BONSITY: The new name for Alvogen’s Teriparatide Injection 620 mcg/2.48 mL; same affordable alternative to FORTEO® (teriparatide injection)
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BONSITY teriparatide injection logo

The new name for Alvogen’s Teriparatide Injection 620 mcg/2.48 mL

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Vertebrae

Efficacy and Safety

Helping patients build new bone for more than 20 years

Teriparatide—the active ingredient in BONSITY—has been a mainstay anabolic therapy for osteoporosis since 2002.1

BONSITY helps three types of patients with osteoporosis build new bone2

Studies have demonstrated the efficacy of daily teriparatide injections in postmenopausal women with osteoporosis, in men with primary or hypogonadal osteoporosis, and in men and women with glucocorticoid-induced osteoporosis.

Select an indication to see the efficacy data:

BONSITY builds new bone in postmenopausal women with osteoporosis23

A clinical study evaluated the efficacy and safety of teriparatide injection (20 mcg daily; n=541) compared with placebo (n=544) in postmenopausal women. Patients were studied for a median of 19 months and a maximum of 24 months. In addition to study drug or placebo, patients took daily calcium and vitamin D supplements.

Middle-aged woman with red glasses and short dark hair and a red shirt
Actor portrayal.
Teriparatide reduces fracture risk in postmenopausal women
9.3%
Absolute risk reduction in new vertebral fractures
9.3% ARR (95% CI: 5.5-13.1) and 65% RRR (95% CI: 45-78) of 1 or more new vertebral fractures (fracture incidence: 5.0% teriparatidea vs 14.3% placebo).
Teriparatide (n=444) vs placebo (n=448).
2.9%
Absolute risk reduction in nonvertebral fractures
2.9% ARR and 53% RRR of any nonvertebral fracture (fracture incidenceb: 2.6% teriparatide vs 5.5% placebo).
Teriparatide (n=541) vs placebo (n=544).
ARR=absolute risk reduction; RRR=relative risk reduction.
ap≤0.001 compared with placebo.
bp<0.05.
Teriparatide improves bone mineral density (BMD) in postmenopausal women
Lumbar spine
9.7%
Teriparatide
(n=541)
(p<0.001)
vs
1.1%
Placebo
(n=544)
Femoral neck
2.8%
Teriparatide
(n=541)
(p<0.05)
vs
-0.7%
Placebo
(n=544)
Total hip
2.6%
Teriparatide
(n=541)
(p<0.05)
vs
-1.0%
Placebo
(n=544)
Data represent mean percent change in BMD from baseline to endpoint (median duration of treatment: 19 months).

BONSITY increases bone mass in men with primary or hypogonadal osteoporosis23

A randomized study compared BMD changes in men treated with 20 mcg teriparatide daily via subcutaneous injection (n=151) compared with placebo (n=147) for a median of 10 months. Study participants also received daily vitamin D and calcium supplements.

Middle-aged man with a mustache wearing a blue plaid shirt
Actor portrayal.
Mean percent change in BMD in men
Lumbar spine
5.9%
Teriparatide
(n=151)
(p<0.001)
vs
0.5%
Placebo
(n=147)
Femoral neck
1.5%
Teriparatide
(n=151)
(p<0.05)
vs
0.3%
Placebo
(n=147)
Total hip
1.2%
Teriparatide
(n=151)
vs
0.5%
Placebo
(n=147)
Data represent mean percent change in BMD from baseline to endpoint (median duration of treatment: 10 months).

BONSITY builds bone mass in men and women with corticosteroid-induced osteoporosis23

In an 18-month trial, men and women receiving sustained glucocorticoid therapy for chronic rheumatologic, respiratory, or other conditions were treated with 20 mcg teriparatide daily via subcutaneous injection (n=214). Patients also received daily calcium and vitamin D supplements. An active comparator was also assessed, but data from that treatment are not included here.

