RECORLEV- levoketoconazole tablet 
Xeris Pharmaceuticals, Inc.

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MEDICATION GUIDE
RECORLEV®

MEDICATION GUIDE RECORLEV® (re kor ' lev) (levoketoconazole) tablets, for oral use

What is the most important information I should know about RECORLEV?

RECORLEV can cause serious side effects, including:

Call your healthcare provider right away if you have any of the following signs or symptoms:

RECORLEV should not be used if you have any of the following conditions:

Your healthcare provider will do liver tests before and during treatment with RECORLEV.

Call your healthcare provider right away if you feel severe lightheadedness or if you faint during treatment with RECORLEV.

Your healthcare provider will check your heart with a test called an electrocardiogram (ECG) and do blood tests to check your blood electrolyte levels before and during treatment with RECORLEV.

RECORLEV should not be taken with certain other medicines that cause QT prolongation. Talk to your healthcare provider about the medicines you are taking before you start taking RECORLEV.

Call your healthcare provider right away if you have one or more of the following symptoms, as these may be symptoms of reduced adrenal function:

Your healthcare provider will collect blood or urine samples to measure your cortisol.

What is RECORLEV?

Do not take RECORLEV if you:

Before taking RECORLEV, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RECORLEV and other medicines may affect each other causing side effects. RECORLEV may affect the way other medicines work, and other medicines may affect how RECORLEV works.

How should I take RECORLEV?

What should I avoid while taking RECORLEV?

What are the possible side effects of RECORLEV?

RECORLEV may cause serious side effects, including:

The most common side effects of RECORLEV include nausea/vomiting, hypokalemia (low potassium), hemorrhage (easy bleeding)/contusion (easy bruising), high blood pressure, headache, liver injury, abnormal uterine bleeding, erythema (redness of the skin), fatigue, abdominal pain/dyspepsia (upset stomach), arthritis, upper respiratory infection, myalgia (muscle pain), abnormal heart rhythm, back pain, sleep disturbances, and peripheral edema (fluid retention).

RECORLEV may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of RECORLEV.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store RECORLEV?

Keep RECORLEV and all medicines out of the reach of children.

General information about the safe and effective use of RECORLEV.

Medications are sometimes prescribed for purposes other than those listed in this Medication Guide. Do not use RECORLEV for a condition for which it was not prescribed. Do not give RECORLEV to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RECORLEV that is written for health professionals.

What are the ingredients in RECORLEV?

Active ingredients: levoketoconazole.

Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, modified corn starch, and silicified microcrystalline cellulose.

Distributed by: Xeris Pharmaceuticals, Inc., Chicago, IL 60607

For more information, go to www.Recorlev.com or call 1-877-937-4737.

This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 06/2023

Revised: 6/2023
Xeris Pharmaceuticals, Inc.