SONDELBAY INJECTION 20 MCG/80 MCL [SIN16802P]

Product Info

SONDELBAY INJECTION 20 MCG/80 MCL

[SIN16802P]

1 INDICATIONS AND USAGE
Sondelbay is indicated:

• For the treatment of postmenopausal women with osteoporosis who are at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant of previous osteoporosis therapy, based upon physician assessment. In postmenopausal women with osteoporosis, teriparatide increases BMD and reduces the risk of vertebral and nonvertebral fractures.

• To increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. These include men with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment. In men with primary or hypogonadal osteoporosis, teriparatide increases BMD. The effects of teriparatide on risk for fracture in men have not been studied.

• For the treatment of men and women with glucocorticoid-induced osteoporosis at high risk for fracture. See CLINICAL STUDIES (12.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dosage is 20 mcg given subcutaneously once a day.

2.2 Administration Instructions

• Administer Sondelbay as a subcutaneous injection into the thigh or abdominal region. Sondelbay is not approved for intravenous or intramuscular use.

• Sondelbay should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur [see WARNINGS and PRECAUTIONS (4.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

• Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. Sondelbay is a clear and colorless liquid. Do not use if solid particles appear or if the solution is cloudy or colored. Patients and/or caregivers who administer Sondelbay should receive appropriate training and instruction on the proper use of the Sondelbay prefilled delivery device (pen) from a qualified health professional.

2.3 Recommended Treatment Duration
Use of Sondelbay for more than 2 years during a patient’s lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture [see WARNINGS and PRECAUTIONS (4.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

3 CONTRAINDICATIONS
Sondelbay is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients.