Adenovirus Type 4

Drug overview for ADENOVIRUS TYPE 4 (adenovirus vaccine live type-4):

Generic name: adenovirus vaccine live type-4
Drug class: Adenovirus Type 4 Vaccine
Therapeutic class: Biologicals

Adenovirus vaccine is available in the US as adenovirus type 4 and type 7 vaccine live oral containing viable, selected strains of human adenovirus type 4 and type 7 prepared in human diploid fibroblast cell cultures. Adenovirus vaccine is used to stimulate active immunity to the adenovirus serotypes represented in the vaccine.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for ADENOVIRUS TYPE 4 (adenovirus vaccine live type-4) have been approved by the FDA:

Indications:
Adenovirus types 4, 7 vaccination

Professional Synonyms:
Active immunization against adenovirus types 4, 7
Prophylaxis for adenovirus types 4, 7 infection
Vaccination for prevention of adenovirus types 4, 7 infection

The following dosing information is available for ADENOVIRUS TYPE 4 (adenovirus vaccine live type-4):

Dosing
Administration
Dosing Information
Generic

No enhanced Dosing information available for this drug.

Adenovirus type 4 and type 7 vaccine live oral is administered orally as 2 separate tablets. One tablet contains the adenovirus type 4 vaccine component and one tablet contains the adenovirus type 7 vaccine component. Adenovirus type 4 and type 7 vaccine tablets contain live adenovirus inside an enteric coating.

The tablets are designed so that they pass through the stomach intact and release live vaccine virus in the intestines. The tablets should be swallowed whole and should not be chewed or crushed. If the tablets are chewed, the adenovirus will be released too soon and could expose the upper respiratory tract to live vaccine virus and result in adenovirus disease.

To facilitate swallowing of adenovirus vaccine tablets and reduce the risk of inadvertent chewing, the tablets should be taken with a small amount of water. Both vaccine tablets may be swallowed at the same time or they may be swallowed separately, one after the other, whichever is easier to accomplish without chewing. If adenovirus vaccine tablets are accidentally chewed, the vaccine should be cleared from the mouth by swishing and swallowing several sips of water, followed by swishing antiseptic mouthwash for 30 seconds and then spitting the used mouthwash into a container.

The used mouthwash should be considered biohazardous material and handled and disposed of according to local guidelines. Such individuals should be advised to seek medical care if they develop symptoms of fever or respiratory infection and should inform their clinician about the chewed tablets. Administration of adenovirus type 4 and type 7 vaccine live oral should be deferred in individuals with vomiting and/or diarrhea.

(See Concomitant Illness under Cautions: Warnings/Precautions.) Adenovirus type 4 and type 7 vaccine live oral may be given simultaneously with or at any interval before or after other vaccines. (See Drug Interactions: Vaccines.)

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for ADENOVIRUS TYPE 4 (adenovirus vaccine live type-4):

Contraindicated
Severe
Moderate

There are 4 contraindications. These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.

