Palopegteriparatide

Palopegteriparatide is used in adults to treat low levels of parathyroid hormone, which is a natural substance needed to control the amount of calcium in the blood.

Palopegteriparatide may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Palopegteriparatide is injected under the skin once per day.

Ask your doctor or pharmacist if you do not understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it according to state or local laws. Keep out of the reach of children and pets.

Your healthcare provider will show you where to inject palopegteriparatide. Do not inject into the same spot two times in a row.

Do not change your dose or stop using this medicine without your doctor's advice.

Your blood will be tested before, during, and after treatment with palopegteriparatide.

You may be given other medications to help prevent serious side effects or allergic reactions. Keep taking these medicines for as long as your doctor has prescribed.

Store this medicine in the original container in the refrigerator, away from heat and light. Do not freeze.

After first use, palopegteriparatide can be stored in the original container at room temperature, away from light, for up to 14 days.

Palopegteriparatide can change calcium levels in your blood. Inform your doctor if you experience nausea, vomiting, dizziness, increased thirst, muscle spasms or contractions, numbness or tingling around your mouth, fingers, or toes, depression, issues with thinking or memory, irregular heart rhythm, or seizures.

Contact your doctor immediately if you have any persistent pain or a hard lump (induration) under your skin that is tender to the touch or swelling under your skin.

You should not use palopegteriparatide if you are allergic to it.

Tell your doctor if you have or have ever had:

• radiation treatment to your body;
• used medicine to treat osteoporosis;
• a blood test that shows an unexplained high level of alkaline phosphatase;
• used digoxin or drugs that can affect calcium levels in your blood;
• Paget's disease of the bone;
• any bone disease or problems, including cancer; or
• any risk or family history of cancer of the bone.

It is not known if palopegteriparatide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using palopegteriparatide.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Palopegteriparatide may cause serious side effects. Call your doctor right away if you have:

• seizures;
• pain that does not go away;
• itchy rash or hives;
• depression, problems with thinking or memory;
• irregular heart rhythm;
• low blood pressure (feeling like you might pass out);
• hard lump (induration) under the skin that is tender to touch; or
• muscle spasms or contractions, numbness or tingling around your mouth, or in your fingers and toes.

Common side effects of palopegteriparatide may include:

• headache;
• back pain;
• diarrhea;
• sore throat;
• confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss;
• pain, bruising, swelling, or irritation where the medicine was injected; or
• drop in blood pressure or feeling light-headed when standing up.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Hypoparathyroidism:

Initial dose: 18 mcg subcutaneously once a day Maintenance dose: Increase or decrease by 3 mcg subcutaneously once a day, with goal of maintaining serum calcium within a normal range without supplementation. -The recommended dosing range is 6 mcg to 30 mcg subcutaneously once a day.-Do not increase dose more often than every 7 days, or decrease dose more often than every 3 days. Maximum dose: 30 mcg subcutaneously once a day Comments:-Refer to the manufacturer product information for dosing, titration, and monitoring recommendations. -If adequate response is not achieved with maximum dose, consider adding or restarting calcium and/or active vitamin D and/or seek other treatment options. -Some patients may require dose increases over time to maintain the same therapeutic effect. -Patients may continue calcium supplementation sufficient to meet daily dietary requirements.-Monitoring of serum calcium is recommended regularly during treatment. -Limitations of use: ---Titration recommendations were only evaluated in patients who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment. ---This drug was not studied for acute post-surgical hypoparathyroidism.Use: For the treatment of hypoparathyroidism

Use the medicine as soon as possible, but skip the missed dose if you are more than 12 hours late for it. Do not use two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect palopegteriparatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.