Osilodrostat

Generic name: Osilodrostat
Brand names: Isturisa
Dosage form: oral tablet (1 mg; 10 mg; 5 mg)
Drug class: Adrenal corticosteroid inhibitors

Usage of Osilodrostat

Osilodrostat is used in adults to treat Cushing's disease that cannot be treated with pituitary surgery.

Osilodrostat may also be used for purposes not listed in this medication guide.

Osilodrostat side effects

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

Osilodrostat may cause serious side effects. Call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • swelling in your feet or ankles, feeling short of breath;
  • decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods;
  • increased adrenal gland hormones--hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes; or
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.
  • Common side effects of osilodrostat may include:

  • nausea;
  • feeling tired;
  • headache; or
  • swelling.
  • 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.

    Before taking Osilodrostat

    Tell your doctor if you have ever had:

  • a heart rhythm disorder;
  • long QT syndrome (in you or a family member);
  • congestive heart failure;
  • high blood pressure;
  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
  • fluid retention; or
  • liver disease.
  • Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether osilodrostat will harm an unborn baby. However, having Cushing's disease during pregnancy may cause complications such as diabetes or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating Cushing's disease may outweigh any risks to the baby.

    Do not breastfeed while using osilodrostat, and for at least 1 week after your last dose.

    Osilodrostat is not approved for use by anyone younger than 18 years old.

    Relate drugs

    How to use Osilodrostat

    Usual Adult Dose for Cushing's Syndrome:

    Initial dose: 2 mg orally twice a dayTitration: Initially by 1 to 2 mg twice a day, no more frequently than every 2 weeks-Further titration (after reaching 10 mg orally twice a day): By 5 mg twice a day every 2 weeksMaximum dose: 30 mg orally twice a dayComments:-The dose should be titrated based on rate of cortisol changes, individual tolerability, and individual improvement in signs/symptoms of Cushing's disease.-If a patient tolerates 10 mg twice a day and continues to have elevated 24-hour urine free cortisol (UFC) level above the upper limit of normal (ULN), the dosage can be titrated further by 5 mg twice a day every 2 weeks.-Cortisol levels should be monitored from at least two 24-hour UFC collections every 1 to 2 weeks until adequate clinical response is maintained.-The maintenance dosage is individualized and determined by titration based on cortisol levels and patient's signs/symptoms; the maintenance dosage varied between 2 and 7 mg twice a day in clinical trials.-Once maintenance dosage achieved, cortisol levels should be monitored at least every 1 to 2 months or as indicated.Use: For the treatment of patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative

    Warnings

    Osilodrostat can cause serious side effects, such as heartbeat problems or decreased adrenal gland hormones. Call your doctor at once if you have irregular heartbeats, stomach pain, vomiting, loss of appetite, tiredness, or feeling light-headed.

    What other drugs will affect Osilodrostat

    Osilodrostat can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

    Other drugs may affect osilodrostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords

    AI Assitant