Evenity Dosage/Direction for Use

Treatment should be initiated and supervised by specialist physicians experienced in the management of osteoporosis.
Posology: The recommended dose is 210 mg romosozumab (administered as two subcutaneous injections of 105 mg each) once monthly for 12 months.
Patients should be adequately supplemented with calcium and vitamin D before and during treatment (see Contraindications and Precautions).
Patients treated with EVENITY should be given the package leaflet and the patient alert card.
Following completion of romosozumab therapy, transition to antiresorptive therapy is recommended in order to extend the benefit achieved with romosozumab beyond 12 months.
Missed doses: If the romosozumab dose is missed, administer as soon as it can be feasible. Thereafter, the next romosozumab dose should not be given earlier than one month after the last dose.
Special populations: Elderly: No dose adjustment is necessary in elderly patients (see also Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions). Serum calcium should be monitored in patients with severe renal impairment or receiving dialysis (see Precautions).
Hepatic impairment: No clinical trials have been conducted to evaluate the effect of hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of romosozumab in paediatric patients (age <18 years) have not yet been established. No data are available.
Method of administration: Subcutaneous use: To administer the 210 mg dose, 2 subcutaneous injections of romosozumab should be given into the abdomen, thigh, or upper arm. The second injection should be given immediately after the first one but at a different injection site.
Administration should be performed by an individual who has been trained in injection techniques.
For instructions on handling and disposal see Special precautions for disposal and other handling under Cautions for Usage.