Palopegteriparatide Injection

WHY is this medicine prescribed?

Palopegteriparatide is used for the treatment of hypoparathyrodism in adults. Palopegteriparatide is in a class of medications called parathyroid agents. It works by increasing the amount of parathyroid hormone to maintain appropriate calcium levels in the body.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Palopegteriparatide comes as an injection to inject subcutaneously (under the skin). It is usually given once daily in the evening when you are sitting or lying down. Give the injection into your abdomen (stomach area) or the front of your thigh and be sure to change the place where you give the injection each day. Only give the injection when you can sit or lie down. Use palopegteriparatide 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 palopegteriparatide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a dose of palopegteriparatide and gradually increase or decrease your dose based on your laboratory results and symptoms.

Ask your pharmacist or doctor for a copy of the manufacturer's information (Medication Guide) for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking palopegteriparatide,

• tell your doctor and pharmacist if you are allergic to palopegteriparatide, any other medications, or any of the ingredients in palopegteriparatide injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking palopegteriparatide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have a family history of bone disease or if you have or ever had any type of bone disease, including bone cancer, or treatment of your bones with radiation therapy.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking palopegteriparatide, call your doctor.

• you should know that palopegteriparatide may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking palopegteriparatide. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you have missed your dose by less than 12 hours, give your dose. However, if it the dose has been missed by more than 12 hours, skip the missed dose and continue your regular dosing schedule. If your treatment is delayed or interrupted by 3 days or more call your doctor before restarting palopegteriparatide. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• injection site reactions
• dizziness or lightheadedness
• headache
• diarrhea
• back pain

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• nausea, vomiting, dizziness, feeling thirsty, confusion, muscle weakness, and irregular heartbeat
• tingling in your fingertips, toes, lips or tongue, muscle spasms or cramps, oral numbness, depression, have problems thinking or remembering, abnormal heart rhythms, and seizures
• pain in any areas of your body that does not go away or any new or unusual lumps or swelling under your skin that is tender to touch

Palopegteriparatide may cause osteosarcoma (bone cancer). Talk to your doctor about the risks of taking this medication.

Palopegteriparatide 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).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it the refrigerator until you first use it. After first use, you may store it for up to 14 days at room temperature (below 30°C [86°F]). After each use, remove the needle and put the pen cap on to protect from light. Properly dispose of the pen 14 days after your first use.

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.

What should I do in case of OVERDOSE?

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:

• nausea, vomiting, dizziness, feeling thirsty, confusion, muscle weakness, and irregular heartbeat

What OTHER INFORMATION should I know?

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

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking palopegteriparatide.

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.