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Drug overview for BCG (TICE STRAIN) (bcg live):
Generic name: BCG LIVE
Drug class: BCG
Therapeutic class: Antineoplastics
BCG vaccine is a lyophilized preparation of live, attenuated organisms of the Calmette-Guerin strain of Mycobacterium bovis that is used to stimulate active immunity to tuberculosis.
No enhanced Uses information available for this drug.
Generic name: BCG LIVE
Drug class: BCG
Therapeutic class: Antineoplastics
BCG vaccine is a lyophilized preparation of live, attenuated organisms of the Calmette-Guerin strain of Mycobacterium bovis that is used to stimulate active immunity to tuberculosis.
No enhanced Uses information available for this drug.
DRUG IMAGES
- BCG (TICE STRAIN) VIAL
The following indications for BCG (TICE STRAIN) (bcg live) have been approved by the FDA:
Indications:
Malignant tumor of urinary bladder
Prevention of recurrent bladder carcinoma
Professional Synonyms:
Bladder cancer
Bladder carcinoma
Bladder malignancy
Malignant neoplasm of bladder
Indications:
Malignant tumor of urinary bladder
Prevention of recurrent bladder carcinoma
Professional Synonyms:
Bladder cancer
Bladder carcinoma
Bladder malignancy
Malignant neoplasm of bladder
The following dosing information is available for BCG (TICE STRAIN) (bcg live):
The optimal dosage regimen for adjuvant therapy with intravesical BCG has not been established. Although no comparative studies have been performed, various strains of BCG appear to be effective. The dose amount expressed in milligrams varies according to the BCG strain.
The typical dose of BCG used for intravesical instillation is 1-8 x 108 colony-forming units (CFUs) for the TICE(R) strain of BCG or 10.5+-8.7 x 108 CFUs for the Theracys(R) strain of BCG.
Limited evidence suggests that intravesical therapy with lower doses of BCG may provide similar efficacy with reduced toxicity in patients with superficial bladder cancer; however, further study is needed to determine the comparative efficacy of low-dose BCG therapy. The addition of intradermal BCG does not affect outcome of intravesical BCG therapy and is not recommended.
Following surgery, the initial course of therapy is once weekly instillation of BCG for 6 consecutive weeks. A second 6-week course of therapy with intravesical BCG may be required for optimal response. An interval of rest between the 2 courses of therapy is necessary to avoid suppression of immune response and to optimize tumor response to intravesical BCG.
According to some clinicians, the optimal schedule for induction therapy in patients receiving intravesical BCG for carcinoma in situ consists of an initial 6-week course of once-weekly treatment followed by 6 weeks of rest and then once weekly treatment for 3 additional weeks. Although retreatment with BCG in patients experiencing recurrence of tumor following an initial complete response to BCG therapy often is effective, alternative therapy should be considered in patients with noninvasive papillary tumor that does not respond to two 6-week courses of BCG therapy. Patients with progression to T1 tumor or recurrence of either T1 tumor or carcinoma in situ within 3 months following completion of a single 6-week course of intravesical BCG are at high risk of developing muscle-invasive disease, and alternative therapy, such as cystectomy, should be considered.
In patients with BCG-refractory CIS of the urinary bladder who are not candidates for immediate cystectomy, intravesical therapy with valrubicin has been used.
Evidence from clinical trials indicates that long-term maintenance therapy with intravesical BCG increases rates of complete response and delays tumor recurrence in patients with superficial bladder cancer who are at high risk of progression and/or recurrence of disease. In a randomized trial of patients with papillary tumors (stage Ta or T1) at increased risk of recurrence or associated with CIS, the addition of maintenance therapy with a 3-week series of intravesical and percutaneous BCG administered once weekly at 3 and 6 months following an initial 6-week induction course and then every 6 months for 3 years delayed tumor recurrence compared with a single 6-week course of therapy; however, most patients did not receive all scheduled maintenance treatments because of adverse effects of BCG, and no effect on overall survival was demonstrated. Other investigators have reported maintenance therapy with once-monthly intravesical instillations of BCG for 1 year following completion of initial therapy.
