teriparatide (Rx)

Brand and Other Names:Forteo, parathyroid hormone, more...Bonsity
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

prefilled injectable pen

  • 250mcg/mL (2.4 mL [Forteo, Bonsity])

Osteoporosis

Treatment of postmenopausal women with osteoporosis at high risk for fracture

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

Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture

20 mcg SC qDay

Safety and efficacy have not been evaluated beyond 2 years of treatment; therefore, not recommended

Dosing Modifications

Renal impairment

  • CrCl <30 mL/min: Dose adjustment not necessary; in clinical trial, AUC and half-life increased but maximum plasma concentration did not increase

Hepatic impairment

  • No studies have been performed in patients with hepatic impairment

Idiopathic Osteoporosis (Orphan)

Orphan designation for treatment of idiopathic osteoporosis

Orphan sponsor

  • Biomeasure, Inc; 27 Maple St; Milford, MA 01757-3650

Hypoparathyroidism (Orphan)

Orphan designation for treatment of hypoparathyroidism

Orphan sponsor

  • Entera Bio, Ltd; Kiryat Hadassah Minrav Bldg, 5th Floor, P. O. Box 12117; Jeusalem 91220, Israel

Safety and efficacy not established

Do not use in children and adolescents with open epiphyses due to increased baseline risk of osteosarcoma

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Interactions

Interaction Checker

and teriparatide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Pain (21.3%)

            Arthralgia (10.1%)

            1-10%

            Rhinitis (9.6%)

            Asthenia (8.7%)

            Nausea (8.5%)

            Dizziness (8%)

            Headache (7.5%)

            Hypertension (7.1%)

            Increased cough (6.4%)

            Pharyngitis (5.5%)

            Constipation (5.4%)

            Dyspepsia (5.2%)

            Diarrhea (5.1%)

            Rash (4.9%)

            Insomnia (4.3%)

            Depression (4.1%)

            Pneumonia (3.9%)

            Vertigo (3.8%)

            Dyspnea (3.6%)

            Neck pain (3%)

            Vomiting (3%)

            Syncope (2.6%)

            Leg cramps (2.6%)

            Angina pectoris (2.5%)

            Gastrointestinal disorder (2.3%)

            Tooth disorder (2%)

            Postmarketing Reports

            Osteosarcoma

            Hypercalcemia

            Allergic Reactions

            Hyperuricemia

            Respiratory System: Acute dyspnea, chest pain

            Musculoskeletal: Muscle spasms of the leg or back

            Other: Injection site reactions including injection site pain, swelling and bruising; orofacial edema

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            Warnings

            Black Box Warnings

            In rats, increased risk of osteosarcoma has been observed; do not prescribe for patients at high risk for osteosarcoma (eg, those with Paget disease, unexplained alkaline phosphatase elevation, open epiphyses, or previous external-beam or implant radiation therapy involving skeleton)

            Contraindications

            Hypersensitivity

            High risk for osteosarcoma

            Cautions

            Hypercalcemia may predispose to digoxin toxicity

            Orthostatic hypotension may occur

            Urolithiasis, bone metastases, metabolic bone disease (other than osteoporosis), open epiphyses, Paget disease, preexisting hypercalcemia

            Use of drug for >2 years during patient lifetime not recommended

            Use caution in cardiovascular disease, renal and/or hepatic impairment, and patients with active or recent urolithiasis

            Drug interaction overview

            • Digoxin
              • A single teriparatide dose did not alter the effect of digoxin on the systolic time interval
              • Owing to teriparatide may transiently increase serum calcium, use with caution in patients taking digoxin
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            Pregnancy & Lactation

            Pregnancy

            There are no available data on use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; consider discontinuing drug when pregnancy is recognized

            Animal data

            • In animal reproduction studies, drug increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times 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

            Lactation

            Not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on breastfed infant; because of potential for osteosarcoma shown in animal studies, advise patients that breastfeeding is not recommended during therapy

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant human parathyroid hormone; stimulates osteoblast function, increases calcium absorption, and increases renal tubular reabsorption of calcium; these effects lead to increased bond mineral density, bone mass, and strength

            Absorption

            Bioavailability: 95%

            Onset: 3 months

            Peak serum time: 30 min

            Peak plasma concentration: 109.5 pg/mL

            AUC: 149.8 pg⋅hr/mL

            Concentration: Calcium, 9.68 mg/dL

            Distribution

            Vd: 0.12 L/kg

            Metabolism

            No metabolism or excretion studies have been performed

            Mechanisms of metabolism and elimination of PTH(1-34) and intact PTH have been extensively described in published literature

            Peripheral metabolism of PTH is believed to occur by non-specific enzymatic mechanisms in the liver followed by excretion via the kidneys

            Elimination

            Half-life: 0.79 hr (Bonsity 20-mcg); 0.083 hr (Forteo IV); ~1 hr (Forteo SC)

            Total body clearance: Women, 62 L/hr; men, 94 L/hr

            Excretion: Urine

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            Administration

            SC Administration

            SC administration only

            During use period, minimize time out of the refrigerator; deliver the dose immediately following removal from refrigerator

            Administer into the thigh or abdominal wall

            No data available on the safety or efficacy of IV/IM injection

            Administer under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur

            Visually inspect for particulate matter and discoloration before administration, whenever solution and container permit; appears clear and colorless liquid

            Do not use if solid particles appear or if the solution is cloudy or colored

            Patients and caregivers administering medication should receive appropriate training and instruction on the proper use

            Storage

            Refrigerate at 2-8ºC (36-46ºF)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.