Presentation and Status in Health Basket
2.4 ml (28 doses of 20 mcg)
Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture: The recommended dose is 20 mcg subcutaneously once a day.
Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture: The recommended dose is 20 mcg subcutaneously once a day.
Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture: The recommended dose is 20 mcg subcutaneously once a day.
• FORTEO should be administered as a subcutaneous injection into the thigh or abdominal wall. There are no data available on the safety or efficacy of intravenous or intramuscular injection of FORTEO.
• FORTEO should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. FORTEO is a clear and colorless liquid. Do not use if solid particles appear or if the solution is cloudy or colored.
• Patients and caregivers who administer FORTEO should receive appropriate training and instruction on the proper use of the FORTEO delivery device from a qualified health professional.
Treatment Duration: The safety and efficacy of FORTEO have not been evaluated beyond 2 years of treatment. Consequently, use of the drug for
more than 2 years during a patient’s lifetime is not recommended.
Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture: FORTEO is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, FORTEO increases BMD reduces the risk of vertebral and
Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture: FORTEO is indicated to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture: FORTEO is indicated for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
Do not use FORTEO in patients with:
• Hypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis.
• Pregnancy and lactation.
• Severe renal impairment.
Osteosarcoma: In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. FORTEO should not be prescribed for patients at increased baseline risk of osteosarcoma.
• Paget’s disease of bone. Unexplained elevations of alkaline phosphatase may indicate Paget’s disease of bone.
• Pediatric and young adult patients with open epiphyses.
• Prior external beam or implant radiation therapy involving the skeleton. Treatment Duration: The safety and efficacy of FORTEO have not been evaluated beyond 2 years of treatment. Consequently, use of the drug for more than 2 years during a patients’ lifetime is not recommended.
Bone Metastases and Skeletal Malignancies: Patients with bone metastases or a history of skeletal malignancies should not be treated with FORTEO.
Metabolic Bone Diseases: Patients with metabolic bone diseases other than osteoporosis should not be treated with FORTEO.
Hypercalcemia and Hypercalcemic Disorders: FORTEO has not been studied in patients with pre-existing hypercalcemia. These patients should not be treated with FORTEO because of the possibility of exacerbating hypercalcemia. Patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, should not be treated with FORTEO.
Urolithiasis or Pre-existing Hypercalciuria: In clinical trials, the frequency of urolithiasis was similar in patients treated with FORTEO and placebo. However, FORTEO 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. FORTEO should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
Orthostatic Hypotension: FORTEO should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur. In short-term clinical pharmacology studies with teriparatide, transient episodes of symptomatic orthostatic hypotension were observed in 5% of patients. 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, it was relieved by placing the person in a reclining position, and it did not preclude continued treatment.
Drug Interactions: Hypercalcemia may predispose patients to digitalis toxicity. Because FORTEO transiently increases serum calcium, patients receiving digoxin should use FORTEO with caution.
Clinical Trials Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Treatment of Osteoporosis in Men and Postmenopausal Women: The safety of this product in the treatment of osteoporosis in men and postmenopausal women was assessed in two randomized, double-blind, placebo-controlled trials of 1382 patients (21% men, 79% women) aged 28 to 86 years (mean 67 years). The median durations of the trials were 11 months for men and 19 months for women, with 691 patients exposed to this product and 691 patients to placebo. All patients received 1000 mg of calcium plus at least 400 IU of vitamin D supplementation per day.
The incidence of all cause mortality was 1% in the this product group and 1% in the placebo group. The incidence of serious adverse events was 16% in Forteo patients and 19% in placebo patients. Early discontinuation due to adverse events occurred in 7% of patients and 6% of placebo patients.