The safety and efficacy of routine use of maintenance BCG therapy have not been fully determined, and maintenance therapy with BCG generally is associated with an increased incidence of adverse local and systemic effects. Further study is needed to establish an optimal schedule for intravesical BCG and to determine whether maintenance therapy prolongs survival.
The typical dose of BCG used for intravesical instillation is 1-8 x 108 colony-forming units (CFUs) for the TICE(R) strain of BCG or 10.5+-8.7 x 108 CFUs for the Theracys(R) strain of BCG.
Limited evidence suggests that intravesical therapy with lower doses of BCG may provide similar efficacy with reduced toxicity in patients with superficial bladder cancer; however, further study is needed to determine the comparative efficacy of low-dose BCG therapy. The addition of intradermal BCG does not affect outcome of intravesical BCG therapy and is not recommended.
Following surgery, the initial course of therapy is once weekly instillation of BCG for 6 consecutive weeks. A second 6-week course of therapy with intravesical BCG may be required for optimal response. An interval of rest between the 2 courses of therapy is necessary to avoid suppression of immune response and to optimize tumor response to intravesical BCG.
According to some clinicians, the optimal schedule for induction therapy in patients receiving intravesical BCG for carcinoma in situ consists of an initial 6-week course of once-weekly treatment followed by 6 weeks of rest and then once weekly treatment for 3 additional weeks. Although retreatment with BCG in patients experiencing recurrence of tumor following an initial complete response to BCG therapy often is effective, alternative therapy should be considered in patients with noninvasive papillary tumor that does not respond to two 6-week courses of BCG therapy. Patients with progression to T1 tumor or recurrence of either T1 tumor or carcinoma in situ within 3 months following completion of a single 6-week course of intravesical BCG are at high risk of developing muscle-invasive disease, and alternative therapy, such as cystectomy, should be considered.
In patients with BCG-refractory CIS of the urinary bladder who are not candidates for immediate cystectomy, intravesical therapy with valrubicin has been used.
Evidence from clinical trials indicates that long-term maintenance therapy with intravesical BCG increases rates of complete response and delays tumor recurrence in patients with superficial bladder cancer who are at high risk of progression and/or recurrence of disease. In a randomized trial of patients with papillary tumors (stage Ta or T1) at increased risk of recurrence or associated with CIS, the addition of maintenance therapy with a 3-week series of intravesical and percutaneous BCG administered once weekly at 3 and 6 months following an initial 6-week induction course and then every 6 months for 3 years delayed tumor recurrence compared with a single 6-week course of therapy; however, most patients did not receive all scheduled maintenance treatments because of adverse effects of BCG, and no effect on overall survival was demonstrated. Other investigators have reported maintenance therapy with once-monthly intravesical instillations of BCG for 1 year following completion of initial therapy.
The safety and efficacy of routine use of maintenance BCG therapy have not been fully determined, and maintenance therapy with BCG generally is associated with an increased incidence of adverse local and systemic effects. Further study is needed to establish an optimal schedule for intravesical BCG and to determine whether maintenance therapy prolongs survival.
No enhanced Administration information available for this drug.
