Ebola zaire vaccine, live (Intramuscular)

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

This vaccine should only be given by your doctor or under their immediate supervision.

It is very important that your doctor checks your progress at regular visits to ensure this vaccine is working properly and to look for any 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.

In deciding to use a vaccine, you and your doctor will weigh the risks of the vaccine against its benefits. Here are some important points to consider for this vaccine:

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 about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how Ervebo® affects children younger than 12 months. Safety and effectiveness have not been established for this age group.

Geriatric

Studies conducted so far have not found geriatric-specific problems that would limit the usefulness of Ervebo® in older adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may adjust the dose, or other precautions may be necessary. When you receive this vaccine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may choose 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 necessary in some situations. 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 certain types of food because interactions may happen. 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

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

• Rice protein allergy—This vaccine should not be used in patients with this condition.

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

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.