Drug Interaction	Drug Names
Selected Live Viral Vaccines/Selected Immunoglobulins SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Immune globulin(IG) products may prevent the immune system from properly responding to the vaccine.(1-19) CLINICAL EFFECTS: Administration of selected live viral vaccines after immunoglobulins may impair the efficacy of the vaccine.(1-19) Administration of immunoglobulins within 2-4 weeks after selected live viral vaccines impair the efficacy of the vaccine.(1-4,15) PREDISPOSING FACTORS: The amount of antigen-specific antibody present in the administered immunoglobulin product determines the duration of this interaction.(15) PATIENT MANAGEMENT: The recommendations regarding this interaction are conflicting. The Centers for Disease Control and Prevention(CDC) immunization recommendations for spacing of live vaccines and antibody-containing products include the following(15): - Live attenuated influenza vaccine, rotavirus, zoster and Ty21a typhoid vaccines may be given any time before, concurrent, with, or after administration of any immune globulin. Yellow fever vaccine may also be given in areas where donor blood products are unlikely to contain a substantial quantity of yellow fever antibody. - Administration of measles or varicella containing vaccines should be postponed for the following intervals after immunoglobulin therapy: Hepatitis B IG, Tetanus IG - 3 months Rabies IG - 4 months Varicella IG - 5 months Measles prophylaxis IG - 6 months if nonimmunocompromised Botulinum IG Intravenous, CMV IG Intravenous, Hepatitis A IG - 6 months Intravenous Immune Globulin(IVIG) - 8 to 11 months depending upon the dose Monoclonal antibody to RSV F protein (palivizumab) - none - Administration of antibody-containing products should be delayed 2 weeks after administration of live vaccines, except for influenza, rotavirus, zoster and typhoid vaccines as noted above. CDC guidelines state that in circumstances where there is high-risk of vaccine-preventable disease, it is acceptable to administer a dose of vaccine prior to completion of these intervals.(16) Manufacturer recommendations are as follows: Administration of a live viral vaccine should be postponed for at least three months in patients who have received the following immunoglobulin therapy: anthrax immunoglobulin,(19) cytomegalovirus immunoglobulin,(1) hepatitis B immunoglobulin,(5,6) rabies immunoglobulin,(7) tetanus immunoglobulin,(8-11) vaccinia immunoglobulin,(18) and zoster immunoglobulin.(2) Administration of a live viral vaccine should be postponed for at least six months in patients who have received the following immunoglobulin therapy: botulinum neurotoxin a/b immune globulin.(17) The Australian, Canadian, and US manufacturers of human immunoglobulin state that live viral vaccines should be postponed for three months in patients who have received human immunoglobulin.(6,12,13,18) The UK manufacturer states that vaccines may be compromised for one year and vaccines should be postponed in children for at least seven months.