Studies in Men and Women with Glucocorticoid-Induced Osteoporosis: The safety of FORTEO in the treatment of men and women with glucocorticoid-induced osteoporosis was assessed in a randomized, double-blind, active-controlled trial of 428 patients (19% men, 81% women) aged 22 to 89 years (mean 57 years) treated with ≥ 5mg per day prednisone or equivalent for a minimum of 3 months. The duration of the trial was 18 months with 214 patients exposed to FORTEO and 214 patients exposed to oral daily bisphosphonate (active control). All patients received 1000 mg of calcium plus 800 IU of vitamin D supplementation per day.
The incidence of all cause mortality was 4% in the FORTEO group and 6% in the active control group. The incidence of serious adverse events was 21% in FORTEO patients and 18% in active control patients, and included pneumonia (3% FORTEO, 1% active control). Early discontinuation because of adverse events occurred in 15% of FORTEO patients and 12% of active control patients, and included dizziness (2% FORTEO, 0% active control).
Adverse events reported at a higher incidence in the FORTEO group and with at least a 2% difference in FORTEO-treated patients compared with active control-treated patients were: nausea (14%, 7%), gastritis (7%, 3%), pneumonia (6%, 3%), dyspnea (6%, 3%), insomnia (5%, 1%), anxiety (4%, 1%), and herpes zoster (3%, 1%), respectively.
See prescribing information for full details.
Digoxin: A single FORTEO dose did not alter the effect of digoxin on the systolic time interval (from electrocardiographic Q-wave onset to aortic valve closure, a measure of digoxin’s calcium-mediated cardiac effect). However, because FORTEO may transiently increase serum calcium, FORTEO should be used with caution in patients taking digoxin.
Hydrochlorothiazide: The coadministration of hydrochlorothiazide 25 mg with teriparatide did not affect the serum calcium response to teriparatide 40 mcg. The effect of coadministration of a higher dose of hydrochlorothiazide with teriparatide on serum calcium levels has not been studied.
Furosemide: Coadministration of intravenous furosemide (20 to 100 mg) with teriparatide 40 mcg in healthy people and patients with mild, moderate, or severe renal impairment (CrCl 13 to 72 mL/min) resulted in small increases in the serum calcium (2%) and 24-hour urine calcium (37%) responses to teriparatide that did not appear to be clinically important.
Pregnancy and Lactation
Pregnancy: FORTEO is contraindicated for use during pregnancy. There are no available data on FORTEO use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. If pregnancy occurs, Forteo should be discontinued.
In animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m²), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose. The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk in the US general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Lactation: FORTEO is contraindicated for use during breast-feeding. It is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant. Because of the potential for osteosarcoma shown with teriparatide in animal studies, Forteo is contraindicated for use during breast-feeding.
Women of childbearing potential / Contraception in females: Women of childbearing potential should use effective methods of contraception during use of FORTEO. If pregnancy occurs, FORTEO should be discontinued.
Incidents of overdose in humans have not been reported in clinical trials. Teriparatide has been administered in single doses of up to 100 mcg and in repeated doses of up to 60 mcg/day for 6 weeks. The effects of overdose that might be expected include a delayed hypercalcemic effect and risk of orthostatic hypotension. Nausea, vomiting, dizziness, and headache might also occur.
In postmarketing spontaneous reports, there have been cases of medication errors in which the entire contents (up to 800 mcg) of the FORTEO delivery device (pen) have been administered as a single dose. Transient events reported have included nausea, weakness/lethargy and hypotension. In some cases, no adverse events occurred as a result of the overdose. No fatalities associated with overdose have been reported.
Overdose Management: There is no specific antidote for teriparatide. Treatment of suspected overdose should include discontinuation of FORTEO, monitoring of serum calcium and phosphorus, and implementation of appropriate supportive measures, such as hydration.
Storage and Handling: The FORTEO delivery device should be stored under refrigeration at 2° to 8°C at all times. Recap the delivery device when not in use to protect the cartridge from physical damage and light. During the use period, time out of the refrigerator should be minimized; the dose may be delivered immediately following removal from the refrigerator. Do not freeze. Do not use FORTEO if it has been frozen.