BCG intravesical live (Rx)

Brand and Other Names:Tice BCG
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravesical solution

  • 1-8 x 10&sup8; CFU/vial

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 hr and then voided

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 hr and then voided

Not recommended

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Interactions

Interaction Checker

and BCG intravesical live

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (2)

            • ceftaroline

              ceftaroline decreases effects of BCG intravesical live by pharmacodynamic antagonism. Contraindicated. Contraindicated; wait until antibiotic treatment completed.

            • certolizumab pegol

              certolizumab pegol decreases effects of BCG intravesical live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            Serious - Use Alternative (9)

            • beclomethasone, inhaled

              beclomethasone, inhaled increases effects of BCG intravesical live by Other (see comment). Avoid or Use Alternate Drug. Comment: May interfere with response to intravesicle TICE BCG response.

            • bedaquiline

              BCG intravesical live decreases effects of bedaquiline by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid concomitant use of intravesical BCG and antibiotics, particulary those given via IV or oral routes and those with activity against mycobacteria.

            • cabazitaxel

              cabazitaxel decreases effects of BCG intravesical live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

            • hydroxyurea

              hydroxyurea decreases effects of BCG intravesical live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).

            • imipenem/cilastatin

              imipenem/cilastatin decreases effects of BCG intravesical live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Intravesical BCG prescribing information states that antimicrobial therapy for other infections may interfere with the effectiveness of BCG intravesical. Antibiotics with activity against mycobacteria are of the greatest concern; however, avoiding all antimicrobial therapy during treatment is currently recommended.

            • imipenem/cilastatin/relebactam

              imipenem/cilastatin/relebactam decreases effects of BCG intravesical live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Intravesical BCG prescribing information states that antimicrobial therapy for other infections may interfere with the effectiveness of BCG intravesical. Antibiotics with activity against mycobacteria are of the greatest concern; however, avoiding all antimicrobial therapy during treatment is currently recommended.

            • methotrexate

              methotrexate decreases effects of BCG intravesical live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ocrelizumab

              ocrelizumab decreases effects of BCG intravesical live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of ocrelizumab with BCG intravesical because immunosuppressive effects may decrease the efficacy of BCG intravesical.

            • rifaximin

              rifaximin decreases effects of BCG intravesical live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Suspend BCG intravesical live therapy during antibiotic therapy.

            Monitor Closely (2)

            • ponesimod

              ponesimod and BCG intravesical live both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • siponimod

              siponimod and BCG intravesical live both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            Minor (0)

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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

              Mechanism of Action

              Live, attenuated strain of bacillus Calmette-Guerin Mycobacterium bovis; stimulates immune response when used intravesiularly for treatment of bladder carcinoma in situ; superficial tomor cells of the urothelium are destroyed following a local inflammatory response where macrophage and leukocyte infiltration of the bladder.

              Pharmacokinetics

              No studies conducted

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              Administration

              Intravesicular Bladder 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 4°C-25°C (39°F-77°F), 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

              Retain in bladder 2 hr and then voided

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              Images

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              Patient Handout

              Patient Education
              BCG live intravesical

              BCG - INTRAVESICAL

              COMMON BRAND NAME(S): Theracys

              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 (e.g., high/persistent fever).

              USES: This medication is used to treat a certain type of bladder cancer (carcinoma in situ-CIS) and prevent it from returning. It is also used to prevent another type of bladder cancer (papillary tumor) from returning after surgery to remove it. This medication works by causing the body's defense system (immune system) to become more active.This form of the medication is not used to prevent tuberculosis.

              HOW TO USE: This medication is given into the bladder through a tube (catheter) by a health care professional as directed by your doctor. This medication is usually given weekly for the first 6 weeks and then less often thereafter as directed by your doctor.Do not drink any fluids for 4 hours before treatment. The medication is left in the bladder for up to 2 hours and then released by urinating. Follow your doctor's instructions carefully. There may be some burning pain when you first urinate. Since the urine contains live bacteria that may infect you or others, you must sit down to urinate for 6 hours after treatment to avoid splashing of the urine. After each time you urinate during this 6-hour period, pour household bleach (about the same amount of bleach as the amount of urine) into the toilet, then wait 15 minutes before flushing. Always wash your hands afterward. Talk to your doctor about other important things you must do to prevent infection.Drink plenty of fluids after your first urination unless otherwise directed by your doctor. Doing so helps clear the medication from your body.

              SIDE EFFECTS: Bladder irritation (e.g., difficult/painful/frequent/bloody urination), fever, or chills may occur. High/persistent fever may be a sign of an infection. Tell your doctor or pharmacist promptly if any of these effects occur, persist, or worsen. Your doctor may prescribe additional medications to help control these symptoms. Nausea, vomiting, loss of appetite, or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: muscle/joint pain, pain/swelling of the testes, unusual tiredness, fast/pounding heartbeat, shortness of breath, cough, vision changes, redness/swelling/pain in the eye, eye sensitivity to light, severe stomach/abdominal pain, yellowing skin/eyes.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: immune system problems (including HIV, certain cancers such as leukemia/lymphoma), radiation treatment, current infection/fever (e.g., bladder infection, active tuberculosis), injury/procedure in the bladder within the last 7 days (e.g., catheterization, biopsy, signs of bloody urine).Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood vessel disease (aneurysm), man-made medical devices/parts in the body (e.g., pacemakers, artificial joints, arterial grafts).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is recommended that women receiving this medication avoid pregnancy. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.This drug should not be used with the following medications because very serious interactions may occur: antibiotics (including isoniazid, rifampin, penicillins such as amoxicillin, macrolides such as erythromycin), drugs that weaken the immune system (including abatacept, corticosteroids such as prednisone, cancer chemotherapy), mefloquine.If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting BCG vaccine.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.This medication may interfere with the tuberculosis (TB) skin test, possibly causing false test results. If a skin test is needed, it is recommended that patients finish it before treatment.This document does not contain all possible interactions. Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Keep all regular medical and laboratory appointments.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor right away for a new dosing schedule.

              STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.