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Precautions and Warnings With Belimumab

It's important to review belimumab's precautions and warnings with your healthcare provider before beginning treatment. This includes telling him or her if you have a history of cancer or tuberculosis, as well as if you are planning on becoming pregnant or breastfeeding. It's also important to know that the drug can increase your risk for potentially serious viral, fungal, or bacterial infections.

What Should I Tell My Healthcare Provider?

Talk with your healthcare provider prior to starting belimumab (Benlysta®) if you have:
  • Cancer (or have had cancer in the past)
  • A history of tuberculosis
  • An infection of any kind, including a viral, fungal, or bacterial infection
  • A weakened immune system due to human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or any other cause
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Breastfeeding
  • Pregnant or thinking of becoming pregnant.
Make sure to tell your healthcare provider about any medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Belimumab Warnings and Precautions

Some warnings and precautions to be aware of prior to using this medication include the following:
  • In studies, more people using belimumab died of various causes, compared to the people receiving the placebo. It is currently unclear how to interpret this data.
  • Because belimumab suppresses the immune system, it can make it harder for your body to get over an infection. You could develop potentially serious bacterial, viral, or fungal infections. Contact your healthcare provider immediately if you experience any signs of infection, such as:
    • Confusion or difficulty thinking
    • Fever or chills
    • Sore throat
    • Body aches
    • Sores or wounds that do not heal, are red, or ooze pus
    • Painful urination.
  • Like other immunosuppressants, belimumab may, at least theoretically, increase the risk for developing certain cancers, including skin cancer. Protect your skin by limiting your time in the sun and wearing protective clothing and sunscreen when you are outside. Also, contact your healthcare provider if you notice any skin changes, discoloration, or changes in the shape or size of moles.
  • This medication can cause serious allergic reactions. Signs of such problems might include:
    • Hives
    • Itching
    • Wheezing
    • Swelling of the mouth or throat
    • Low blood pressure
    • Difficulty breathing.
Belimumab can also cause similar-appearing "infusion reactions" that might include:
    • A slow heart rate
    • Muscle pain
    • Headache
    • Rash
    • Itching
    • Low blood pressure
    • Headache
    • Nausea.
Your healthcare provider may give you medications beforehand to help reduce the chance of such problems occurring.
  • Belimumab may react with a few other medications (see Drug Interactions With Belimumab for more information).
  • It is not known if belimumab passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to starting the drug (see Benlysta and Breastfeeding).
  • This product 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 Benlysta and Pregnancy).

Belimumab Drug Information

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