Teva-Teriparatide Injection: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-TERIPARATIDE INJECTION is a prescription medicine used to treat osteoporosis by forming new bone. TEVA-TERIPARATIDE INJECTION is approved for use in both men and postmenopausal women with severe osteoporosis. TEVA-TERIPARATIDE INJECTION is also approved for use in both men and women with severe osteoporosis related to use of corticosteroid medicines, such as prednisone, who are at high risk for having broken bones (fractures). These include men and women with either a history of broken bones or those with a low bone mineral density (BMD).

What it does:

TEVA-TERIPARATIDE INJECTION builds new bone faster than the old bone is lost. Your bones become stronger as you continue to use TEVA-TERIPARATIDE INJECTION, and your risk for fracture will be reduced.

When it should not be used:

Only take TEVA-TERIPARATIDE INJECTION if your doctor has prescribed it for you.

Do not take TEVA-TERIPARATIDE INJECTION if you:

• have had an allergic reaction to teriparatide or one of its ingredients.
• suffer from high calcium level (pre-existing hypercalcemia).
• suffer from kidney problems (severe renal impairment).
• have other bone diseases.
• have high levels of alkaline phosphatase.
• have had radiation therapy involving your bones.
• have ever been diagnosed with bone cancer or other cancers that have spread (metastasized) to your bones.
• are a child or growing adult.

• are pregnant or breast-feeding.

• have trouble injecting yourself and do not have someone who can help you.

What the medicinal ingredient is:

TEVA-TERIPARATIDE INJECTION contains teriparatide, which is the same as the active part of a natural hormone called parathyroid hormone or "PTH".

What the important nonmedicinal ingredients are:

In addition to the active ingredient teriparatide, inactive ingredients are glacial acetic acid, sodium acetate (trihydrate), mannitol, metacresol (preservative), and water for injection. In addition, hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust product pH.

What dosage forms it comes in:

TEVA-TERIPARATIDE INJECTION is supplied as a sterile solution for subcutaneous injection in a 3 mL glass cartridge pre-assembled into a disposable pen delivery device. Each mL contains 250 mcg teriparatide (as teriparatide acetate). Each cartridge pre-assembled into a pen device delivers 20 mcg of TEVA-TERIPARATIDE INJECTION per dose each day for up to 28 days.

WARNINGS AND PRECAUTIONS

As part of drug testing, teriparatide, the active ingredient in TEVA-TERIPARATIDE INJECTION, was given to rats for a significant part of their lifetime. In these studies, teriparatide caused some rats to develop osteosarcoma, a bone cancer. The potential to cause osteosarcoma in rats was increased with higher doses and longer periods of treatment. Osteosarcoma in humans is a serious but very rare cancer. Osteosarcoma occurs in about 4 out of every million people each year. None of the patients in the clinical trials developed osteosarcomas. Osteosarcoma has been rarely reported in people who took prescription TEVA-TERIPARATIDE INJECTION. You should discuss any safety concerns you have about the use of TEVA-TERIPARATIDE INJECTION with your doctor.

INTERACTIONS WITH THIS MEDICATION

Tell your health care provider and pharmacist about all the medicines you are taking when you start taking TEVA-TERIPARATIDE INJECTION, and if you start taking a new medicine after you start TEVA-TERIPARATIDE INJECTION treatment. Tell them about all medicines you get with prescriptions and without prescriptions, as well as herbal or natural remedies. Your doctor and pharmacist need this information to help keep you from taking a combination of products that may harm you.

PROPER USE OF THIS MEDICATION

• Take TEVA-TERIPARATIDE INJECTION once daily for as long as your doctor prescribes it for you.
• Refer to the Pen User Manual for instructions on how to use the TEVA-TERIPARATIDE INJECTION pen. The TEVA-TERIPARATIDE INJECTION prefilled pen injector will deliver a preset dose of 20 mcg.
• Take one subcutaneous injection of TEVA-TERIPARATIDE INJECTION each day. The injection may be given into the thigh or abdomen.
• TEVA-TERIPARATIDE INJECTION can be taken at any time of day. To help you remember to take TEVA-TERIPARATIDE
• INJECTION, take it at about the same time each day (for example, at bedtime).
• You should take your TEVA-TERIPARATIDE INJECTION shortly after you take it out of the refrigerator as described in the Pen User Manual. A warming period is not needed. Put the pen back into the refrigerator immediately after use
• If you forget or are unable to take TEVA-TERIPARATIDE INJECTION at your usual time, take it at your next regularly scheduled time. Do not take more than one injection in the same day.
• Calcium and/or vitamin D may be taken at the same time as TEVA-TERIPARATIDE INJECTION. You should discuss with your doctor how much calcium and vitamin D to take each day.

• TEVA-TERIPARATIDE INJECTION can be taken with or without food or drink.

