TM Owner Xeris Biopharma
Recorlev 150mg Tablet
Global Shipping : Reliable Global Distribution Network
Express Delivery : Priority Shipping for Every Order
Secure Payments : Trusted Payment Protection System
Disclaimer
Secure Handling
24/7 Worldwide Support
Global Access
Worldwide Access to Health
Cold-Chain Expert
Excellence in Cold-Chain
Trusted Supply
Certified Medical Supply
Indications & Clinical Uses
- Recorlev 150 mg is a film-coated tablet containing levoketoconazole, an oral cortisol-synthesis inhibitor (a purified enantiomer of ketoconazole), approved for the treatment of endogenous hypercortisolaemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative.
- Recorlev is not approved to treat fungal infections, despite being chemically related to the antifungal ketoconazole, and should never be confused with or substituted for antifungal ketoconazole tablets.
- Treatment starts at a low dose and is titrated upward based on 24-hour urinary free cortisol levels, liver enzymes and ECG results, under specialist endocrinology supervision.
- Recorlev is taken by mouth, usually twice daily; it is self-administered at home once the dose is stabilised, but requires regular clinic visits for blood tests and heart monitoring throughout treatment.
Side Effects
- Recorlev carries a boxed warning for hepatotoxicity and QT prolongation.
- Very commonly reported reactions (in more than 1 in 5 patients) include nausea and vomiting, low potassium, bruising or bleeding, high blood pressure, headache, liver injury, abnormal uterine bleeding, skin redness, fatigue, abdominal pain, joint pain, upper respiratory infection, muscle pain, irregular heartbeat, back pain, sleep disturbance and swelling of the legs or feet.
- Serious liver injury, sometimes fatal or requiring transplant, has occurred with ketoconazole-related drugs regardless of dose or duration - get urgent help for yellowing skin or eyes, dark urine, pale stools, unusual tiredness or right-upper abdominal pain.
- Recorlev can also prolong the heart's QT interval, which may cause dangerous irregular heartbeats; report fainting, palpitations or seizures immediately.
Precautions & Warnings
- Recorlev is contraindicated in people with cirrhosis, acute or poorly controlled chronic liver disease, recurrent gallstone-related symptoms, extensive liver metastases, a prior history of drug-induced liver injury from ketoconazole or related azole antifungals, or baseline liver enzymes above three times the upper limit of normal.
- It is also contraindicated with a baseline QTcF interval over 470 msec, a history of torsades de pointes or ventricular arrhythmia, and with other QT-prolonging medicines.
- Liver enzymes must be checked before starting and monitored frequently (weekly for the first six weeks, then every two weeks, then monthly), alongside a baseline ECG and periodic ECGs during dose changes; low potassium or magnesium must be corrected first.
- Recorlev can lower testosterone and cause adrenal insufficiency (hypocortisolism), so cortisol levels and symptoms are monitored too.
- It is not recommended in pregnancy; women of reproductive potential should use effective contraception.
Avoid Interactions
- Recorlev is a strong inhibitor of the CYP3A4 liver enzyme, so it must not be combined with sensitive CYP3A4 substrates or with any drug that prolongs the QT interval, including many antiarrhythmics, some antipsychotics and certain antibiotics - this combination is contraindicated because of the risk of life-threatening irregular heartbeat.
- Strong CYP3A4 inhibitors and inducers should be avoided for two weeks before and throughout treatment.
- If taken with atorvastatin, the lowest possible statin dose is used and muscle symptoms are monitored; if taken with metformin, blood sugar, kidney function and vitamin B12 are monitored more closely.
- Antacids and other gastric-acid-reducing medicines can reduce Recorlev absorption and should be separated in timing or avoided.
- Avoid excessive alcohol, and tell your healthcare provider about every prescription, over-the-counter medicine and supplement you take.
References
Frequently Asked Questions
Recorlev (levoketoconazole) treats high cortisol levels (Cushing's syndrome) in adults when surgery isn't possible or hasn't worked. It's a 150 mg tablet taken by mouth, usually twice daily. Recorlev is not an antifungal and must not be substituted for ketoconazole antifungal tablets, despite being chemically related.
Recorlev (levoketoconazole) tablets are taken by mouth, usually twice daily, starting at a low dose that your endocrinologist increases gradually based on 24-hour urine cortisol tests, liver blood tests and ECG results. You take it yourself at home, but need regular clinic visits for monitoring throughout treatment.
Recorlev carries a boxed warning for serious, sometimes fatal, liver injury and QT prolongation (a heart rhythm problem). Common effects include nausea, low potassium, bruising, high blood pressure and headache. Get urgent help for yellowing skin, dark urine, fainting or palpitations - these can signal liver or heart problems.
Avoid any medicine that prolongs the QT interval, strong CYP3A4 inhibitors or inducers, and antacids taken at the same time as Recorlev, since they change absorption. Avoid excessive alcohol. Tell your prescriber about every medicine and supplement you use, since Recorlev interacts with many drugs, including atorvastatin and metformin.
Recorlev requires liver blood tests before starting, then weekly for six weeks, every two weeks for six more, then monthly. You'll also need a baseline ECG to check your heart's QT interval, repeated at each dose increase, plus periodic cortisol and testosterone checks during treatment.
Recorlev is not recommended during pregnancy, and women of reproductive potential should use effective contraception while taking it. Recorlev can also reduce testosterone levels, sometimes causing low libido, gynaecomastia or reduced sperm count in men. Discuss family planning with your endocrinologist before starting treatment.
Trusted & Reliable – Your Partner in Global Distribution.
We provide comprehensive lines of pharmaceutical products to support all your healthcare distribution needs.
