Teriparatide Injection delivers proven clinical experience and affordability to help your patients at high risk for fracture increase bone densityδ. 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.
Alvogen’s Teriparatide Injection is an FDA-approved treatment option comparable to Forteo®‡
Active ingredient
teriparatide
Strength
620 mcg/2.48 mL (250 mcg/mL)
Dosing
28 days
Indications
3 patient populations
Administration
single-patient-use pen 20 mcg per dose
* Not automatically substituted for Forteo.
‡ Forteo is a registered trademark of Eli Lily and Company, which has no affiliation with Alvogen.
Proven Clinical Experience
Teriparatide Injection significantly reduced the risk of osteoporotic fractures, while increasing bone mineral density (BMD), in postmenopausal women at high risk for fracture, as compared to placebo.1§
- 65% Relative risk reduction in new vertebral fractures (5.0% vs. 14.3%, P<0.001)1
- 53% Relative risk reduction in new nonvertebral fractures (2.6% vs. 5.5%, P<0.05)1
- Significantly increased BMD at the lumbar spine, femoral neck, total hip, and total body (P<0.05)1
§ Study Design: A multicenter, prospective, double-blind study in 1,637 postmenopausal women with osteoporosis, of whom 90% had a spine fracture. Patients received once-daily 20-mcg dose of Teriparatide Injection (n=541) or placebo (n=544). Patients were treated for median time of 19 months, and maximum of 24 months. All women took calcium and vitamin D daily.
References:
- Teriparatide Injection [Prescribing Information]. Morristown, NJ: Alvogen, Inc.; 2023.
- Forteo [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company; 2012.
- Data on file.
Indications & Important Safety Information
Indications
Teriparatide Injection is a prescription medicine used in both men and postmenopausal women with osteoporosis who are at high risk for having bone fractures—defined as those who have had a fracture related to osteoporosis, who are at high risk for fracture, or who cannot use other osteoporosis treatments. It is also used for treating osteoporosis associated with glucocorticoid medicines, such as prednisone, in patients who are at high risk for fracture.
Important Safety Information
Do not use Teriparatide Injection if you are allergic to any of its ingredients. Serious allergic reactions may occur.
Before taking Teriparatide Injection, inform your healthcare provider if you have a bone disease other than osteoporosis; have bone cancer or a history of bone cancer, have trouble injecting yourself, are a child or young adult whose bones are still growing, have had radiation therapy, have a greater risk of getting bone cancer, have been diagnosed with too much calcium in your blood, have or have had a skin condition with wounds caused by too much calcium, have or have had kidney stones, take medicines that contain digoxin, are pregnant or thinking about becoming pregnant, are breastfeeding or plan to breastfeed, or have any other medical conditions. Tell your healthcare provider about all the medicines you take.
Teriparatide can cause serious side effects, including bone cancer, increased calcium in your blood, worsening of your kidney stones, and a decrease in blood pressure upon changing positions. Dizziness, accelerated heartbeat, or a feeling of faintness may occur, usually within four hours of taking Teriparatide Injection, and typically go away within a few hours. You should not use Teriparatide Injection for more than two years during your lifetime unless your healthcare provider finds that you need longer treatment.
Other side effects include pain, nausea, and joint aches.
Injection site reactions can include pain, swelling and bruising.
If symptoms persist, stop taking Teriparatide Injection and call your healthcare provider.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088 to report any additional negative side effects to the FDA.
For additional safety information, please see the Medication Guide and Prescribing Information, including the full User Manual which accompanies the delivery device.