Version May 2024
Note: Dosing and administration based on US percutaneous product (TICE strain); formulation/dosing/route may vary in other regions (consult local product labeling). If neonate known to be HIV-infected, vaccination is not recommended (Ref).
Immunization against tuberculosis: Percutaneous: Half-strength dilution: 0.2 to 0.3 mL as a single dose. Administer tuberculin test after 2 to 3 months; repeat vaccination after 1 year of age for negative tuberculin test if indications persist. Note: Initial lesion usually appears after 10 to 14 days consisting of small, red papule at injection site and reaches maximum diameter of 3 mm in 4 to 6 weeks.
Note: Dosing and administration based on US percutaneous product (TICE strain); formulation/dosing/route may vary in other regions (consult local product labeling). According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (Ref).
Immunization against tuberculosis: Infants, Children, and Adolescents: Percutaneous: Full-strength: 0.2 to 0.3 mL as a single dose; conduct postvaccinal tuberculin test in 2 to 3 months; if test is negative, repeat vaccination (at age ≥1 year). Note: Initial lesion usually appears after 10 to 14 days consisting of small, red papule at injection site and reaches maximum diameter of 3 mm in 4 to 6 weeks.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Bacillus Calmette-Guerin (BCG) percutaneous vaccine (US product, consult local product information for non-US vaccine): Drug information")
Note: Dosing and administration based on US percutaneous product (TICE strain); formulation/dosing/route may vary in other regions (consult local product labeling).
Immunization against tuberculosis: Percutaneous: 0.2 to 0.3 mL (full-strength dilution); conduct postvaccinal tuberculin test in 2 to 3 months; if test is negative, repeat vaccination. Note: Initial lesions usually appear after 10 to 14 days and consist of small, red papules at injection site, which reach maximum diameter of 3 mm in 4 to 6 weeks.
Prevention of leprosy (off-label use): Percutaneous: 0.2 to 0.3 mL (full-strength dilution); a single dose offers partial protection against leprosy; an additional dose may confer greater protection, however, studies do not specify appropriate interval (Ref). Note: Timing of vaccination and chemoprophylaxis should be taken into consideration since chemoprophylaxis may kill BCG (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Local reactions may persist for up to 3 months; more severe manifestations may occur up to 5 months after vaccination and persist for several weeks.
Frequency not defined:
Dermatologic: Pustules (at injection site), skin ulceration at injection site
Hematologic & oncologic: Cervical lymphadenopathy, lymphadenitis (includes local and suppurative), lymphadenopathy (axillary)
Infection: BCG infection (BCG osteomyelitis; may occur from 4 months to 2 years after vaccination)
Local: Induration at injection site, injection site lesion, itching at injection site, tenderness at injection site
Respiratory: Flu-like symptoms
Prior hypersensitivity to the vaccine or any component of the formulation; immunosuppressed patients or persons with congenital or acquired immune deficiencies (eg, HIV infection, leukemia, lymphoma, cancer therapy, immunosuppressive therapy such as corticosteroids); active tuberculosis (TB) disease (active TB).
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]).
• BCG reaction: Local adverse effects may include moderate axillary or cervical lymphadenopathy and induration/pustule formation at the injection site; lasting as long as 3 months or more. Severe ulceration, regional suppurative lymphadenitis with draining sinuses, and caseous lesions or purulent drainage may occur within 5 months and persist for several weeks. Systemic adverse effects lasting 1 to 2 days and similar to a flu-like syndrome (fever, anorexia, myalgia, and neuralgia) are generally caused by hypersensitivity to the vaccine.
• Disseminated infections: May cause BCG infection, particularly in immunocompromised patients. If signs and symptoms of a systemic BCG infection occur (eg, fever of ≥103°F or acute local reactions lasting longer than 2 to 3 days), permanently discontinue BCG vaccination and begin therapy with ≥2 antimycobacterial agents while conducting a diagnostic evaluation. Infection from vaccine is not sensitive to pyrazinamide. BCG osteomyelitis affecting the epiphyses of the long bones is the most common disseminated infection and may occur 4 months to 2 years after vaccination.
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]).
• HIV: Use is contraindicated in persons with HIV (ACIP [Kroger 2023]). Should be administered with caution to persons in groups at high risk for HIV. Persons with HIV thought to be infected with Mycobacterium tuberculosis should be strongly recommended for tuberculosis preventive therapy.
Concurrent drug therapy issues:
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or non-live) for which a person is eligible at a single visit, unless contraindications exist (ACIP [Kroger 2023]).
Special populations:
• Altered immunocompetence: Use is contraindicated in immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]). Household and close contacts of persons with altered immunocompetence may receive most age-appropriate vaccines (ACIP [Kroger 2023]). Live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible; live vaccines should not be administered for at least 3 months after immunosuppressive therapy (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
• Positive PPD reaction: Determine PPD status prior to use. BCG vaccination is not recommended for persons with a positive PPD reaction.
Special handling:
• Biohazard agent: Contains live, attenuated mycobacteria. Use appropriate precautions for handling and disposal. BCG is a biohazard; proper preparation technique, handling, and disposal of all equipment in contact with BCG as a biohazard material is recommended. BCG infections have been reported in healthcare workers due to accidental exposure (needlestick, skin laceration); nosocomial infections have been reported in patients receiving parenteral medications prepared in areas where BCG was prepared. To avoid cross contamination, do not prepare parenteral medications in an area where BCG has been prepared.
