Description
Osilodrostat is used to treat endogenous hypercortisolemia (high levels of cortisol in the blood) in patients with Cushing's syndrome who cannot have surgery or who had undergone surgery but still have the disease.
Cushing's disease is caused by a tumor in the pituitary gland that releases too much adrenocorticotropin, a hormone that signals the adrenal glands to produce cortisol. Cortisol leads to high blood pressure, diabetes, weakened bones and muscles, easy bruising, and blood clots in the arms and legs. Osilodrostat prevents the overproduction of cortisol.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of osilodrostat in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of osilodrostat in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Fezolinetant
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Posaconazole
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Adagrasib
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Avacopan
- Azithromycin
- Bedaquiline
- Boceprevir
- Buprenorphine
- Buserelin
- Carbamazepine
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Cobicistat
- Conivaptan
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Desflurane
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Clopidogrel
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Electrolyte imbalance (low potassium or magnesium in the blood) or
- Heart failure or
- Heart rhythm problems (eg, QT prolongation, bradyarrhythmia)—Use with caution. May increase risk for more side effects.
- Hypertension (high blood pressure)—Use with caution. May make this condition worse.
- Infection or
- Stress, physical—Use with caution. May cause cortisol levels to lower even more.
- Kidney disease, moderate to severe or
- Liver disease, moderate to severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
You may take this medicine with or without food.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For endogenous hypercortisolemia:
- Adults—At first, 2 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 30 mg 2 times a day.
- Children—Use and dose must be determined by your doctor.
- For endogenous hypercortisolemia:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Osilodrostat lowers the cortisol levels in the body, which could lead to adrenal insufficiency, hypertension (low blood pressure), electrolyte imbalance, or hypoglycemia (low blood sugar levels). Cortisol is lowered further during an infection or physical stress. Check with your doctor right away if you have nausea, vomiting, unusual tiredness or weakness, stomach pain, loss of appetite, or dizziness.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.
Osilodrostat may cause hypokalemia (low potassium levels in the blood), edema (swelling), or worsen hypertension (high blood pressure). Your doctor may give you a medicine, supplement, or salt substitute the contains potassium to correct your potassium levels. Check with your doctor right away if you have seizures, decreased urine, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea, vomiting, numbness or tingling in the hands, feet, or lips, trouble with breathing, unusual tiredness or weakness, swelling in the arms or legs, blurred vision, dizziness, headache, or pounding in the ears.
This medicine may cause acne and increased hair growth on the face, back, arms, and legs in female patients. Talk to your doctor if you have concerns about this.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- chills
- confusion
- cough
- darkening of the skin
- decreased urine
- diarrhea
- difficult, burning, or painful urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- fast, pounding, or irregular heartbeat or pulse
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- headache
- increased thirst
- joint pain
- loss of appetite
- lower back or side pain
- mental depression
- mood changes
- muscle pain or cramps
- nausea
- nervousness
- numbness or tingling in the hands, feet, or lips
- pale skin
- pounding in the ears
- runny nose
- seizures
- shivering
- skin rash
- slow heartbeat
- sore throat
- sweating
- swelling of the arms or legs
- trouble sleeping
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Less common
- Fainting
- irregular heartbeat, recurrent
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acne
- anxiety
- back pain
- decreased appetite
- depression
- difficulty in moving
- heartburn
- increased hair growth, especially on the face
- indigestion
- muscle stiffness
- stomach discomfort, upset, or pain
- stuffy nose
- thinning or loss of hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20484209
