Paltusotine (By mouth)

Paltusotine (pal-TOO-soe-teen)

Treats acromegaly (a growth hormone disorder).

Brand Name(s):

Palsonify

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine on an empty stomach. Take this medicine with a glass of water at least 6 hours after a meal and at least 1 hour before the next meal.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how paltusotine works. Tell your doctor if you are using any of the following:
  • Carbamazepine, cyclosporine, efavirenz
  • Blood pressure medicine (including beta blockers)
  • Insulin or oral diabetes medicine
  • Stomach medicine (including proton pump inhibitors)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, gallbladder disease, heart rhythm problems, diabetes, thyroid problems, or vitamin B12 deficiency.
• This medicine may cause the following problems:
  • Gallstones, which may lead to swelling of the gallbladder or pancreas
  • Changes in blood sugar level
  • Heart rhythm problems
  • Thyroid problems, including hypothyroidism (underactive thyroid gland)
  • Problems with absorbing dietary fats and steatorrhea (fatty stools)
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Diarrhea, fat in stools, stomach cramps, weight loss
• Increased thirst, hunger, or urination
• Severe stomach pain with nausea and vomiting, yellow skin or eyes, stomach fullness, fever
• Shaking, trembling, sweating, fast or pounding heartbeat, fainting or lightheadedness, confusion
• Slow heartbeat, weight gain, muscle cramps or stiffness, feeling cold, unusual tiredness or weakness
• Swelling in your hands, ankles, or feet

If you notice these less serious side effects, talk with your doctor:

• Decreased appetite

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 12/4/2025