Increased risk of osteosarcoma in rats receiving high doses of teriparatide; dependent on dose and treatment duration.
Use only in patients for whom the benefits outweigh the risks.
Do not use in patients with an increased baseline risk for osteosarcoma (i.e., patients with Paget’s disease of bone or unexplained increases in serum alkaline phosphatase concentrations, pediatric patients or young adults with open epiphyses, and patients who received prior radiation therapy involving the skeleton).
REMS:
FDA approved a REMS for teriparatide to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of teriparatide and consists of the following: medication guide and communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
TERIPARATIDE (terr ih PAR a tyd) increases bone mass and strength. It helps make healthy bone and to slow bone loss. This medicine is used to prevent bone fractures.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine comes in an injection pen device. This pen injects the medicine under your skin. Follow the directions on the prescription label. You will be taught how to use this medicine. Take your medicine at regular intervals. Do not take your medicine more often than directed.
Do not use this medicine if it has solid particles in it, or if it is cloudy or colored. It should be clear and colorless.
Be sure that you are using your pen device correctly. A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. Your doctor may order blood tests and other tests to see how you are doing.
You should make sure you get enough calcium and vitamin D while you are taking this medicine, unless your doctor tells you not to. Discuss the foods you eat and the vitamins you take with your health care professional.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
pain, redness, irritation or swelling at the injection site
stomach upset
trouble sleeping
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Recap the pen injector when not in use to protect it from light and damage. Use quickly after taking out of the refrigerator and return to refrigerator right after using. Throw away any unused medicine 28 days after the first injection from the device. Do not use after the expiration date printed on the pen and pen packaging.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
