an anaphylactic event following administration Vaccination may not protect all individuals; vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission Safety and effectiveness have not been assessed in immunocompromised individuals; weigh the risk of vaccination in immunocompromised individuals against the risk of disease due to Zaire ebolavirus Vaccine virus RNA has been detected by RT-PCR in blood, saliva, urine, and fluid from skin vesicles of vaccinated adults; transmission of vaccine virus is a theoretical possibility Drug interaction overview Interference with laboratory tests Following vaccination, individuals may test positive for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens GP-based testing may have limited diagnostic value during period of vaccine viremia, in the presence of vaccine-derived Ebola GP, and following antibody response to the vaccine Pregnancy There are no adequate and well-controlled studies in pregnant women, and human data available from clinical trials are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy Consider the woman’s risk of exposure to Zaire ebolavirus before vaccination Clinical considerations Fetal and neonatal outcomes are universally poor among pregnant women infected with Zaire ebolavirus Majority of such pregnancies end in miscarriage or stillbirth In pregnancies where live birth does occur, neonates generally do not survive Potential for transmission of the vaccine virus from mother to the fetus/neonate is unknown Lactation Human data are not available to assess the effects on milk production, its presence in breast milk, or its effects on the breastfed child Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child or from the underlying maternal condition For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccinePregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Recombinant vesicular stomatitis virus-Zaire ebolavirus (rVSV-ZEBOV; V920) is a replication-competent vaccine Genetically engineered to express a glycoprotein from the Zaire ebolavirus to provoke a neutralizing immune response to the Ebola virus IM Preparation Thaw vial at room temperature until no visible ice is present; do not thaw vial in a refrigerator Gently invert vial several times Visually inspect for particulate matter and discoloration before use, vaccine is a colorless to slightly brownish-yellow liquid with no particulates visible Use the vaccine immediately after thawing Withdraw 1-mL dose from vial using a sterile needle and sterile syringe IM Administration Administer a 1-mL dose IM, preferably in the deltoid area of the nondominant arm Discard unused portion Storage Unopened vials: Freeze at -80 to -60ºC (-112 to -76ºF) in the original carton to protect from light; do not thaw the vial in a refrigerator Thawed vials: If not used immediately, refrigerate at 2-8ºC (35.6-46.4ºF) for a total time of no more than 2 weeks and at room temperature (up to 25ºC; 77ºF) for a total time of no more than 4 hr No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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