BCG vaccine

BCG vaccine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

BCG vaccine is an immunologic adjuvant that is FDA approved for the prophylaxis of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure. Common adverse reactions include percutaneous injection site reaction, nausea, axillary or cervical lymphadenopathy, , induration, cystitis, dysuria, hematuria, increased frequency of urination, urgent desire to urinate, influenza-like illness, malaise, shivering.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Tuberculosis; Prophylaxis

• BCG VACCINE (TICE® strain) is indicated for the prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure. As with any vaccine, immunization with BCG VACCINE may not protect 100% of susceptible individuals.

The Advisory Committee on Immunization Practices (ACIP) and the Advisory Committee for the Elimination of Tuberculosis has recommended that BCG vaccination be considered in the following circumstances.

• TB Exposed Tuberculin Skin Test-Negative Infants and Children

• BCG vaccination is recommended for infants and children with negative tuberculin skin tests who are (a) at high risk of intimate and prolonged exposure to persistently untreated or ineffectively treated patients with infectious pulmonary tuberculosis and who cannot be removed from the source of exposure and cannot be placed on long-term primary preventive therapy, or (b) continuously exposed to persons with infectious pulmonary tuberculosis who have bacilli resistant to isoniazid and rifampin, and the child cannot be separated from the presence of the infectious patient.

• TB Exposed Health Care Workers (HCW) in High Risk Settings

• BCG vaccination of HCWs should be considered on an individual basis in settings where (a) a high percentage of TB patients are infected with M. tuberculosis strains resistant to both isoniazid and rifampin, (b) transmission of such drug resistant M. tuberculosis strains to HCWs and subsequent infection are likely, and (c) comprehensive TB infection control precautions have been implemented and have not been successful. Vaccination should not be required for employment or for assignment of HCWs in specific work areas. HCWs considered for BCG vaccination should be counseled regarding the risks and benefits associated with both BCG vaccinations and TB preventive therapy.

• Exposed Health Care Workers in Low Risk Settings

• BCG vaccination is not recommended for HCWs in settings in which the risk for M. tuberculosis transmission is low.

• Dosing Information

• Preparation of Agent:

• The preparation of the BCG VACCINE suspension should be done using aseptic technique. To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG VACCINE has been prepared. A separate area for the preparation of the BCG VACCINE suspension is recommended. All equipment, supplies and receptacles in contact with BCG VACCINE should be handled and disposed of as biohazardous. The pharmacist or individual responsible for mixing the agent should wear gloves, and take precautions to avoid contact of BCG with broken skin. If preparation cannot be performed in a biocontainment hood, then a mask and gown should be worn to avoid inhalation of BCG organisms and inadvertent exposure to broken skin.

• Using aseptic methods, 1 mL of Sterile Water for Injection, USP at 4-25°C (39-77°F), is added to one vial of vaccine (see Pediatric Dose below for pediatric use). Gently swirl the vial until a homogenous suspension is obtained. Avoid forceful agitation which may cause clumping of the mycobacteria.

• Persons administering vaccines should take necessary precautions to minimize risk for spreading disease. Hands should be washed before each new patient is seen. Syringes and needles used for applications must be sterile and preferably disposable to minimize the risk of contamination. A separate needle and syringe should be used for each application. Disposable needles and the multiple puncture device should be discarded as biohazardous waste in labeled, puncture-proof containers to prevent inadvertent needlestick injury or reuse.{22} After use, any unused vaccine and all materials exposed to the product should be immediately placed in a biohazard container and disposed of in an appropriate manner.

• Reconstituted vaccine should be kept refrigerated, protected from exposure to direct sunlight, and used within 2 hours. Freezing of the reconstituted product is not recommended.

• Note: DO NOT filter the contents of the BCG VACCINE vial. Precautions should be taken to avoid exposing the BCG VACCINE to direct sunlight. Bacteriostatic solutions must be avoided. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstitution should result in a uniform suspension of the bacilli.

• Treatment and Schedule:

• BCG vaccination is reserved for persons who have a reaction of less than 5mm induration after skin testing with 5 TU of PPD tuberculin. The preferred method of skin testing is the Mantoux tuberculin skin-test using 0.1 mL of 5 tuberculin units (TU) of PPD.{3} It is recommended that a Mantoux skin-test be performed prior to BCG vaccination to demonstrate the absence of tuberculous infection.

• The vaccine is to be administered after fully explaining the risks and benefits to the vaccinee, parent, or guardian. BCG vaccination should not be given to individuals previously infected with M. tuberculosis. The vaccine is administered percutaneously utilizing a sterile multiple puncture device. The multiple puncture device consists of a plastic holder for a thin, wafer-like stainless steel plate 7/8" by 1 1/8", from which 36 points protrude. After the vaccine is prepared, the skin site is cleansed with an alcohol or acetone sponge and allowed to dry thoroughly.

Carcinoma in situ of bladder; Treatment and Prophylaxis

• Dosing Information

• Dosage

Malignant tumor of urinary bladder, Stage Ta and/or T1 papillary tumors following transurethral resection; Prophylaxis

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of BCG vaccine in adult patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of BCG vaccine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Tuberculosis; Prophylaxis

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of BCG vaccine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of BCG vaccine in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of BCG vaccine in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of BCG vaccine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of BCG vaccine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of BCG vaccine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of BCG vaccine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of BCG vaccine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of BCG vaccine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of BCG vaccine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of BCG vaccine with respect to specific gender populations.

Race

There is no FDA guidance on the use of BCG vaccine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of BCG vaccine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of BCG vaccine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of BCG vaccine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of BCG vaccine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of BCG vaccine in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of BCG vaccine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of BCG vaccine in the drug label.

Pharmacology

There is limited information regarding BCG vaccine Pharmacology in the drug label.

Mechanism of Action

Structure

File:BCG vaccine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of BCG vaccine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of BCG vaccine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of BCG vaccine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of BCG vaccine in the drug label.

How Supplied

Storage

There is limited information regarding BCG vaccine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of BCG vaccine in the drug label.

Precautions with Alcohol

• Alcohol-BCG vaccine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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