IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TERIPARATIDE - INJECTION

(TER-i-PAR-a-tide)

COMMON BRAND NAME(S): Forteo

WARNING: Teriparatide has been shown to increase bone tumors (osteosarcoma) in rats. However, this occurred at doses higher than the usual human dose. It is unknown if this medication can cause bone tumors in humans. Therefore, this medication should not be used by people with increased risk for bone tumors (including people with Paget\'s disease of bone or people who had radiation treatment involving the bones).

USES: Teriparatide is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. It is similar to a natural hormone in your body (parathyroid hormone). It works by increasing bone mass and strength. This effect helps to decrease the risk of getting a fracture. This medication is not recommended for use in children or young adults whose bones are still growing.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using teriparatide and each time you get a refill. If you have any questions, ask your doctor or pharmacist. A health care professional should instruct you on the proper usage of this medication. Also, learn all preparation and usage instructions in the user manual. If any of the information is unclear, consult your doctor or pharmacist. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Inject this medication under the skin as directed by your doctor, usually once daily into the thigh or abdomen. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

SIDE EFFECTS: Dizziness or fast heartbeat may occur within 4 hours after using this medication. These symptoms may persist for a few minutes to a few hours. This effect should go away after several doses as your body adjusts to the medication. It is best to lie or sit down if these symptoms occur. Muscle cramps/spasms or pain/swelling/bruising at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, constipation, unusual tiredness, mental/mood changes (such as confusion). A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section. Before using teriparatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bone disorders (such as bone cancer), high level of calcium in the blood (hypercalcemia), kidney stones. This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor\'s approval. Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, severe dizziness, unusual tiredness.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as calcium levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.

MISSED DOSE: If you miss a dose and remember on the same day, use it as soon as you remember. If you remember on the next day, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Refrigerate between 36-46 degrees F (2-8 degrees C) away from light. Do not freeze. Do not use this medication if it has been frozen. This medication should be used immediately after removing from the refrigerator and then returned to refrigerator after use. Recap the pen when not in use. Each pen may be used for up to 28 days. Mark the day when you start using the pen. Discard the pen after 28 days, even if there is still medication in the pen. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised September 2017. Copyright(c) 2017 First Databank, Inc.