(14) The US manufacturer of immune globulin-hyaluronidase states that immune response to live attenuated vaccines may be impaired for up to 6 months, or for a year or more in the case of measles vaccine.(15) Cytomegalovirus immunoglobulin(1) or human immunoglobulin(3) should not be administered to patients who have received a live vaccine in the previous two weeks. If a live viral vaccine is given within two weeks of zoster immunoglobulin,(1) repetition of the vaccination three months after the completion of immunoglobulin should be considered. DISCUSSION: CDC Immunization Recommendations(15)provide discussion, charts, and further details regarding appropriate use and timing of vaccine therapy.(16)	ALYGLO, ANTHRASIL (NATIONAL STOCKPILE), ASCENIV, BABYBIG, BIVIGAM, CNJ-016 (NATIONAL STOCKPILE), CUTAQUIG, CUVITRU, CYTOGAM, FLEBOGAMMA DIF, GAMASTAN, GAMMAGARD LIQUID, GAMMAGARD S-D, GAMMAKED, GAMMAPLEX, GAMUNEX-C, HEPAGAM B, HIZENTRA, HYPERHEP B, HYPERRAB, HYPERTET, HYQVIA, HYQVIA IG COMPONENT, IMOGAM RABIES-HT, KEDRAB, NABI-HB, OCTAGAM, PANZYGA, PRIVIGEN, VARIZIG, XEMBIFY
Live Vaccines; Live BCG/Selected Immunosuppressive Agents SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1) CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2) PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency. PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)	ABECMA, ABRAXANE, ABRILADA(CF), ABRILADA(CF) PEN, ABRILADA(CF) PEN (2 PACK), ACTEMRA, ACTEMRA ACTPEN, ACTIMMUNE, ADALIMUMAB-AACF(CF), ADALIMUMAB-AACF(CF) (2 PK), ADALIMUMAB-AACF(CF) PEN (2 PK), ADALIMUMAB-AACF(CF) PEN CROHNS, ADALIMUMAB-AACF(CF) PEN PS-UV, ADALIMUMAB-AATY(CF) (2 PACK), ADALIMUMAB-AATY(CF) (2 PK), ADALIMUMAB-AATY(CF) AI CROHNS, ADALIMUMAB-AATY(CF) AUTOINJ(2), ADALIMUMAB-AATY(CF) AUTOINJECT, ADALIMUMAB-ADAZ(CF), ADALIMUMAB-ADAZ(CF) PEN, ADALIMUMAB-ADBM(CF), ADALIMUMAB-ADBM(CF) PEN, ADALIMUMAB-ADBM(CF) PEN CROHNS, ADALIMUMAB-ADBM(CF) PEN PS-UV, ADALIMUMAB-ADBM(CF)PEN, ADALIMUMAB-FKJP(CF), ADALIMUMAB-FKJP(CF) PEN, ADALIMUMAB-RYVK(CF), ADALIMUMAB-RYVK(CF) AUTOINJECT, ADBRY, ADBRY AUTOINJECTOR, ADCETRIS, ADRIAMYCIN, ADRUCIL, AFINITOR, AFINITOR DISPERZ, AKEEGA, ALFERON N, ALIMTA, ALIQOPA, ALKERAN, ALUNBRIG, AMJEVITA(CF), AMJEVITA(CF) AUTOINJECTOR, AMTAGVI, ARAVA, ARCALYST, ARRANON, ARSENIC TRIOXIDE, ARZERRA, ASPARLAS, ASTAGRAF XL, ATGAM, AUBAGIO, AUCATZYL, AUGTYRO, AVONEX, AVONEX (4 PACK), AVONEX PEN, AVONEX PEN (4 PACK), AVSOLA, AXTLE, AZACITIDINE, AZASAN, AZATHIOPRINE, AZATHIOPRINE SODIUM, BAFIERTAM, BAVENCIO, BELEODAQ, BELRAPZO, BENDAMUSTINE HCL, BENDEKA, BENLYSTA, BESPONSA, BESREMI, BETASERON, BEXAROTENE, BICNU, BIMZELX, BIMZELX AUTOINJECTOR, BLEOMYCIN SULFATE, BLINCYTO, BORTEZOMIB, BORUZU, BOSULIF, BRAFTOVI, BREYANZI, BREYANZI CD4 COMPONENT, BREYANZI CD8 COMPONENT, BRIUMVI, BRUKINSA, BUSULFAN, BUSULFEX, CABOMETYX, CAELYX, CALQUENCE, CAMPATH, CAMPTOSAR, CAPECITABINE, CAPRELSA, CARBOPLATIN, CARMUSTINE, CARVYKTI, CELLCEPT, CHLORAMBUCIL, CIBINQO, CIMZIA, CIMZIA (2 PACK), CISPLATIN, CLADRIBINE, CLOFARABINE, COLUMVI, COMETRIQ, COPIKTRA, COSENTYX, COSENTYX (2 SYRINGES), COSENTYX SENSOREADY (2 PENS), COSENTYX SENSOREADY PEN, COSENTYX SYRINGE, COSENTYX UNOREADY PEN, COSMEGEN, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE