Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ERENUMAB
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
ERENUMAB
1 Pre-Filled Syringes
Alcon-Couvreur NV
PASURTA ® INJECTION Erenumab (70 mg/ml & 140 mg/ml) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. WHAT PASURTA IS USED FOR 2. HOW PASURTA WORKS 3. BEFORE YOU USE PASURTA 4. HOW TO USE PASURTA 5. WHILE YOU ARE USING IT 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF PASURTA 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION 11. SERIAL NUMBER 12. INSTRUCTION FOR USE OF PASURTA WHAT PASURTA IS USED FOR Pasurta is a medicine used to prevent migraine in adults who have at least 4 migraine days per month. It contains the active substance erenumab, which belongs to a group of medicines called anti-Calcitonin Gene-Related Peptide (CGRP) receptor antibody. HOW PASURTA WORKS Pasurta works by blocking the activity of CGRP molecule, which has been linked to migraine. BEFORE YOU USE PASURTA - _When you must not use it _ If you have had an allergic reaction to Pasurta or to any of its ingredients. See “ PRODUCT DESCRIPTION ” section below for all ingredients. Ask your doctor if you are not sure. TELL YOUR HEALTHCARE PROVIDER OR GET EMERGENCY MEDICAL HELP IMMEDIATELY: If you get any symptoms of a serious allergic reaction, such as rash or swelling usually of the face, mouth, tongue, or throat; or difficulty breathing. Serious allergic reactions can happen within minutes, but some may happen more than one week after using Pasurta. If you have severe constipation or constipation associated with symptoms such as severe or constant belly pain, vomiting, swelling of belly or bloating. Severe constipation can happen after receiving Pasurta. In some cases, patients have been hospitalized or needed surgery. - _Before you start to use it _ _Children and adolescents (below 18 _ _years) _ The use of Pasurta has not been studied in children under 18 years of age. _Older people (65 years or above) _ You can use Pasurta if you are aged 65 years or over at the same dose as for other adults. _Pregnancy and lactation _ Pasurta has not been studied in pregnant women. It is Baca dokumen lengkapnya
Novartis Page 2 Malaysia Package Leaflet 23-Mar-2022 PASURTA ® PASURTA ® Anti-Calcitonin Gene-Related Peptide Receptor (anti-CGRPR) monoclonal antibody ATC code: N02CD01 _ _ DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS 70 mg erenumab in 1.0 mL (70 mg/mL) solution is a solution that is clear, colorless to yellowish, and practically free from particles. 70 mg/mL solution for injection in a pre-filled syringe, subcutaneous use. 140 mg erenumab in 1.0 mL (140 mg/mL) solution is a solution that is clear, colorless to yellowish, and practically free from particles. 140 mg/mL solution for injection in a pre-filled syringe, subcutaneous use. ACTIVE SUBSTANCE Erenumab. EXCIPIENTS Sucrose, Glacial acetic acid, Polysorbate 80, Water for injection, Sodium hydroxide. INDICATIONS Pasurta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. DOSAGE REGIMEN AND ADMINISTRATION DOSAGE The recommended dose of Pasurta is 70 mg administered once monthly. Some patients may benefit from a dosage of 140 mg administered once monthly [see section CLINICAL STUDIES] If Pasurta dose is missed, administer as soon as possible. Thereafter, Pasurta can be scheduled monthly from the date of the last dose. SPECIAL POPULATIONS PEDIATRICS The safety and effectiveness of Pasurta has not been studied in pediatric patients. GERIATRICS Clinical studies of Pasurta did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. No dose adjustment is required as the pharmacokinetics of erenumab are not affected by age. RENAL IMPAIRMENT No dose adjustment is necessary in patients with mild to moderate renal impairment. Population pharmacokinetic analysis of integrated data from the Pasurta clinical trials did not reveal a Novartis Page 3 Malaysia Package Leaflet 23-Mar-2022 PASURTA ® difference in the pharmacokinetics of erenumab in patients with mild or moderate renal impairment relative to those with normal renal function. Patients Baca dokumen lengkapnya