Country: Israel
Language: English
Source: Ministry of Health
BEROTRALSTAT AS DIHYDROCHLORIDE
NEOPHARM (ISRAEL)1996 LTD
B06AC06
CAPSULES
BEROTRALSTAT AS DIHYDROCHLORIDE 110 MG
PER OS
Required
BIOCRYST PHARMACEUTICALS, INC, USA
BEROTRALSTAT
ORLADEYO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older
2022-08-08
FILE NAME Orladeyo_israel_PIL_ENG-D14-F PRODUCT orladeyo_ JOB NO. SO22001095 LANGUAGE English ARTWORK Patient Leaflet DOCUMENT HISTORY VER. DATE CHANGE DESCRIPTION BY 29-Nov-22 16:09 Last save _OUR EXPERTISE. YOUR SUCCESS._ PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only ORLADEYO® 110 MG, hard gelatin capsules ORLADEYO® 150 MG, hard gelatin capsules THE ACTIVE SUBSTANCE AND ITS QUANTITY PER DOSAGE UNIT: Each Orladeyo capsule contains berotralstat (as dihydrochloride) 110 mg or 150 mg. For a list of inactive ingredients and allergens in the preparation: see section 6 "Additional information" in this leaflet. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Orladeyo is intended to prevent attacks of Hereditary Angioedema (HAE) in adults and children aged 12 and older . Restriction of use: Orladeyo is not intended for the treatment of an acute attack of Hereditary Angioedema. THERAPEUTIC GROUP: Orladeyo belongs to the group of haematological drugs used to treat hereditary angioedema. ATC code: B06AC06 Berotralstat, the active ingredient in Orladeyo, blocks the activity of kallikrein enzymes in plasma, resulting in low levels of bradykinin. This prevents the swelling and pain that can be caused by attacks of hereditary angioedema. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: YOU ARE SENSITIVE (ALLERGIC) TO THE ACTIVE INGREDIENT OR TO ANY OF THE OTHER INGREDIENTS IN THIS MEDICINE (SEE SECTION 6). BEFORE TREATMENT WITH ORLADEYO, INFORM YOUR DOCTOR IF : • You have liver problems or are undergoing kidney dialysis. SPECIAL WARNINGS REGARDING THE USE OF Read the complete document
1 FULL PRESCRIBING INFORMATION NAME OF THE MEDICINAL PRODUCT Orladeyo ® 110 mg Orladeyo ® 150 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Orladeyo 110 mg Each hard capsule contains 110 mg berotralstat (as dihydrochloride). Orladeyo 150 mg Each hard capsule contains 150 mg berotralstat (as dihydrochloride). The inactive ingredients are listed in section 11. PHARMACEUTICAL FORM Hard gelatin capsule for oral use. 1 INDICATIONS AND USAGE ORLADEYO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older. Limitations of Use: The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for treatment of acute HAE attacks. Additional doses or doses of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation _[see Warnings and Precautions (5.1)]._ 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSAGE The recommended dosage of ORLADEYO is one 150 mg capsule taken orally once daily with food. 2.2 RECOMMENDED DOSAGE IN PATIENTS WITH HEPATIC IMPAIRMENT No dosage adjustment of ORLADEYO is recommended for patients with mild hepatic impairment (Child-Pugh Class A) _[see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]_. In patients with moderate or severe hepatic impairment (Child-Pugh B or C), the recommended dosage of ORLADEYO is one 110 mg capsule taken orally once daily with food _[see Use in Specific _ _Populations (8.7) and Clinical Pharmacology (12.3)]_. 2.3 RECOMMENDED DOSAGE FOR CONCOMITANT USE WITH P-GP OR BCRP INHIBITORS In patients with chronic administration of P-gp or BCRP inhibitors (e.g., cyclosporine), the recommended dosage of ORLADEYO is one 110 mg capsule taken orally once daily with food _[see _ _Drug Interactions (7.1) and Clinical Pharmacology (12.3)]_. 2 2.4 DOSAGE ADJUSTMENT IN PATIENTS WITH PERSISTENT GI REACTIONS Gastrointestinal (GI) reactions may occur in patients receiving ORLADEYO _[s Read the complete document