Tymlos is a man-made form of parathyroid hormone that exists naturally in the body. Abaloparatide increases bone mineral density and bone strength, which may prevent fractures.

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

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

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

It is not recommended that people use Tymlos for more than 2 years during their lifetime.

Tymlos 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.

Call your doctor at once if you have bone pain, unusual body aches, or a lump or swelling under your skin.

Avoid smoking cigarettes or drinking alcohol. Smoking or heavy drinking can reduce your bone mineral density, making fractures more likely.

Before taking this medicine

You should not use Tymlos if you are allergic to abaloparatide.

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

To make sure Tymlos is safe for you, 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

• trouble injecting yourself with Tymlos and you 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.

Tymlos is for use only in women who can no longer get pregnant. It is not known whether abaloparatide will harm an unborn baby. Tell your doctor if you think you may be pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Use Tymlos exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Tymlos 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 a Tymlos injection pen, cartridge, or syringe even if you changed the needle. Sharing these devices can pass infections from person to person.

Use Tymlos 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 Tymlos. 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 Tymlos. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Tymlos can cause dizziness. Always give your injection at a time and place where you can sit or lie down for a short time.

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.

Tymlos 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.

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

Usual Adult Dose for Osteoporosis:

80 mcg subcutaneously once a day

Comments:
-Cumulative use of this drug and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient's lifetime is not recommended.
-Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Use: For the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy; in postmenopausal women with osteoporosis, this drug reduces the risk of vertebral fractures and nonvertebral fractures

You should not use Tymlos if you are allergic to abaloparatide.

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

To make sure Tymlos is safe for you, 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

• trouble injecting yourself with Tymlos and you 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.

Tymlos is for use only in women who can no longer get pregnant. It is not known whether abaloparatide will harm an unborn baby. Tell your doctor if you think you may be pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

Get emergency medical help if you have signs of an allergic reaction to Tymlos: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• 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 - severe pain in your side or lower back, blood in your urine, painful or difficult urination.

Common Tymlos 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.

Other drugs may interact with abaloparatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.