Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Isturisa

Descriptions


Osilodrostat is used to treat Cushing's disease in patients who cannot have pituitary 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
  • Fluconazole
  • Ketoconazole
  • 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
  • Alfuzosin
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bedaquiline
  • Boceprevir
  • Buprenorphine
  • Buserelin
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clomipramine
  • Clozapine
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Droperidol
  • Ebastine
  • Efavirenz
  • Encorafenib
  • Entrectinib
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Famotidine
  • Felbamate
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Fostemsavir
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Glasdegib
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Idelalisib
  • Iloperidone
  • Imipramine
  • Indinavir
  • Inotuzumab Ozogamicin
  • Itraconazole
  • Ivabradine
  • Ivosidenib
  • Lapatinib
  • Lenvatinib
  • Leuprolide
  • Levofloxacin
  • Lofexidine
  • Lopinavir
  • Lumefantrine
  • Macimorelin
  • Mefloquine
  • Methadone
  • Methotrimeprazine
  • Metronidazole
  • Mifepristone
  • Mirtazapine
  • Mizolastine
  • Moricizine
  • Moxifloxacin
  • Nafarelin
  • Nefazodone
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Osimertinib
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perphenazine
  • Pimavanserin
  • Pipamperone
  • Pitolisant
  • Ponesimod
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Ribociclib
  • Risperidone
  • Ritonavir
  • Selpercatinib
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Siponimod
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tolterodine
  • Toremifene
  • Trazodone
  • Triclabendazole
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voclosporin
  • Voriconazole
  • Vorinostat
  • Zotepine
  • Zuclopenthixol

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 Cushing's disease:
      • 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.

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 (hypocortisolism) 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

  1. Bladder pain
  2. bloody or cloudy urine
  3. blurred vision
  4. chills
  5. confusion
  6. cough
  7. darkening of the skin
  8. decreased urine
  9. diarrhea
  10. difficult, burning, or painful urination
  11. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  12. dry mouth
  13. fast, pounding, or irregular heartbeat or pulse
  14. fever
  15. frequent urge to urinate
  16. general feeling of discomfort or illness
  17. headache
  18. increased thirst
  19. joint pain
  20. loss of appetite
  21. lower back or side pain
  22. mental depression
  23. mood changes
  24. muscle pain or cramps
  25. nausea
  26. nervousness
  27. numbness or tingling in the hands, feet, or lips
  28. pale skin
  29. pounding in the ears
  30. runny nose
  31. seizures
  32. shivering
  33. skin rash
  34. slow heartbeat
  35. sore throat
  36. sweating
  37. swelling of the arms or legs
  38. trouble sleeping
  39. troubled breathing with exertion
  40. unusual bleeding or bruising
  41. unusual tiredness or weakness
  42. vomiting

Less common

  1. Fainting
  2. 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

  1. Acne
  2. anxiety
  3. back pain
  4. decreased appetite
  5. depression
  6. difficulty in moving
  7. heartburn
  8. increased hair growth, especially on the face
  9. indigestion
  10. muscle stiffness
  11. stomach discomfort, upset, or pain
  12. stuffy nose
  13. 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.