Teriparatide (rDNA origin) Injection (patient information)

IMPORTANT WARNING:

Teriparatide causes osteosarcoma (cancer of the bones) in laboratory rats. It is possible that teriparatide may also increase the chances that humans will develop this rare but serious cancer. Because of this risk, teriparatide should not be used to prevent osteoporosis, to treat mild osteoporosis, or by people who can take other medications for osteoporosis. You should not use teriparatide unless you have osteoporosis and at least one of the following conditions is met: you have already had at least one bone fracture; your doctor has determined that you are at high risk of fractures; or you cannot take or do not respond to other medications for osteoporosis. Tell your doctor if you have or have ever had a bone disease such as Paget's disease, bone cancer or a cancer that has spread to the bone, or radiation therapy of the bones. Your doctor will order certain tests to see if teriparatide is right for you.

Talk to your doctor about the risks of taking teriparatide.

Why is this medication prescribed

Teriparatide is used to treat osteoporosis in men and postmenopausal women who are at high risk of fractures (broken bones). Osteoporosis is a disease that causes bones to weaken and break more easily. Teriparatide contains a synthetic form of natural human hormone called parathyroid hormone (PTH). It reduces the risk of fractures by causing the body to build new bone and by increasing bone strength and density (thickness).

How should this medicine be used

Teriparatide comes as a solution to inject in the fatty layer just under the skin (subcutaneously). It is usually injected once a day. To help you remember to take teriparatide, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use teriparatide exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You can inject teriparatide yourself or have a friend or relative perform the injections. Before you use teriparatide yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it. The instructions for use include solutions to problems you may have when you try to use teriparatide. Check the instructions if you have difficulty following the directions below.

Teriparatide comes in a pen that contains enough medication for 28 doses. Use a new needle for each injection. Needles are sold separately. Ask your doctor or pharmacist if you have questions about the type of needles to use. Dispose of used needles in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

To inject teriparatide, follow these steps:

• Remove your teriparatide pen from the refrigerator and check to be sure it is safe to use. It should be labeled with the correct name of the medication and an expiration date that has not passed and should contain a clear colorless solution. Do not use the syringe if it is expired, is cloudy, or contains flakes. Do not remove the pen from the refrigerator until you are ready to begin the injection process. There is no need to allow the medication to warm up before use.
• Wash your hands with soap and water.
• Pull off the pen cap and wipe the rubber seal on the end of the pen with an alcohol swab.
• Get a fresh needle to attach to the pen. Remove the paper tab from the outer needle shield but do not remove the cap. Place the needle over the end of the pen and turn it to the right until it is tight.
• Hold the pen with the needle pointing up and remove both needle shields. You may throw away the inner shield, but save the outer shield to use when you remove the needle.
• 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.
• Pull the dose knob out until you see a zero in the dose window.
• Turn the knob to the right until the number 1 appears in the dose window.
• Hold the pen with the needle pointing up and gently tap the clear cartridge holder with your finger so that air bubbles collect near the top.
• Push the injection button all the way up with your thumb. A small amount of liquid will come out of the needle. Keep pressing until the liquid stops coming out. A diamond will appear in the dose window. If no liquid comes out of the needle when you push the button, repeat steps 6-10.
• Turn the knob to the right until an arrow appears in the dose window. The raised notches on the dose knob and pen will be in line.
• Pull the dose knob out until you see a zero in the dose window.
• Turn the knob to the right until the number 2 appears in the dose window. The pen is now ready to inject.
• Choose an injection site on either of your thighs or your stomach, and clean it as directed by your doctor. Be sure a chair or bed is nearby so you can sit or lie down if you are dizzy after the injection.
• Gently pinch up a fold of skin, and push the needle straight in. Look at the dose window to be sure it still shows the number 2.
• Use your thumb to push the injection button all the way in. Hold the button down while counting slowly to 5.
• 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 doctor for directions.
• Carefully replace the outer needle shield. Your doctor will show you how to do this. Remove the capped needle by turning it to the left; throw it away.
• Put the cap back onto the pen and check the markings on the cartridge holder. These markings tell how much medication is left in the pen. Be sure your next pen is ready when the bottom of the plunger reaches the 60 mark.
• Put the pen back in the refrigerator right away.

Teriparatide controls osteoporosis but does not cure it. Continue to take teriparatide even if you feel well. Do not stop taking teriparatide without talking to your doctor.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking teriparatide

• tell your doctor and pharmacist if you are allergic to teriparatide, mannitol, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention either of the following: digoxin (Digitek, Lanoxin) and hydrochlorothiazide (HCTZ, Hydrodiuril, Microzide). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• in addition to the conditions listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had any condition that causes you to have too much calcium in your blood, such as disease of the parathyroid gland; kidney or urinary tract stones; and liver, kidney, or heart disease.
• you should know that teriparatide should only be used by women once they have passed menopause and, therefore, cannot become pregnant or breastfeed. Teriparatide should not be used during pregnancy or while breast-feeding.
• you should know that teriparatide may cause fast heartbeat, dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking teriparatide. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. Be sure a chair is nearby when you inject teriparatide so you can sit down if you get dizzy.

What special dietary instructions should I follow

It is important that you get enough calcium and vitamin D while you are taking teriparatide. Your doctor may prescribe supplements if your dietary intake is not enough. Talk to your doctor about doing weight-bearing exercise. Also talk to your doctor about avoiding cigarette smoking and avoiding drinking large amounts of alcohol.

What should I do if I forget a dose

Take the missed dose as soon as you remember it that day. However, if the day has already passed, skip the missed dose and continue your regular dosing schedule. Never inject more than one dose per day.

Side Effects

Mild Side Effects

Teriparatide may cause side effects. Tell your doctor if any of these symptoms or those listed in the SPECIAL PRECAUTIONS section are severe or do not go away:

• pain
• headache
• weakness
• diarrhea
• heartburn or sour stomach
• leg cramps
• dizziness
• depression

Severe Side Effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them call your doctor immediately:

• chest pain
• fainting
• difficulty breathing
• fever, sore throat, chills, and other signs of infection
• upset stomach
• vomiting
• constipation
• lack of energy
• muscle weakness

Teriparatide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the pen it came in with the cap on and without a needle attached, tightly closed, and out of reach of children. Store it in the refrigerator but do not freeze it. Protect it from light. Throw away any medication that is outdated or no longer needed. Throw away the pen 28 days after you first use it, even if it is not empty. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• upset stomach
• vomiting
• dizziness
• headache
• lightheadedness and fainting on standing
• constipation
• lack of energy
• muscle weakness

What other information should I know

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to teriparatide.

Do not let anyone else take your medication. Never share a teriparatide pen. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Forteo®