Palopegteriparatide Injection

What is this medication?

PALOPEGTERIPARATIDE (pal OH peg TER i PAR a tide) treats low levels of parathyroid hormone (hypoparathyroidism). It works by replacing parathyroid hormone normally made by the body. Parathyroid hormone helps regulate and maintain calcium levels in your blood. Calcium is a mineral that plays an important role in building strong bones and maintaining heart health.

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

COMMON BRAND NAME(S): YORVIPATH

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, such as Paget disease or osteoporosis
• Bone cancer
• Have had radiation therapy that involves the bones
• An unusual or allergic reaction to palopegteriparatide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

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.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

If you use a pen, take off the outer needle cover before giving the dose.

It is important that you put your used needles and syringes 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.

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 unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at the normal time. Do not take double or extra doses.

What may interact with this medication?

• Calcium supplements
• Digoxin
• Medications for osteoporosis, such as alendronate

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. Tell your care team if your symptoms do not start to get better or if they get worse.

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

This medication may cause a sudden drop in blood pressure when you get up from sitting or lying down. You may feel dizzy or faint. Move slowly and have something sturdy to hold onto when you stand.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication. Talk to your care team right away if you have pain that does not go away or unusual lumps or swelling under your skin.

Do not share pens or cartridges 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
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet

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

• Diarrhea
• Dizziness
• Feeling faint or lightheaded
• Headache
• 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.

Before first use: Store in the refrigerator. Do not freeze. Get rid of any unused medication after the expiration date.

After first use: Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F) for up to 14 days. Protect from light. Get rid of any unused medication after 14 days or after it expires, whichever is first.

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.