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More Safety Info on Azficel-T

Specific Azficel-T Warnings and Precautions

Warnings and precautions to be aware of prior to using this medication include the following:
 
  • Excessive bruising and bleeding may occur if this treatment is used for someone with a bleeding disorder or for someone who is taking medications that increase the risk of bleeding (see Drug Interactions With Azficel-T for more information).
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  • There have been reports of a skin reaction known as leukocytoclastic vasculitis after treatment with azficel-T. This is a condition involving inflammation of blood vessels that leads to purple spots and may progress to serious skin damage.
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  • There have been reports of cold sores occurring after treatment with azficel-T.
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  • Azficel-T should probably be avoided by people undergoing chemotherapy treatment, for a few different reasons. First, chemotherapy might interfere with azficel-T, making it less effective. Also, people undergoing chemotherapy usually have a weakened immune system and are therefore more likely to develop serious infections after the injections.
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  • There has been one report of skin cancer near the area of azficel-T injection in one person. This cancer developed seven months after the injections.
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  • At least theoretically, there is a risk that the initial biopsies, which are required to make the personalized azficel-T product, or the injections themselves, could cause scarring, particularly in people prone to excessive scarring. Although this has not yet been reported, it is still something to consider.
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  • People who have certain genetic conditions affecting the skin may have abnormal reactions to azficel-T. These conditions include Ehlers-Danlos syndrome, achondroplasia, osteogenesis imperfecta, epidermolysis bullosa, Marfan syndrome, and ataxia-telangiectasia.
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  • Make sure your healthcare provider knows if you have any condition that affects your immune system. Having an underactive immune system may put you at risk for developing skin infections after azficel-T injections. Having an overactive immune system might somehow affect the safety and/or efficacy of this product.
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  • It is unknown if azficel-T passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see LaViv and Breastfeeding).
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  • Azficel-T is considered a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see LaViv and Pregnancy).
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Azficel-T Drug Information

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