abaloparatide

What is the most important information I should know about abaloparatide?

Abaloparatide has caused bone cancer (osteosarcoma) in animals but it is not known whether this would occur in people using this medicine. Talk with your doctor about your own risk.

What is abaloparatide?

Abaloparatide is used to treat osteoporosis in postmenopausal women who have a high risk of bone fracture.

Abaloparatide is also used to increase bone density in men with osteoporosis who are at high risk for bone fracture.

Abaloparatide is used to treat people who cannot use another treatment for osteoporosis or other treatments did not work well.

Abaloparatide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using abaloparatide?

Abaloparatide is not for use in children or young adults whose bones are still growing.

Tell your doctor if you have ever had:

• Paget's disease or a bone disease other than osteoporosis;
• high blood levels of calcium;
• overactive parathyroid glands;
• bone cancer or radiation treatment involving your bones;
• a kidney stone; or
• f you have trouble injecting yourself with abaloparatide and do not have someone to help you.

Abaloparatide has caused bone cancer (osteosarcoma) in animals but it is not known whether this would occur in people using this medicine. Talk with your doctor about your own risk.

How should I use abaloparatide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Abaloparatide is injected under the skin, usually once per day. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Never share an injection pen, cartridge, or syringe even if you changed the needle. Sharing these devices can pass infections from person to person.

Use abaloparatide at the same time each day with or without food or drink.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Use only the injection pen provided with abaloparatide. Do not transfer the medicine to a syringe or other injection device or you could get an overdose.

Your healthcare provider will show you where on your body to inject abaloparatide. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Abaloparatide is only part of a complete treatment program that also includes diet changes, exercise, taking vitamin or mineral supplements, and changing certain behaviors. Follow your doctor's instructions very closely.

You may need medical tests during and after treatment.

Before first use, store the medication in the refrigerator.

After first use, store the medication for up to 30 days at room temperature.

Do not freeze or expose to heat.

Each prefilled injection pen contains enough abaloparatide for 30 separate injections. Throw the pen away after 30 days, even if there is still medicine left inside.

Abaloparatide is often given for only 2 years. Your doctor will determine how long to treat you with this medicine.

What happens if I miss a dose?

Use the missed dose on the same day you remember it. Use your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.

What happens if I overdose?

Overdose symptoms may include headache, dizziness, vomiting, rapid heartbeats, feeling light-headed, or fainting.

What should I avoid while using abaloparatide?

What are the possible side effects of abaloparatide?

• a light-headed feeling, like you might pass out (may occur within 4 hours after injection);
• bone pain;
• unusual body aches;
• a new or worsening lump or swelling under your skin;
• pounding heartbeats or fluttering in your chest;
• high calcium levels --confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss; or
• signs of a kidney stone --pain in your side or lower back, blood in your urine, painful or difficult urination.

Common side effects may include:

• dizziness, spinning sensation;
• redness, swelling and pain at the injection site;
• joint and bone pain;
• bruising;
• headache;
• fast heart rate;
• nausea, upper stomach pain, bloating, diarrhea; or
• feeling very tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect abaloparatide?

Other drugs may affect abaloparatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about abaloparatide.