Patient Medication Information: uses, side effects, how to take - Apo-Teriparatide Injection
ABOUT THIS MEDICATION
What the medication is used for:
APO-TERIPARATIDE INJECTION is a prescription medicine used to treat osteoporosis by forming new bone. APO-TERIPARATIDE INJECTION is approved for use in both men and postmenopausal women with severe osteoporosis. APO-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:
APO-TERIPARATIDE INJECTION builds new bone faster than the old bone is lost. Your bones become stronger as you continue to use APO-TERIPARATIDE INJECTION, and your risk for fracture will be reduced.
When it should not be used:
Only take APO-TERIPARATIDE INJECTION if your doctor has prescribed it for you.
Do not take APO-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:
APO-TERIPARATIDE INJECTION contains teriparatide, which is the same as the active part of a natural hormone called parathyroid hormone or "PTH".
What the nonmedicinal ingredients are:
In addition to the active ingredient teriparatide, inactive ingredients are glacial acetic acid, mannitol, metacresol (preservative), sodium acetate (anhydrous) and water for injection. In addition, hydrochloric acid and/or sodium hydroxide may have been added to adjust product pH.
What dosage forms it comes in:
APO-TERIPARATIDE INJECTION is supplied as a sterile solution for subcutaneous injection in a 2.4 mL glass cartridge pre-assembled into a disposable pen delivery device. Each mL contains 250 mcg teriparatide. Each cartridge pre-assembled into a pen device delivers 20 mcg of APO-TERIPARATIDE INJECTION per dose each day for up to 28 days.
WARNINGS AND PRECAUTIONS
As part of drug testing, teriparatide, the active ingredient in APO-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 APO-TERIPARATIDE INJECTION. You should discuss any safety concerns you have about the use of APO-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 APO-TERIPARATIDE INJECTION, and if you start taking a new medicine after you start APO-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 APO-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 APO-TERIPARATIDE INJECTION pen. The APO-TERIPARATIDE INJECTION prefilled pen injector will deliver a preset dose of 20 mcg.
- Take one subcutaneous injection of APO-TERIPARATIDE INJECTION each day. The injection may be given into the thigh or abdomen.
- APO-TERIPARATIDE INJECTION can be taken at any time of day. To help you remember to take APO-TERIPARATIDE INJECTION, take it at about the same time each day (for example, at bedtime).
- You should take your APO-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 APO-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 APO-TERIPARATIDE INJECTION. You should discuss with your doctor how much calcium and vitamin D to take each day.
APO-TERIPARATIDE INJECTION can be taken with or without food or drink.
Keep all medicines, including APO-TERIPARATIDE INJECTION, away from
- The APO-TERIPARATIDE INJECTION pen contains a sterile, colorless, clear solution. Do not use if solid particles appear or if the solution is cloudy or coloured. APO-TERIPARATIDE INJECTION should never be used beyond the date indicated on the carton.
- Never share an APO-TERIPARATIDE INJECTION pen with others, even if they have a similar disease. Their doctor should decide if APO-TERIPARATIDE INJECTION is right for them. APO-TERIPARATIDE INJECTION has been prescribed just for you.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
- Most of the side effects of APO-TERIPARATIDE INJECTION are mild. The most common side effects of APO-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 APO-TERIPARATIDE INJECTION, ask your doctor, nurse, or pharmacist for more information.
HOW TO STORE IT
- Your APO-TERIPARATIDE INJECTION pen should be stored in the refrigerator between 2°C to 8°C at all times.
- Your APO-TERIPARATIDE INJECTION pen can be used for up to 28 days including the first injection from the pen.
- The APO-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 APO-TERIPARATIDE INJECTION if it has been frozen.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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MORE INFORMATION
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes 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
- (http://www.apotex.ca/products), or by calling 1-800-667-4708.
Last revised: SEP 25, 2024
IMPORTANT: PLEASE READ
PrAPO-TERIPARATIDE INJECTION
Teriparatide Injection
User Manual
Before you use your new APO-TERIPARATIDE INJECTION pen, please read the entire front and back of this User Manual completely. Follow the directions carefully when using the APO-TERIPARATIDE INJECTION pen.
Do not share your pen or needles as this may risk transmission of infectious agents.
Your APO-TERIPARATIDE INJECTION pen contains 28 days of medication.
Write down your first injection date here: ___/_____/____.
Refrigerate the APO-TERIPARATIDE INJECTION pen immediately after every use.
| APO-TERIPARATIDE INJECTION Pen Parts* |
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Always wash your hands before every injection. Prepare the injection site as directed by your healthcare professional.
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| After pulling off the white cap, clean the rubber seal on the end of the APO-TERIPARATIDE INJECTION pen cartridge with an alcohol swab. |
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2
Attach new
needle
1
Pull off White pen cap
Pull off paper tab.
