Drug Interactions between bcg and Hyolev MB

GENERALLY AVOID: Antibiotics may interfere with the anti-tumor activity of intravesical BCG, which contains a live, attenuated strain of Mycobacterium bovis. Some researchers have suggested that antibiotic therapy prior to or concurrently with BCG therapy may affect therapeutic efficacy via changes in the urinary microbiome. It is considered contraindicated to use intravesical BCG in patients with concurrent febrile illness, active tuberculosis, and/or urinary tract infections. Intravesical BCG is sensitive to most antibiotics, particularly those that are routinely used in the treatment of tuberculosis such as streptomycin, para-aminosalicylic acid (PAS), isoniazid (INH), rifampin, and ethambutol. It is reportedly not sensitive to pyrazinamide or cycloserine. Regardless of clinical susceptibility data, however, most antibacterials may still interfere with BCG in the bladder due to their high urinary recovery. One retrospective study in 276 high-risk non-muscle invasive bladder cancer patients receiving intravesical BCG reported a significantly higher 5-year recurrence-free survival rate in patients who did not receive antibiotic therapy than in those treated with long-course (>=7 days) antibiotics (ciprofloxacin, levofloxacin, cefaclor, cefpodoxime, or cefixime).

MANAGEMENT: Intravesical BCG should not be used in individuals with concurrent infections. For patients being treated with antibiotics, intravesical instillations of BCG should generally be postponed until completion of antibiotic therapy. If a bacterial urinary tract infection (UTI) occurs, therapy with intravesical BCG should be postponed or interrupted until complete resolution of the infection (e.g., negative urine culture and completion of antibiotic(s) and/or urinary antiseptic(s)), not only because antimicrobial administration may diminish the anti-tumor efficacy of BCG, but also because the combination of a UTI and BCG-induced cystitis may lead to more severe adverse effects in the genitourinary tract. There are no data to suggest that the acute, local urinary tract toxicity common with intravesical administration of BCG is due to mycobacterial infection, thus antituberculosis drugs should not be used to prevent or treat the local, irritative toxicities of intravesical BCG.

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MONITOR CLOSELY: The following interaction applies only to products containing sodium biphosphate that are used for bowel cleansing. It does not apply to products containing sodium biphosphate that are used for other, non-laxative related purposes.

Coadministration with agents that affect renal function or perfusion such as diuretics, ACE inhibitors, angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of acute phosphate nephropathy associated with the use of bowel-cleansing phosphate solutions. The risk and/or severity of fluid and electrolyte disturbances may also be increased, which can lead to serious adverse events including cardiac arrhythmias, seizures, and renal impairment. Acute phosphate nephropathy is a rare adverse event that presents as acute renal failure with minimal proteinuria and a bland urine sediment. Renal biopsy findings are consistent with nephrocalcinosis and include acute and/or chronic renal tubular injury, calcium-phosphate crystal deposition in the distal tubules and collecting ducts, and no other pattern of histological injury. The risk of acute phosphate nephropathy stems from the large phosphate load, fluid shifts, and decreased intravascular volume, which can be exacerbated in the presence of medications that affect renal perfusion or function. In reported cases, acute renal failure was typically diagnosed within two to five months of colonoscopy. These cases often resulted in permanent impairment of renal function, some requiring long-term dialysis.

MANAGEMENT: Caution is advised when bowel-cleansing phosphate preparations are prescribed in patients treated with agents that affect renal function or perfusion, particularly if they are frail or elderly. Bowel-cleansing phosphate preparations should not be used in patients who have impaired renal function or perfusion, dehydration, or uncorrected electrolyte abnormalities. In patients at risk for acute phosphate nephropathy, baseline and postprocedure labs including serum electrolytes, calcium, phosphate, BUN, and creatinine should be performed. Patients should be advised not to exceed the recommended dosage of their bowel-cleansing preparation and to drink sufficient quantities of clear fluids during before, during, and after bowel cleansing. Limited data suggest that administration of an electrolyte rehydration solution may attenuate the electrolyte abnormalities and hypovolemia. Hospitalization and intravenous fluid hydration may be appropriate for frail or elderly patients who may be unable to drink an adequate volume of fluid.

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