Teriparatide Injection

— THERAPEUTIC CATEGORIES —
  • Bone disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Teriparatide Injection Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Teriparatide (recombinant) 250mcg/mL; soln for SC inj; contains m-cresol.

    Pharmacological Class

    Hormone (human parathyroid hormone, recombinant).

    How Supplied

    Single-patient-use pens (2.48mL)—1

    Manufacturer

    Alvogen

    Mechanism of Action

    Teriparatide stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.

    Teriparatide Injection Indications

    Indications

    Postmenopausal osteoporosis in women who are at high risk for fracture. To increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. Treatment of men and women with osteoporosis associated with sustained glucocorticoid therapy at high risk for fracture (see full labeling).

    Teriparatide Injection Dosage and Administration

    Adult

    20mcg SC once daily into thigh or abdominal wall. Give supplemental calcium and vitamin D if daily intake is inadequate. Consider treating for more than 2 years only if patient remains at or has returned to having high risk for fracture.

    Children

    Not established.

    Teriparatide Injection Contraindications

    Not Applicable

    Teriparatide Injection Boxed Warnings

    Not Applicable

    Teriparatide Injection Warnings/Precautions

    Warnings/Precautions

    Increased baseline risk for osteosarcoma (eg, open epiphyses, metabolic bone diseases other than osteoporosis including Paget's disease of bone, bone metastases, history of skeletal malignancies, prior skeletal radiation therapy, hereditary disorders predisposing to osteosarcoma), underlying hypercalcemic disorder (eg, primary hyperparathyroidism): avoid. Risk for cutaneous calcification and calciphylaxis (esp. underlying autoimmune disease, kidney failure). Discontinue if calciphylaxis develops or stable cutaneous calcification worsens. Urolithiasis. Hypercalciuria. Hepatic or renal impairment. Pregnancy. Nursing mothers: not recommended.

    Teriparatide Injection Pharmacokinetics

    Absorption

    Absolute bioavailability: ~95%. Peak serum concentrations are reached about 30 minutes after SC inj.

    Distribution

    Volume of distribution: ~0.12 L/kg.

    Metabolism

    Hepatic.

    Elimination

    Half-life: 0.79 ± 0.35 hour. Systemic clearance: ~62 L/hr (women); 94 L/hr (men).

    Teriparatide Injection Interactions

    Interactions

    Caution with digoxin (teriparatide-induced hypercalcemia increases risk of toxicity). Increased risk for calciphylaxis development with warfarin or systemic corticosteroids.

    Teriparatide Injection Adverse Reactions

    Adverse Reactions

    Arthralgia, pain, nausea; transient orthostatic hypotension, cutaneous calcification, hypercalcemia, hyperuricemia, inj site reactions.

    Teriparatide Injection Clinical Trials

    See Literature

    Teriparatide Injection Note

    Not Applicable

    Teriparatide Injection Patient Counseling

    See Literature

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