Uses for Ervebo

Ebola zaire vaccine, live is used to prevent disease caused by Zaire ebolavirus. It works by causing your immune system to produce its own protection (antibodies) against the virus.

This vaccine is to be given only by or under the immediate supervision of your doctor.

Before using Ervebo

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Ervebo® in children younger than 12 months of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Ervebo® in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adalimumab
• Anifrolumab-fnia
• Betibeglogene Autotemcel
• Canakinumab
• Deucravacitinib
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Fingolimod
• Hyaluronidase
• Ixekizumab
• Leniolisib
• Methotrexate
• Ozanimod
• Ponesimod
• Ritlecitinib
• Rozanolixizumab-noli
• Secukinumab
• Spesolimab-sbzo
• Tacrolimus
• Teplizumab-mzwv
• Tralokinumab-ldrm
• Ublituximab-xiiy
• Upadacitinib
• Valoctocogene Roxaparvovec-rvox
• Voclosporin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Rice protein allergy—Should not be used in patients with this condition.

• Weak immune system—This condition may decrease the useful effects of the vaccine.

Proper use of Ervebo

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.

It is very important that your doctor check your progress at regular visits to make sure that this vaccine is working properly and to check 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 receive 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 certain 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.

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.

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Ervebo® in children younger than 12 months of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Ervebo® in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adalimumab
• Anifrolumab-fnia
• Betibeglogene Autotemcel
• Canakinumab
• Deucravacitinib
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Fingolimod
• Hyaluronidase
• Ixekizumab
• Leniolisib
• Methotrexate
• Ozanimod
• Ponesimod
• Ritlecitinib
• Rozanolixizumab-noli
• Secukinumab
• Spesolimab-sbzo
• Tacrolimus
• Teplizumab-mzwv
• Tralokinumab-ldrm
• Ublituximab-xiiy
• Upadacitinib
• Valoctocogene Roxaparvovec-rvox
• Voclosporin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Rice protein allergy—Should not be used in patients with this condition.

• Weak immune system—This condition may decrease the useful effects of the vaccine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

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 adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue 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 occur 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.