Dosing & Uses
Dosage Forms & Strengths
intravesical solution
- 1-8 x 108; 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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (3)
- 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.
- ublituximab
ublituximab and BCG intravesical live both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
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%)
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
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.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
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Tice BCG intravesical - | 50 mg vial |  | |
| Tice BCG intravesical - | 50 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 (such as fever that doesn't go away, chills, cough).
USES: This medication is used to treat or prevent certain types of bladder cancer. 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: See also Warning section.Nausea, vomiting, loss of appetite, or diarrhea may occur. If any of these effects last or get worse, 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 you have any serious side effects, including: signs of bladder irritation (such as difficult/painful/frequent/bloody urination), muscle/joint pain, pain/swelling of the testes, unusual tiredness, fast/pounding heartbeat, shortness of breath, 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, get medical help right away 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.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. 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.Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (including HIV, certain cancers such as leukemia/lymphoma), radiation treatment, current infection/fever (such as bladder infection, active tuberculosis), certain blood vessel disease (aneurysm), injury/procedure in the bladder within the last 7 days (such as catheterization, biopsy, signs of bloody urine), man-made medical devices/parts in the body (such as 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 unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: 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.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.
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 medical and lab 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 October 2023. Copyright(c) 2023 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.
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
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