Teva has announced the launch of Tetridar® (teriparatide), the 20 microgram/ 80 microlitres Solution for injection in a pre-filled pen for treating patients living with osteoporosis. The treatment simulates osteoblastic activity and new bone tissue formation, reducing the risk of fracture in those with osteoporosis. The new treatment is bioequivalent and functionally comparable to the original, Forsteo®.i It is estimated that there are currently 300,000 people in Ireland living with osteoporosis with only 15% of people diagnosed. ii
Teriparatide is a self-injecting device which can be administered at home with a recommended dose of 20 micrograms, to be administered once daily by subcutaneous injection in the thigh or abdomen. Each dose of 80 microlitres contains 20 micrograms of teriparatide and one pre-filled pen of 2.4ml contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml). Alongside treatment with teriparatide, supplemental calcium and vitamin D should also be taken by patients if dietary intake is inadequate. iii
Patients must be trained to use the proper injection technique and on the correct use of the pen. The maximum treatment duration should be no more than 24 months and treatment should not be repeated over a patient’s lifetime. Following cessation of teriparatide therapy, patients should be continued on other osteoporosis therapies.
Of those living with the osteoporosis in Ireland, one in four men and one in two women over 50 will develop a fracture due to the condition during their lifetime.ii Teriparatide is indicated for the treatment of osteoporosis in postmenopausal women, men at increased risk of fracture and those in glucocorticoid-induced osteoporosis. It is generally considered a second line therapy for the treatment of osteoporosis however may be considered first line therapy in specific cases such as postmenopausal women at very high risk of fracture or patients with glucocorticoid-induced osteoporosis and multiple prior vertebral fractures.
Paul Neill, Director Generics Products Teva Ireland said, “Tetridar® will help with the prevention of osteoporotic fractures and aid the overall management of osteoporosis. It is worrying to see that an estimated 85% of people living with osteoporosis in Ireland are going undiagnosed. A fracture, or worry of one, can have a huge impact on a person’s quality of life, both mentally and physically”.
The most commonly observed adverse events in osteoporosis patients treated with teriparatide are nausea, pain in limb, headaches and dizziness. Teriparatide has been shown to reduce the risk of vertebral and non-vertebral fractures and increase lumbar spine and hip BMD in postmenopausal women, increase lumbar spine and femoral neck BMD in male patients with osteoporosis and have greater anti-fracture efficacy and greater increase in lumbar spine and hip BMD in those with glucocorticoid-induced osteoporosis.iii
Osteoporosis is progressive, systemic skeletal disorder characterised by low bone mass and micro-architectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. iv Worldwide, osteoporosis causes more than 8.9 million fractures annually, resulting in an osteoporotic fracture every three seconds. v
