Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: UCB Pharma S.A., Allée de la Recherche, 60, B-1070 Bruxelles, Belgium
EVENITY is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture (see section 5.1).
Treatment should be initiated and supervised by specialist physicians experienced in the management of osteoporosis.
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 sections 4.3 and 4.4).
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.
If the romosozumab dose is missed, it should be administered as soon as it can be feasible. Thereafter, the next romosozumab dose should not be given earlier than one month after the last dose.
No dose adjustment is necessary in elderly patients (see also section 5.2).
No dose adjustment is required in patients with renal impairment (see section 5.2). Serum calcium should be monitored in patients with severe renal impairment or receiving dialysis (see section 4.4).
No clinical trials have been conducted to evaluate the effect of hepatic impairment (see section 5.2).
The safety and efficacy of romosozumab in paediatric patients (age <18 years) have not yet been established. No data are available.
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 section 6.6.
There is no experience with overdose in clinical trials. There is no known antidote to romosozumab or specific treatment for overdose. In case of overdose, it is recommended that patients are monitored closely and given appropriate treatment.
3 years.
When taken out of the refrigerator for use, EVENITY should not be returned to the refrigerator but can be kept at room temperature (up to 25°C) for up to 30 days in the original container. If not used within this period, the product should be discarded.
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the pre-filled syringe or pre-filled pen in the outer carton in order to protect from light.
EVENITY 105 mg solution for injection in pre-filled pen:
A single use, disposable, handheld, mechanical injection device pre-assembled with pre-filled syringe containing 1.17 ml solution. The syringe inside the pen is made from cyclo olefin polymer plastic with a stopper (chlorobutyl) and insert molded stainless steel needle with elastomeric needle shield (synthetic rubber).
Pack size of 2 pre-filled pens.
Multipack containing 6 (3 packs of 2) pre-filled pens.
EVENITY 105 mg solution for injection in pre-filled syringe:
A single use, disposable, pre-filled syringe containing 1.17 ml solution. The syringe is made from cyclo olefin polymer plastic with a stopper (chlorobutyl) and insert molded stainless steel needle and elastomeric needle shield (synthetic rubber).
Pack size of 2 pre-filled syringes.
Multipack containing 6 (3 packs of 2) pre-filled syringes.
Not all pack sizes may be marketed.
The solution should be visually inspected for particles and discoloration prior to administration. EVENITY should not be used if the solution is discolored, cloudy, or contains particles.
Prior to subcutaneous administration, romosozumab should be allowed to sit at room temperature for at least 30 minutes before injecting. This will help make the injection more comfortable. It should not be warmed in any other way.
Do not shake.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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