Ervebo (Intramuscular)

Ebola zaire vaccine, live is used to prevent illness caused by Zaire ebolavirus. It helps your immune system create its own protection (antibodies) against the virus.

This vaccine must be given only by your doctor or under their direct supervision.

It is very important that your doctor checks your progress at regular visits to make sure this vaccine is working properly and to look for unwanted effects.

This vaccine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the vaccine.

Make sure any doctor or dentist who treats you knows that you are using this vaccine. This vaccine may affect the results of some medical tests.

This vaccine may not protect everyone who receives it. This vaccine will not treat symptoms of Zaire ebolavirus if you already have the disease.

In deciding to use a vaccine, you and your doctor need to think about the risks and benefits of the vaccine together. For this vaccine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. When using non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done on how Ervebo® affects children younger than 12 months of age. Its safety and effectiveness in this age group have not been established.

Geriatric

Currently, studies have not found any specific problems in older adults that would limit the usefulness of Ervebo®.

Breast Feeding

There are no adequate studies in women to determine if there is any risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In these cases, your doctor might adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below when receiving this vaccine. The following interactions have been chosen based on their possible significance and may not include all possible interactions.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide against using this vaccine or change some of the other medicines you take.

• Deflazacort

Receiving this vaccine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Adalimumab
• Anifrolumab-fnia
• Betibeglogene Autotemcel
• Bimekizumab-bkzx
• Canakinumab
• Deucravacitinib
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Etrasimod
• Everolimus
• Fingolimod
• Hyaluronidase
• Infliximab
• Ixekizumab
• Leniolisib
• Methotrexate
• Mirikizumab-mrkz
• Ozanimod
• Ponesimod
• Ritlecitinib
• Rozanolixizumab-noli
• Secukinumab
• Spesolimab-sbzo
• Tacrolimus
• Teplizumab-mzwv
• Tocilizumab
• Tralokinumab-ldrm
• Ublituximab-xiiy
• Upadacitinib
• Ustekinumab
• Valoctocogene Roxaparvovec-rvox
• Vamorolone
• Voclosporin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this vaccine. Make sure to tell your doctor if you have any other medical issues, especially:

• Rice protein allergy—This vaccine should not be used if you have this condition.

• Weak immune system—This condition may reduce the effectiveness of the vaccine.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Chills
• decreased appetite
• diarrhea
• difficulty in moving
• fever
• headache
• joint pain, tenderness, swelling
• muscle aches, cramps, pains, or stiffness
• nausea
• sleepiness or unusual drowsiness
• stomach pain
• unusual tiredness or weakness

Less common

• Redness, blistering, peeling, or loosening of the skin
• vomiting

Rare

• Joint stiffness

Incidence not known

• Chest tightness
• cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• trouble breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to tell you how to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects persist or are bothersome, or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• crying, irritability, or screaming

Less common

• Irritation or soreness of the mouth
• sweating

Other side effects not listed may also happen 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.

In the U.S.

• Ervebo

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine, Live

A nurse or other trained health professional will give you this vaccine in a hospital. This vaccine is given as a shot into a muscle.

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