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen prior to vaccination to prevent fever decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Appropriate use: BCG vaccine should not be used for the treatment of tuberculosis (TB) disease (active TB).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection:
Generic: 50 mg (1 ea)
Yes
Solution (reconstituted) (BCG Vaccine Injection)
50 mg (per each): $188.48
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Note: Administration based on US percutaneous product (TICE strain); formulation/dosing/route may vary in other regions (consult local product labeling).
Percutaneous: Should only be given percutaneously; do not administer IV, SubQ, IM, or intradermally. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (Ref). Apply vaccine with syringe and needle by dropping onto 1- to 2-inch area of horizontally positioned surface of cleansed, dry site (deltoid region of arm preferred); pulling skin tight, puncture skin with multiple puncture device centered over the vaccine; apply pressure for 5 seconds (do not “rock” device). After successful puncture, spread vaccine evenly using the edge of the device over puncture area; an additional 1 to 2 drops of vaccine may be added to ensure a very wet vaccination site. Apply loose covering and keep dry for 24 hours. When used for immunization against tuberculosis, US federal law requires that the name of medication; date of administration; the vaccine manufacturer; lot number of vaccine; and the administering person's name, title, and address be entered into the patient's permanent medical record. Multiple puncture device for vaccination available from Organon Teknika (1-800-662-6842).
Note: Administration based on US percutaneous product (TICE strain); formulation/dosing/route may vary in other regions around the globe (consult local product labeling).
Should only be given percutaneously; do not administer IV, SubQ, IM, or intradermally. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (Ref).
Apply vaccine with syringe and needle by dropping onto 1 to 2 inch area of horizontally positioned surface of cleansed, dry site (deltoid region of arm preferred); pulling skin tight, puncture skin with multiple puncture device centered over the vaccine; apply pressure for 5 seconds (do not "rock" device). After successful puncture, spread vaccine evenly using the edge of the device over puncture area; an additional 1 to 2 drops of vaccine may be added to ensure a very wet vaccination site. Apply loose covering and keep dry for 24 hours.
When used for immunization against tuberculosis, US federal law requires that the name of medication, date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.
Hazardous agent (NIOSH 2016 [group 1]).
Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.
NIOSH recommends double gloving, a protective gown, and ventilated engineering controls (a class II biological safety cabinet or a compounding aseptic containment isolator), and closed system transfer devices (CSTDs) for preparation. Double gloving and a gown are required during administration (NIOSH 2016).
Store intact vials at 2°C to 8°C (36°F to 46°F). Protect from sunlight. Store reconstituted vaccine in refrigerator; use within 2 hours of mixing. Do not freeze vaccine after reconstitution.
Active immunization against Mycobacterium tuberculosis in persons not previously infected and who are at high risk for exposure (FDA approved in all ages); has also been used for the prevention of leprosy
BCG vaccine is not routinely administered for the prevention of M. tuberculosis in the US. The Center for Disease Control and Prevention (CDC) recommends vaccination be considered for the following (CDC 2011):
• Infants and children with a negative tuberculin skin test who are continually exposed to (and cannot be separated from) persons who are untreated or ineffectively treated for TB disease when the child cannot be given long-term treatment for infection or continual exposure to persons with TB caused by strains resistant to isoniazid and rifampin.
• Health care workers with a high percentage of patients with M. tuberculosis strains resistant to both isoniazid and rifampin, if there is ongoing transmission of the resistant strains and subsequent infection is likely, or if comprehensive infection-control precautions have not been successful. In addition, health care workers should be counseled on the risks and benefits of vaccination and treatment of latent TB infection.
BCG (intravesical) to treat bladder cancer may be confused with BCG (vaccine) for immunization
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Antibiotics: May diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Anti-CD20 B-Cell Depleting Therapies: May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Risk C: Monitor therapy
Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Etrasimod: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Etrasimod may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Immune Globulins: May diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Leniolisib: May diminish the therapeutic effect of Vaccines (Live). Risk C: Monitor therapy
Methotrexate: May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Methotrexate may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Rabies Immune Globulin (Human): May diminish the therapeutic effect of Vaccines (Live). Management: Avoid administering the measles vaccine within 4 months after administration of rabies immune globulin. Avoid administering other live vaccines within 3 months after administration of rabies immune globulin. Risk D: Consider therapy modification
Teplizumab: May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Teplizumab: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccines-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tezepelumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tralokinumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: Consider therapy modification
Ustekinumab: May enhance the adverse/toxic effect of BCG Products. Specifically, the risk of infection may be increased. Ustekinumab may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Vaccines (Live): May diminish the therapeutic effect of other Vaccines (Live). Management: Two or more injectable or nasally administered live vaccines not administered on the same day should be separated by at least 28 days (ie, 4 weeks). If not, the vaccine administered second should be repeated at least 4 week later. Risk C: Monitor therapy
In general, women should avoid conception for 4 weeks after vaccination with live vaccines (ACIP [Kroger 2023]).
Animal reproduction studies have not been conducted. BCG vaccine is not recommended for use in pregnant women. Because of the theoretical risk to the fetus, women known to be pregnant generally should not receive live, attenuated virus vaccines (ACIP [Kroger 2023]).
PPD test prior to vaccination and 2 to 3 months postvaccination. Monitor for flu-like symptoms ≥72 hours, fever ≥103°F, acute local reactions lasting >2 to 3 days. Monitor for syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
BCG vaccine is an attenuated, live bacterial culture of the Bacillus of Calmette and Guérin (BCG) strain of Mycobacterium bovis and induces active immunity against Mycobacterium tuberculosis.
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