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|Teriparatide

TERIPARATIDE (Systemic)†

† Not commercially available in Canada.

Category

• Osteoporosis therapy
• Diagnostic aid, hypoparathyroidism vs. pseudohypoparathyroidism

Description

Teriparatide (ter-i-PAR-a-tide) is a synthetic form of the natural human parathyroid hormone and is used by injection to treat osteoporosis. Teriparatide forms new bone, increases bone mineral density and bone strength, and as a result reduces the chance of getting a fracture (broken bone). Teriparatide can be used by men or postmenopausal women with osteoporosis who are at high risk for having fractures. Teriparatide can be used by people who have had a fracture related to osteoporosis, or who have multiple risk factors for fracture, or who cannot use other osteoporosis treatments.

Teriparatide has been used by injection into a vein as a test to help diagnose problems of the parathyroid gland. This test determines whether you have hypoparathyroidism or a type of pseudohypoparathyroidism.

This product, for use as a test to help diagnose problems of the parathyroid gland, was withdrawn from the U.S. market in January 1997.

Before Using This Medicine

In deciding to use a medicine the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For teriparatide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to peptides, gelatin, or teriparatide. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Teriparatide should not be used during pregnancy. Teriparatide has been associated with fetal abnormalities in animals.

Breast-feeding—It is not known whether teriparatide passes into the breast milk. However, teriparatide is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children—This medicine is not available for use in children. Teriparatide should not be used in children or young adults due to possible adverse effects on growing bones.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in young adults. Nonetheless, elderly patients may be more sensitive than younger adults to the effects of teriparatide.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

When you are taking teriparatide it is especially important that you health care professional knows if you are taking the following:

• Digitalis (digitoxin, digoxin [e.g., Lanoxin])—Teriparatide may increase the adverse effects of this medicine.

Other medical problems—The presence of other medical problems may affect the use of teriparatide. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone cancer or other cancers that have spread to your bones, or prior history or
• Bones that are still growing or
• High concentration of an enzyme called alkaline phosphatase in the blood or
• Hypercalcemia (too much calcium in your blood), pre-existing or
• Other metabolic bone diseases or
• Paget"s disease of bone or
• Radiation therapy of bones, or prior history—Teriparatide should not be used in people with these conditions. In drug testing of this medicine on rats, it caused some rats to develop osteosarcoma, a bone cancer. It is not known if humans treated with this medicine also have a higher chance of getting osteosarcoma.

• Urolithiasis, active or recent—Teriparatide may may cause the condition to worsen

Proper Use of This Medicine

If you are injecting this medicine yourself, use it exactly as directed by your doctor. Special patient directions come with teriparatide injection. Read the directions carefully before using the medicine. Make sure you understand:

• Where to give the injection
• How to give the injection.
• How long the injection is stable

If you have any questions about any of this, check with your health care professional.

Do not use if you see solid particles in the liquid.

Do not use if past the expiration date on package.

For the first few doses of teriparatide, inject the medicine where you can sit or lie down right away if you get dizzy.

Dosing—Follow your doctors orders or the directions on the label . If you have any questions about the proper dose of teriparatide, ask your doctor.

• For subcutaneous injection dosage form:
  • For osteoporosis:
    • Adults—20 micrograms (mcg) once daily, injected into the thigh or abdominal wall
    • Children—Teriparatide should not be used in children

Missed dose—If you miss a dose of this medicine, take it as soon as possible on that day. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses (do not take more than one injection in the same day).

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from direct light.
• Store the prefilled pen of teriparatide in the refrigerator. Do not freeze. Do not use the medicine if it has been frozen.
• Do not keep outdated medicine or medicine no longer needed. Discard the teriparatide pen 28 days after the first injection, even if there is still medicine in it. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not inject this medicine into a vein or muscle.

This medicine may cause lightheadedness or fast heartbeats. If this happens, sit or lie down until you feel better. If you do not feel better, call your health care provider before continuing treatment

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Check with your doctor as soon as possible if any of the following side effects occur

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as bone cancer. Discuss these possible effects with your doctor.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 12/21/2004

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