Levoketoconazole (Oral route)

Pronunciation:

lee-voe-kee-toe-KON-a-zole

Brand Names:

  • Recorlev

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

HepatotoxicityCases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in patients receiving levoketoconazole.Levoketoconazole is contraindicated in patients with cirrhosis, acute liver disease or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease.Evaluate liver enzymes prior to and during treatment. Interrupt levoketoconazole treatment immediately if signs of hepatotoxicity occur.QT ProlongationLevoketoconazole is associated with dose-related QT interval prolongation. QT interval prolongation may lead to life-threatening ventricular dysrhythmias such as torsades de pointes.Coadministration of levoketoconazole with other drugs that prolong the QT interval associated with ventricular arrhythmias, including torsades de pointes, and use in patients with a prolonged QTcF interval of greater than 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome (including first-degree family history) are contraindicated.Perform an ECG and correct hypokalemia and hypomagnesemia prior to and during treatment. Temporarily discontinue levoketoconazole if QTcF interval exceeds 500 msec .

Classifications:

Therapeutic—

Steroid Synthesis Inhibitor

Chemical—

Imidazole

Uses of This Medicine:

Levoketoconazole is used to treat endogenous hypercortisolemia (high cortisol levels) in patients with Cushing's syndrome who cannot have surgery or who had surgery that did not work well.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of levoketoconazole in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levoketoconazole in the elderly.

Breast-feeding—

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.

Other medicines—

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.

  • Acalabrutinib
  • Alfentanil
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Anagrelide
  • Apixaban
  • Apomorphine
  • Aprepitant
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Avanafil
  • Avapritinib
  • Azithromycin
  • Bedaquiline
  • Bepridil
  • Bosutinib
  • Budesonide
  • Buprenorphine
  • Buserelin
  • Buspirone
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Cisapride
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clomipramine
  • Clozapine
  • Cobimetinib
  • Colchicine
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Dabigatran Etexilate
  • Dabrafenib
  • Darifenacin
  • Darolutamide
  • Darunavir
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Digoxin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Dronedarone
  • Droperidol
  • Efavirenz
  • Elagolix
  • Eletriptan
  • Eliglustat
  • Encorafenib
  • Entrectinib
  • Eplerenone
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Everolimus
  • Famotidine
  • Felbamate
  • Felodipine
  • Fexinidazole
  • Fexofenadine
  • Finerenone
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Fluticasone
  • Formoterol
  • Fosaprepitant
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gilteritinib
  • Glasdegib
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibrexafungerp
  • Ibrutinib
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indinavir
  • Inotuzumab Ozogamicin
  • Itraconazole
  • Ivabradine
  • Ivacaftor
  • Ivosidenib
  • Ketoconazole
  • Lapatinib
  • Lefamulin
  • Lenvatinib
  • Leuprolide
  • Levofloxacin
  • Lofexidine
  • Lomitapide
  • Lovastatin
  • Lumefantrine
  • Lurasidone
  • Macimorelin
  • Maraviroc
  • Mefloquine
  • Mesoridazine
  • Methadone
  • Methotrimeprazine
  • Metronidazole
  • Midazolam
  • Midostaurin
  • Mifepristone
  • Mizolastine
  • Mobocertinib
  • Moricizine
  • Moxifloxacin
  • Nafarelin
  • Naldemedine
  • Naloxegol
  • Nelfinavir
  • Nicardipine
  • Nilotinib
  • Nintedanib
  • Nisoldipine
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Osilodrostat
  • Osimertinib
  • Oxaliplatin
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perphenazine
  • Pimavanserin
  • Pimozide
  • Pipamperone
  • Piperaquine
  • Pitolisant
  • Ponesimod
  • Posaconazole
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Ribociclib
  • Rimegepant
  • Risperidone
  • Ritonavir
  • Rivaroxaban
  • Saquinavir
  • Selpercatinib
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sildenafil
  • Simvastatin
  • Sirolimus
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tamoxifen
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Temsirolimus
  • Terfenadine
  • Tetrabenazine
  • Thioridazine
  • Ticagrelor
  • Tipranavir
  • Tolterodine
  • Tolvaptan
  • Toremifene
  • Trazodone
  • Triazolam
  • Triclabendazole
  • Trimipramine
  • Triptorelin
  • Ubrogepant
  • Vandetanib
  • Vardenafil
  • Velpatasvir
  • Vemurafenib
  • Venetoclax
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voclosporin
  • Voriconazole
  • Vorinostat
  • Voxilaprevir
  • Ziprasidone
  • Zotepine
  • Zuclopenthixol

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.

