Version May 2024
Adenovirus immunization: Oral: Adults ≤50 years: One tablet each of type 4 and type 7 taken together as a single vaccine dose.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Adolescents ≥17 years: Refer to Adult dosing.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.
>10%:
Gastrointestinal: Nausea (5% to 14%)
Nervous system: Headache (7% to 30%)
Respiratory: Cough (10% to 12%), nasal congestion (8% to 15%), pharyngolaryngeal pain (8% to 13%)
1% to 10%:
Gastrointestinal: Diarrhea (3% to 10%)
Respiratory: Rhinorrhea (4%)
Miscellaneous: Fever (≤1%)
Frequency not defined:
Gastrointestinal: Gastritis, gastroenteritis, hematochezia
Genitourinary: Hematuria
Respiratory: Pneumonia
Postmarketing:
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)
Nervous system: Guillain-Barre syndrome
Severe hypersensitivity to adenovirus (types 4 and 7) vaccine or any component of the formulation; pregnancy; inability to swallow the tablet whole
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) unless it involves vomiting or diarrhea (ACIP [Kroger 2022).
• GI illness: Vomiting or diarrhea may decrease the effectiveness of the vaccine (may reduce adenovirus replication within the GI tract); administration should be postponed in patients with vomiting or diarrhea.
Concurrent drug therapy issues:
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (ACIP [Kroger 2022]).
Special populations:
• Immunocompromised patients: The safety and effectiveness of use in immunocompromised patients has not been evaluated. Severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) generally should not receive live vaccines; may have a reduced response to vaccination or may have an adverse event secondary to replication. Household and close contacts of persons with altered immunocompetence may receive most age appropriate vaccines (ACIP [Kroger 2022]). Live vaccines should be administered ≥4 weeks prior to planned immunosuppression, and avoided within 2 weeks of immunosuppression when feasible; live vaccines should not be administered for at least 3 months after immunosuppressive therapy (ACIP [Kroger 2022]; (IDSA [Rubin 2014]).
Dosage form specific issues:
• Albumin: Formulation contains albumin, which may carry a remote risk of viral transmission, including a theoretical risk of Creutzfeldt-Jakob disease transmission.
Other warnings/precautions:
• Appropriate administration: Tablets should be swallowed whole; do not chew. Chewing could potentially release the virus into the respiratory tract leading to disease.
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2022]).
• 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 (eg, patients with HIV, cancer), or pregnant persons for 28 days following administration. Wash hands frequently, especially following bowel movements, for 28 days after administration.
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 peach tablets]
No
Product is approved for use in military populations
Oral: 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.
If purchased under CDC contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
Oral: 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.
If purchased under CDC contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
In the US, the appropriate CDC-approved Vaccine Information Statement (VIS) should be provided to the patient/caregiver before administering each dose of this vaccine. If purchased under CDC contract, the VIS must be provided and the VIS edition date and date it was provided to the patient/caregiver should be recorded. VIS is available at https://www.cdc.gov/vaccines/hcp/vis/about/facts-vis.html.
Adenovirus disease prevention: Active immunization against acute febrile respiratory disease caused by adenovirus types 4 and 7 in persons 17 through 50 years of age (approved for use in military populations)
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Cladribine: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Cladribine may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines 4 weeks prior to therapy if possible. Risk D: Consider therapy modification
Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Risk C: Monitor therapy
Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Etrasimod: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Etrasimod may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Immunosuppressants (Cytotoxic Chemotherapy): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Leniolisib: May diminish the therapeutic effect of Vaccines (Live). Risk C: Monitor therapy
Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Teplizumab: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccines-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tezepelumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tralokinumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: Consider therapy modification
Patients of childbearing potential should avoid becoming pregnant for 6 weeks following vaccination.
Use in pregnancy is contraindicated.
Naturally-occurring adenovirus infections are associated with fetal harm. Information following inadvertent use during pregnancy is limited. Pregnant patients should use caution if in close contact with vaccinated individuals for 28 days following vaccine administration.
It is not known if adenovirus (types 4 and 7) vaccine is present 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 present in human breast milk, caution should be used if administered to a breastfeeding patient.
Nonattenuated 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.
Onset: 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)
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