Teriparatide is a parathyroid hormone analog sold in the U.S. under 2 brand and generic names, for postmenopausal osteoporosis and hypoparathyroidism. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Bonsity (application NDA211939). Other teriparatide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dosage is 20 mcg subcutaneously once a day ( 2.1 ) Consider supplemental calcium and Vitamin D based on individual patient needs ( 2.1 ) Administer as a subcutaneous injection into the thigh or abdominal region ( 2.2 ) Administer initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur ( 2.2 ) Use of teriparatide for more than 2 years during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture ( 2.3 ) 2.1 Recommended Dosage The recommended dosage is 20 mcg given subcutaneously once a day. Instruct patients to take supplemental calcium and vitamin D if daily dietary intake is inadequate. 2.2 Administration Instructions Administer BONSITY as a subcutaneous injection into the thigh or abdominal region. BONSITY is not approved for intravenous or intramuscular use. BONSITY 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 ( 5.4 )] . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (BONSITY 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 BONSITY should…
Most common adverse reactions (>10%) include: arthralgia, pain, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Men with Primary or Hypogonadal Osteoporosis and Postmenopausal Women with Osteoporosis The safety of teriparatide in the treatment of osteoporosis in men and postmenopausal women was assessed in two randomized, double-blind, placebo-controlled trials of 1382 patients (21% men, 79% women) aged 28 to 86 years (mean 67 years) [see Clinical Studies ( 14.1 , 14.2 )] . The median durations of the trials were 11 months for men and 19 months for women, with 691 patients exposed to teriparatide and 691 patients to placebo. All patients received 1000 mg of calcium plus at least 400 IU of vitamin D supplementation per day. The incidence of all-cause mortality was 1% in the teriparatide group and 1% in the placebo group. The incidence of serious adverse events was 16% in the teriparatide group and 19% in the placebo group. Early discontinuation due to adverse events occurred in 7% in the…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | Generic | $568 | View → | |
| 2 | Not yet rated | Prescription | Injectable | Generic | $568 |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
BONSITY is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. Hypersensitivity reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.2 )] . Patients with hypersensitivity to teriparatide or to any of its excipients ( 4 )
Digoxin: Transient hypercalcemia may predispose patients to digitalis toxicity ( 5.5 , 7.1 ) 7.1 Digoxin Sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity. Teriparatide may transiently increase serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when BONSITY is used in patients receiving digoxin [see Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.3 )] .