Version May 2024
BCG (intravesical) contains live, attenuated mycobacteria. Because of the potential risk for transmission, prepare, handle, and dispose of Bacillus Calmette-Guérin (BCG) as a biohazard material.
BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG (intravesical) for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas where BCG (intravesical) was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG.
Bladder cancer:
TICE BCG: Induction: Intravesicular: One dose (~50 mg or 1 vial) instilled into the bladder (retain for 2 hours) once weekly for 6 weeks beginning 7 to 14 days after biopsy (may repeat cycle 1 time if tumor remission not achieved), followed by maintenance therapy of ~50 mg (one vial) approximately once a month for at least 6 to 12 months.
Guideline recommendations: According to the American Urological Association/Society of Urologic Oncology guideline on the diagnosis and treatment of nonmuscle invasive bladder cancer, and the Society for Immunotherapy of Cancer clinical practice guideline on immunotherapy for the treatment of urothelial cancer, BCG (intravesical) induction and 1 year of maintenance therapy should be considered for intermediate-risk disease; in high-risk disease, induction and 3 years of maintenance therapy should be administered (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Bacterial urinary tract infection: Withhold BCG (intravesical) treatment until complete resolution of infection.
Persistent fever or acute febrile illness consistent with BCG infection: Discontinue BCG (intravesical) treatment. Begin therapy with 2 or more antimycobacterial agents (do not use single agent therapy) while conducting a diagnostic evaluation.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Genitourinary: Bladder mucosa irritation (bladder irritability: 60%), dysuria (52% to 60%), hematuria (26% to 38%), urinary frequency (40% to 50%), urinary urgency (6% to 50%)
Nervous system: Pain (17%)
Respiratory: Flu-like symptoms (24% to 33%)
Miscellaneous: Fever (17% to 20%)
1% to 10%:
Cardiovascular: Cardiac disorder (2%)
Dermatologic: Diaphoresis (3%), skin rash (≤3%)
Endocrine & metabolic: Weight loss (≤2%)
Gastrointestinal: Abdominal pain (2%), anorexia (≤2%), diarrhea (≤1%), nausea (≤7%), vomiting (≤3%)
Genitourinary: Bladder pain (≤4%), bladder spasm (≤8%; including contracted bladder), cystitis (6%), epididymitis (≤1%), hemorrhagic cystitis (9%), nocturia (5%), orchitis (≤1%), prostatitis (≤1%), pyuria (≤1%), urethritis (≤1%), urinary incontinence (2% to 4%), urinary tract infection (2%), urinary tract obstruction (≤1%), urine sedimentation abnormality (debris: 2%)
Hematologic & oncologic: Anemia (≤1%), disorder of hemostatic components of blood (≤1%), granuloma (hepatic: ≤1%), leukopenia (≤1%), thrombocytopenia (≤1%)
Hepatic: Hepatitis (≤1%)
Hypersensitivity: Hypersensitivity reaction (2%)
Infection: Abscess (genital; ≤2%), sepsis (BCG sepsis: ≤1%; including disseminated)
Nervous system: Chills (9%), dizziness (≤2%), fatigue (≤7%), headache (≤2%), malaise (≤7%), neurologic abnormality (≤1%), rigors (3%)
Neuromuscular & skeletal: Arthralgia (≤3%), arthritis (≤3%), myalgia (≤3%)
Respiratory: Pneumonitis (≤1%), respiratory system disorder (2%)
Miscellaneous: Inflammation (genital; ≤2%)
Frequency not defined:
Hepatic: Increased liver enzymes
Infection: BCG infection
Nervous system: Lethargy
Immunosuppressed patients or persons with congenital or acquired immune deficiencies whether due to concurrent diseases (eg, HIV infection, leukemia, lymphoma), cancer therapy (cytotoxic drugs, radiation therapy), or immunosuppressive therapy (eg, corticosteroids); tuberculosis (TB) disease (active TB); concurrent febrile illness, urinary tract infection, or gross hematuria; recent (TICE BCG: <7 to 14 days) biopsy, transurethral resection (TUR), or traumatic catheterization
Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to BCG (intravesical) or any component of the formulation; invasive bladder cancer; concomitant use with antituberculosis drugs, including streptomycin, para-aminosalicylic acid, isoniazid, rifampicin, and ethambutol; pregnancy; breastfeeding.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• BCG reaction: A systemic granulomatous illness occurring following exposure to BCG is referred to as a systemic BCG reaction when any of the following are present without another detectable etiology: Febrile episodes with flu-like symptoms lasting >72 hours; fever ≥39.5°C (103°F); pneumonitis; hepatitis; organ dysfunction outside of the GU tract with granulomatous inflammation; clinical signs of sepsis. It may be difficult to determine if reaction is due to infection process or inflammatory hypersensitivity. Fatalities have been reported with systemic BCG reactions. Local symptoms (prostatitis, epididymitis, orchitis) lasting >2 to 3 days may also suggest active infection.
• Bladder irritation: BCG (intravesical) may cause symptoms of bladder irritability which usually begin 4 to 6 hours after instillation and may last 24 to 72 hours; symptoms may increase in severity following each instillation.
