Abaloparatide Injection

Abaloparatide injection is used to treat osteoporosis (condition in which the bones become thin and weak and break easily) in women who have undergone menopause ('change in life,' end of menstrual periods), who are at high risk of fractures (broken bones) (history of fracture from osteoporosis or multiple risk factors for fracture) or who have failed or not tolerated other medications. Abaloparatide injection is also used to treat osteoporosis in men who are at high risk of fracture or who have failed or not tolerated other medications. Abaloparatide injection contains a synthetic form of a natural human hormone called parathyroid hormone (PTH). It works by causing the body to build new bone and by increasing bone strength and density (thickness).

Abaloparatide injection comes as a solution (liquid) to inject subcutaneously (under the skin). It is usually given once a day. Use abaloparatide injection at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use abaloparatide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You can inject abaloparatide injection yourself or have a friend or relative perform the injections. Before you use abaloparatide injection yourself the first time, carefully read the manufacturer's instructions. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it. Be sure to ask your pharmacist or doctor if you have any questions about how to inject this medication.

Abaloparatide injection comes in a pen that contains enough medication for 30 doses. Do not transfer the medication to another syringe. Dispose of your pen 30 days after first opening even if it still contains unused medication.

You should inject abaloparatide injection into the lower stomach area. Avoid giving your injection within the 2-inch area around your belly button. Talk to your doctor about how to change your injection site for each injection. Do not give abaloparatide injection into your veins or muscles. Do not inject into areas where the skin is tender, bruised, red, scaly, hard, or where you have scars or stretch marks.

Always look at your abaloparatide injection before you inject it. It should be clear and colorless. Do not use abaloparatide injection if it has particles in it, or if it is cloudy or colored.

Be sure you know what other supplies, such as needles, you will need to inject your medication. Ask your doctor or pharmacist what type of needles you will need to inject your medication. Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Throw away needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

You should know that abaloparatide injection may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position as well as a fast or pounding heartbeat and nausea. This usually occurs within 4 hours after receiving your dose and generally goes away within a few hours. You should receive your first several doses of abaloparatide injection where you can sit or lie down right away if necessary.

Your doctor may recommend calcium and vitamin D supplements to take during your treatment.

Abaloparatide injection controls osteoporosis but does not cure it. Continue to use abaloparatide injection even if you feel well. Do not stop using abaloparatide injection without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving abaloparatide injection,

• tell your doctor and pharmacist if you are allergic to abaloparatide, any other medications, or any of the ingredients in abaloparatide injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any condition that causes you too have too much calcium in the blood, hyperparathyroidism (condition in which the body produces too much parathyroid hormone [natural substance needed to control the amount of calcium in the blood]), or kidney stones.
• you should know that abaloparatide has caused osteosarcoma (cancer of the bone) in rats but it is unknown whether it causes it in humans. Abaloparatide is not recommended in individuals at higher risk of osteosarcoma, which included anyone with the following conditions: any other bone disease, history of cancer with metastases to the bone, history of radiation therapy to the bones, or any family history of bone cancer.
• you should know that abaloparatide injection should only be used by women once they have passed menopause and, therefore, cannot become pregnant or breastfeed. Abaloparatide injection should not be used during pregnancy or while breastfeeding.

Unless your doctor tells you otherwise, continue your normal diet.

Use the missed dose as soon as you remember it that day. However, if the day has already passed, skip the missed dose and continue your regular dosing schedule. Never inject more than one dose per day.

Abaloparatide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• sense of spinning
• headache
• tiredness
• upper stomach pain or bloating
• nausea
• diarrhea
• pain in joints
• redness, pain, or swelling in the area where the medication was injected

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• signs of high blood calcium: nausea, vomiting, constipation, lack of energy, and muscle weakness
• pain in the lower back or lower stomach
• painful urination
• blood in the urine

Abaloparatide injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Before the first use, store abaloparatide pens in the refrigerator, but do not freeze them. After the first use, store your abaloparatide pen for up to 30 days at room temperature. Discard the pen after 30 days at room temperature.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea
• vomiting
• constipation
• dizziness
• headache
• lightheadedness and fainting on standing
• lack of energy
• muscle weakness

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to abaloparatide injection.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Tymlos^®