• Keep all medicines, including TEVA-TERIPARATIDE INJECTION, away from children.
• The TEVA-TERIPARATIDE INJECTION pen contains a sterile, colorless, clear solution. Do not use if solid particles appear or if the solution is cloudy or coloured. TEVA-TERIPARATIDE INJECTION should never be used beyond the date indicated on the carton.
• Never share a TEVA-TERIPARATIDE INJECTION pen with others, even if they have a similar disease. Their doctor should decide if TEVA-TERIPARATIDE INJECTION is right for them. TEVA-TERIPARATIDE INJECTION has been prescribed just for you.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• Most of the side effects of TEVA-TERIPARATIDE INJECTION are mild. The most common side effects of TEVA-TERIPARATIDE INJECTION are dizziness, nausea, pain in and around joints, and leg cramps.

• If you become dizzy do not drive or operate machinery; you should sit or lie down until the symptoms go away. If symptoms continue or get worse, you should call a doctor before continuing treatment.

• Contact your health care provider if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
• If you have any problems or questions while taking TEVA-TERIPARATIDE INJECTION, ask your doctor, nurse, or pharmacist for more information.

HOW TO STORE IT

• Your TEVA-TERIPARATIDE INJECTION pen should be stored in the refrigerator between 2°C to 8°C at all times.
• Your TEVA-TERIPARATIDE INJECTION pen can be used for up to 28 days including the first injection from the pen, if stored properly.
• The TEVA-TERIPARATIDE INJECTION pen should be properly disposed of after 28 days of first use, even if it is not completely empty.
• Do not freeze. Do not use TEVA-TERIPARATIDE INJECTION if it has been frozen.

Reporting Side Effects

MORE INFORMATION

If you want more information about TEVA-TERIPARATIDE INJECTION:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and include this Consumer Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.tevacanada.com, or by calling 1-800-268-4127.

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

Last revised: April 11, 2023

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User Manual

Before you use your new TEVA-TERIPARATIDE INJECTION PEN, please read the entire User Manual completely. Follow the directions carefully when using the TEVA-TERIPARATIDE INJECTION PEN.

Do not share your delivery device or needles as this may risk transmission of infectious agents.

Your TEVA-TERIPARATIDE INJECTION PEN contains 28 days of medicine. Throw away the TEVA-TERIPARATIDE INJECTION PEN after 28 days, even if it is not completely empty. Do not inject more than one dose of TEVA-TERIPARATIDE INJECTION PEN in the same day.

Do not transfer TEVA-TERIPARATIDE INJECTION PEN to a syringe.

Write down your first injection date here: ______ / ______ / ______.

Throw away after: ______ / ______ / ______.

Refrigerate the TEVA-TERIPARATIDE INJECTION PEN immediately after every use.

TEVA-TERIPARATIDE INJECTION PEN Parts*

*Needles not included. Pen needles from 29 to 31 gauge (Becton, Dickinson and Company) are recommended for use with this device. Ask your healthcare professional which needle gauge and length are best for you. Always use a NEW needle for each injection.

Wash your hands before every injection. Prepare the injection site as your healthcare professional instructed.

1. Pull off blue cap Check the TEVA-TERIPARATIDE INJECTION PEN label to make sure you have the right medicine and that it has not expired. Do not use it if the TEVA-TERIPARATIDE INJECTION PEN looks damaged, the medicine in the cartridge is not clear and colourless, or if it has particles in it. After pulling off the blue cap, clean the rubber seal on the end of the TEVA-TERIPARATIDE INJECTION PEN cartridge with an alcohol swab.

2. Attach new needle Pull off paper tab. Push needle straight onto medicine cartridge.

Screw on needle clockwise until it stops (3 to 5 clockwise turns). Pay attention that the needle is properly fixed. Pull off large needle cover and save it.

3. Set dose Pull out black injection button until it stops and the red stripe shows. If you cannot pull out the black injection button, see Troubleshooting, Problem E, on back page. out the black injection button, see Troubleshooting, Problem E, on back page. Check to make sure red stripe shows.

Pull off small needle protector and throw away.

4. Inject dose Gently hold a fold of skin on your thigh or abdomen and insert needle straight into skin. Push in the black injection button until it stops. Hold the button and count to 5 s-l-o-w-l-y. You must wait until the count of 5 to make sure you receive the correct dose. Then pull the needle from your skin.

5. Confirm dose IMPORTANT After completing the injection:

Once the needle is removed from your skin, take your thumb off the black injection button. Check to make sure the black injection button is all the way in. If the yellow shaft does not show, you have finished the injection steps the right way. You should NOT see any of the yellow shaft. If you do and have already injected the medicine, do not inject yourself a second time on the same day. Instead, you MUST reset the TEVA-TERIPARATIDE INJECTION PEN (see Troubleshooting, Problem A, on back page).

6. Remove needle Put large needle cover on needle. Do not try to put the needle cover back on with your hands. Unscrew the covered needle all the way by giving the large needle cover 3 to 5 counter-clockwise turns. Pull off needle and throw away as directed by your healthcare professional.

Push blue cap back on. Right after use, place TEVA-TERIPARATIDE INJECTION PEN in the refrigerator.

