Teriparatide
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From MedlinePlus, U.S. National Library of Medicine
Parathyroid Hormone Analog
Dosing in kidney impairment
Renal Impairment In 5 patients with severe renal impairment (CrCl<30 mL/minute), the AUC and T 1/2 of teriparatide were increased by 73% and 77%, respectively. Maximum serum concentration of teriparatide was not increased. It is unknown whether FORTEO alters the underlying metabolic bone disease seen in chronic renal impairment [see Clinical Pharmacology] .
Dosing in liver impairment
Hepatic Impairment No studies have been performed in patients with hepatic impairment [see Clinical Pharmacology] .
Preparation and administration
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Administration Instructions Administer FORTEO as a subcutaneous injection into the thigh or abdominal region. FORTEO is not approved for intravenous or intramuscular use. FORTEO should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur [see Warnings and Precautions] .
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (FORTEO is a clear and colorless liquid). Do not use if solid particles appear or if the solution is cloudy or colored. Patients and/or caregivers who administer FORTEO should receive appropriate training and instruction on the proper use of the FORTEO prefilled delivery device (pen) from a qualified health professional.
Discard the delivery device 28 days after first use.
Drug interactions
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Digoxin: Transient hypercalcemia may predispose patients to digitalis toxicity ( 5.6 , 7.1 )
7.1 Digoxin Sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity. FORTEO may transiently increase serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when FORTEO is used in patients receiving digoxin [see Warnings and Precaution ( 5.6 ) and Clinical Pharmacology ( 12.3 )] .
Contraindications
4 CONTRAINDICATIONS FORTEO is contraindicated in patients with a history of severe hypersensitivity to teriparatide or any of the inactive ingredients of FORTEO. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.2 )] . Patients with severe hypersensitivity to teriparatide or any of the inactive ingredients of FORTEO( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary 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. Consider discontinuing FORTEO when pregnancy is recognized. 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/m 2 ), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose (see Data) .
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. Data Animal Data In animal reproduction studies, pregnant mice received teriparatide during organogenesis at subcutaneous doses equivalent to 8 to 267 times the human dose (based on body surface area, mcg/m 2 ). At subcutaneous doses ≥60 times the human dose, the fetuses showed an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib).
When pregnant rats received teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings. In a perinatal/postnatal study in pregnant rats dosed subcutaneously from organogenesis through lactation, mild growth retardation was observed in female offspring at doses ≥120 times the human dose. Mild growth retardation in male offspring and reduced motor activity in both male and female offspring were observed at maternal doses of 540 times the human dose. There were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
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Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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