FORTEO INJECTION 20 MCG/80MCL [SIN12593P]

Product Info

FORTEO INJECTION 20 MCG/80MCL

[SIN12593P]

Indication

1 INDICATIONS AND USAGE

Forteo 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, Forteo 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, Forteo increases BMD. The effects of Forteo 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.

Dosing

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosage is 20 mcg given subcutaneously once a day.

2.2 Administration Instructions

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

• Forteo 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. Forteo 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 Forteo should receive appropriate training and instruction on the proper use of the Forteo prefilled delivery device (pen) from a qualified health professional.

2.3 Recommended Treatment Duration

Use of Forteo 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].

Contraindications

3 CONTRAINDICATIONS

Forteo is contraindicated in patients with hypersensitivity to Forteo or to any of its excipients.