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
BCG (TICE STRAIN) VIAL | Maintenance | Adults instill 50 mg by intravesical route once weekly for 6 weeks |
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
BCG (TICE STRAIN) VIAL | Maintenance | Adults instill 50 mg by intravesical route once weekly for 6 weeks |
The following drug interaction information is available for BCG (TICE STRAIN) (bcg live):
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 |
---|---|
BCG Vaccines/Mefloquine 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: Mefloquine may attenuate the immunization response to vaccines with attenuated live bacteria, such as BCG vaccine.(1) CLINICAL EFFECTS: Concurrent use may make the vaccine ineffective.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of mefloquine states that vaccinations with vaccines containing attenuated live bacteria should be completed three days before the initiation of mefloquine.(1) DISCUSSION: The manufacturer of mefloquine states that attenuation of immunization response to vaccines with attenuated live bacteria cannot be excluded and therefore the manufacturer of mefloquine states that vaccinations with vaccines containing attenuated live bacteria should be completed three days before the initiation of mefloquine.(1) |
MEFLOQUINE HCL |
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 |
Talimogene laherparepvec/Selected Immunosuppressants 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: Talimogene laherparepvec is a live, attenuated herpes simplex virus.(1) CLINICAL EFFECTS: Concurrent use of talimogene laherparepvec in patients receiving immunosuppressive therapy may cause a life-threatening disseminated herpetic infection.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Talimogene laherparepvec is contraindicated in immunosuppressed patients.(1) The magnitude of immunocompromise and associated risks due to immunosuppressant drugs should be determined by a physician. DISCUSSION: Concurrent use of talimogene laherparepvec in patients receiving immunosuppressive therapy may cause a life-threatening disseminated herpetic infection.(1) |
IMLYGIC |
Nadofaragene Firadenovec/Selected Immunosuppressants 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: Nadofaragene firadenovec may contain low levels of replication-competent adenovirus.(1) CLINICAL EFFECTS: Concurrent use of nadofaragene firadenovec in patients receiving immunosuppressive therapy may cause disseminated adenovirus infection.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Individuals who are immunosuppressed or immune-deficient should not receive nadofaragene firadenovec.(1) DISCUSSION: Nadofaragene firadenovec is a non-replicating adenoviral vector-based gene therapy but may contain low levels of replication-competent adenovirus. Immunocompromised persons, including those receiving immunosuppressant therapy, may be at risk for disseminated adenovirus infection.(1) |
ADSTILADRIN |
There are 4 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 BCG/Selected Antimycobacterials SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Bacillus Calmette-Guerin (BCG) is a live, attenuated strain of Mycobacterium bovis (M.bovis) used to induce a granulomatous response in the treatment of localized bladder cancer and as a vaccine to prevent tuberculosis.(1-2) Co-treatment with antibacterial agents active against M.bovis may lead to an attenuation of the immune response associated with BCG administration.(1-2) CLINICAL EFFECTS: The effectiveness of chemotherapy may be impaired, or the vaccine may be ineffective. Agents linked to this monograph may have activity against M.bovis: amikacin, capreomycin, ciprofloxacin, clofazimine, cycloserine, ethambutol, ethionamide, gatifloxacin, isoniazid, kanamycin, levofloxacin, moxifloxacin, ofloxacin, rifabutin, rifampin, rifapentine, and streptomycin. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Intravesical instillation of BCG should be postponed during treatment with antibacterials which may decrease effectiveness.(2) Administration of BCG vaccine to patients receiving antibiotic therapy should only be done under close medical supervision.(1) If a patient develops a systemic BCG infection due to intravesicular or vaccine administration, treatment with multiple antimycobacterial agents may be required. DISCUSSION: Because antibiotic therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of BCG vaccine states that administration of BCG vaccine to patients receiving antibiotic therapy should only be done under close medical supervision.(1) Pyrazinamide is not included in this interaction as BCG is not sensitive to pyrazinamide.(2) |
AMIKACIN SULFATE, ARIKAYCE, AVELOX IV, BAXDELA, CIPRO, CIPROFLOXACIN, CIPROFLOXACIN HCL, CIPROFLOXACIN-D5W, CLOFAZIMINE, CYCLOSERINE, ETHAMBUTOL HCL, GATIFLOXACIN SESQUIHYDRATE, ISONIAZID, KANAMYCIN SULFATE, LEVOFLOXACIN, LEVOFLOXACIN HEMIHYDRATE, LEVOFLOXACIN-D5W, MOXIFLOXACIN, MOXIFLOXACIN HCL, OFLOXACIN, PRIFTIN, RIFABUTIN, RIFADIN, RIFAMPIN, STREPTOMYCIN SULFATE, TALICIA, TRECATOR |
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 |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
Drug Interaction | Drug Names |
