Why is this medicine prescribed?
Osilodrostat is used to treat high levels of cortisol (a hormone produced by your adrenal glands) in certain patients with Cushing's syndrome (a condition in which the body produces too much cortisol). Osilodrostat is in a class of medications called cortisol synthesis inhibitors. It works by stopping the body from making cortisol.
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?
Osilodrostat comes as a tablet to take by mouth. Take with food or without food twice a day. Take osilodrostat at around the same times every day.
Take osilodrostat 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 osilodrostat and gradually increase your dose, not more than once every 2 weeks.
Your doctor may decrease your dose or interrupt your treatment. This depends on how well the medication works for you and the side effects you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take osilodrostat even if you feel well. Do not stop taking osilodrostat without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
What special precautions should I follow?
Before taking osilodrostat,
- 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.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking osilodrostat. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death), an irregular heartbeat, or any other heart problem; low levels of potassium or magnesium in your blood; high blood pressure; or liver or kidney problems.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking osilodrostat, call your doctor.
- tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are taking osilodrostat and for 1 week after your final dose.
- you should know that osilodrostat may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
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.
Symptoms of overdose may include:
- nausea, vomiting, tiredness or lack of energy, stomach pain, loss of appetite, dizziness, or fainting
What side effects can this medicine cause?
Osilodrostat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- nausea
- vomiting
- diarrhea
- stomach pain
- decreased appetite
- headache
- unusual tiredness or weakness
- runny nose, congestion, cough, sore throat, fever, or other signs of infection
- muscle, joint, or back pain
- rash
- difficulty falling asleep or staying asleep
- hair loss
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- nausea, vomiting, tiredness or lack of energy, stomach pain, loss of appetite, or dizziness
- swelling of the arms, hands, feet, ankles, or lower legs
- unusual or excessive hair growth on the face or body or unusual acne in women
Osilodrostat 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 will order certain lab tests to check your body's response to osilodrostat. Your doctor will also order an electrocardiogram (ECG; test that measures the electrical activity in the heart) before and during your treatment.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking osilodrostat.
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.