A middle-aged woman with short gray hair in a navy blue sweater wrapping her arms around a middle-aged man in a light blue sweater with a white beard and glasses
Actor portrayals.
Mean percent change in BMD in men and women on sustained glucocorticoid therapy
Lumbar spine
7.2%
Teriparatide
(n=214)
(p<0.001)
Femoral neck
3.7%
Teriparatide
(n=214)
(p<0.001)
Total hip
3.6%
Teriparatide
(n=214)
(p<0.001)
Data represent mean percent change in BMD from baseline to endpoint (18 months).

Safety and tolerability of BONSITY

In clinical studies of teriparatide, the most common adverse reactions in patients taking teriparatide vs placebo include2:

Pain
21.3%
Teriparatide
(n=691)
vs
20.5%
Placebo
(n=691)
Arthralgia
10.1%
Teriparatide
(n=691)
vs
8.4%
Placebo
(n=691)
Nausea
8.5%
Teriparatide
(n=691)
vs
6.7%
Placebo
(n=691)

BONSITY is an affordable once-daily teriparatide injection

79% of Medicare Part D lives have access to BONSITY.3

Explore coverage and savings

Streamlined administration

BONSITY is designed for ease of use for both patients and caregivers.

Learn how to use

Questions about BONSITY?

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Important Safety Information

Indications for use

BONSITY is indicated:

  • For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, BONSITY reduces the risk of vertebral and nonvertebral fractures.
  • To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.
  • For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.

Contraindications

BONSITY is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis.

Warnings and Precautions

Osteosarcoma: An increased incidence of osteosarcoma was observed in male and female rats treated with BONSITY. Osteosarcoma has been reported in patients treated with BONSITY in the post marketing setting. There are limited data assessing the risk of osteosarcoma beyond 2 years of BONSITY use. Avoid use in patients with: open epiphyses; metabolic bone diseases including Paget's disease of the bone; bone metastases or history of skeletal malignancies; prior external beam or implant radiation therapy involving the skeleton; and hereditary disorders predisposing to osteosarcoma.

Hypercalcemia and Cutaneous Calcification: BONSITY may cause hypercalcemia and may exacerbate hypercalcemia. Avoid BONSITY in patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism.

Serious reports of calciphylaxis and worsening of previously stable cutaneous calcification have been reported in patients taking BONSITY. Risk factors include underlying autoimmune disease, kidney failure, and concomitant warfarin or systemic corticosteroid use. Discontinue in patients developing calciphylaxis or worsening of previously stable cutaneous calcification.

Risk of Urolithiasis: BONSITY has not been studied in patients with active urolithiasis. If BONSITY-treated patients have pre-existing hypercalciuria or suspected/known active urolithiasis, consider measuring urinary calcium excretion. Consider the risks and benefits in patients with active or recent urolithiasis because of risk of exacerbation.

Orthostatic Hypotension: BONSITY should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur.

Risk of Digoxin Toxicity: Hypercalcemia may predispose patients to digitalis toxicity because BONSITY transiently increases serum calcium.

Adverse reactions

The most common adverse reactions in clinical trials included: arthralgia, pain, and nausea. Other adverse reactions include dizziness and leg cramps.

Use in specific populations

Pregnancy and Lactation

There is no available data on BONSITY use in pregnant women. Consider discontinuing when pregnancy is recognized.

It is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant. Breastfeeding is not recommended.

For additional safety information, please see the full Prescribing Information, including Medication Guide, and full User Manual that accompanies the delivery device.

You are encouraged to report negative side effects of prescription drugs to Alvogen at 1-866-770-3024 or the FDA at www.fda.gov/medwatch, or call 1-800-FDA-1088.

References:

  1. FORTEO® [prescribing information]. Indianapolis, IN: Eli Lilly and Company.
  2. BONSITY® [prescribing information]. Morristown, NJ: Alvogen, Inc.
  3. Data on file. Alvogen, Inc.

Contact

For questions regarding BONSITY, including insurance coverage:

For medical questions or to report adverse events:

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BONSITY teriparatide injection logo
BONSITY® is a registered trademark of Pfenex, Inc.
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BON-WWW-2025  06/25