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BCG intravesical live (Rx)Brand and Other Names:TheraCys, Tice BCG

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravesical solution

  • 1-8 x 10^8CFU/vial
  • 10^8-10^9CFU/vial
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Carcinoma in Situ (CIS) of the Urinary Bladder

Tice BCG: 1 vial of Tice BCG suspended in preservative-free saline 50 mL instilled into bladder by gravity flow via catheter; agent should be retained in bladder 2 hours and then voided

TheraCys: One dose consists of intravesical instillation of BCG 81 mg; insert catheter into bladder under aseptic conditions and drain bladder; instill 53 mL suspension of TheraCys slowly by gravity, begin 7-14 days after biopsy or transurethral resection

  • Induction: administer 1 dose each week for 6 consecutive weeks
  • Maintenance, administer 1 dose 3, 6, 12, 18, and 24 months following initial dose

Papillary Tumors

Indicated for prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR)

Limitations: BCG live is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence

Tice BCG: 1 vial of Tice BCG suspended in preservative-free saline 50 mL instilled into bladder by gravity flow via catheter; agent should be retained in bladder 2 hours and then voided

TheraCys: One dose consists of intravesical instillation of BCG 81 mg; insert catheter into bladder under aseptic conditions and drain bladder; instill 53 mL suspension of TheraCys slowly by gravity, begin 7-14 days after biopsy or transurethral resection

  • Induction: administer 1 dose each week for 6 consecutive weeks
  • Maintenance, administer 1 dose 3, 6, 12, 18, and 24 months following initial dose

Tice BCG Administration

Patients should not drink fluids for 4 hours before treatment and should empty their bladder prior to Tice BCG administration

Draw 1 mL of sterile diluent (preservative-free NS) at 4C-25C (39F-77F), into a small syringe and add to one ampule to resuspend

Leave them in contact for about 1 minute

Then mix the suspension by withdrawing it into the syringe and expelling it gently back into the ampule 2 or 3 times

Avoid the production of foam; do not shake

Dilute the reconstituted product in an additional 49 mL of saline diluent, bringing the total volume to 50 mL

Instill into bladder slowly by gravity flow, via the catheter

Administration

See also BCG vaccine

Monitor q3Months for recurrence/progression of CIS

Not recommended

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Interactions

Interaction Checker

BCG intravesical live and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dysuria (60%)

            Urinary frequency (50%)

            Hematuria (39%)

            Fever (38%)

            Chills (34%)

            Flu like syndrome (33%)

            Cystitis (29%)

            Anemia (21%)

            Urinary urgency (18%)

            UTI (18%)

            Pain (17%)

            Nausea (16%)

            Vomiting (16%)

            Anorexia (11%)

            Nocturia (11%)

            Leukopenia (5%)

            1-10%

            Genital pain (10%)

            Renal toxicity (10%)

            Arthralgia (7%)

            Myalgia (7%)

            Urinary incontinence (7%)

            Urinary retention (6%)

            Abdominal pain (5%)

            Coagulopathy (<5%)

            Constipation (<5%)

            Contracted bladder (5%)

            Pulmonary infection (<5%)

            Skin rash (<5%)

            Thrombocytopenia (<5%)

            Diarrhea (3%)

            Rigors (3%)

            Respiratory unclassified (2%)

            Weight loss (2%)

            Hepatic granuloma (1%)

            Hepatitis (1%)

            Pneumonitis (1%)

            Urethritis (1%)

            Urinary obstruction (1%)

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            Warnings

            Black Box Warnings

            Contains live, attenuated mycobacteria; potential risk for transmission

            Prepare, handle, and dispose of as a biohazardous material

            BCG infections have been reported in health care providers, primarily from exposures resulting from accidental needle sticks or skin lacerations during preparation for administration

            Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG live was reconstituted

            Capable of infection dissemination when administered by intravesical route; serious infections, including fatal infections, have been reported

            Contraindications

            Immunosuppression (any cause), febrile illness, active tuberculosis

            Perforated bladder mucosa

            Cautions

            May cause tuberculin sensitivity

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: excretion in milk unknown/not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Half-Life: no studies conducted

            Metabolism: no studies conducted

            Excretion: no studies conducted

            Mechanism of Action

            Live, attenuated Mycobacterium bovis; stimulates immune response

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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