Pays: Israël
Langue: anglais
Source: Ministry of Health
ROMOSOZUMAB
AMGEN EUROPE B.V.
M05BX06
SOLUTION FOR INJECTION
ROMOSOZUMAB 90 MG / 1 ML
S.C
Required
AMGEN INC. (REFERRED TO AS AMGEN THOUSAND OAKS OR ATO), USA
ROMOSOZUMAB
EVENITY is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
2020-06-17
EVENITY ® (romosozumab 105 mg) Prescriber Guide Important information on minimising risk to ensure safe and effective use. This Prescriber guide format and content were approved by the Ministry of Health in September 2020 Evenity_Israel_English_Prescriber Guide_v2.0 dated September 2020 page | 2 EVENITY ® (romosozumab) Prescriber Guide 1. ABOUT THIS GUIDE • EVENITY ® (romosozumab) is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk for fracture; for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. • This guide contains important safety information for healthcare professionals to aid with minimizing key risks when prescribing romosozumab. • The patient if their caregiver should be educated about treatment risks and provided with a Patient Alert Card. • Refer to the Israel Prescribing Information (PI) for more details. 2. ABOUT ROMOSOZUMAB Romosozumab in bone decreases bone resorption. Limitations of Use the duration of EVENITY use should be limited to 12 monthly doses. If osteoporosis -resorptive agent should be considered. The first dose of EVENITY should be administered by a healthcare provider only. jection can be performed by an individual who has been properly trained by a healthcare provider only. ld be given immediately after the first one but at a different injection site. ons of the Israel package leaflet. page | 3 EVENITY ® (romosozumab) Prescriber Guide EACH DOSE COMPRISES TWO INJECTIONS AT DIFFERENT SITES Two pre- = 1 DOSE OUTER AREA OF UPPER ARM STOMACH AREA (ABDOMEN) THIGH DIFFERENT 3. KEY RISKS This guide covers the risks of hypocalcaemia and myocardial infarction For detailed information about these and other please refer to the romosozumab Israel Prescribing Information. ROMOSOZUMAB IS CONTRAINDICATED IN PATIENTS WITH HYPOCALCAEMIA. PATIENTS SHOULD HAVE THEIR SERUM CALCIUM LEVELS MEASURED BEFORE INITIATING ROMOSOZUMAB THERAPY AND SHOULD BE MONITORED FOR SIGNS AND SYMPTOMS OF HYPOCALCAEMIA THROUGHOUT Lire le document complet
EVENITY ® ROMOSOZUMAB 105 MG/1.17 ML (90 MG / ML) SOLUTION FOR SUBCUTANEOUS INJECTION IN PRE-FILLED SYRINGE FULL PRESCRIBING INFORMATION WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH • EVENITY MAY INCREASE THE RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH _[SEE CONTRAINDICATIONS (4)]_. EVENITY SHOULD NOT BE INITIATED IN PATIENTS WHO HAVE HAD A MYOCARDIAL INFARCTION OR STROKE WITHIN THE PRECEDING YEAR. CONSIDER WHETHER THE BENEFITS OUTWEIGH THE RISKS IN PATIENTS WITH OTHER CARDIOVASCULAR RISK FACTORS. IF A PATIENT EXPERIENCES A MYOCARDIAL INFARCTION OR STROKE DURING THERAPY, EVENITY SHOULD BE DISCONTINUED. 1 INDICATIONS AND USAGE TREATMENT OF POSTMENOPAUSAL WOMEN WITH SEVERE OSTEOPOROSIS AT HIGH RISK FOR FRACTURE EVENITY is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. LIMITATIONS OF USE The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered _[see Dosage and Administration _ _(2.2) and Clinical Studies (14.1)]_ . PATIENT SAFETY INFORMATION CARD AND PRESCRIBER GUIDE The marketing of EVENITY is subject to a risk management plan (RMP) including a Patient safety information Card (Patient Alert card) and a Prescriber guide providing important safety information. Please ensure you are familiar with this material as it contains important safety information. The Patient alert card emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment and the implications of this treatment including the need for compliance. Lire le document complet