MONOHYDRATE, CYCLOSPORINE, CYCLOSPORINE MODIFIED, CYLTEZO(CF), CYLTEZO(CF) PEN, CYLTEZO(CF) PEN CROHN'S-UC-HS, CYLTEZO(CF) PEN PSORIASIS-UV, CYTARABINE, DACARBAZINE, DACTINOMYCIN, DANZITEN, DARAPRIM, DARZALEX, DARZALEX FASPRO, DASATINIB, DAUNORUBICIN HCL, DAURISMO, DECITABINE, DEXRAZOXANE, DIMETHYL FUMARATE, DOCETAXEL, DOCIVYX, DOXIL, DOXORUBICIN HCL, DOXORUBICIN HCL LIPOSOME, DUPIXENT PEN, DUPIXENT SYRINGE, EBGLYSS PEN, EBGLYSS SYRINGE, EFLORNITHINE HCL, ELAHERE, ELLENCE, ELREXFIO, ENBREL, ENBREL MINI, ENBREL SURECLICK, ENHERTU, ENSPRYNG, ENTYVIO, ENTYVIO PEN, ENVARSUS XR, EPIRUBICIN HCL, EPKINLY, ERBITUX, ERLOTINIB HCL, ERWINASE, ETOPOPHOS, ETOPOSIDE, EVEROLIMUS, EVOMELA, FARESTON, FARYDAK, FINGOLIMOD, FLOXURIDINE, FLUDARABINE PHOSPHATE, FLUOROURACIL, FOLOTYN, FRINDOVYX, FYARRO, GAMIFANT, GAVRETO, GAZYVA, GEFITINIB, GEMCITABINE HCL, GENGRAF, GILENYA, GLEEVEC, GLEOSTINE, GLIADEL, GRAFAPEX, HADLIMA, HADLIMA PUSHTOUCH, HADLIMA(CF), HADLIMA(CF) PUSHTOUCH, HEPZATO, HERCEPTIN, HERCEPTIN HYLECTA, HERCESSI, HERZUMA, HICON, HULIO(CF), HULIO(CF) PEN, HUMIRA, HUMIRA PEN, HUMIRA(CF), HUMIRA(CF) PEN, HUMIRA(CF) PEN CROHN'S-UC-HS, HUMIRA(CF) PEN PSOR-UV-ADOL HS, HYCAMTIN, HYRIMOZ, HYRIMOZ PEN, HYRIMOZ(CF), HYRIMOZ(CF) PEDIATRIC CROHN'S, HYRIMOZ(CF) PEN, HYRIMOZ(CF) PEN CROHN-UC START, HYRIMOZ(CF) PEN PSORIASIS, ICLUSIG, IDAMYCIN PFS, IDARUBICIN HCL, IFEX, IFOSFAMIDE, ILARIS, ILUMYA, IMAAVY, IMATINIB MESYLATE, IMBRUVICA, IMDELLTRA, IMFINZI, IMKELDI, IMURAN, INFLECTRA, INFLIXIMAB, INFUGEM, INQOVI, INREBIC, IRESSA, IRINOTECAN HCL, ISTODAX, IVRA, IWILFIN, IXEMPRA, JAKAFI, JAYPIRCA, JEMPERLI, JEVTANA, KADCYLA, KANJINTI, KEMOPLAT, KESIMPTA PEN, KEVZARA, KEYTRUDA, KINERET, KISQALI, KYMRIAH, LEFLUNICLO, LEFLUNOMIDE, LEMTRADA, LENALIDOMIDE, LEUKERAN, LEVAMISOLE HCL, LITFULO, LONSURF, LOQTORZI, LUNSUMIO, LUPKYNIS, LUTATHERA, LYNPARZA, MATULANE, MAVENCLAD, MAYZENT, MECHLORETHAMINE HCL, MEKINIST, MEKTOVI, MELPHALAN HCL, MERCAPTOPURINE, METHOTREXATE, METHOTREXATE SODIUM, MITOMYCIN, MITOXANTRONE HCL, MONJUVI, MUTAMYCIN, MYCOPHENOLATE MOFETIL, MYCOPHENOLIC ACID, MYFORTIC, MYHIBBIN, MYLERAN, MYLOTARG, NELARABINE, NEMLUVIO, NEORAL, NEXAVAR, NILOTINIB HCL, NIPENT, NULOJIX, OCREVUS, OCREVUS ZUNOVO, OGIVRI, OJJAARA, OLUMIANT, OMVOH, OMVOH PEN, ONCASPAR, ONIVYDE, ONTRUZANT, ONUREG, OPDIVO, OPDIVO QVANTIG, OPDUALAG, ORENCIA, ORENCIA CLICKJECT, OTULFI, OXALIPLATIN, PACLITAXEL, PACLITAXEL PROTEIN-BOUND, PARAPLATIN, PAZOPANIB HCL, PEGASYS, PEMETREXED, PEMETREXED DISODIUM, PEMFEXY, PEMRYDI RTU, PERJETA, PHESGO, PLEGRIDY, PLEGRIDY PEN, PLUVICTO, POLIVY, POMALYST, PONVORY, POTELIGEO, PRALATREXATE, PROCARBAZINE HCL, PROGRAF, PROLEUKIN, PURIXAN, PYRIMETHAMINE, PYZCHIVA, QUALAQUIN, QUININE HCL, QUININE SULFATE, REBIF, REBIF REBIDOSE, REMICADE, RENFLEXIS, REVLIMID, REVUFORJ, REZUROCK, RIABNI, RINVOQ, RINVOQ LQ, RITUXAN, RITUXAN HYCELA, ROMIDEPSIN, RUBRACA, RUXIENCE, RYDAPT, RYLAZE, RYSTIGGO, RYTELO, SANDIMMUNE, SAPHNELO, SARCLISA, SCEMBLIX, SELARSDI, SILIQ, SIMLANDI(CF), SIMLANDI(CF) AUTOINJECTOR, SIMPONI, SIMPONI ARIA, SIMULECT, SIROLIMUS, SKYRIZI, SKYRIZI ON-BODY, SKYRIZI PEN, SODIUM IODIDE I-131, SORAFENIB, SOTYKTU, SPEVIGO, SPRYCEL, STELARA, STEQEYMA, STIVARGA, STRONTIUM-89 