Description
Bacillus Calmette-Guérin (BCG) vaccine is given by injection to help prevent tuberculosis (TB). TB is a serious disease that can cause severe illness. It is spread by close contact with people who already have TB, such as people living in the same house. Some infected people do not appear to be sick, but they can still spread TB to others. BCG vaccine does not provide 100% protection. Therefore it is important to avoid people with TB, even if you have received the vaccine.
BCG vaccine is to be administered only by or under the direct supervision of a doctor.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
BCG vaccine has been used widely in children, and it has not been reported to cause different side effects or problems in children than it does in adults.
Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of BCG vaccine in the elderly with use in other age groups.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Abarelix
- Abemaciclib
- Abiraterone
- Acalabrutinib
- Adagrasib
- Ado-Trastuzumab Emtansine
- Afamitresgene Autoleucel
- Afatinib
- Aldesleukin
- Alectinib
- Alemtuzumab
- Alpelisib
- Altretamine
- Aminoglutethimide
- Aminolevulinic Acid
- Amivantamab-vmjw
- Anastrozole
- Apalutamide
- Arsenic Trioxide
- Asciminib
- Asparaginase
- Atezolizumab
- Avapritinib
- Avelumab
- Axicabtagene Ciloleucel
- Axitinib
- Azacitidine
- Belantamab Mafodotin
- Belinostat
- Belumosudil
- Belzutifan
- Bendamustine
- Bevacizumab
- Bexarotene
- Bicalutamide
- Binimetinib
- Bleomycin
- Blinatumomab
- Bortezomib
- Bosutinib
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adalimumab
- Anifrolumab-fnia
- Ansuvimab-zykl
- Antithymocyte Globulin Rabbit
- Atidarsagene Autotemcel
- Atoltivimab
- Azathioprine
- Baricitinib
- Belatacept
- Betibeglogene Autotemcel
- Bimekizumab-bkzx
- Brodalumab
- Canakinumab
- Certolizumab Pegol
- Cyclosporine
- Deucravacitinib
- Deuruxolitinib
- Dupilumab
- Efgartigimod Alfa-fcab
- Elivaldogene Autotemcel
- Emapalumab-lzsg
- Etanercept
- Etrasimod
- Fidanacogene Elaparvovec-dzkt
- Fingolimod
- Golimumab
- Guselkumab
- Hexaminolevulinate
- Hyaluronidase
- Immune Globulin
- Inebilizumab-cdon
- Infliximab
- Ixekizumab
- Lebrikizumab-lbkz
- Leniolisib
- Lovotibeglogene Autotemcel
- Mirikizumab-mrkz
- Mycophenolate Mofetil
- Mycophenolic Acid
- Nemolizumab-ilto
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abatacept
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Fever—If an infection is present, the chance of side effects from BCG vaccine may be increased
- Immunity problems—BCG vaccine may not work properly in persons with decreased natural immunity; also, the risk of side effects from BCG vaccine may be increased.
- Widespread skin infections
Proper Use
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
More common
- Accumulation of pus
- peeling or scaling of the skin
- sores at place of injection
- sores at different sites of the skin
- swollen lymph glands
Rare
- Cough
- fever
- increase in bone pain
- skin rash
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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