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BCG vaccine live (Rx)Brand and Other Names:BCG Vaccine (Tice strain)

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

suspension reconstituted

  • 50mg (Tice BCG)
  • 81mg (TheraCys)
more...

Tuberculosis Immunization

Used as TB immunization, primarily in developing countries

ACIP recommended use: TB exposed health care workers in high risk settings

0.2-0.3 mL percutaneous

Conduct tuberculin test 2-3 months after percutaneous administration; if test negative repeat vaccination

Immunotherapy for Bladder Cancer

Initiate treatment 7-14 days after biopsy

TheraCys: Instill one dose into bladder; retain for 2 hr; repeat dose once weekly for 6 weeks followed by 1 treatment at 3, 6, 12, 18, and 24 months after initial treatment

TICE BCG: Instill one dose into blatter; retain for 2 hr; repeat dose once weekly for 6 weeks (may repeat cycle once) followed by once monthly for 6-12 months

Administration

Okay to give Hib, DTP, OPV, IPV, MMR, influenza, and hepatitis B at same time

Dosage Forms & Strengths

suspension reconstituted

  • 50mg (Tice BCG)
  • 81mg (TheraCys)
more...

Tuberculosis Immunization

Used as TB immunization, primarily in developing countries

ACIP recommended use: TB exposed TB skin test-negative infants and children

<1 month

  • Half-strength (reconstitute with 2 mL instead of 1 mL sterile water)
  • 0.2-0.3 mL percutaneous
  • Conduct tuberculin test 2-3 months after percutaneous administration; if test negative repeat vaccination after 1 year

>1 month

  • 0.2-0.3 mL percutaneous
  • Conduct tuberculin test 2-3 months after percutaneous administration; if test negative repeat vaccination

Additional Information

Okay to give Hib, DTP, OPV, IPV, MMR, influenza, and hepatitis B at same time

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Interactions

Interaction Checker

BCG vaccine live and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
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            Adverse Effects

            >10%

            Malaise (7-40%)

            Fever (17-38%)

            Pain (17%)

            Chills (9-34%)

            Nausea/vomiting (3-16%)

            Dysuria (52-60%)

            Hematutia (26-39%)

            Urinary urgency (6-18%)

            Infection (2-18%)

            Anemia (21%)

            Flu-lik syndrome (24-33%)

            1-10%

            Rash (2-3%)

            Diarrhea (6%)

            Abdominal pain (2-3%)

            Headache (2%)

            Leukopenia (6%)

            Genital inflammation /abscess (2%)

            Renal toxicity (10%)

            Hemorrhagic cystitis (9%)

            Nocturia (5%)

            Urinary incontinence (2-6%)

            Arthralgia/myalgia (3-7%)

            Pulmonary infection (3%)

            <1%

            Urea nitrogen in blood increased

            Creatinine increased

            Disseminated sepsis

            Hepatitis

            Coagulopathy

            Myoglobinuria

            Nephritis

            Uveitis

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            Warnings

            Black Box Warning

            Intravesical administration may cause disseminated infections

            Contains live attenuated mycobacteria (handle with care and dispose properly)

            Contraindications

            Hypersensitivity, immunosuppression (corticosteroids)

            Acquired immune deficiencies

            Active tuberculosis

            HIV infected patients

            Bladder

            • Febrile illness
            • Urinary tract infection
            • Gross hematuria
            • Biopsy
            • Transurethral resection
            • Traumatic catherization

            Cautions

            Bacillus Calmette-Guérin strain of Mycobacterium bovis

            Patient should have Mantoux skin test prior to vaccine administration

            Following vaccination, Mantoux skin test usually positive; this is not a sensitive indicator of degree of protection

            Immunity not permanent; duration unpredictable

            Treat anaphylactoid reactions immediately

            Intravesical administration may cause symptoms of bladder irritability 4-6 hr after instillation and increase in severity following each instillation; may last 24-72 hr

            Use caution in patients with small bladder capacity

            Postpone intravesical instillation during antibiotic therapy

            Vaccination not recommended for patients with positive PPD reaction

            Not for the treatment of active tuberculosis or prevention of cancer

            May not result in effective immunity in all patients

            Packaging may contain latex

            Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

            Up-to-date vaccination schedules available at www.cdc.gov/nip/publications

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Not known if excreted in breast milk, 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.

            more...
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            Pharmacology

            Mechanism of Action

            M. bovis strain in the vaccine, immunologically similar to M. tuberculosis, produces cell-mediated immunity and simulates M. tuberculosis infection

            May convey active immunity via stimulation of production of endogenously produced antibodies

            The onset of protection from disease is relatively slow, but duration is long lasting (years)

            In bladder cancer a local inflammatory reaction may lead to destruction of superficial tumor cells of the endothellium; stimulates the host's immune system to reject the tumor

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            Images

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            Formulary

            FormularyPatient Discounts

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            • Compare formulary status to other drugs in the same class.
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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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