	TEVA-TERIPARATIDE INJECTION PEN

Troubleshooting
Problem			Solution
A. The yellow shaft is still showing after I push in the black injection button. How do I reset my TEVA-TERIPARATIDE INJECTION PEN?			You can prevent this problem by always using a NEW needle for each injection, ensuring the needle is properly attached, and by pushing the black injection button all the way in. To reset the TEVA-TERIPARATIDE INJECTION PEN, follow the steps below. 1. If you have already injected, DO NOT inject yourself a second time on the same day. 2. Remove the needle. 3. Repeat step 2 ‘Attach new needle’ and step 3 ‘Set dose’ of the instruction. 4. Point the needle down into an empty container. Push in the black injection button until it stops. Hold it in. You may see a small stream or drop of fluid. When you have finished, the black injection button should be all the way in. 5. If you still see the yellow shaft showing, contact your healthcare professional. Repeated resetting of your TEVA-TERIPARATIDE INJECTION PEN may lead to loss of daily doses.
B. How can I tell if TEVA-TERIPARATIDE INJECTION PEN works?			The black injection button should be all the way in to show that the full dose of medicine has been injected from the TEVA-TERIPARATIDE INJECTION PEN. Use a new needle every time you inject to be sure your TEVA-TERIPARATIDE INJECTION PEN will work properly.
C. I see an air bubble in my TEVA-TERIPARATIDE INJECTION PEN.			A small air bubble will not affect your dose and it will not harm you. You can continue to take your dose as usual.
D. I cannot get the needle off.			1. Put the large needle cover on the needle. 2. Use the large needle cover to unscrew the needle. 3. Unscrew the needle all the way by giving the large needle cover 3 to 5 counter-clockwise turns. 4. If you still cannot get the needle off, ask someone to help you.
E. What should I do if I have difficulty pulling out the black injection button?			Ask your healthcare professional for advice, you may need to use a new TEVA-TERIPARATIDE INJECTION PEN. When the black injection button cannot be pulled out, it means there is not enough medicine in your TEVA-TERIPARATIDE INJECTION PEN for another dose. You may still see some medicine left in the cartridge.

Cleaning and Storage

Cleaning Your TEVA-TERIPARATIDE INJECTION PEN

• Wipe the outside of the TEVA-TERIPARATIDE INJECTION PEN with a damp cloth.
• Do not place the TEVA-TERIPARATIDE INJECTION PEN in water, or wash or clean it with any liquid.

Storing Your TEVA-TERIPARATIDE INJECTION PEN

• Refrigerate the TEVA-TERIPARATIDE INJECTION PEN immediately after use. Read and follow the instructions in the Consumer Information Insert on how to store the medication.
• Do not store the TEVA-TERIPARATIDE INJECTION PEN with a needle attached as this may cause air bubbles to form in the medicine cartridge.
• Store the TEVA-TERIPARATIDE INJECTION PEN with the blue cap on.
• Never store the TEVA-TERIPARATIDE INJECTION PEN in the freezer.
• If the TEVA-TERIPARATIDE INJECTION PEN has been frozen, throw the device away and use a new TEVA-TERIPARATIDE INJECTION PEN.
• If the TEVA-TERIPARATIDE INJECTION PEN has been left out of the refrigerator, do not throw the pen away. Place the pen back in the refrigerator and call Teva Canada Limited (see Contact Information).

Other Important Notes

• The TEVA-TERIPARATIDE INJECTION PEN contains 28 days of medicine.
• Do not transfer the medication to a syringe. This may result in you taking the wrong dose of medicine.
• Write down your first injection date on a calendar.
• Read and follow the instructions in the Consumer Information insert for using the medicine.
• Check the TEVA-TERIPARATIDE INJECTION PEN label to make sure you have the correct medicine and that it has not expired.

• Contact TEVA (see Contact Information) if you notice any of the following:

  • The TEVA-TERIPARATIDE INJECTION PEN appears damaged.
  • The medicine is not clear and colourless, or if it has particles, do not use it.
• Use a new needle for each injection.
• During injection, you may hear one or more clicks – this is normal device operation.
• Do not share your medication.
• The TEVA-TERIPARATIDE INJECTION PEN is not recommended for use by the blind or visually impaired persons without the assistance of a person trained in the proper use of the device.
• Keep your TEVA-TERIPARATIDE FOR INJECTION PEN and needles out of the reach and sight of children.

Disposal of Pen Needles and Delivery Device

Disposal of Pen Needles and the TEVA-TERIPARATIDE INJECTION PEN Device

• Before disposing of the TEVA-TERIPARATIDE INJECTION PEN device, be sure to remove the pen needle.
• Dispose of your TEVA-TERIPARATIDE INJECTION PEN and used needles as directed by your healthcare professional and local institutional policies.
• Dispose of the device 28 days after first use.

Contact Information

If you have questions or need help with your TEVA-TERIPARATIDE INJECTION PEN, contact your healthcare professional or Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

www.tevacanada.com

Last Revised: April 17, 2023