Bcg Vaccine (Tice Strain) (BCG vaccine, live/PF)
Last reviewed · Source: First Databank (FDB) drug data
Overview
BCG vaccine is a lyophilized preparation of live, attenuated organisms of the Calmette-Guerin strain of Mycobacterium bovis that is used to stimulate active immunity to tuberculosis infection.
BCG vaccine is a lyophilized preparation of live, attenuated organisms of the Calmette-Guerin strain of Mycobacterium bovis. BCG vaccine commercially available in the US contains the TICE substrain of BCG and is administered by percutaneous administration via a multiple-puncture device.
Vaccination with BCG promotes trained immunity mediated by innate immune cells such as monocytes, macrophages, and natural killer cells.
USES: This vaccine is used to help prevent tuberculosis (TB). It is recommended for people who have not been infected with the disease but are at an increased risk of getting it. Those at increased risk include certain health care personnel and children who live with or spend much time with people with tuberculosis.
This vaccine contains live bacteria that have been weakened. It works by increasing the body's natural defense (immunity) against the bacteria. Vaccines may not fully protect everyone who receives them.
This form of the vaccine is not used to treat or prevent bladder cancer.
Generic name: BCG vaccine, live/PF
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Bcg Vaccine (Tice Strain)
Indications
The following indications are listed for Bcg Vaccine (Tice Strain):
- Tuberculosis Prophylaxis
Also known as: Tb Prophylaxis.
Dosing
No dosing information is available for this tab.
BCG vaccine is administered percutaneously in the deltoid region using a sterile, single-use, multiple-puncture device; the vaccine should not be administered IV, intramuscularly, subcutaneously, or intradermally.
BCG vaccine for percutaneous administration is commercially available as a lyophilized powder; the powder should be reconstituted prior to administration. To prepare an adult dose, reconstitute the vaccine by adding 1 mL of sterile water for injection to one single-dose vial of the vaccine. To prepare a pediatric dose, reconstitute the vaccine by adding 2 mL of sterile water for injection to one single-dose vial of the vaccine. Gently swirl the vial until a homogenous suspension is obtained; avoid forceful agitation of the vial. Do not filter the contents of the vial. The reconstituted vaccine should be kept refrigerated (do not freeze), protected from direct sunlight, and used within 2 hours. Discard any unused portions.
To administer the vaccine, prepare and clean the skin. Drop the immunizing dose (0.2-0.3 mL) of BCG onto the surface of the skin and spread over a 1 by 2 inch area using the multiple-puncture device. An additional 1-2 drops of the vaccine may be added to ensure a very wet vaccination site. Loosely cover the site and keep dry for 24 hours after administration.
Store intact vials of BCG vaccine refrigerated (2-8degreesC) and protect from direct sunlight.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Individuals with impaired immunologic responses because of HIV infection, congenital immunodeficiency (e.g., chronic granulomatous disease or interferon gamma receptor deficiency), leukemia, lymphoma, or generalized malignancy.
*Individuals who are immunosuppressed as a result of steroid use or treatment with alkylating agents, antimetabolites, or radiation.
*HIV-infected or immunocompromised infants, children, or adults.
*Individuals with allergies to any component of the vaccine or an anaphylactic or allergic reaction to a previous dose.
*Individuals with active tuberculosis (TB).
*Infants, children, or adults with severe immune deficiency syndromes, and children with a family history of immune deficiency disease.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Local reactions are common after BCG vaccination.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
BCG vaccine is used in pediatric patients. Infants younger than 1 month of age should receive 1/2 of the usual dose.
It is not known whether BCG vaccine can cause fetal harm if administered during pregnancy. Animal reproduction studies have not been conducted with the vaccine. CDC recommends that pregnant women not receive BCG vaccination pending further studies to support safety in this population.
It is not known whether BCG vaccine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from BCG in nursing infants, a decision should be made whether to discontinue nursing or not to vaccinate, taking into account the importance of tuberculosis vaccination to the mother.
Clinical studies did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in response between elderly and younger patients. An intact immune system is a prerequisite for BCG vaccination. If the immune status of an elderly patient, or any patient, is in question, withhold BCG vaccination until immune status has been evaluated.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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