Why is this medicine prescribed?
Paltusotine is used to treat certain patients with acromegaly (rare condition that causes bones, organs and tissues to grow bigger). Paltusotine is in a class of medications called somatostatin receptor agonists. It works by stopping the production of growth hormone that causes the bones and tissues to grow bigger.
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?
Paltusotine comes as a tablet to take by mouth. Take without food once a day, at least 6 hours after and 1 hour before a meal, and with water. Take paltusotine at around the same time every day.
Take paltusotine 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 low dose of paltusotine and gradually increase your dose, not more than once every 2 to 4 weeks.
Paltusotine controls acromegaly but does not cure it. It may take a while before you feel the full benefit of paltusotine. Continue to take paltusotine even if you feel well. Do not stop taking paltusotine without talking to your doctor.
What special precautions should I follow?
Before taking paltusotine,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- some medications should not be taken with paltusotine. Other medications may cause dosing changes or extra monitoring when taken with paltusotine. Make sure you have discussed any medications you are currently taking or plan to take before starting paltusotine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking paltusotine, please get the advice of your doctor or pharmacist.
- the following nonprescription or herbal products may interact with paltusotine: St. John's Wort, omeprazole, lansoprazole, esomeprazole. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking paltusotine. Do not start any of these medications while taking paltusotine without discussing with your healthcare provider.
- tell your doctor if you have or have ever had gallstones or gallbladder disease, diabetes, thyroid disease, heart arrhythmias, pancreatic condition or disease, vitamin B12 deficiency or anemia.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking paltusotine, call your doctor.
What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.
What should I do if I forget to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
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.
What side effects can this medicine cause?
Paltusotine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- diarrhea
- belly pain
- nausea
- reduced appetite
- feeling of heart racing
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- sharp pain or cramping in upper stomach area that may worsen after eating or rotate to the back; nausea and vomiting; yellowing of the skin or whites of the eyes; dark urine; bloating or gas
- extreme thirst or hunger; increased amount or frequency of urinating; feeling tired; blurry vision
- shakiness; sweating; dizziness; confusion
- extreme tiredness; feeling weak; dizzy or lightheaded; fainting or near fainting episodes; feeling like heart is racing
- extreme tiredness; changes in weight (unexpected weight gain or loss); intolerance to cold or heat; dry skin or hair; thinning hair or hair loss; constipation or diarrhea; sweating; bulging or puffy eyes; changes in mood; changes in menstrual cycle
- loose stools; belly pain; bloating or gas; weight loss; changes in stools such as oil, greasy or bulky or pale or yellow stools
- pale skin; extreme tiredness; weakness; shortness of breath; numbness or tingling in hands or feet; sore tongue or mouth sores; vision problems; difficulty concentrating; mood changes
Paltusotine 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 at room temperature and away from excess heat and moisture (not in the bathroom).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to paltusotine.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.