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COVID-19 Vaccines/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Immunosuppressants and immunomodulators may prevent the immune system from properly responding to the COVID-19 vaccine.(1,2) CLINICAL EFFECTS: Administration of a COVID-19 vaccine with immunosuppressants or immunomodulators may interfere with vaccine-induced immune response and impair the efficacy of the vaccine. However, patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: In an effort to optimize COVID-19 vaccine response, the American College of Rheumatology (ACR) published conditional recommendations for administration of COVID-19 vaccines with immunosuppressants and immunomodulators.(1) The CDC also provides clinical considerations for COVID-19 vaccination in patients on immunosuppressants.(2) The CDC states that all immunocompromised patients over 6 months of age should receive at least 1 dose of COVID-19 vaccine if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for specific recommendations based on age, vaccination history, and vaccine manufacturer.(2) The ACR states that in general, immunosuppressants and immunomodulators should be held for 1-2 weeks after each vaccine dose. See below for specific recommendations for certain agents.(1) The CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy.(2) Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted.(1,2) B-cell depleting agents, including rituximab: The ACR recommends consulting with the rheumatologist to determine optimal timing of COVID-19 vaccination. Measuring CD19 B cells may be considered to determine need for a booster vaccine dose. If B cell levels are not measured, a supplemental vaccine dose 2-4 weeks before the next scheduled dose of rituximab is recommended.(1) The CDC states that the utility of B-cell quantification to guide clinical care is not known and is not recommended. Patients who receive B-cell depleting therapy should receive COVID-19 vaccines about 4 weeks before the next scheduled dose. For patients who received 1 or more doses of COVID-19 vaccine during treatment with B-cell-depleting therapies that were administered over a limited period (e.g., as part of a treatment regimen for certain malignancies), revaccination may be considered. The suggested interval to start revaccination is about 6 months after completion of the B-cell-depleting therapy.(2) Abatacept: - Subcutaneous abatacept should be withheld for 1-2 weeks after each vaccine dose, as disease activity allows. - For intravenous abatacept, time administration so that vaccination will occur 1 week before the next abatacept infusion.(1) Cyclophosphamide: When feasible, administer cyclophosphamide one week after each COVID-19 vaccine dose.(1) Recipients of hematopoietic cell transplant or CAR-T-cell therapy who received one or more doses of COVID-19 vaccine prior to or during treatment should undergo revaccination following the current CDC recommendations for unvaccinated patients. Revaccination should start at least 3 months (12 weeks) after transplant or CAR-T-cell therapy.(2) TNF-alpha inhibitors and cytokine inhibitors: The ACR was not able to reach consensus on whether to modify dosing or timing of these agents with COVID-19 vaccination.(1) The CDC includes these agents in their general recommendation to hold therapy for at least 2 weeks following vaccination.(2) DISCUSSION: The ACR convened a COVID-19 Vaccine Guidance Task Force to provide guidance on optimal use of COVID-19 vaccines in rheumatology patients. These recommendations are based on limited clinical evidence of COVID-19 vaccines in patients without rheumatic and musculoskeletal disorders and evidence of other vaccines in this patient population.(1) The ACR recommendation for rituximab is based on studies of humoral immunity following receipt of other vaccines. These studies have uncertain generalizability to vaccination against COVID-19, as it is unknown if efficacy is attributable to induction of host T cells versus B cell (antibody-based) immunity.(1) The ACR recommendation for mycophenolate is based on preexisting data of mycophenolate on non-COVID-19 vaccine immunogenicity. Emerging data suggests that mycophenolate may impair SARS-CoV-2 vaccine response in rheumatic and musculoskeletal disease and transplant patients.(1) The ACR recommendation for methotrexate is based on data from influenza vaccines and pneumococcal vaccines with methotrexate.(1) The ACR recommendation for JAK inhibitors is based on concerns related to the effects of JAK inhibitors on interferon signaling that may result in a diminished vaccine response.(1) The ACR recommendation for subcutaneous abatacept is based on several studies suggesting a negative effect of abatacept on vaccine immunogenicity. The first vaccine dose primes naive T cells, naive T cell priming is inhibited by CTLA-4, and abatacept is a CTLA-4Ig construct. CTLA-4 should not inhibit boosts of already primed T cells at the time of the second vaccine dose.(1) |
COMIRNATY 2024-2025, MODERNA COVID 24-25(6M-11Y)EUA, NOVAVAX COVID 2024-2025 (EUA), PFIZER COVID 2024-25(5-11Y)EUA, PFIZER COVID 2024-25(6M-4Y)EUA, SPIKEVAX 2024-2025 |
The following contraindication information is available for BCG (TICE STRAIN) (bcg live):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 8 contraindications.
