palopegteriparatide 168 mcg/0.56 mL subcutaneous pen injector

Generic name:
Palopegteriparatide - injection

Brand name(s)
Yorvipath

Palopegteriparatide is a man-made form of parathyroid hormone, a certain natural substance made by the body. Parathyroid hormone helps maintain the balance of calcium and phosphorus in the body. This medication is used to treat low levels of parathyroid hormone.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using palopegteriparatide and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once daily. The injection is given in the thighs or abdomen (except for a 2-inch area around your belly button). The dosage is based on your medical condition, lab tests, and response to treatment.

If you are using a new pen, take the medication out of the refrigerator at least 20 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave, place it in hot water, or leave it in direct sunlight).

Before using, check this product for cloudiness, particles, or discoloration. If you see any of these things, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is red, swollen, or scarred. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition does not get better or if it gets worse.

Dizziness, lightheadedness, or fast heartbeat may occur right after using this medication. If these effects occur, sit or lie down right away. Giving your dose at bedtime or getting up slowly from a sitting or lying position may also help lessen these effects. Bruising/redness at the injection site, headache, diarrhea, back pain, or sore throat may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

High blood calcium can occur, especially when you first start using this medication and after a dose increase. Tell your doctor right away if you have symptoms such as nausea, vomiting, constipation, unusual thirst, muscle weakness, unusual tiredness, confusion, or irregular heartbeat.

Low blood calcium can also occur, especially if you stop using this medication, or if you miss a dose of this medication. Tell your doctor right away if you develop symptoms of low blood calcium, such as tingling in your fingertips/toes/lips/tongue, muscle spasms/cramps, numbness in your mouth, depression, problems thinking or remembering, or seizures.

Tell your doctor right away if you have any serious side effects, including:

• fainting

Medications like palopegteriparatide have been shown to increase bone cancer (osteosarcoma) in rats. It is unknown if palopegteriparatide can cause bone cancer in humans. Tell your doctor right away if you have any symptoms of bone cancer, including: bone pain, unusual growths/lumps.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using palopegteriparatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bone diseases (such as Paget's disease)
• personal/family history of bone cancer
• radiation treatment
• high level of calcium in the blood (hypercalcemia)
• kidney stones

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as calcium/vitamin D levels) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is more than 12 hours after the missed dose, skip the missed dose. Use your next dose at the regular time. If you miss 3 or more doses in a row, contact your doctor or pharmacist right away. Do not double the dose to catch up.

Store unused medication in the refrigerator. Do not freeze. Keep the medication in the original packaging to protect from light. After first use, store the medication at room temperature and discard after 14 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.