Benlysta Warnings and Precautions

• 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.
 

• Breastfeeding
• Pregnant or thinking of becoming pregnant.
 

• In studies, more people using Benlysta died of various causes, compared to the people receiving the placebo. It is currently unclear how to interpret this data.
 
• Because Benlysta 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, including:
 
• 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, Benlysta 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 drug 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.

Benlysta 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.

• Benlysta may react with a few other medications (see Benlysta Drug Interactions for more information).
 
• It is not known if Benlysta passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to starting treatment (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).