• Disseminated infections: May cause disseminated (including fatal) infections following intravesical administration. Instillation to actively bleeding mucosa may promote systemic BCG infection or sepsis. To prevent serious infections, avoid trauma and/or introduction of contaminants into the urinary tract; postpone treatment for at least 1 to 2 weeks following TUR, biopsy, traumatic catheterization, or gross hematuria. Do not use in patients with concurrent infections. Use caution in patients with aneurysms and prosthetic devices; ectopic BCG infection may occur at these sites. Infection from BCG (intravesical) is not sensitive to pyrazinamide. Do not use prophylactic antimycobacterial therapy to prevent local adverse events during treatment (there is no data to support use and may alter efficacy). Determine PPD status prior to use (rule out tuberculosis [TB] disease [active TB] prior to treatment initiation). Prior to intravesical instillation, patients with a positive PPD test should be further assessed for signs and/or symptoms of TB infection (latent TB) or disease (active TB). BCG may persist in the urinary tract for several months after treatment; delayed manifestations of disseminated BCG infection may develop months to years after BCG therapy. Patients who receive immunosuppressive therapy after BCG therapy may be at higher risk for disseminated infection. Some male genitourinary tract infections (orchitis or epididymitis) have been refractory to multiple antituberculosis drug therapies and have required orchiectomy.
Disease-related concerns:
• Small bladder capacity: Intravesical instillation may be associated with increased risk of severe local reactions in the presence of small bladder capacity.
• Urinary tract infection: If a bacterial urinary tract infection occurs during therapy, withhold instillation until complete resolution of infection.
Dosage form specific issues:
• Latex: Packaging may contain natural latex rubber.
Special handling:
• Biohazard agent: BCG (intravesical) contains live, attenuated mycobacteria. Use appropriate biohazard precautions for handling and disposal. BCG is a biohazard; properly prepare, handle, and dispose of all equipment in contact with BCG as a biohazard material. BCG infections have been reported in health care workers due to accidental exposure (needle stick, skin laceration); nosocomial infections have been reported in patients (including immunosuppressed patients) receiving parenteral medications prepared in areas where BCG was prepared. To avoid cross contamination, do not prepare parenteral medications in an area where BCG has been prepared.
Other warnings/precautions:
• Appropriate use: BCG (intravesical) is not a vaccine for the prevention of cancer.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Intravesical [preservative free]:
Tice BCG: 50 mg (1 ea)
No
Suspension (reconstituted) (Tice BCG Intravesical)
50 mg (per each): $188.48
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Intravesical:
Oncotice: 50 mg (1 ea)
Verity-BCG: 40 mg (1 ea)
For intravesicular (bladder instillation) administration only; do not administer IV, SUBQ, IM, or intradermally.
Intravesicular: Patients should not drink fluids for 4 hours prior to instillation. Empty or drain bladder. Instill BCG (intravesical) by gravity; remove catheter after instillation is complete. Retain BCG (intravesical) for as long as possible, up to 2 hours. Patient should lie prone for at least 15 minutes, then rotate positions (lie on right side, left side, abdomen, and back) every 15 minutes to maximize bladder surface exposure. Following bladder instillation, patients should be instructed to void in a seated position in order to avoid the splashing of urine; burning may occur with the first void following therapy. Prior to flushing, disinfect the urine for 15 minutes with an equal amount of household bleach (this should be done for the first 6 hours after each instillation). After administration, patients should drink plenty of water in order to flush the bladder.
Hazardous agent (NIOSH 2016 [group 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
Bladder cancer: Treatment and prophylaxis of carcinoma in situ of the urinary bladder; prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection.
Limitations of use: BCG (intravesical) is not recommended for stage TaG1 (low-grade) papillary tumors unless judged to be at high risk for recurrence. BCG (intravesical) is not recommended for papillary tumors of stages higher than T1. BCG (intravesical) is not recommended for immunization against tuberculosis.
BCG (intravesical) may be confused with BCG vaccine (immunization)
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Antibiotics: May diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
Anti-CD20 B-Cell Depleting Therapies: May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Hexaminolevulinate: BCG (Intravesical) may diminish the diagnostic effect of Hexaminolevulinate. Risk X: Avoid combination
Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Methotrexate: May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Methotrexate may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Myelosuppressive Agents: May diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
Teplizumab: May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Ustekinumab: May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of infection may be increased. Ustekinumab may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Patients who may become pregnant should be advised to avoid pregnancy while on BCG (intravesical) therapy.
Animal reproduction studies have not been conducted. BCG (intravesical) is not recommended for use during pregnancy.
It is not known if BCG (intravesical) is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, a decision should be made to discontinue breastfeeding or avoid use of BCG (intravesical), taking into account the importance of BCG (intravesical) to the patient.
PPD test prior to initiation
Intravesical treatment: Monitor for signs/symptoms of toxicity/infection following every treatment. Signs that antituberculous therapy may be needed: Flu-like symptoms ≥72 hours, fever ≥101.3°F, systemic symptoms which worsen with each treatment, persistently abnormal liver function tests, prostatitis, epididymitis or orchitis of >2 to 3 day duration
BCG (intravesical) is an attenuated strain of bacillus Calmette-Guérin (Mycobacterium bovis) used as a biological response modifier. BCG, when used intravesicularly for treatment of bladder carcinoma in situ, is thought to cause a local, chronic inflammatory response involving macrophage and leukocyte infiltration of the bladder. BCG (intravesical) is active immunotherapy which stimulates the host's immune mechanism to reject the tumor.
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