Teriparatide, Injection ter-ih-PAR-a-tide

What are other names for this medicine?

Type of medicine: osteoporosis treatment

Generic and brand names: teriparatide, injection; Forteo

What is this medicine used for?

This medicine is given by injection (shots) to treat osteoporosis (loss of bone mass) in men and postmenopausal women (women who no longer have regular monthly periods). This medicine is only given if you have a high risk of bone fracture.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• bone cancer or other cancer that has spread to your bones
• hypercalcemia (too much calcium in the blood)
• kidney stones
• Paget's disease of the bone or any other bone disease
• radiation therapy involving your bones

Also tell your healthcare provider if you are taking digoxin. Your dose or condition may need to be monitored closely if you are taking digoxin.

In drug testing studies, this medicine caused some lab animals to develop osteosarcoma, a bone cancer. It is not known if people treated with this medicine also have a higher chance of getting bone cancer. Talk with your healthcare provider about the possible risks and benefits of this medicine so you can decide if it is right for you.

Females of childbearing age: Talk with your health care provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your health care provider's approval.

How do I use it?

This medicine comes in a cartridge that holds an exact dosage for each day for up to 28 days. The cartridge comes with a disposable pen device for injections. Check the label on the medicine for directions about your specific dose. Carefully read and follow the directions that come in the package of medicine each time you get a refill. Ask your healthcare provider or pharmacist about anything you do not understand.

Use this medicine exactly as your healthcare provider prescribes. Do not use more or less or use it longer than prescribed. Do not stop using this medicine without your healthcare provider's approval. You will inject this medicine once a day. You may use it at any time of the day. It is a good idea to use it at about the same time each day.

The shots are given just under the skin. Your healthcare provider will show you how to use the pen. Be sure you know how and when to have shots. Wash your hands before using this medicine. Make sure that the medicine is clear and colorless. Do not use the medicine if it is cloudy or discolored.

Follow these steps to give yourself the shots:

1. Remove the pen from the refrigerator. Do not remove the pen from the refrigerator until you are ready to give a shot. There is no need to allow the medicine to warm up before use.
2. Pull off the pen cap and wipe the rubber seal on the end of the pen with an alcohol swab.
3. Place a fresh needle over the end of the pen and turn it to the right until it is tight. The pen must be primed before every injection.
4. Turn the dose knob to the right until an arrow appears in the dose window. The raised notches on the pen and dose knob will be in line.
5. Pull the dose knob out until you see a zero in the dose window.
6. Turn the knob to the right until the number 1 appears in the dose window. The number 1 means “ready to prime”.
7. Hold the pen with the needle pointing up and gently tap the cartridge holder with your finger so that air bubbles collect near the top.
8. Push the injection button up until a small amount of liquid comes out of the needle. Keep pressing until the liquid stops coming out. A diamond will appear in the dose window. This means the priming is complete.
9. Turn the knob to the right until an arrow appears in the dose window. Pull the dose knob out until you see a zero in the dose window, then turn the knob to the right until the number 2 appears. The pen is now ready to inject.
10. Choose an injection site on either of your thighs or your stomach, and clean it as directed by your provider.
11. Gently pinch up a fold of skin, and push the needle straight in. Push the injection button all the way in. Hold the button down while counting slowly to 5.
12. Remove the needle from your skin. You should see a diamond in the dose window. If you do not see a diamond, you did not receive the full dose, and you should call your provider for directions.
13. Reset the pen for the next dose by turning the knob to the right until you see an arrow in the dose window. The raised notches on the pen and dose knob will be in line.
14. Carefully replace the outer needle shield and remove the capped needle by turning it to the left. Dispose of the used needle as directed by your healthcare provider.
15. Recap the pen and put it back into the refrigerator right after each use.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not take more than 1 injection per day. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, dizziness, headache, lightheadedness, fainting.

What should I watch out for?

You may get dizzy or get a fast heartbeat after the first few doses. For the first few doses inject the medicine where you can sit or lie down right away if you get dizzy. If you do not feel better after sitting or lying down, contact your healthcare provider.

You will need to have blood tests and bone density tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If your healthcare provider recommends calcium and Vitamin D supplements, you can take them at the same time as you inject this medicine.

If you have continuing nausea, vomiting, constipation, low energy, or muscle weakness while taking this medicine, contact your healthcare provider right away. These may be signs there is too much calcium in your blood.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away). If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Leg cramps or pain that is severe and continues; continuing nausea, vomiting, constipation, low energy, or muscle weakness; trouble breathing; chest pain.

Other: Dizziness; lightheadedness; leg cramps; heartburn; headache; pain, swelling, or redness at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• alcohol
• digoxin (Digitek, Lanoxin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the refrigerator. Do not let it freeze. Protect it from heat, high humidity, and bright light. Do not use the medicine if:

• it has been frozen
• it is cloudy or has particles floating in it
• the medicine is any color other than colorless
• the expiration date has passed.

Throw away the pen 28 days after you first use it, even if it is not empty.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.