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Considerations for Treatment | BENLYSTA (belimumab) for Intravenous Use

The day before your infusion of BENLYSTA IV...

Confirm your infusion appointment.
Whether you’ll be receiving your infusion at your doctor’s office, an infusion center, or a hospital, give them a call the day before to confirm your appointment.

Confirm your transportation.
If you’ve arranged for a ride to or from your appointment, follow up to confirm your ride’s availability.

On the day of your infusion of BENLYSTA IV...

Bring something to do.
It takes about one hour to receive the full dose of BENLYSTA. There is also preparation time before as well as observation time after the infusion that may vary, so consider bringing something to help you pass the time, such as:

  • A book
  • A music player & headphones
  • A portable video player
  • A friend or family member to talk to
  • A magazine
  • A crossword puzzle
  • A small pillow

When you arrive for your infusion, tell the attending healthcare provider if you have any allergies. You may receive medication prior to the infusion, which may help reduce your chance of having an allergic reaction. It is not known if these medications will help reduce the chance of an allergic reaction to BENLYSTA. A healthcare provider will watch you closely while you are receiving BENLYSTA IV and after your infusion for signs of a reaction.

Things to watch for...

Serious allergic or infusion reactions can happen on the day of or days after receiving BENLYSTA IV and may cause death.

Symptoms of an allergic or infusion reaction may include:

  • itching
  • swelling of the face, lips, mouth, tongue, or throat
  • trouble breathing
  • anxiousness
  • low blood pressure
  • dizziness or fainting
  • headache
  • nausea
  • skin rash, redness, or swelling

Your healthcare provider will watch you closely while you are receiving BENLYSTA and after your infusion for signs of a reaction. Tell your healthcare provider or get emergency medical help right away if you have any of these symptoms.

After your infusion of BENLYSTA IV

Depending on how you feel, you may be able to return to your usual activities.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Going forward...

If you have any questions, call your doctor or BENLYSTA Gateway at 1-877-4-BENLYSTA (1-877-423-6597), Monday through Friday, 8 AM to 8 PM Eastern Time.

Available resources to consider

Ask your healthcare provider about your insurance benefits and financial assistance options.
It’s important to have a clear understanding of your insurance coverage for BENLYSTA. If you have additional questions regarding your insurance coverage or financial assistance, feel free to call the BENLYSTA Gateway at 1-877-4-BENLYSTA (1-877-423-6597).

Sign the BENLYSTA Gateway enrollment form.
Your healthcare provider may ask you to sign this form if he or she is using this optional service to verify your insurance benefits. If you need help paying for BENLYSTA, the form can also be used to apply for one of our assistance programs. Your healthcare provider will complete the form along with you and fax it to the BENLYSTA Gateway at 1-877-850-9901.

Call us with questions.
If you’ve talked to your doctor and still have questions about BENLYSTA, your insurance benefits, or our financial assistance programs, you can call the BENLYSTA Gateway and get answers from a live person. Call 1-877-4-BENLYSTA (1-877-423-6597) toll-free, Monday through Friday, 8 AM to 8 PM Eastern Time.

Join BENLYSTA Connects.
You have the option to join this free, customized support program. Fill out a simple questionnaire to receive informative e-mails, a newsletter about BENLYSTA, and a personalized Doctor Discussion Guide for use in conversations with your doctor. Join by completing this form or by calling BENLYSTA Gateway at 1-877-4-BENLYSTA.

Considerations for Treatment

Download and print this guide to help in preparing for your treatment

Know your lupus

Visit our FAQ section to learn more

What is BENLYSTA?

BENLYSTA is a prescription medication used to treat adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.

It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus, and it has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.

Do not receive BENLYSTA if you are allergic to belimumab or to any of the ingredients in BENLYSTA.

Important Safety Information

The most important information to know about BENLYSTA

BENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects.

Important Safety Information

The most important information to know about BENLYSTA

BENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects.

Tell your healthcare provider right away if you have any of the symptoms listed below while receiving BENLYSTA

  • Infections: fever, chills, pain or burning with urination, urinating often, coughing up mucus, shortness of breath, or diarrhea/vomiting.
  • Heart problems: chest discomfort or pain, shortness of breath, cold sweats, nausea, dizziness, or discomfort in other areas of the upper body.
  • Allergic (hypersensitivity) reactions: itching, swelling of the face, lips, mouth, tongue, or throat, trouble breathing, anxiousness, low blood pressure, dizziness or fainting, headache, nausea, or skin rash. Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death.
  • Mental health problems and suicide: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping, new or worse anxiety or depression, acting on dangerous impulses, other unusual changes in your behavior or mood, or thoughts of hurting yourself or others.

Before receiving BENLYSTA also discuss with your healthcare provider if you:

  • think you have an infection or have infections that keep coming back. You should not receive BENLYSTA if you have an infection unless your healthcare provider tells you to.
  • have or have had mental health problems such as depression or thoughts of suicide.
  • have recently received a vaccination or if you think you may need a vaccination. If you are receiving BENLYSTA, you should not receive live vaccines.
  • are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • are allergic to other medicines.
  • are receiving other biologic medicines, monoclonal antibodies, or IV infusions of cyclophosphamide (CYTOXAN®).
  • have or have had any type of cancer.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby. Females who are able to become pregnant should talk to their healthcare provider about whether or not they will use birth control (contraception) and receive BENLYSTA. If BENLYSTA is recommended, you should use an effective method of birth control while receiving BENLYSTA and for at least 4 months after the final dose of BENLYSTA. Tell your healthcare provider right away if you become pregnant during your treatment with BENLYSTA or if you think you may be pregnant. If you become pregnant while receiving BENLYSTA, talk to your healthcare provider about enrolling in the BENLYSTA Pregnancy Registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of this registry is to monitor the health of you and your baby.
  • are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your healthcare provider should talk about whether or not you should receive BENLYSTA and breastfeed.

Possible side effects of BENLYSTA

  • Progressive multifocal leukoencephalopathy (PML). PML is a serious and life-threatening brain infection. PML can result in death or severe disability. Tell your healthcare provider right away if you notice any new or worsening medical problems: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, or loss of vision.
  • Cancer. Medicines that affect the immune system including BENLYSTA, may increase your risk of certain cancers.

The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, cough, trouble sleeping, leg or arm pain, depression, headache, and pain, redness, itching, or swelling at the site of injection (when given subcutaneously). These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects.

Other Important Information

In clinical studies, there have been mixed results regarding how well BENLYSTA works in black/African American patients. Therefore, you should consult with your healthcare provider to determine if BENLYSTA is right for you.


Please see Prescribing Information and Medication Guide for BENLYSTA.

For more information, call the BENLYSTA Gateway at 1-877-4-BENLYSTA (1-877-423-6597)
Monday through Friday, 8 AM to 8 PM Eastern Time.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.