIZIMPRO Malaysia LPD, Dated 17 07 June February 20192020 : EU/UK PIL, Dated April 2019 : US PIL, Dated September 2018 Reason for Change : PfLEET 2019-0052133 (D), - New PIL creation : PfLEET 2020-0058603 (D), To update as per BOH recommendation and to align as per new template Pfizer Confidential _Consumer Medication Information Leaflet (RiMUP)_ VIZIMPRO ® FILM COATED TABLET Dacomitinib (15mg, 30mg, 45mg) 1 WHAT IS IN THIS LEAFLET 1. What VIZIMPRO is used for 2. How VIZIMPRO works 3. Before you use VIZIMPRO 4. How to use VIZIMPRO 5. While you are using it 6. Side effects 7. Storage and Disposal of VIZIMPRO 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 10.11. 11. Serial Number WHAT VIZIMPRO IS USED FOR VIZIMPRO contains the active substance dacomitinib, which is an oral kinase inhibitor. VIZIMPRO is a prescription medicine used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). VIZIMPRO can be used as your first treatment if your tumour has certain types of abnormal epidermal growth factor receptor (EGFR) gene(s). Your doctor will perform a test to make sure that VIZIMPRO is right for you. VIZIMPRO is used to treat adults with a type of lung cancer called non-small cell lung cancer. If a test has shown that your cancer has certain changes (mutations) in a gene called epidermal growth factor receptor (EGFR) and has spread to your other lung or other organs, your cancer is likely to respond to treatment with VIZIMPRO. It is not known if VIZIMPRO is safe and effective in children. VIZIMPRO can be used as your first treatment once your lung cancer has spread to your other lung or other organs. HOW VIZIMPRO WORKS VIZIMPRO inhibits the activity of epidermal growth factor receptor ( Aqra d-dokument sħiħ
Pfizer Confidential 1 PFIZER VIZIMPRO ® 15 MG FILM-COATED TABLETS VIZIMPRO ® 30 MG FILM-COATED TABLETS VIZIMPRO ® 45 MG FILM-COATED TABLETS FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations _[see Dosage and Administration (2.1)]_ . 2 DOSAGE AND ADMINISTRATION 2.1 PATIENT SELECTION Select patients for the first-line treatment of metastatic NSCLC with VIZIMPRO based on the presence of an EGFR exon 19 deletion or exon 21 L858R substitution mutation in tumor specimens. 2.2 RECOMMENDED DOSAGE The recommended dosage of VIZIMPRO is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. VIZIMPRO can be taken with or without food _[see Dosage and Administration (2.4) and Clinical Pharmacology (10)]_ . Take VIZIMPRO the same time each day. If the patient vomits or misses a dose, do not take an additional dose or make up a missed dose but continue with the next scheduled dose. 2.3 DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS Reduce the dose of VIZIMPRO for adverse reactions as described in Table 1. Dosage modifications for specific adverse reactions are provided in Table 2. TABLE 1. VIZIMPRO RECOMMENDED DOSE REDUCTIONS FOR ADVERSE REACTIONS DOSE LEVEL DOSE (ONCE DAILY) First dose reduction 30 mg Second dose reduction 15 mg Pfizer Confidential 2 TABLE 2. VIZIMPRO DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS ADVERSE REACTION SEVERITY A DOSAGE MODIFICATION Interstitial lung disease (ILD) _[see Warnings _ _and Precautions _ _(5.1)] _ Any Grade • Permanently discontinue VIZIMPRO. Diarrhea _[see _ _Warnings and _ _Precautions _ _(5.2)] _ Grade 2 • Withhold VIZIMPRO until recovery to less than or equal to Grade 1; then resume VIZIMPRO at the same dose level. • For recurrent Grade 2 diarrhea, withhold until recovery to less than or equal to Grade 1; then resume VIZIMPRO at a re Aqra d-dokument sħiħ