Paltusotine

Paltusotine is used to treat adults with acromegaly when surgery has not been effective or is not possible.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Paltusotine is usually taken once per day. Follow your doctor's instructions.

Take with water on an empty stomach, at least 1 hour before a meal or 6 hours after a meal.

Your thyroid function and vitamin B-12 levels may need to be checked often.

Your blood sugar will also need to be checked regularly, and you may need other frequent medical tests.

Store this medicine in the original container at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• gallbladder problems;
• low or high blood sugar; or
• slow heart rate.

It is not known if paltusotine 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 paltusotine.

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

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

• irregular heartbeats (fast, slow, or uneven heart rate);
• new or worsening bloating, fatty or loose stools, change in color of stools, or weight loss;
• underactive thyroid--tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures;
• gallbladder problems--chalky-colored stools, stomach pain after eating, nausea, heartburn, and severe upper stomach pain that may spread to your back; or
• high or low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, feeling jittery, increased thirst, increased urination, dry mouth, fruity breath odor.

Common side effects of paltusotine may include:

• nausea, vomiting, diarrhea, stomach pain;
• loss of appetite;
• high blood sugar; or
• irregular heartbeats, including slow heart rate.

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.

Usual Adult Dose for Acromegaly:

Initial dose: 40 mg orally once a day-During initiation period: Dosage may be temporarily reduced to 20 mg orally once a day if needed, based on tolerability.---Once adverse reactions have resolved, resume 40 mg orally once a day.After 2 to 4 weeks on 40 mg once a day: Based on insulin-like growth factor-1 (IGF-1) levels, titrate to 60 mg orally once a day.Use: For the treatment of patients with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option

Take the medicine as soon as you can, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions regarding any limitations on food, drinks, or activities.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• heart or blood pressure medication such as a beta-blocker (carvedilol, labetalol, metoprolol, propranolol, and others); or
• proton pump inhibitor (stomach acid reducer) -- omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, and others.

This list is not complete. Other drugs may affect paltusotine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.