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EVENITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 105 MG/1.17 ML [SIN16208P]
Active ingredients: EVENITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 105 MG/1.17 ML
Last updated 26 October 2025
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Product Info
EVENITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 105 MG/1.17 ML
[SIN16208P]
Product information
Active Ingredient and Strength | ROMOSOZUMAB - 105 MG/1.17 ML |
Dosage Form | INJECTION, SOLUTION |
Manufacturer and Country | PATHEON ITALIA S.P.A - ITALY |
Registration Number | SIN16208P |
Licence Holder | AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | M05BX06 |
4.1 Therapeutic Indications
Postmenopausal Osteoporosis
EVENITY is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
4.2 Dosage and Administration
Dosage
The recommended dose of EVENITY is 210 mg administered subcutaneously. Administer EVENITY once every month for 12 doses.
Patients should be adequately supplemented with calcium and vitamin D [see Contraindications (4.3), Special Warnings and Precautions for Use (4.4), and Clinical Data (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
If the EVENITY dose is missed, administer as soon as it can be rescheduled. Thereafter, EVENITY can be scheduled every month from the date of the last dose.
After completing EVENITY therapy, consider transition to another osteoporosis therapy [see Pharmacodynamic Properties (5.1) and Clinical Data (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
Method of Administration
Subcutaneous use. Administration should be performed by an individual who has been trained to administer the product.
To administer the 210 mg dose, give 2 subcutaneous injections of EVENITY.
For detailed instructions on storage, handling, and administration, follow the directions provided in the “Instructions for Use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Important Administration Instructions
Visually inspect EVENITY for particles and discoloration prior to administration. EVENITY is a clear to opalescent, colourless to light yellow solution. Do not use if the solution is cloudy or discoloured or contains particles.
Administer EVENITY in the abdomen, thigh, or upper arm subcutaneously. If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection. Do not inject into areas where the skin is tender, bruised, red, or hard.
4.3 Contraindications
Hypocalcaemia
EVENITY is contraindicated in patients with uncorrected hypocalcaemia [see Special Warnings and Precautions for Use (4.4), Adverse Reactions (4.8), and Special Populations (4.6) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
Hypersensitivity
EVENITY is contraindicated in patients with known clinically significant hypersensitivity to romosozumab or to any component of the product formulation [see Special Warnings and Precautions for Use (4.4) and List of Excipients (6.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
Myocardial Infarction and Stroke
EVENITY is contraindicated in patients with a history of myocardial infarction or stroke [see Special Warnings and Precautions for Use (4.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].