Usual Adult Dose for Tuberculosis - Prophylaxis

Drop 0.2 to 0.3 mL of vaccine from syringe onto cleansed deltoid and spread over a 1 to 2 inch area using the edge of the multiple puncture device.

• Prepare vaccine, clean skin administration site on deltoid with alcohol or acetone sponge and allow to dry thoroughly.
• Position arm to maintain a horizontal surface where vaccine is to be placed.
• Drop vaccine on skin as described above.
• Grasp the arm firmly underneath, tensing the skin.
• Center the multiple puncture device over the vaccine area and apply firm downward pressure so that the device points are well buried in the skin; maintain pressure for 5 seconds - do no "rock" the device.
• Release pressure under arm and remove the device.
• If the points did not puncture the skin, repeat the above procedure.
• Spread the vaccine as evenly as possible over the puncture area with the edge of the device; an additional 1 to 2 drops of vaccine may be added to ensure a very wet vaccination site.
• Discard device in a biohazardous sharps container
• Loosely cover the site and keep dry for 24 hours.

Comments:

• Vaccination is reserved for patients with a less than 5 mm induration after testing with 5 tuberculin units (TU) of PPD tuberculin.
• The Mantoux skin test with 0.1 mL of 5 TU of PPD tuberculin is preferred, and is recommended to be performed prior to vaccination to demonstrate absence of tuberculosis infection.
• Fully explain the risks and benefits of this vaccine before administration.
• Tuberculin reactivity from vaccination should be documented.
• Perform a tuberculin skin test 2 to 3 months after vaccination; repeat vaccination for a negative response to a 5 TU tuberculin test.
• Immunization will not protect all susceptible individuals.

Use: Prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure

Usual Adult Dose for Urinary Tumor

One vial of BCG suspended in 50 mL preservative free saline, intravesically into the bladder, and retained for 2 hours before voiding

• Standard treatment is one treatment per week for 6 weeks.
• May repeat standard treatment once for lack of tumor remission if clinical situation warrants.
• After standard treatment, administer about monthly for at least 6 to 12 months

Comments:

• Not recommended for stage TaG1 papillary tumors unless they are judged to be high risk of recurrence.
• Do not inject subcutaneously or intravenously.
• Patients should not drink fluids for 4 hours before treatment.
• Patients should empty their bladders before treatment.
• Patients unable to retain the solution for 2 hours should be allowed to void sooner.
• During retention, the patient should be repositioned every 15 minutes, from left side to right side and lying on their back and abdomen to maximize bladder surface exposure.

Uses:

• Treatment and prophylaxis of carcinoma in situ of the urinary bladder
• Prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection

Usual Pediatric Dose for Tuberculosis - Prophylaxis

Children 1 month and older:
Drop 0.2 to 0.3 mL of vaccine from syringe onto cleansed deltoid and spread over a 1 to 2 inch area using the edge of the multiple puncture device.

• Prepare vaccine, clean skin administration site on deltoid with alcohol or acetone sponge and allow to dry thoroughly.
• Position arm to maintain a horizontal surface where vaccine is to be placed.
• Drop vaccine on skin as described above.
• Grasp the arm firmly underneath, tensing the skin.
• Center the multiple puncture device over the vaccine area and apply firm downward pressure so that the device points are well buried in the skin; maintain pressure for 5 seconds - do no "rock" the device.
• Release pressure under arm and remove the device.
• If the points did not puncture the skin, repeat the above procedure.
• Spread the vaccine as evenly as possible over the puncture area with the edge of the device; an additional 1 to 2 drops of vaccine may be added to ensure a very wet vaccination site.
• Discard device in a biohazardous sharps container
• Loosely cover the site and keep dry for 24 hours.

Infants under 1 month:

• Reduce dose by one half by using 2 mL of sterile water for injection when reconstituting.
• If response to a 5 TU tuberculin test is negative, AND indications for vaccination persist, administer a full dose after 1 year of age.

Comments:

• Vaccination is reserved for patients with a less than 5 mm induration after testing with 5 tuberculin units (TU) of PPD tuberculin.
• The Mantoux skin test with 0.1 mL of 5 TU of PPD tuberculin is preferred, and is recommended to be performed prior to vaccination to demonstrate absence of tuberculosis infection.
• Fully explain the risks and benefits of this vaccine before administration.
• Tuberculin reactivity from vaccination should be documented.
• Perform a tuberculin skin test 2 to 3 months after vaccination; repeat vaccination for a negative response to a 5 TU tuberculin test.
• Immunization will not protect all susceptible individuals.

Use: Prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING(S):

• This product contains live, attenuated mycobacteria.
• Because of the transmission risk, it should be prepared, handled, and disposed of as a biohazard material.
• BCG infections have been reported in health care workers, primarily from exposures from needle sticks or skin lacerations during preparation of the product.
• Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas where BCG was reconstituted.
• BCG is capable of dissemination when administered intravesically, and serious infections, including fatalities, have been reported in patients receiving BCG intravesically.

Safety and efficacy for treatment of superficial bladder cancer have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Do not administer intravenously, subcutaneously, intramuscularly or intradermally.

Storage requirements:

• Refrigerate; protect from light

Reconstitution/preparation techniques:

• To avoid cross contamination, do not prepare parenteral drugs in areas where this drug has been in use.
• Handle this product as potentially infectious; all equipment and materials used during reconstitution and administration should be disposed of as biohazardous material.
• The manufacturer product information should be consulted.

Patient advice:

• Immunization will not protect all susceptible individuals.
• Inform patients/guardians of risks and benefits, including variable efficacy data with this vaccine, interference with diagnosis of newly acquired tuberculosis infections, and potentially serious complications in immune compromised patients.
• No dressing is required after vaccination, but recommend loosely covering the site and keeping it dry for 24 hours.
• Keep vaccination site clean until the local reaction disappears.
• This vaccine contains live organisms.
• Although the vaccine won't survive long in a dry state, it is possible to infect others.
• After vaccination, small red papules usually appear within 10 to 14 days, after which they scale and slowly subside.
• Six months after vaccination there is usually no visible sign of the vaccination, although sometimes a faint pattern may still be visible.
• Patients who tend to form keloids may have more visible evidence of vaccination.
• Flu like symptoms may occur 24 to 48 hours after vaccination; patients should call their healthcare provider if fever is 103F or higher, or if local reactions last longer than 2 to 3 days.

Frequently asked questions

• Does the BCG vaccine for TB help with COVID-19 (coronavirus)?