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TEVA-TERIPARATIDE is a brand name for Teriparatide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Carcinogenicity Two carcinogenicity bioassays were conducted in Fischer 344 rats. In these studies, rats were given daily subcutaneous teriparatide injections at doses that resulted in systemic exposures between 3 and 60 times higher than the systemic exposure observed in humans following a subcutaneous dose of 20 mcg (based on AUC comparison).
Teriparatide treatment resulted in increases in the incidence of bone tumours, including osteosarcoma, that occurred in association with dose-dependant exaggerated increases in bone mass. The studies showed that the occurrence of bone tumours was dependent upon dose and duration of exposure.
Osteosarcoma was not observed in teriparatide clinical trials. Though osteosarcoma has been reported in a post-market setting, increased incidence of osteosarcoma has not been observed with teriparatide treatment in observational studies.
g. ). General The safety and efficacy of teriparatide have been evaluated up to 2 years in studies GHAC, GHAJ, GHBJ and GHCA (median 19 months in women in study GHAC and 10 months in men in study GHAJ). An additional clinical study (GHBZ) evaluated the safety and efficacy of teriparatide for up to 3 years.
In general, the maximum lifetime exposure to TEVA- TERIPARATIDE INJECTION for an individual patient should be 24 months. Use of TEVA- TERIPARATIDE INJECTION for more than 24 months during a patient’s lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture.
In clinical trials, the frequency of urolithiasis was similar in patients treated with teriparatide and placebo. However, teriparatide has not been studied in patients with active urolithiasis. If active urolithiasis or pre-existing hypercalciuria are suspected, measurement of urinary calcium excretion should be considered.
TEVA-TERIPARATIDE INJECTION should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition. Hypotension In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension were observed.
Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, was relieved by placing subjects in a reclining position, and did not preclude continued treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Teriparatide in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Patients experiencing symptoms associated with hypotension should not drive or operate machinery until they become asymptomatic. Teva-Teriparatide Injection Page 6 of 61 Information for Patients For safe and effective use of TEVA-TERIPARATIDE INJECTION, the physician should inform patients about the following: General: Physicians should instruct their patients to read the Consumer Information Leaflet and Pen User Manual before starting therapy with TEVA-TERIPARATIDE INJECTION and re-read them each time the prescription is renewed.
Osteosarcomas in rats:
Patients should be made aware that teriparatide caused osteosarcomas in rats. Post-market data have not detected increased incidence of osteosarcoma in patients treated with teriparatide.
Orthostatic hypotension:
Patients should be instructed that if they feel lightheaded after injection, they should sit or lie down until the symptoms resolve. If symptoms persist or worsen, patients should be instructed to consult a physician before continuing treatment.
Patients experiencing symptoms associated with hypotension should not drive or operate machinery until they become asymptomatic (see WARNINGS AND PRECAUTIONS, Hypotension). , nausea, vomiting, constipation, lethargy, muscle weakness).
Use of the pen:
Patients should be instructed on how to properly use the prefilled delivery device (refer to Pen User Manual) and properly dispose of needles, and be advised not to share their pens with other patients.
Other Osteoporosis Treatment and Prevention Measures:
Patients should be informed regarding the roles of supplemental calcium and/or vitamin D, weight-bearing exercise, and modification of certain behavioral factors such as cigarette smoking and/or alcohol/coffee consumption.
Special Populations Pregnant Women and Women of Childbearing Potential:
TEVA-TERIPARATIDE INJECTION should not be administered to women who are pregnant. The effect of teriparatide treatment on human fetal development has not been studied. Women of childbearing potential should use effective methods of contraception during use of TEVA-TERIPARATIDE INJECTION.
Should pregnancy occur, TEVA-TERIPARATIDE INJECTION should be discontinued (see CONTRAINDICATIONS).
Nursing Women:
There have been no clinical studies to determine if teriparatide is secreted into breast milk. TEVA-TERIPARATIDE INJECTION should not be administered to nursing mothers (see CONTRAINDICATIONS).
Teva-Teriparatide Injection Page 7 of 61 Pediatrics:
Teriparatide has not been studied in pediatric populations. TEVA-TERIPARATIDE INJECTION should not be used in children or young adults with open epiphyses (see CONTRAINDICATIONS).
Premenopausal Women:
Before initiating therapy with TEVA-TERIPARATIDE INJECTION in premenopausal women with glucocorticoid-induced osteoporosis, risk factors such as low BMD, length and dosage of glucocorticoid therapy, previous fractures, family history, high bone turnover, level of underlying disease activity, low sex steroid level or low body mass index, should be considered.
Geriatrics:
Of the patients receiving teriparatide in the osteoporosis treatment trial […]