Drug Information

Adenovirus

Adenovirus (types 4, 7) vaccine
Copyright 1978-2011 Lexicomp, Inc. All rights reserved.
Pharmacologic Category

  • Vaccine, Live (Viral)
Dosing: AdultAdenovirus immunization: Oral: Adults ≤50 years: One tablet each of type 4 and type 7 taken together as a single vaccine dose

Dosing: PediatricAdolescents ≥17 years: Refer to Adult dosing.

Dosage Forms: U.S.Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, enteric coated, oral [combination package]:

Adenovirus type 4 ≥4.5 log10 TCID50 [contains albumin (human); 100 white tablets]

Adenovirus type 7 ≥4.5 log10 TCID50 [contains albumin (human); 100 white tablets]

Generic Equivalent Available: U.S.No

AdministrationOral: Swallow tablets whole, do not chew, crush, or split. Both tablets (type 4 and type 7) are to be taken together as a single dose.

UsePrevention of acute febrile respiratory disease caused by adenovirus types 4 and 7 (approved for use in military populations)

>10%:

Central nervous system: Headache (7% to 30%)

Gastrointestinal: Nausea (5% to 14%)

Respiratory: Nasal congestion (8% to 15%), pharyngolaryngeal pain (12% to 13%), cough (10% to 12%)

1% to 10%:

Central nervous system: Fever (≤1%)

Gastrointestinal: Diarrhea (3% to 10%)

Neuromuscular & skeletal: Limb pain (4%)

Respiratory: Rhinorrhea (4%)

<1% (Limited to important or life-threatening): Gastritis, gastroenteritis, hematuria, hematochezia, pneumonia

ContraindicationsSevere hypersensitivity to adenovirus (types 4 and 7) vaccine or any component of the formulation; pregnancy; inability to swallow the table whole

Warnings/Precautions Disease-related concerns:

• Gastrointestinal illness: Vomiting or diarrhea may decrease the effectiveness of the vaccine (may reduce adenovirus replication within the gastrointestinal tract); administration should be postponed in patients with vomiting or diarrhea.

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Special populations:

• Immunocompromised patients: The safety and effectiveness of use in immunocompromised patients has not been evaluated.

Other warnings/precautions:

• Albumin: Formulation contains albumin, which may carry a remote risk of viral transmission, including a theoretical risk of Creutzfeldt-Jakob disease transmission.

• Appropriate administration: Tablets should be swallowed whole; do not chew. Chewing could potentially release the virus into the respiratory tract leading to disease.

• Viral shedding: Contains live viruses that are shed in the stool and may be transmitted. If exposed, close contacts (including those recently vaccinated) may develop adenovirus infection. Vaccinated individuals should use caution if in close contact with children <7 years of age, immunocompromised patients, or pregnant women for 28 days following administration. Wash hands frequently, especially following bowel movements, for 28 days after administration.

Prescribing and Access RestrictionsProduct is approved for use in military populations

Drug Interactions

AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). Risk D: Consider therapy modification

Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Risk D: Consider therapy modification

Fingolimod: May enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Fingolimod may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Hydroxychloroquine: May enhance the adverse/toxic effect of Vaccines (Live). Risk D: Consider therapy modification

Immune Globulins: May diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for up to six months following immune globulin administration. Live vaccine given immediately prior to immune globulin administration may require repeat vaccination. Risk D: Consider therapy modification

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Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: AzaTHIOprine; Beclomethasone; Beclomethasone (Oral Inhalation); Betamethasone; Budesonide; Budesonide (Systemic, Oral Inhalation); Corticotropin; Cortisone; Cytarabine (Liposomal); Dexamethasone; Dexamethasone (Systemic); Fludrocortisone; Fluticasone; Fluticasone (Oral Inhalation); Hydrocortisone; Hydrocortisone (Systemic); Hydroxychloroquine; Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; Mometasone; PrednisoLONE; PrednisoLONE (Systemic); PredniSONE; Triamcinolone; Triamcinolone (Systemic). Risk X: Avoid combination

Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Risk D: Consider therapy modification

Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Risk D: Consider therapy modification

Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Risk D: Consider therapy modification

Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, a scheduled PPD skin test should not be administered for at least 4 weeks following the administration of the vaccine. Risk D: Consider therapy modification

Pregnancy ImplicationsUse in pregnancy is contraindicated. Naturally-occurring adenovirus infections are associated with fetal harm. Information following inadvertent use during pregnancy is limited. Women of childbearing potential should avoid becoming pregnant for 6 weeks following vaccination. Healthcare providers are encouraged to enroll women exposed to adenovirus vaccine during pregnancy (or pregnancies occurring within 6 weeks of vaccination) in the Adenovirus Pregnancy Registry at 1-866-790-4549. Pregnant women should use caution if in close contact with vaccinated individuals for 28 days following vaccine administration.

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LactationExcretion in breast milk unknown/use caution

Breast-Feeding ConsiderationsIt is not known if adenovirus (types 4 and 7) vaccine is excreted in breast milk. However, viral shedding may occur and individuals should use caution when in close contact with children <7 years of age. Because many viruses are excreted in human breast milk, caution should be used if administered to a lactating woman.

Mechanism of ActionNonattenuated preparation of live adenovirus types 4 and 7 designed to release the live viruses in the intestine and replicate (in the intestinal tract) to induce immunity in individuals without (or with low) existing neutralizing antibodies to adenovirus types 4 and 7.

Pharmacodynamics/KineticsOnset: Viral shedding in the stool begins at 7 days; seroconversion occurs ~26 days following vaccination

Duration: Viral shedding no longer detected at 28 days

Absorption: Passes through stomach to release live virus into the intestine; not detected in serum (limited data; Lyons, 2008)

REFERENCES

  1. Centers for Disease Control and Prevention (CDC), “Recommendations of the Advisory Committee on Immunization Practices (ACIP): General Recommendations on Immunization,” MMWR Recomm Rep, 2011, 60(2):1-64. [PubMed 21293327]
  2. Lyons A, Longfield J, Kuschner R, et al, “A Double-Blind, Placebo-Controlled Study of the Safety and Immunogenicity of Live, Oral Type 4 and Type 7 Adenovirus Vaccines in Adults,” Vaccine, 2008, 26(23):2890-8. [PubMed 18448211]
January 2015
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