Tymlos 80 mcg/dose (3,120 mcg/1.56 mL) subcutaneous pen injector

Generic name:
Abaloparatide - injection

Pronunciation
(a-BAL-oh-PAR-a-tide)

Brand name(s)
Tymlos

Abaloparatide 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 should not be used for children or young adults whose bones are still growing.

Read the Medication Guide and Instructions For Use provided by your pharmacist before you start using abaloparatide and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once daily. The injection is given in the abdomen. When you give the first several doses, make sure you are in a place where you can sit or lie down if you have dizziness.

Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Dizziness or fast heartbeat may occur within 4 hours after using this medication. If these effects occur, sit or lie down right away. These symptoms usually go away within a few hours. These effects should go away after several doses as your body adjusts to the medication. Redness/pain/swelling at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor 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 you have any serious side effects, including:

• signs of a high level of calcium in the blood (such as nausea, vomiting, constipation, unusual tiredness, muscle weakness, mental/mood changes including confusion)

Abaloparatide has been shown to increase bone cancer (osteosarcoma) in rats. It is unknown if this medication can cause bone cancer in humans. Tell your doctor right away if you have any symptoms of bone cancer, including: bone pain, unusual growths/lumps.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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.

Before using abaloparatide, 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, Paget's disease)
• radiation treatment
• high level of calcium in the blood
• kidney stones
• kidney disease
• high level of parathyroid hormone

This drug may make you dizzy. Alcohol or marijuana (cannabis) 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 (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not usually used in women of childbearing age. It is unlikely to be used during pregnancy or breastfeeding. Consult your doctor if you have any questions about this medication.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: nausea, vomiting, severe dizziness, unusual tiredness, headache.

Do not share this medication with others.

Lab and/or medical tests (such as blood calcium level, bone density) should be done while you are using this medication. Keep all medical and lab appointments.

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. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice.

If you miss a dose, use it as soon as you remember. If you don't remember until the next day, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store unopened pens in the refrigerator. Do not freeze. After the first use of a pen, store it at room temperature away from heat. This medication expires 30 days after the pen is first used. 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.

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.