HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use ERVEBOsafely and effectiv ely. See full prescribing information for ERVEBO.ERVEBO�(Ebola Zaire Vaccine, Live)Suspensionfor intramuscular inj ectionInitial U.S. Approv al: 2019-------------------------------INDICATIONS AND USAGE-------------------------------ERVEBO� is a vaccine indicated for the prevention of disease caused by Zaire ebolavirusin individuals 18 years of age and older.(1)Limitations ofUse (1.1)�T he duration of protection conferred by ERVEBO is unknown.�ERVEBO does not protect against other species of Ebolavirusor Marburgvirus.�Effectiveness of the vaccine when administered concurrently with antiviral medication,immune globulin (IG), and/or blood or plasma transfusions is unknown. --------------------------DOSAGE AND ADMINISTRATION--------------------------�Administera single1mL dose of ERVEBOintramuscularly. (2.1)------------------------DOSAGE FORMS AND STRENGTHS-----------------------�1mL suspensionfor injection supplied as a single-dose vial.(3)----------------------------------CONTRAINDICATIONS----------------------------------�Severe allergic reaction (e.g., anaphylaxis) to any component of ERVEBO.(4)--------------------------WARNINGS AND PRECAUTIONS--------------------------�Anaphylaxis has been observed following administrationof ERVEBO. Appropriate medical treatment and supervision must be available in case of anaphylactic event following the administration of ERVEBO. (5.1)�Vaccinated individualsshould continue to adhere to infection control practices to prevent Zaire ebolavirusinfection and transmission. (5.2)�Vaccine virus RNA has been detected in blood, saliva, urine, and fluid from skin vesicles of vaccinated adults; transmission of vaccine virus is a theoretical possibility. (5.4)----------------------------------ADVERSE REACTIONS----------------------------------�T he most common injection-site adverse events were injection-site pain (70%), swelling (17%), and redness(12%). (6.1)�T he most common systemic adverse events reported following vaccination with ERVEBOwere headache (37%), feverishness(34%), muscle pain(33%), fatigue (19%), joint pain(18%), nausea (8%), arthritis (5%),rash (4%)andabnormal sweating(3%).(6.1)To report SUSPECTED ADVERSE REACTIONS, contactMerck Sharp & Dohme Corp.,a subsidiary of Merck & Co., Inc., at 1-877-888-4231or VAERSat 1-800-822-7967or w ww.vaers.hhs.gov.See 17 for PATIENT COUNSELING INFORMATION and FDA-approv ed patient labeling. Patient Information aboutERVEBO� (pronounced �er-VEE-boh")(Ebola Zaire Vaccine, Live)Before you get ERVEBO�, read this document and be sure you understand all of the information. Keep this document. You may need to read it again.If you have questions or side effects, ask your health care provider. This information does not take the place of talking about ERVEBO with your health care provider.You may be advised to get this vaccinein an emergency situation.What is ERVEBO??ERVEBOis a vaccine to prevent disease caused by Zaire ebolavirusin individuals who are18 years of age and older. ?This vaccineis given to help protect you from getting Ebola virus disease caused by one typeof Ebola virus. This vaccine will not protect you from disease caused by other types of Ebola virus.?You cannot get Ebola virus disease from ERVEBO.?After gettingERVEBO, you should continue to protect yourselffrom being exposed to Ebola virus.?ERVEBO might not protect everyone who gets the vaccine.What should I tell my health care provider before I get ERVEBO?You should tell your health care provider if you:?have ever had an allergic reaction to a vaccine or medicine?have ever had an allergicreaction to ERVEBO, rice protein or any of the ingredients in this vaccine?are pregnant or breastfeeding?think you may be pregnant or are planning to have a baby?have a weakened immune system or take medicines or treatments that might weaken your immune system?have close contact with anyone who has a weakened immune systemHow will I get ERVEBO?You will get this vaccineas an injection in the top of your arm.What are the side effects of ERVEBO?Serious allergic reactions have been observed after administration of ERVEBO.Tell your health care providerpromptly about any unusual or severe symptoms that develop after you receive this vaccine. Get medical care right away if you have signs of an allergic reaction, which may include:?wheezing or trouble breathing?swelling of the face, lips, tongue, or other parts of the body?generalized itching, redness, flushing or itchy bumpson the skin Other side effects:?Pain, swelling, or redness where you got this vaccine?Fever ?Feeling tired?Joint pain?Muscle aches
?Headache?Chills?Excessive sweating?Nausea?Skin rash (including blisters)?Joint swellingCertain white blood cell counts can become lower than normalafter vaccination but are not associatedwith illness and go back to normal.Most side effects go awaywithin a few days. Joint pain and swelling may last for weeks, months, or yearsin some people. In some people, joint pain and swellingmay come back after initially going away. Other information?ERVEBO may cause you to have a positive test for Ebola, even if you don�t have the disease.Tell your health care providerthat you received ERVEBO. Your health care providermight need to do adifferenttest.What is in ERVEBO?Active ingredient:live Vesicular Stomatitis Virus in which its surface protein has been replaced with that of Zaire ebolavirus.Inactive ingredients:recombinant human serum albumin, tromethamine (Tris) buffer.This vaccine contains a trace amount of rice protein.What if I have other questions? ?To learn more about ERVEBO, talk to your health care provideror visitwww.merckvaccines.com.?Keep this information about ERVEBO. You might want to look at it again.For patent information: www.merck.com/product/patent/home.htmlCopyright � 2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.If you have any side effect that bothers you or does not go away, tell your doctor, pharmacist or nurse.There may be other side effects that are not listed here.Talk to your doctor, pharmacist or nurse if you have questions or concernsabout possible side effects.You may also report any side effects to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or directly to Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.
All rights reserved.usppi-v920-i-1912r000This Patient Information has been approved by the U.S. Food and DrugAdministration.Issued: 12/2019
