Palopegteriparatide
Generic name: palopegteriparatide
Brand name: Yorvipath Prefilled Pen
Dosage form: subcutaneous solution (168 mcg/0.56 mL; 294 mcg/0.98 mL; 420 mcg/1.4 mL)
Drug class: Parathyroid hormone and analogs
What is palopegteriparatide?
Palopegteriparatide is used in adults to treat low levels of parathyroid hormone; a natural substance needed to control the amount of calcium in the blood.
Palopegteriparatide may also be used for purposes not listed in this medication guide.
Palopegteriparatide side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Palopegteriparatide may cause serious side effects. Call your doctor at once if you have:
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pain that does not go away;
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itchy, rash, hives;
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depression, problems with thinking or memory;
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irregular heart rhythm;
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low blood pressure (feeling like you might pass out);
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hard lump (induration) under the skin that is tender to touch; or
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muscle spasms or contractions, numbness or tingly feeling around your mouth, or in your fingers and toes.
Common side effects of palopegteriparatide may include:
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confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss;
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pain, bruising, swelling, or irritation where the medicine was injected; or
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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 FDA at 1-800-FDA-1088.
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Warnings
Palopegteriparatide may affect calcium levels in the blood. Tell your doctor if you have nausea, vomiting, dizziness, feeling thirsty, muscle spasms or contractions, numbness or tingly feeling around your mouth, or in your fingers and toes, depression, problems with thinking or memory, irregular heart rhythm, or seizures.
Call your doctor at once if you have any pain that does not go away or a hard lump (induration) under the skin that is tender to touch or swelling under your skin.
Before taking this medicine
You should not use palopegteriparatide if you are allergic to it.
Tell your doctor if you have or have ever had:
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radiation treatment to your body;
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use medicine to treat osteoporosis;
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a blood test that shows unexplained high level of alkaline phosphatase;
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use digoxin or drugs can affect calcium levels in your blood;
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Paget's disease of the bone;
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any bone disease or problems, including cancer; or
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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.
How should I use palopegteriparatide?
Follow all directions 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 don't 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 following 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 place 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 reaction. 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 dosing information
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
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.
What happens if I overdose?
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.
What should I avoid while using palopegteriparatide?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect palopegteriparatide?
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.
More about palopegteriparatide
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- Drug class: parathyroid hormone and analogs
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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