BENLYSTA (Belimumab)

BENLYSTA

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Important Safety Information

BENLYSTA (belimumab) is an infusion medication used to treat patients with active systemic lupus erythematosus (SLE) who are five years of age or older. It is unknown if BENLYSTA is safe in patients with severe active lupus nephritis or severe active central nervous system lupus.

If you have an infection or suffer from chronic infections, talk with your doctor about your options. You should get any existing infections under control prior to starting treatment with BENLYSTA. Also, tell your doctor about all current medications you’re taking — whether they’re prescribed, over-the-counter, vitamins, or herbal supplements. In addition, mention whether you have recently been vaccinated. BENLYSTA should not be mixed with live vaccines.

Tell your doctor if you have a history of cancer or any type of medical issue. This includes mental health conditions — such as depression, anxiety, or thoughts of suicide.

What is the most important information I should know about BENLYSTA?

It is unknown whether BENLYSTA could be harmful to an unborn child. Talk to your doctor if you’re pregnant, think you could be pregnant, or are planning on becoming pregnant. There is a pregnancy registry to track how the medication affects your health and the health of your baby. To enroll or for more information, call (877) 681-6296.

It is unknown whether BENLYSTA can be passed to your baby through breastfeeding. Talk with your medical provider if you’re currently breastfeeding or plan to do so.

Side Effects of BENLYSTA

As with any prescription medication, BENLYSTA carries a risk of side effects. Some of the most common ones include:

  • Headache
  • Shortness of breath
  • Fever
  • Chills
  • Nausea
  • Diarrhea
  • Stuffy or runny nose
  • Dizziness

BENLYSTA could also cause more serious side effects, including:

Depression

Tell your doctor immediately if you’re experiencing insomnia, anxiety, depression, unusual changes in your mood, and/or thoughts of harming yourself and others — including suicide.

Serious Allergic Reactions

Seek emergency care if you experience itching, swelling of the face, lips, or tongue, breathing difficulties, sore throat, dizziness, low blood pressure, headache, nausea, skin rash, coughing up mucus, or skin sores. Allergic reactions make occur suddenly during or after treatment.

Cardiovascular Conditions

Seek emergency care if you experience chest pain or tightness, cold sweats, breathing difficulties, dizziness, nausea, or pain or discomfort in other parts of the body. More severe symptoms may occur if left untreated.

Progressive Multifocal Leukoencephalopathy (PML)

PML is a serious brain infection. Seek medical attention immediately if you experience dizziness, memory loss, loss of balance, loss of vision, or difficulty talking or walking.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

BENLYSTA is a prescription medication to treat patients five years of age or older with active systemic lupus erythematosus (SLE). The recommended dosage is 10mg/kg at two-week intervals for the first three doses, and at four-week intervals thereafter. Each infusion treatment lasts approximately one hour.

Please refer to the full prescribing information.