CHLORIDE, SUNITINIB MALATE, SUTENT, SYLVANT, TABLOID, TACROLIMUS, TACROLIMUS XL, TALTZ AUTOINJECTOR, TALTZ AUTOINJECTOR (2 PACK), TALTZ AUTOINJECTOR (3 PACK), TALTZ SYRINGE, TALVEY, TALZENNA, TARCEVA, TARGRETIN, TASCENSO ODT, TASIGNA, TECARTUS, TECELRA, TECENTRIQ, TECENTRIQ HYBREZA, TECFIDERA, TECVAYLI, TEMODAR, TEMOZOLOMIDE, TEMSIROLIMUS, TEPADINA, TEPYLUTE, TERIFLUNOMIDE, TEVIMBRA, TEZSPIRE, THALOMID, THIOGUANINE, THIOTEPA, THYMOGLOBULIN, TOFACITINIB CITRATE, TOFIDENCE, TOPOTECAN HCL, TOREMIFENE CITRATE, TORISEL, TORPENZ, TRAMETINIB, TRAZIMERA, TREANDA, TREMFYA, TREMFYA PEN, TREMFYA PEN INDUCTION PK-CROHN, TRIFLURIDINE, TRISENOX, TRUQAP, TRUXIMA, TYENNE, TYENNE AUTOINJECTOR, TYSABRI, UNITUXIN, UPLIZNA, USTEKINUMAB, USTEKINUMAB-AEKN, USTEKINUMAB-TTWE, VALRUBICIN, VALSTAR, VANFLYTA, VELCADE, VELSIPITY, VENCLEXTA, VENCLEXTA STARTING PACK, VERZENIO, VIDAZA, VINBLASTINE SULFATE, VINCASAR PFS, VINCRISTINE SULFATE, VINORELBINE TARTRATE, VITRAKVI, VIVIMUSTA, VOTRIENT, VYVGART, VYVGART HYTRULO, VYXEOS, WEZLANA, XALKORI, XELJANZ, XELJANZ XR, XELODA, XOFIGO, XPOVIO, YESCARTA, YESINTEK, YONDELIS, YUFLYMA(CF) (2 PACK), YUFLYMA(CF) AI CROHN'S-UC-HS, YUFLYMA(CF) AUTOINJECT (2 PCK), YUFLYMA(CF) AUTOINJECTOR, YUSIMRY(CF) PEN, ZEJULA, ZEPOSIA, ZEPZELCA, ZEVALIN, ZOKINVY, ZORTRESS, ZYDELIG, ZYMFENTRA, ZYMFENTRA (2 PACK), ZYMFENTRA PEN (2 PACK), ZYNYZ
Selected Live Viral Vaccines/Rho Immunoglobulin SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Immune globulin products may prevent the immune system from properly responding to the vaccine.(1-6) CLINICAL EFFECTS: Administration of a live viral vaccine after immunoglobulins may impair the efficacy of the vaccine.(1-6) Administration of immunoglobulins within 2-4 weeks after a live viral vaccine impair the efficacy of the vaccine.(1-6) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Administration of a live viral vaccine should be postponed for three months in patients who have received immunoglobulin therapy, including Rho immunoglobulin.(1-6) If a live viral vaccine is given within two to four weeks of rho immunoglobulin, then repeat vaccination three months after the completion of immunoglobulin should be considered.(2-4) DISCUSSION: Administration of a live viral vaccine after immunoglobulins(1-6) or administration of immunoglobulins after a live vaccine(3) may impair the efficacy of the vaccine.	HYPERRHO S-D, RHOGAM ULTRA-FILTERED PLUS, RHOPHYLAC, WINRHO SDF
Live Vaccines/Bevacizumab SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Systemic bevacizumab suppresses the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(1) CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency. Intravitreal injections of small doses of bevacizumab for macular degeneration or macular edema are not expected to suppress immune function. PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) Intravitreal injections of small doses of bevacizumab for macular degeneration or macular edema are not expected to suppress immune function. For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)	ALYMSYS, AVASTIN, MVASI, VEGZELMA, ZIRABEV

