Teriparatide

What it is used for

Teriparatide injection 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, teriparatide injection 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.

Teriparatide injection is a parathyroid hormone analog, (PTH 1-34), indicated for: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy

Storing it

Cleaning Your BONSITY Delivery Device

• Wipe the outside of the BONSITY delivery device with a damp cloth.
• Do not place the BONSITY delivery device in water, or wash or clean it with any liquid.

Storing Your BONSITY Delivery Device

• After each use, refrigerate the BONSITY delivery device right away. Read and follow the instructions in the Medication Guide section "How should I store BONSITY?".
• DO NOT store the BONSITY delivery device with a needle attached. Doing this may cause air bubbles to form in the medicine cartridge.
• Store the BONSITY delivery device with the white cap on.
• DO NOT freeze BONSITY. If the BONSITY delivery device has been frozen, throw the device away and use a new BONSITY delivery device. If the BONSITY delivery device has been left out of the refrigerator, do not throw the delivery device away. Place the delivery device back in the refrigerator and call Alvogen, Inc. (see Contact Information below).

After Injection

Revised November 2024

See Reverse Side for More Information

Disposal Information

Put your used needles in a FDA-cleared sharps disposal container right away after use.

DO NOT throw away (dispose of) loose needles in your household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a container that is:

• Made of a heavy-duty plastic
• Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
• Upright and stable during use
• Leak-resistant
• Properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

DO NOT dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.

DO NOT recycle your used sharps disposal container.

Other Important Notes

• The BONSITY delivery device contains 28 days of medicine.
• Each device contains additional volume to allow troubleshooting of the device 2 times.
• DO NOT transfer BONSITY to a syringe. This may result in you taking the wrong dose of medicine.
• Read and follow the instructions in the User Manual so that you use your BONSITY delivery device the right way.
• Check the BONSITY delivery device label to make sure you have the right medicine and that it has not expired.
• DO NOT use the BONSITY delivery device if it looks damaged. Look at the BONSITY medicine in the cartridge. If the medicine is not clear and colorless, or if it has particles, do not use it. Call Alvogen, Inc. if you notice any of these (see Contact Information below).
• Use a new needle for each injection.
• During injection, you may hear one or more clicks - this is normal.
• The BONSITY delivery device is not recommended for use by the blind or by those who have vision problems without help from a person trained in the proper use of the device.
• Keep your BONSITY delivery device and needles out of the reach of children.

Disposal of Pen Needles and Delivery Device

Disposal of Pen Needles and the BONSITY Delivery Device

• Before throwing away the BONSITY delivery device, be sure to remove the pen needle.
• Throw away your BONSITY delivery device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies.

Contact Information

If you have questions or need help with your BONSITY ® delivery device, contact Alvogen, Inc. at 1-866-770-3024 or your healthcare provider. For more information about BONSITY, go to www.bonsity.com.

Distributed by: Alvogen, Inc. Morristown, NJ 07960 USA

BONSITY ® is a registered trademark of Pfenex Inc.

Revised: November 2024 IFU852-00