Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
OSIMERTINIB AS MESYLATE
ASTRAZENECA (ISRAEL) LTD
L01XE35
TABLETS
OSIMERTINIB AS MESYLATE 80 MG
PER OS
Required
ASTRA ZENECA AB, SWEDEN
OSIMERTINIB
Tagrisso as monotherapy is indicated for: • the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. • the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLCTAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations.
2021-04-30
PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only TAGRISSO ® 40 MG TAGRISSO ® 80 MG TABLETS COMPOSITION: Each tablet contains: Osimertinib (as mesylate) 40 mg Osimertinib (as mesylate) 80 mg For inactive ingredients please refer to Section 6 – “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. Keep this leaflet, you may need it again. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. This medicine is not intended for children under the age of 18. 1. WHAT IS TAGRISSO AND WHAT IS IT USED FOR? TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations. TAGRISSO AS MONOTHERAPY IS INDICATED FOR: • the first-line treatment of adult patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. • the treatment of adult patients with locally advanced or metastatic EGFR (epidermal growth factor receptor) T790M mutation-positive NSCLC. THERAPEUTIC GROUP Anticancer medicine, protein kinase inhibitor. This medicine will be prescribed by a doctor with experience in anticancer therapies. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are hypersensitive to the active ingredient or any of the other ingredients of this medicine (see section 6 below – “Further Information”). • you are using St. John’s Wort ( hypericum perforatum ) concomitantly . SPECIAL WARNINGS REGARDING USE OF TAGRISSO: BEFORE TREATMENT WITH THIS MEDICINE, TELL YOUR DOCTOR IF: • Citiți documentul complet
1 1. NAME OF THE MEDICINAL PRODUCT TAGRISSO 40mg film-coated tablets TAGRISSO 80mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TAGRISSO 40 mg tablets Each tablet contains osimertinib 40mg (equivalent to 47.7mg of osimertinib mesylate) TAGRISSO 80 mg tablets Each tablet contains osimertinib 80mg (equivalent to 95.4mg of osimertinib mesylate) Excipient with known effect This medicine contains 0.3 mg sodium per 40 mg tablet and 0.6 mg sodium per 80 mg tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). TAGRISSO 40 mg tablets: Beige, 9mm, round, biconvex tablet, debossed with AZ and 40 on one side and plain on the reverse. TAGRISSO 80 mg tablets Beige, 7.25 x 14.5 mm, oval, biconvex tablet, debossed with AZ and 80 on one side and plain on the reverse. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications - TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations. Tagrisso as monotherapy is indicated for: - the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. 2 - the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. 4.2 Posology and method of administration Select patients with resectable tumors for the adjuvant treatment of NSCLC with TAGRISSO based on the presence of EGFR exon 19 deletions or exon 21 L858R mutations in tumor specimens. Treat patients in the adjuvant setting until disease recurrence, or unacceptable toxicity, or for up to 3 years. Treat patients with metastatic lung cancer until disease progression or unacceptable toxicity. Treatment with TAGRISSO should be initiated by a physician experienced in the use of anticancer therapies. When considering the use of TAGRISSO, EGFR mutation status Citiți documentul complet