There are 6 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Systemic Corticosteroids; Corticotropin (ACTH)/Live Vaccines SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system. In severely immunocompromised patients, virus replication after administration of live, attenuated-virus vaccines can be enhanced and/or the immune response to the vaccine may be decreased.(1) CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1) PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. Live vaccines should be deferred for at least 1 month after discontinuation of high-dose systemic steroids administered for 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 4 weeks after a live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued.(1) The US manufacturer of corticotropin(2) and triamcinolone(3) and the Australian manufacturer of dexamethasone(4) state that administration of live or live-attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids or corticotropin. The manufacturer of deflazacort states that live or live-attenuated vaccines should be administered at least 4 to 6 weeks prior to initiation of therapy with deflazacort.(5) DISCUSSION: Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1) Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)	ACTHAR, ACTHAR SELFJECT, ADRENOCORTICOTROPHIC HORMONE, AGAMREE, ALDOSTERONE, ALKINDI SPRINKLE, ANUCORT-HC, ANUSOL-HC, BECLOMETHASONE DIPROPIONATE, BETA 1, BETALOAN SUIK, BETAMETHASONE ACETATE MICRO, BETAMETHASONE ACETATE-SOD PHOS, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SOD PHOS-ACETATE, BETAMETHASONE SOD PHOS-WATER, BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE VALERATE, BSP 0820, BUDESONIDE, BUDESONIDE DR, BUDESONIDE EC, BUDESONIDE ER, BUDESONIDE MICRONIZED, BUPIVACAINE-DEXAMETH-EPINEPHRN, CELESTONE, CLOBETASOL PROPIONATE MICRO, CORTEF, CORTENEMA, CORTICOTROPHIN, CORTIFOAM, CORTISONE ACETATE, CORTROPHIN, DEFLAZACORT, DEPO-MEDROL, DESONIDE MICRONIZED, DESOXIMETASONE, DESOXYCORTICOSTERONE ACETATE, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE ACETATE, DEXAMETHASONE ACETATE MICRO, DEXAMETHASONE INTENSOL, DEXAMETHASONE ISONICOTINATE, DEXAMETHASONE MICRONIZED, DEXAMETHASONE SOD PHOS-WATER, DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE-0.9% NACL, DMT SUIK, DOUBLEDEX, EMFLAZA, EOHILIA, FLUDROCORTISONE ACETATE, FLUNISOLIDE, FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE MICRO, FLUOCINONIDE MICRONIZED, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE MICRO, HEMADY, HEMMOREX-HC, HEXATRIONE, HYDROCORTISONE, HYDROCORTISONE ACETATE, HYDROCORTISONE SOD SUCCINATE, KENALOG-10, KENALOG-40, KENALOG-80, LIDOCIDEX-I, MAS CARE-PAK, MEDROL, MEDROLOAN II SUIK, MEDROLOAN SUIK, METHYLPREDNISOLONE, METHYLPREDNISOLONE AC MICRO, METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE SODIUM SUCC, MILLIPRED, MILLIPRED DP, MOMETASONE FUROATE, ORAPRED ODT, ORTIKOS, PEDIAPRED, PREDNISOLONE, PREDNISOLONE ACETATE MICRONIZE, PREDNISOLONE MICRONIZED, PREDNISOLONE SODIUM PHOS ODT, PREDNISOLONE SODIUM PHOSPHATE, PREDNISONE, PREDNISONE INTENSOL, PREDNISONE MICRONIZED, PRO-C-DURE 5, PRO-C-DURE 6, PROCTOCORT, RAYOS, SOLU-CORTEF, SOLU-MEDROL, TAPERDEX, TARPEYO, TRIAMCINOLONE, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE DIACETATE, TRIAMCINOLONE DIACETATE MICRO, TRILOAN II SUIK, TRILOAN SUIK, UCERIS, VERIPRED 20, ZCORT
Live Vaccines/Methotrexate (low strength injection, oral) SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: A variety of disease modifying agents such as methotrexate suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(1) CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency. PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) CDC recommendations for zoster vaccine state it may be administered to patients receiving methotrexate if the dose is < or = to 0.4 mg/kg/week for treatment of rheumatoid arthritis, psoriasis, inflammatory bowel disease or other conditions.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)	METHOTREXATE, OTREXUP, RASUVO, TREXALL, XATMEP
Tuberculin Testing/Live Vaccines SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Measles infection and severe acute and chronic infections may induce an anergic state resulting in a false-negative tuberculin test. The live measles vaccine, as well as other live vaccines (e.g. smallpox, varicella, yellow fever) theoretically may also suppress response to tuberculin testing, though the degree of suppression may be less than that expected from acute infection with wild-type virus.(1-4) CLINICAL EFFECTS: Tuberculin testing that is performed more than one day but less than 28 days after administration of a live vaccine may result in a false negative tuberculin response. Tuberculin testing may be administered simultaneously with live vaccines.