Abaloparatide Injection

What is this medication?

ABALOPARATIDE (a ball oh PAR a tide) treats osteoporosis. It works by making your bones stronger and less likely to break (fracture).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): TYMLOS

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bone disease other than osteoporosis
• High levels of an enzyme called alkaline phosphatase in the blood
• High levels of calcium in the blood
• History of cancer in the bone
• Kidney stone
• Paget's disease
• Parathyroid disease
• Receiving radiation therapy
• An unusual or allergic reaction to abaloparatide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription label at the same time every day. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and pens in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress.

You may need blood work done while you are taking this medication.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

You should make sure that you get enough calcium and vitamin D while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication.

Do not share pens with anyone, even if the needle is changed. Each pen should only be used by one person. Sharing could cause an infection.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• High calcium level—increased thirst or amount of urine, nausea, vomiting, confusion, unusual weakness or fatigue, bone pain
• Kidney stones—blood in the urine, pain or trouble passing urine, pain in the lower back or sides
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Dizziness
• Fatigue
• Headache
• Nausea
• Pain, redness, or irritation at injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store unopened pens in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Avoid exposure to heat. Get rid of any unopened medication after the expiration date.

After the first use, store your pen for up to 30 days at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not store with a needle attached to the pen. Use the pen for only 30 days. Get rid of your pen 30 days after first opening it even if the pen still contains medication.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.