BCG Vaccine

BCG vaccine live is a live vaccine used for immunization against tuberculosis and as immunotherapy for bladder cancer.

• BCG vaccine live is available under the following different brand names: BCG Vaccine (Tice strain)

Adult and pediatric dosage

Suspension reconstituted

• 50mg (Tice BCG)
• 81mg (TheraCys)

Tuberculosis Immunization

Adult dosage

• 0.2-0.3 mL percutaneous

Pediatric dosage

Children below 1 month age

• Half-strength (reconstitute with 2 mL instead of 1 mL sterile water)
• 0.2-0.3 mL percutaneous

Children above 1 month age

• 0.2-0.3 mL percutaneous

Immunotherapy for Bladder Cancer

• Initiate treatment 7-14 days after the biopsy
• TheraCys: Instill one dose into the 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 the cycle once) followed by once monthly for 6-12 months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of BCG vaccine live include:

• increased urination,
• painful urination,
• fever, and
• flu symptoms

Serious side effects of BCG vaccine live include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• chills,
• aches,
• weakness,
• flu-like symptoms,
• cough,
• pain or burning while urinating,
• a weak stream of urine,
• trouble emptying the bladder,
• blood in the urine,
• dark-colored urine,
• vomiting,
• upper stomach pain,
• yellowing of the skin or eyes,
• not feeling well, and
• burning, itching, odor, discharge, pain, tenderness, redness, or swelling of the genital or rectal area,

Rare side effects of BCG vaccine live include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, 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, health care provider, or pharmacist first.

• BCG vaccine live has severe interactions with the following drugs:
  • belimumab
  • certolizumab pegol
  • ibrutinib
  • ixekizumab
  • lomustine
  • mechlorethamine
  • melphalan
  • onasemnogene abeparvovec
  • oxaliplatin
  • procarbazine
  • secukinumab
• BCG vaccine live has serious interactions with at least 137 drugs.
• BCG vaccine live has moderate interactions with the following drugs:
  • anthrax immune globulin
  • belatacept
  • cytomegalovirus immune globulin (CMV IG)
  • hepatitis B immune globulin (HBIG)
  • imipenem/cilastatin
  • imipenem/cilastatin/relebactam
  • immune globulin IM (IGIM)
  • immune globulin IV (IGIV)
  • immune globulin SC
  • obinutuzumab
  • ponesimod
  • rabies immune globulin, human (RIG)
  • tetanus immune globulin (TIG)
  • vaccinia immune globulin intravenous
• BCG vaccine live has minor interactions with the following drugs:
  • chloroquine
  • Rho(D) immune globulin

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, 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 this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity, immunosuppression (corticosteroids)
• Acquired immune deficiencies
• Active tuberculosis
• HIV infected patients
• Bladder
  • Febrile illness
  • Urinary tract infection
  • Gross hematuria
  • Biopsy
  • Transurethral resection
  • Traumatic catheterization

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using BCG vaccine live?”

Long-Term Effects

• See “What Are Side Effects Associated with Using BCG vaccine live?”

Cautions

• Bacillus Calmette-Guérin strain of Mycobacterium bovis
• The patient should have a Mantoux skin test before vaccine administration
• Following vaccination, Mantoux skin test is usually positive; this is not a sensitive indicator of the 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

Pregnancy and Lactation

• Use with caution if benefits outweigh the risk during pregnancy
• Lactation
  • Not known if excreted in breast milk, not recommended.