(1-4) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The CDC states that live vaccines (e.g. MMR and varicella) and tuberculin testing may be administered within one day of each other at separate administration sites. If it has been more than one day since tuberculin testing has been administered, the live vaccine can be given at any interval after the tuberculin test. However, if the live vaccine has been administered more than one day previously and tuberculin testing is indicated, tuberculin testing should be deferred for at least 4-6 weeks.(1-4) DISCUSSION: Suppression of response to tuberculin testing has been observed following measles infection, live measles vaccination, and live smallpox vaccination. The degree of suppression after live virus vaccination is likely to be less than that from an acute infection with wild-type virus. There is no data on suppression of response to tuberculin testing with other live vaccines. In the absence of data, the CDC recommends tuberculin testing within one day that a live vaccine is administered. Otherwise the tuberculin test should be deferred for at least 4-6 weeks.(1-4)	APLISOL, TUBERSOL
Live Vaccines; Live BCG/Hydroxyurea SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Hydroxyurea may suppress the immune system.(1) Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(2) CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(2) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(3) PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies), treatments (e.g. radiation) and cytotoxic drugs may all increase the magnitude of immunodeficiency. PATIENT MANAGEMENT: Recommendations for administration of live vaccines in patients on hydroxyurea are dependent on the indication. The US manufacturers of hydroxyurea recommend avoiding live vaccine use in patients taking hydroxyurea. Evaluate hematologic status prior to and during treatment with hydroxyurea. Provide supportive care and modify the dose or discontinue hydroxyurea as needed.(1) The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued.(2) The ACIP recommendations state that routine vaccinations patients with secondary immunodeficiency such as sickle cell disease are likely effective. Live viral and bacterial vaccines are contraindicated in patients with generalized malignant neoplasm, immunosuppressive, or radiation therapy, depending on immune status.(4) DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(2) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(2) A multicenter, randomized, double-blind, placebo-controlled trial in infants and young children with sickle cell disease (BABY HUG) studied the response to pneumococcal and measles, mumps, and rubella vaccines in patients using hydroxyurea. The authors concluded that hydroxyurea does not appear to have significant deleterious effects on the immune function of infants and children with sickle cell disease. Additional assessments of lymphocyte parameters of hydroxyurea-treated children may be warranted. No changes in current immunization schedules are recommended; however, for endemic disease or epidemics, adherence to accelerated immunization schedules for the measles, mumps, and rubella vaccine should be reinforced.(5)	DROXIA, HYDREA, HYDROXYUREA, SIKLOS, XROMI
Live Vaccines; Live BCG/Teplizumab SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Teplizumab may cause lymphopenia and suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1,2) CLINICAL EFFECTS: The expected serum antibody response may not be obtained. The vaccine may result in illness.(1,2) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(3) PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency. PATIENT MANAGEMENT: The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live-attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) Vaccination should ideally precede the initiation of teplizumab therapy by 8 weeks. Live vaccines are not recommended within the 8 weeks prior to, during, or for 52 weeks after stopping teplizumab therapy.(2) DISCUSSION: Vaccinations may be less effective if administered within 8 weeks before, during, and for 52 weeks following teplizumab therapy.(2) Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)	TZIELD
Live Vaccines/Leniolisib SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Leniolisib modifies the immune system. Immune response to live vaccines may be decreased during treatment with leniolisib.(1) CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1) PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency. PATIENT MANAGEMENT: The manufacturer of leniolisib states live, attenuated vaccinations may be less effective if administered during leniolisib treatment.(1) DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)	JOENJA

