Teriparatide, Injection

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KEY POINTS

• This medicine is given by injection to treat osteoporosis in people at high risk for bone fractures. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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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. You should not take this medicine for more than 2 years.

This medicine may be used to treat other conditions as determined by your healthcare provider.

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)
• Hyperparathyroidism (overactive parathyroid gland)
• Kidney stones
• Low blood pressure
• 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.

Females of childbearing age: Talk with your healthcare 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 healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

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.

Check with your healthcare provider before using this medicine in children under age 18.

You can give yourself these shots or have someone at home give them to you. The shots are given just under the skin with a prefilled pen. Check the label on the medicine for directions about your specific dose. Be sure you know how and when to have shots and how much medicine to use. If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

Carefully read and follow the directions that come in the package of medicine for preparing and giving the shots. Wash your hands before using this medicine.

You will inject this medicine once a day, and it’s best to use it at about the same time each day.

Inject this medicine right away after you take the prefilled pen out of the refrigerator. After each use, safely remove the needle, recap the pen, and put it back in the refrigerator right away.

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?

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.

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. Do not drive or operate machinery unless you are fully alert.

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.

Follow your healthcare provider's instructions about diet and exercise. 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, lab tests, 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; unusual tiredness or weakness; trouble breathing; chest pain; fast or irregular heartbeat; severe dizziness or fainting; unusual mood changes or depression.

Other: Dizziness; lightheadedness; leg cramps; joint pain; heartburn; nausea; headache; trouble sleeping; 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 (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.

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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.