Push needle straight onto the medicine cartridge.
Screw on needle clockwise until firmly attached.
Pull off the large needle cover and save it.
 Pull out black injection button until it stops. If you cannot pull 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. |
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 Gently hold a fold of skin on your thigh or abdomen and insert the needle straight into your skin. |  Push in black injection button until it stops. Hold it in 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 the skin. |
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 | After completing the injection: Once the needle is removed from the 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 you have already injected the medicine, do not inject yourself a second time on the same day. Instead, you MUST reset the APO-TERIPARATIDE INJECTION pen (see Troubleshooting Problem A, on back page). |
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4
Inject
dose
5
Confirm dose
3
Set dose
IMPORTANT
 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 in a puncture-resistant container. |  Replace the pen cap. Right after use, place APO-TERIPARATIDE INJECTION pen in the refrigerator. |
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For additional information, or if you have any questions, please turn to the back of this page.
6
Remove
needle
APO-TERIPARATIDE INJECTION
Teriparatide Injection
| Troubleshooting | |
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| Problem | Solution |
| To reset the APO-TERIPARATIDE INJECTION pen, follow the steps below.
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| The APO-TERIPARATIDE INJECTION pen is designed to inject the full dose every time it is used according to the directions in the User Manual. The black injection button should be all the way in to show that the full dose of medicine has been injected from the APO-TERIPARATIDE INJECTION pen. Use a new needle every time you inject to be sure your APO-TERIPARATIDE INJECTION pen will work properly. |
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| A small air bubble will not affect your dose and it will not harm you. You can continue to take your dose as usual. |
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You can prevent this problem by always using a NEW needle for each injection, and by pushing the black injection button all the way in and s-l-o-w-l-y counting to five.
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| Change to a new APO-TERIPARATIDE INJECTION pen to take your dose as instructed by your healthcare professional. When the black injection button becomes hard to pull out, this means there is not enough medicine in your APO-TERIPARATIDE INJECTION pen for another dose. You may still see some medicine left in the cartridge. |
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Cleaning and Storage
Other Important Notes
Cleaning Your APO-TERIPARATIDE INJECTION Pen
- Wipe the outside of the APO-TERIPARATIDE INJECTION pen with a damp cloth.
- Do not place the APO-TERIPARATIDE INJECTION pen in water, or wash or clean it with any liquid.
Storing Your APO-TERIPARATIDE INJECTION Pen
- After each use, refrigerate the APO-TERIPARATIDE INJECTION pen right away. Read and follow the instructions in the Consumer Information insert on how to store medication.
- Do not store the APO-TERIPARATIDE INJECTION pen with a needle attached. Doing this may cause air bubbles to form in the medicine cartridge.
- Store the APO-TERIPARATIDE INJECTION pen with the white cap on.
- Do not freeze the APO-TERIPARATIDE INJECTION pen. If the APO-TERIPARATIDE INJECTION pen has been frozen, throw the device away and use a new APO-TERIPARATIDE INJECTION pen.
If the APO-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 Apotex at 1-800-667-4708.
- The APO-TERIPARATIDE INJECTION pen contains 28 days of medication.
- Do not transfer the medication to a syringe. This may result in you taking the wrong dose of medicine.
- Read and follow the instructions in the Consumer Information insert so that you use your APO-TERIPARATIDE INJECTION pen the right way.
- Check the APO-TERIPARATIDE INJECTION pen label to make sure you have the right medication and that it has not expired.
- Do not use the APO-TERIPARATIDE INJECTION pen if it looks damaged. Look at the medicine in the cartridge. If the medicine is not clear and colorless, or if it has particles, do not use it. Call Apotex if you notice any of these (see Contact Information).
- Use a new needle for each injection.
- During injection, you may hear one or more clicks — this is a normal.
- Do not share your medication.
- The APO-TERIPARATIDE INJECTION pen 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 the APO-TERIPARATIDE INJECTION pen out of reach and sight of children.
Disposal of Pen Needles and Device
Disposal of Pen Needles and APO-TERIPARATIDE INJECTION pen
- Before disposing of the APO-TERIPARATIDE INJECTION pen, be sure to remove the pen needle.
- Dispose of your APO-TERIPARATIDE INJECTION pen and used needles as directed by your healthcare professional and local and institutional policies.
Dispose of the device 28 days after first use.
Contact Information
If you have questions or need help with your APO-TERIPARATIDE INJECTION pen, contact your healthcare professional or call 1-800-667-4708.
Apotex Inc., Toronto, Ontario, M9L 1T9
http://www.apotex.ca/products
Document Revision Date: SEP 25, 2024