There are 0 moderate interactions.

The following contraindication information is available for ADENOVIRUS TYPE 4 (adenovirus vaccine live type-4):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

Adenovirus type 4 and type 7 vaccine live oral is contraindicated in pregnant women. (See Pregnancy under Warnings/Precautions: Specific Populations, in Cautions.) Adenovirus type 4 and type 7 vaccine live oral is contraindicated in individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine. Adenovirus type 4 and type 7 vaccine live oral also is contraindicated in individuals who are unable to swallow the vaccine tablets whole without chewing; chewing a vaccine tablet could expose the upper respiratory tract to the live vaccine virus and result in adenovirus disease. (See Administration under Dosage and Administration.)

There are 4 contraindications. Absolute contraindication.

Contraindication List
HIV infection
Immunosuppression
Lactation
Pregnancy

There are 0 severe contraindications.

There are 0 moderate contraindications.

The following adverse reaction information is available for ADENOVIRUS TYPE 4 (adenovirus vaccine live type-4):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in 5% or more of adults 17 through 50 years of age who received adenovirus type 4 and type 7 vaccine live oral include upper respiratory tract infection, headache, nasal congestion, pharyngolaryngeal pain (sore throat), cough, arthralgia, and GI effects (abdominal pain, nausea, diarrhea, vomiting).

There are 8 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Bloody stools Gastritis Gastroenteritis Guillain-barre syndrome Hematuria Hypersensitivity drug reaction Pneumonia

There are 14 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Arthralgia Cough Diarrhea Headache disorder Nasal congestion Nausea Sore throat Upper respiratory infection	Chills Pain in extremities Rhinorrhea Vomiting

Rare/Very Rare
Fever

The following precautions are available for ADENOVIRUS TYPE 4 (adenovirus vaccine live type-4):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of adenovirus type 4 and type 7 vaccine live oral have not been established in infants and children younger than 17 years of age.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Adenovirus type 4 and type 7 vaccine live oral is contraindicated in pregnant women, and pregnancy should be avoided for at least 6 weeks after vaccination. (See Fetal/Neonatal Morbidity and Mortality under Cautions: Warnings/Precautions.) Naturally occurring adenovirus infection has been associated with fetal harm. It is not known whether adenovirus type 4 and type 7 vaccine live oral can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

There were 5 pregnancies reported among women enrolled in a clinical study that evaluated use of adenovirus type 4 and type 7 vaccine live oral in US military recruits 17 years of age and older. Four of these women (3 vaccine recipients and 1 placebo recipient) were estimated to have conceived 2-13 days prior to vaccination; the other woman (vaccine recipient) conceived approximately 21 weeks after vaccination. All 5 women delivered healthy infants with estimated gestational ages of 36-40 weeks.

Data are not available regarding the effect of adenovirus type 4 and type 7 vaccine live oral on labor and delivery. Vaccine virus shed in stools during delivery may result in transmission of the vaccine virus to the neonate.

It is not known whether adenovirus type 4 and type 7 vaccine live oral is distributed into human milk following oral administration. Because many viruses are distributed into milk, the manufacturer states that adenovirus type 4 and type 7 vaccine live oral should be used with caution in nursing women. Some experts state the vaccine should not be used in nursing women.

Safety and efficacy of adenovirus type 4 and type 7 vaccine live oral have not been established in adults 65 years of age or older. Clinical studies evaluating adenovirus type 4 and type 7 vaccine live oral did not include individuals 65 years of age or older, and data are not available to determine whether geriatric individuals respond differently than younger adults.

Adenovirus types 4, 7 vaccination
Z23	Encounter for immunization