Teriparatide

Class
Osteoanabolic agents
Subclass
Recombinant parathyroid hormone analogs
Substance name
Teriparatide
Brand names
Forteo®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Osteoporosis • Corticosteroid-induced
•
20 mcg SC q24h
Administered into the thigh or abdominal region.
Osteoporosis in males • Primary or hypogonadal, if other osteoporosis therapies are ineffective or contraindicated
•
20 mcg SC q24h
Administered into the thigh or abdominal region.
Osteoporosis in males with high risk for fractures • Primary or hypogonadal
•
20 mcg SC q24h
Administered into the thigh or abdominal region.
Osteoporosis in postmenopausal females with high risk for fractures
•
20 mcg SC q24h
Administered into the thigh or abdominal region.
Osteoporosis in postmenopausal females, if other osteoporosis therapies are ineffective or contraindicated
•
20 mcg SC q24h
Administered into the thigh or abdominal region.
Indications for use
Labeled indications
Adults
•
Treatment of osteoporosis (corticosteroid-induced)
•
Treatment of osteoporosis in males (primary or hypogonadal), if other osteoporosis therapies are ineffective or contraindicated
•
Treatment of osteoporosis in males with high risk for fractures (primary or hypogonadal)
•
Treatment of osteoporosis in postmenopausal females with high risk for fractures
•
Treatment of osteoporosis in postmenopausal females, if other osteoporosis therapies are ineffective or contraindicated
Safety risks
Contraindications
Hypersensitivity to teriparatide or its components
High risk for osteosarcoma
•
Avoid using teriparatide in patients with open epiphyses, metabolic bone diseases other than osteoporosis, including Paget's disease of the bone, bone metastases or a history of skeletal malignancies, prior external beam or implant radiotherapy involving the skeleton, or hereditary disorders predisposing to osteosarcoma.
Hypercalcemia
•
Avoid using teriparatide in patients with pre-existing hypercalcemia or an underlying hypercalcemic disorder, such as primary hyperparathyroidism, as teriparatide may cause hypercalcemia and calciphylaxis and exacerbate pre-existing hypercalcemia and previously stable cutaneous calcification.
Warnings and precautions
Digoxin toxicity
•
Use caution in patients taking digoxin, as teriparatide transiently increases serum calcium predisposing patients to digoxin toxicity.
Exacerbation of urolithiasis
•
Use caution in patients with active or recent urolithiasis. Consider measuring urinary calcium excretion in patients with hypercalciuria or active urolithiasis.
Orthostatic hypotension
•
Maintain a high level of suspicion, as teriparatide may cause orthostatic hypotension, especially with the first several doses. Administer initial doses of teriparatide under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur.
Specific populations
Renal impairment
CrCl > 30 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
•
Use with caution. Insufficient evidence whether teriparatide affects the underlying metabolic bone disease in chronic kidney disease.
Renal replacement therapy
Continuous renal replacement
•
No guidance available.
Intermittent hemodialysis
•
No guidance available.
Peritoneal dialysis
•
No guidance available.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Avoid use. Evidence of fetal harm in animals. Consider discontinuing teriparatide when pregnancy is detected.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Unlikely to cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
↑ serum calcium, nausea, pain
Common 1-10%
•
Gastritis, herpes zoster, hypertension, orthostatic hypotension, pharyngitis, pneumonia, angina pectoris, arthralgia, asthenia, constipation, cough, diarrhea, dizziness, dyspnea, headache, indigestion, insomnia, leg cramps, neck pain, ↑ serum uric acid, skin rash, sweating, syncope, rhinitis
Unknown frequency
•
Anaphylaxis, angioedema, calcinosis cutis, hypoparathyroidism, nephrolithiasis, osteosarcoma, muscle spasms, urticaria
Interactions
Drug(s)
Check Interactions
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