Levoketoconazole Oral Tablets

What is this medication?

LEVOKETOCONAZOLE (LEE voe kee toe KON na zole) is used to treat Cushing's disease. It is used when surgery is not an option or has not worked well enough.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Recorlev

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Heart disease
• If you often drink alcohol
• Irregular heartbeat or rhythm
• Liver disease
• Low adrenal gland function
• Low levels of magnesium in the blood
• Low levels of potassium in the blood
• Low stomach acid production
• An unusual or allergic reaction to levoketoconazole, ketoconazole, other medicines, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Avoid medications for your stomach like antacids for at least 2 hours after taking this medication.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following medications:

• Certain medicines for anxiety or sleep like alprazolam, triazolam
• Certain medicines for cholesterol like cerivastatin, lovastatin, simvastatin, lomitapide
• Certain medicines for irregular heart rate like disopyramide, dofetilide, dronedarone, quinidine
• Cisapride
• Colchicine
• Conivaptan
• Ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• Methadone
• Other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• Pimozide
• Ranolazine
• Red yeast rice
• Sirolimus
• Thioridazine
• Tolvaptan

This medication may also interact with:

• Alcohol or any product that contains alcohol
• Aliskiren
• Amlodipine
• Antacids
• Antiviral medicines for HIV or AIDS
• Aprepitant
• Atorvastatin
• Bosentan
• Buprenorphine
• Certain medicine for bladder problems like fesoterodine, solifenacin, tolterodine
• Certain medicines for cancer like bortezomib, busulfan, dasatinib, docetaxel, erlotinib, imatinib, ixabepilone, lapatinib, nilotinib, paclitaxel, trimetrexate, vinca alkaloids
• Certain medicines for depression, anxiety, or psychotic disturbances like aripiprazole, buspirone, haloperidol, quetiapine, risperidone
• Certain medicines for erectile dysfunction like vardenafil, sildenafil, tadalafil
• Certain medicines for pain like alfentanil, fentanyl, oxycodone, sufentanil
• Certain medicines for seizures like carbamazepine, phenytoin
• Certain medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole
• Certain medicines for tuberculosis like isoniazid, INH, rifabutin, rifampin, rifapentine
• Certain medicines that treat or prevent blood clots like dabigatran, rivaroxaban, warfarin
• Cilostazol
• Cinacalcet
• Cyclosporine
• Digoxin
• Eletriptan
• Isradipine
• Metformin
• Nadolol
• Nifedipine
• Praziquantel
• Ramelteon
• Repaglinide
• Salmeterol
• Saxagliptin
• Steroid medicines like budesonide, ciclesonide, dexamethasone, methylprednisolone
• Tacrolimus
• Tamsulosin
• Telithromycin
• Verapamil
• Ziprasidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Your condition will be monitored carefully while you are receiving this medication. It is important not to miss any appointments.

You may need blood work done while you are taking this medication.

Limit alcohol while you are taking this medicine. Alcohol can increase the risk of liver damage.

This medication may make it more difficult to get pregnant/father a child. It is usually temporary. Talk to your care team if you are concerned about your fertility.

Do not breast-feed while taking this medicine or for 1 day after stopping treatment.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, red or dark brown urine, vomiting blood or brown material that looks like coffee grounds, small, red or purple spots on the skin, unusual bleeding or bruising
• Breast enlargement in both males and females
• Changes in emotions or moods
• Changes in sex drive or performance
• Heartbeat rhythm changes—trouble breathing, chest pain, dizziness, fast, irregular heartbeat, feeling faint or lightheaded, falls
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, pain or trouble passing urine
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness, fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusually weak or tired, dizziness, low blood pressure
• Low potassium levels—trouble breathing, chest pain, dizziness, fast, irregular heartbeat, feeling faint or lightheaded, falls, muscle cramps or pain

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Headache
• Nausea
• Stomach pain
• Upset stomach
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.