Levoketoconazole Tablets

What is this medication?

LEVOKETOCONAZOLE (LEE voe KEE toe KON a zole) treats Cushing syndrome, a condition that causes high levels of the hormone cortisol. Cortisol plays an important role in helping your body manage metabolism and respond to stress. Too much cortisol can cause weight gain, high blood pressure, diabetes, and bone loss. This medication works by decreasing levels of cortisol in the body.

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:

• Alcohol use
• Heart disease
• Heart failure
• High or low levels of electrolytes, such as magnesium or potassium, in your blood
• Irregular heartbeat or rhythm
• Liver disease
• Low adrenal gland function
• Slow heartbeat
• An unusual or allergic reaction to levoketoconazole, ketoconazole, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. 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.

Take antacids, PPIs, and other medications that reduce stomach acid at a different time of day than this medication. Take them at least 2 hours after this medication.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

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:

• Certain medications for anxiety or sleep, such as alprazolam, triazolam
• Certain medications for cholesterol, such as cerivastatin, lovastatin, simvastatin, lomitapide
• Certain medications for irregular heart rate, such as disopyramide, dofetilide, dronedarone, quinidine
• Cisapride
• Colchicine
• Conivaptan
• Ergot alkaloids, such as dihydroergotamine, ergonovine, ergotamine, methylergonovine
• Methadone
• Other medications that cause heart rhythm changes
• 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 medications for HIV or AIDS
• Aprepitant
• Atorvastatin
• Bosentan
• Buprenorphine
• Certain medication for bladder problems, such as fesoterodine, solifenacin, tolterodine
• Certain medications for cancer, such as bortezomib, busulfan, dasatinib, docetaxel, erlotinib, imatinib, ixabepilone, lapatinib, nilotinib, paclitaxel, trimetrexate, vinca alkaloids
• Certain medications for depression, anxiety, or mental health conditions, such as aripiprazole, buspirone, haloperidol, quetiapine, risperidone
• Certain medications for erectile dysfunction, such as vardenafil, sildenafil, tadalafil
• Certain medications for pain, such as alfentanil, fentanyl, oxycodone, sufentanil
• Certain medications for seizures, such as carbamazepine, phenytoin
• Certain medications for stomach problems, such as cimetidine, famotidine, omeprazole, lansoprazole
• Certain medications for tuberculosis, such as isoniazid, INH, rifabutin, rifampin, rifapentine
• Certain medications that treat or prevent blood clots, such as dabigatran, rivaroxaban, warfarin
• Cilostazol
• Cinacalcet
• Cyclosporine
• Digoxin
• Eletriptan
• Isradipine
• Metformin
• Nadolol
• Nifedipine
• Praziquantel
• Ramelteon
• Repaglinide
• Salmeterol
• Saxagliptin
• Steroid medications, such as  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. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done before or while taking this medication. Your care team may also give you a test called an electrocardiogram (ECG) to check your heart before and during treatment.

Talk to your care team if you may be pregnant. There are benefits and risks to taking medications during pregnancy. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for 1 day after the last dose.

This medication may cause infertility. It is usually temporary. Talk to your care team if you are concerned about your fertility.

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
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness

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

• Change in sex drive or performance
• Headache
• Mood swings
• Nausea
• Stomach pain
• Unexpected breast tissue growth
• 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 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 it with cat litter, dirt, coffee grounds, or another 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.