Adult Dosing

Treatment of postmenopausal women with osteoporosis who are at high risk for fracture

• Recommended dose: 20 mcg SC qd

Increase of bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture

• Recommended dose: 20 mcg SC qd

Treatment of men and women with glucocorticoid-induced osteoporosis at high risk for fracture

• Recommended dose: 20 mcg SC qd

Note:

• Safety and efficacy of teriparatide have not been evaluated beyond 2 years of treatment
• Should be administered as a SC injection into the thigh or abdominal wall
• Administer initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of postmenopausal women with osteoporosis who are at high risk for fracture
• Increase of bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture
• Treatment of men and women with glucocorticoid-induced osteoporosis at high risk for fracture

• Hypersenstivity to any of the ingredients of the product
• Paget's disease of bone
• Pediatric and young adult patients with open epiphyses
• History of external beam or implant radiation therapy involving the skeleton
• History of skeletal malignancies
• Patients with bone metastases
• Metabolic bone disorders
• Hypercalcemia
• Hyperparathyroidism

• Increased incidence of osteosarcoma has been reported in animal studies using male and female rats; this effect occurred with systemic exposures to teriparatide ranging from 3-60 times the exposure in humans given a 20-mcg dose. Due to uncertain relevance of the rat osteosarcoma finding to humans, prescribe teriparatide only for patients for whom the potential benefits are considered to outweigh the potential risks
• Not recommended for patients who are at increased baseline risk for osteosarcoma such as those with Paget’s disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam/implant radiation therapy involving the skeleton

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Not indicated for patients at increased baseline risk for osteosarcoma such as those with Paget’s disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam/implant radiation therapy involving the skeleton
• Therapy is not recommended for more than 2 years during a patients’ lifetime
• Teriparatide is contraindicated in patients with bone metastases or a history of skeletal malignancies and in those with metabolic bone diseases other than osteoporosis
• Patients with preexisting hypercalcemia and those with underlying hypercalcemic disorder, including primary hyperparathyroidism, should not be treated with teriparatide, as it may exacerbate hypercalcemia
• If active urolithiasis or preexisting hypercalciuria is suspected, consider measurement of urinary calcium excretion. Use with caution in patients with active or recent urolithiasis because of the risk of exacerbation
• Transient orthostatic hypotension may occur during the initial doses of teriparatide

Caution: Use cautiously in

• Patients receiving digoxin

Supplemental Patient Information

• Initiate awareness about the proper use of the delivery device, needle disposal in patients and caregivers who administer teriparatide; the contents of the delivery device should not be transferred to a syringe
• Inform patients about the roles of supplemental calcium and/or vitamin D, weight-bearing exercise, and certain lifestyle modifications
• Instruct patients to promptly contact their physician if they develop persistent symptoms of hypercalcemia such as nausea, vomiting, constipation, muscle weakness, and lethargy

Pregnancy Category:C

Breastfeeding: Safety unknown. Because of the potential for tumorigenecity shown in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.

• CV: Angina pectoris, syncope, orthostatic hypotension, hypertension
• CNS: Headache, dizziness, asthenia, insomnia, vertigo
• PSYCHIATRY: Depression
• GI: Nausea, constipation, diarrhea, dyspepsia, vomiting, gastrointestinal disorder, tooth disorder
• METABOLIC: Transiet hypercalcemia, hyperuricemia
• DERM: Rash, sweating
• EENT: Vertigo
• RESP: Rhinitis, increased cough, pharyngitis, dyspnea, pneumonia
• MUSC: Arthralgia, leg cramps, muscle spasms, neck pain
• MISC: Osteosarcoma (animal studies), pain
• LOCAL: Injection site reaction

• Parathyroid hormone analog; binds to specific high-affinity cell surface receptors leading to regulation of calcium and phosphate metabolism in bone and kidney, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption; also stimulates osteoblastic activity
• Absolute bioavailability: 95%
• Metabolized by liver; CYP450: Unknown
• Renally excreted
• Half-life: 1 hr for subcutaneous administration

US Trade Name(s)

• Forteo

US Availability

Forteo

• INJ: 0.25 mg/mL (2.4 mL prefilled pen)

Canadian Trade Name(s)

• Forteo

Canadian Availability

Forteo

• INJ: 0.25 mg/mL (3 mL, 2.4 mL prefilled pen)

UK Trade Name(s)

• Forsteo

UK Availability

Forsteo

• INJ: 0.25 mg/mL (3 mL, 2.4 mL prefilled pen)

Australian Trade Name(s)

• Forteo

Australian Availability

Forteo

• INJ: 0.25 mg/mL (2.4 mL prefilled pen)

[Outline]

Endocrine/Metabolic

Hormones

Parathyroid Hormone Analogs

Pricing data from www.DrugStore.com in U.S.A.

• Forteo 600 MCG/2.4ML SOLN [Pen] (LILLY)
  2.4 2.4ml = $1019.03
  7.2 2.4ml = $2996.87

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.