RECORLEV

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LEVOKETOCONAZOLE

Available from:

NEOPHARM LTD, ISRAEL

Pharmaceutical form:

TABLETS

Composition:

LEVOKETOCONAZOLE 150 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

XERIS PHARMACEUTICALS, INC., USA

Therapeutic indications:

RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established.

Authorization date:

2023-09-27

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
1986
-
(MEDICINAL PRODUCTS)
THIS MEDICINE IS DISPENSED WITH A DOCTOR'S PRESCRIPTION ONLY
RECORLEV
®
150 mg
TABLETS FOR ORAL USE
ACTIVE INGREDIENT: Each tablet contains Levoketoconazole 150 mg.
For the list of excipients and allergens in the medicinal product,
please see section 2: “Important
information regarding some of the ingredients of the medicine” and
section 6: “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have any further
questions, contact the physician or
the pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them, even
if it seems to you that their medical condition is similar.
WARNING: HEPATOTOXICITY AND QT PROLONGATION
HEPATOTOXICITY
•
CASES
OF
HEPATOTOXICITY
WITH
A
FATAL
OUTCOME
OR
REQUIRING
LIVER
TRANSPLANTATION HAVE BEEN REPORTED WITH USE OF ORAL KETOCONAZOLE. SOME
PATIENTS
HAD
NO
OBVIOUS
RISK
FACTORS
FOR
LIVER
DISEASE.
SERIOUS
HEPATOTOXICITY HAS BEEN REPORTED IN PATIENTS RECEIVING RECORLEV_._
•
RECORLEV
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
DUE
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
RECORLEV TREATMENT IMMEDIATELY IF SIGNS OF HEPATOTOXICITY OCCUR_._
QT PROLONGATION
•
RECORLEV 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 RECORLEV 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
RECORLEV
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg levoketoconazole.
Excipients with known effect: Lactose.
Patients with rare hereditary problems of galactose intolerance, total
lactase deficiency or
glucose-galactose malabsorption should not take this medicine.
For the full list of excipients, see section 13.
3
PHARMACEUTICAL FORM
Tablets.
Plain round biconvex pink film coated tablet with the identifier "LEV
150" in black ink.
WARNING: HEPATOTOXICITY AND QT PROLONGATION
HEPATOTOXICITY
•
CASES
OF
HEPATOTOXICITY
WITH
A
FATAL
OUTCOME
OR
REQUIRING
LIVER
TRANSPLANTATION HAVE BEEN REPORTED WITH USE OF ORAL KETOCONAZOLE. SOME
PATIENTS HAD NO OBVIOUS RISK FACTORS FOR LIVER DISEASE. SERIOUS
HEPATOTOXICITY
HAS BEEN REPORTED IN PATIENTS RECEIVING RECORLEV _ [SEE WARNINGS AND _
_PRECAUTIONS (8.1)]._
•
RECORLEV
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 DUE TO
KETOCONAZOLE
OR ANY AZOLE ANTIFUNGAL THERAPY THAT REQUIRED DISCONTINUATION OF
TREATMENT, OR
EXTENSIVE METASTATIC LIVER DISEASE _[SEE CONTRAINDICATIONS (7),
WARNINGS AND _
_PRECAUTIONS (8.1)]._
•
EVALUATE LIVER ENZYMES PRIOR TO AND DURING TREATMENT. INTERRUPT
RECORLEV TREATMENT IMMEDIATELY IF SIGNS OF HEPATOTOXICITY OCCUR _[SEE
_
_DOSAGE AND ADMINISTRATION (5.1, 5.3, 5.4), WARNINGS AND PRECAUTIONS
(8.1)]._
QT PROLONGATION
•
RECORLEV IS ASSOCIATED WITH DOSE-RELATED QT INTERVAL PROLONGATION. QT
INTERVAL PROLONGATION MAY LEAD TO LIFE-THREATENING VENTRICULAR
DYSRHYTHMIAS
SUCH AS TORSADES DE POINTES _[SEE WARNINGS AND PRECAUTIONS (8.2)]._
•
COADMINISTRATION OF RECORLEV 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
TACHYC