What is this medication?

ABALOPARATIDE (a ball oh PAR a tide) helps increase bone strength. It treats osteoporosis. It may help reduce your risk of a bone 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 calcium in the blood
• high levels of an enzyme called alkaline phosphatase 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 medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection under the skin. Use this medicine at the same time each day. You will be taught how to prepare and give this medicine. Use exactly as directed. Do not take your medicine more often than directed.

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 health care provider 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 pediatrician regarding the use of this medicine 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 doctor or health care professional for regular checks on your progress. You may need blood work done while you are taking this medicine.

You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

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

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

Pens should never be shared. Even if the needle is changed, sharing may result in passing of viruses like hepatitis or HIV.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• high calcium levels (nausea; vomiting; constipation; low energy; muscle weakness)
• kidney stones (blood in the urine; pain when urinating; pain in the lower back or side)
• low blood pressure (dizziness; feeling faint or lightheaded, falls; unusually weak or tired)

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

• dizziness
• headache
• nausea
• pain, redness, or irritation at site where injected
• tiredness

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.

Store unopened pens in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Avoid exposure to heat. Throw away any unopened medicine after the expiration date on the label.

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. Throw away your pen 30 days after first opening it even if the pen still contains medicine.

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.