  • Apalutamide
  • Atorvastatin
  • Boceprevir
  • Carbamazepine
  • Cobicistat
  • Enzalutamide
  • Fosamprenavir
  • Idelalisib
  • Lopinavir
  • Lumacaftor
  • Metformin
  • Mitotane
  • Nefazodone
  • Phenytoin
  • Rifampin
  • St John's Wort

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:

  • Cholelithiasis (gallbladder stones), recurrent or
  • Heart rhythm problems (eg, long QT syndrome, torsades de pointes, ventricular fibrillation, ventricular tachycardia), history of or
  • Liver disease (eg, cirrhosis), active or poorly controlled or
  • Liver injury caused by medicines (eg, ketoconazole), history of—Should not be used in patients with these conditions.
  • Hypokalemia (low levels of potassium), history of or
  • Hypomagnesemia (low levels of magnesium), history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

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. To do so may increase the chance for unwanted effects.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Do not take carbamazepine, efavirenz, isoniazid, mifepristone, mitotane, nevirapine, phenytoin, rifabutin, rifampicin, ritonavir, ritonavir-boosted darunavir, and ritonavir-boosted fosamprenavir 2 weeks before and during treatment with levoketoconazole.

Take antacids (eg, aluminum hydroxide) at least 2 hours after you take this medicine.

Do not drink alcohol while you are using this medicine.

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 hypercortisolemia:
      • Adults—At first, 150 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 1200 mg per day (600 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 While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

You should not use this medicine together with alfentanil (Alfenta®), avanafil (Stendra®), bosutinib (Bosulif®), buspirone (Buspar®), cisapride (Prepulsid®), clarithromycin (Biaxin®), cobimetinib (Cotellic™), conivaptan (Vaprisol®), crizotinib (Xalkori®), dabigatran (Pradaxa®), darifenacin (Enablex®), darunavir (Prezista®), digoxin (Lanoxin®), disopyramide (Norpace®), dofetilide (Tikosyn®), dronedarone (Multaq®), ebastine (Ebast®), eliglustat (Cerdelga®), everolimus (Afinitor®), fexofenadine (Allegra®), ibrutinib (Imburvica™), ivabradine (Corlanor®), lomitapide (Juxtapid®), lovastatin (Mevacor®), methadone (Methadose®), midazolam (Versed®), midostaurin (Rydapt®), naloxegol (Alfenta®), nicardipine (Cardene®), nisoldipine (Alfenta®), pimozide (Alfenta®), quinidine (Alfenta®), ranolazine (Movantik®), saquinavir (Invirase®), simvastatin (Zocor®), sirolimus (Rapamune®), tacrolimus (Astagraf XL®), tipranavir (Aptivus®), triazolam (Halcion®), or vardenafil (Levitra®).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause heart rhythm problems (eg, QT prolongation). Check with your doctor right away if you have chest pain or discomfort, fainting, irregular or slow heart rate, or trouble breathing.

Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of adrenal gland problems (eg, low cortisol levels).

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.

This medicine may decrease testosterone levels in men and women. Check with your doctor right away if you have decreased interest in sexual intercourse, inability to have or keep an erection, loss in sexual ability, desire, drive, or performance, mood changes swelling of the breasts or breast soreness.

Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

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 or vitamin supplements.

Side Effects of This Medicine:

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
Bleeding gums
bloating or swelling of the face, arms, hands, lower legs, or feet
blurred vision
body aches or pain
chills
cough
coughing up blood
darkening of the skin
decreased interest in sexual intercourse
decreased urine
diarrhea
difficulty in swallowing
dizziness
dry mouth
ear congestion
fainting
fever
headache
inability to have or keep an erection
increased menstrual flow or vaginal bleeding
increased thirst
loss in sexual ability, desire, drive, or performance
loss of appetite
loss of voice
mental depression
mood changes
muscle pain or cramps
nausea or vomiting
nervousness
nosebleeds
numbness or tingling in the hands, feet, or lips
paralysis
prolonged bleeding from cuts
pounding in the ears
rapid weight gain
red or black, tarry stools
red or dark brown urine
seizures
slow or fast heartbeat
sneezing
sore throat
stuffy or runny nose
trouble breathing
unusual tiredness or weakness
unusual weight gain or loss
Less common
Swelling of the breasts or breast soreness in both females and males
Incidence not known
Bulging soft spot on head of an infant
change in ability to see colors, especially blue or yellow
chest tightness
dark urine
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
pinpoint red spots on skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
stomach pain, severe
trouble sleeping
unusual bleeding or bruising
yellow eyes or skin

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
Acid or sour stomach
back pain
belching
difficulty in moving
heartburn
indigestion
loss or thinning of the hair
muscle aches or stiffness
pain, swelling, or redness in the joints
stomach discomfort or upset
Incidence not known
Increased sensitivity of the skin to sunlight
redness or other discoloration of the skin
severe sunburn

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.


Last Updated: 6/2/2022

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.

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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
All rights reserved.