Ervebo Generic Name & Formulations
Legal Class
Rx
General Description
Ebola Zaire vaccine, live recombinant (contains a minimum of 72million plaque forming units of vaccine virus in a stabilizer solution containing 10mM tromethamine and 2.5mg/mL rice-derived recombinant human serum albumin); per 1mL; susp for IM inj; may contain trace amounts of rice protein; preservative-, and latex-free.
Pharmacological Class
Ebola Zaire vaccine.
How Supplied
Single-dose vials—10
Manufacturer
Generic Availability
NO
Ervebo Indications
Indications
Prevention of disease due to Zaire ebolavirus.
Limitations of Use
The duration of protection conferred by Ervebo is unknown. Does not protect against other species of Ebolavirus or Marburgvirus. Effectiveness of the vaccine when administered concurrently with antiviral medication, immuneglobulin, and/or blood or plasma transfusions is unknown.
Ervebo Dosage and Administration
Adult
Give by IM inj, preferably in deltoid region of the non-dominant arm. ≥18yrs: administer one (1mL) dose.
Children
<18yrs: not established.
Ervebo Contraindications
Contraindications
Allergy to rice protein.
Ervebo Boxed Warnings
Not Applicable
Ervebo Warnings/Precautions
Warnings/Precautions
Immunization may not protect all individuals. Have appropriate medical treatment and supervision available to manage allergic reactions. Immunocompromised. Possible transmission of vaccine virus. Pregnancy. Nursing mothers.
Ervebo Pharmacokinetics
See Literature
Ervebo Interactions
Interactions
May test (+) results for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens.
Ervebo Adverse Reactions
Adverse Reactions
Inj site reactions (pain, swelling, redness), headache, feverishness, muscle pain, fatigue, joint pain, nausea, arthritis, rash, abnormal sweating.
Ervebo Clinical Trials
See Literature
Ervebo Note
Not Applicable
Ervebo Patient Counseling
See Literature