- Approval Id
- cc143f3e27d8ab84
- Drug Name
- EVENITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 105 MG/1.17 ML
- Product Name
- EVENITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 105 MG/1.17 ML
- Approval Number
- SIN16208P
- Approval Date
- 2021-05-27
- Registrant
- AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD
- Licence Holder
- AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **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.
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- **4.1 Therapeutic Indications**
Postmenopausal Osteoporosis
EVENITY is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
- Contraindications
- **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 \[see Special Warnings and Precautions for Use (4.4) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].
- Atc Code
- M05BX06
- Atc Item Name
- romosozumab
- Pharma Manufacturer Name
- AMGEN BIOTECHNOLOGY SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/2674a0bc2a636200/amgen-biotechnology-singapore-pte-ltd