Absolute contraindication.
Contraindication List |
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Active tuberculosis |
HIV infection |
Hypogammaglobulinemia |
Immunosuppression |
Leukemia |
Malignant lymphoma |
Pregnancy |
Sarcoidosis |
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
Severe List |
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BCG infection |
Fever |
Hematuria |
Urinary tract infection |
There are 0 moderate contraindications.
The following adverse reaction information is available for BCG (TICE STRAIN) (bcg live):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 7 severe adverse reactions.
More Frequent | Less Frequent |
---|---|
Granulomatous prostatitis |
Hemorrhagic cystitis |
Rare/Very Rare |
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Abnormal hepatic function tests BCG infection Epididymitis Hepatitis Leukopenia |
There are 24 less severe adverse reactions.
More Frequent | Less Frequent |
---|---|
Bladder irritability Dysuria Fever Flu-like symptoms Hematuria Increased urinary frequency |
Acute abdominal pain Anorexia Chills Cramps Cystitis Dizziness Headache disorder Hyperhidrosis Malaise Myalgia Nocturia Skin rash Urinary incontinence Urinary tract infection Urinary urgency Weight loss |
Rare/Very Rare |
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Nausea and vomiting Prostatitis |
The following precautions are available for BCG (TICE STRAIN) (bcg live):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
None |
Severe Precaution
None |
Management or Monitoring Precaution
None |
Animal reproduction studies have not been performed with BCG vaccine. It is not known whether the vaccine can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Use of BCG vaccine during pregnancy is not recommended. For pregnant women who plan to travel to areas where the risk of exposure to tuberculosis is expected to be high, the CDC recommends that a tuberculin skin test be performed before and after travel.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for BCG (TICE STRAIN) (bcg live):
WARNING: This medication contains live bacteria that have been weakened to decrease the chances of causing an illness. However, this medication has rarely caused very serious, possibly fatal infections. Tell your doctor right away if you develop any signs of infection (such as fever that doesn't go away, chills, cough).
WARNING: This medication contains live bacteria that have been weakened to decrease the chances of causing an illness. However, this medication has rarely caused very serious, possibly fatal infections. Tell your doctor right away if you develop any signs of infection (such as fever that doesn't go away, chills, cough).
The following icd codes are available for BCG (TICE STRAIN) (bcg live)'s list of indications:
Malignant tumor of urinary bladder | |
C67 | Malignant neoplasm of bladder |
C67.0 | Malignant neoplasm of trigone of bladder |
C67.1 | Malignant neoplasm of dome of bladder |
C67.2 | Malignant neoplasm of lateral wall of bladder |
C67.3 | Malignant neoplasm of anterior wall of bladder |
C67.4 | Malignant neoplasm of posterior wall of bladder |
C67.5 | Malignant neoplasm of bladder neck |
C67.6 | Malignant neoplasm of ureteric orifice |
C67.7 | Malignant neoplasm of urachus |
C67.8 | Malignant neoplasm of overlapping sites of bladder |
C67.9 | Malignant neoplasm of bladder, unspecified |
Prevention of recurrent bladder carcinoma | |
C67 | Malignant neoplasm of bladder |
C67.0 | Malignant neoplasm of trigone of bladder |
C67.1 | Malignant neoplasm of dome of bladder |
C67.2 | Malignant neoplasm of lateral wall of bladder |
C67.3 | Malignant neoplasm of anterior wall of bladder |
C67.4 | Malignant neoplasm of posterior wall of bladder |
C67.5 | Malignant neoplasm of bladder neck |
C67.6 | Malignant neoplasm of ureteric orifice |
C67.7 | Malignant neoplasm of urachus |
C67.8 | Malignant neoplasm of overlapping sites of bladder |
C67.9 | Malignant neoplasm of bladder, unspecified |
D09.0 | Carcinoma in situ of bladder |
Formulary Reference Tool