Benlysta

Benlysta is a prescription medicine that is used with other medicines to treat lupus. Benlysta is in a class of medications called monoclonal antibodies and works by affecting the immune system by blocking the activity of a certain protein in people with lupus. 

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

• Glaxo SmithKline Pharmaceuticals

Benlysta can cause serious side effects. See “Drug Precautions” 

The most common side effects of Benlysta include: 

• nausea 
• diarrhea 
• fever 
• stuffy or runny nose 
• sore throat 
• cough (bronchitis) 
• trouble sleeping 
• leg or arm pain 
• headache (migraine) 
• urinary tract infection 
• decreased white blood cell count (leukopenia) 
• vomiting 
• stomach pain 
• injection site reactions (if medication is given under the skin)

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

These are not all the possible side effects of Benlysta. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

Formal drug interaction studies have not been performed. 

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, and herbal supplements. 

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

• fever  
• chills 
• pain or burning with urination 
• urinating often  
• bloody diarrhea 
• coughing up mucus 

• chest discomfort or pain 
• shortness of breath 
• cold sweats 
• nausea 
• dizziness 
• discomfort in other areas of the upper body 

• thoughts of suicide or dying 
• attempt to commit suicide 
• trouble sleeping (insomnia) 
• new or worse anxiety  
• new or worse depression 
• acting on dangerous impulses 
• other unusual changes in your behavior or mood 
• thoughts of hurting yourself or others

4.  Cancer. Benlysta may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.  

5.  Allergic (hypersensitivity) and infusion reactions. Serious allergic or infusion reactions can happen on the day of or the day after receiving Benlysta and may cause death. Tell your healthcare provider right away if you have any of the following symptoms of an allergic or infusion reaction:

• 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 

• memory loss
• trouble thinking
• dizziness or loss of balance
• difficulty talking or walking
• loss of vision

If you are currently being treated with Benlysta, it is recommended you do not receive live vaccines. 

Do not receive or use this medication if you are allergic to Benlysta or to any of its ingredients. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Benlysta there are no specific foods that you must exclude from your diet when receiving Benlysta.

Before you receive Benlysta, tell your healthcare provider if you: 

• are allergic to Benlysta or to any of its ingredients 
• 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. See “Drug Precautions”.
• 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 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. Tell your healthcare provider if you become pregnant during your treatment with Benlysta. 
• If you become pregnant while receiving Benlysta, talk to your healthcare provider about enrolling in the 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 decide if you will receive Benlysta or breastfeed. You should not do both. 

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Benlysta will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with Benlysta. 

• 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.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Benlysta passes into your breast milk. You and your healthcare provider should decide if you will receive Benlysta or breastfeed. You should not do both. 

This medication comes in an injectable form that is given through a needle in a vein (IV) by a healthcare provider or injected under the skin (subcutaneous) at home. 

Injected into a vein by a healthcare provider:

• You will be given Benlysta by a healthcare provider through a needle placed in a vein (IV infusion). It takes about 1 hour to give you the full dose of Benlysta. 
• Your healthcare provider will tell you how often you should receive Benlysta. 
• Your healthcare provider may give you medicines before you receive Benlysta to help reduce your chance of having a reaction. A healthcare provider will watch you closely while you are receiving Benlysta and after your infusion for signs of a reaction.  

Injected under the skin (subcutaneous) at home:

• This medication will be injected under the skin of your stomach (abdomen) or thigh. 
• Use Benlysta 1 time a week on the same day each week.
• Use this medication exactly as your healthcare provider tells you to. Read the Instructions for Use that comes with this medication for instructions about the right way to give your injections at home.
• This medication may be prescribed as a single-dose autoinjector or as a single-dose prefilled syringe.
• Before you use Benlysta, your healthcare provider will show you or your caregiver how to give the injections and review the signs and symptoms of possible allergic reactions.
• If you miss your dose of Benlysta on your planned day, inject a dose as soon as you remember. Then, inject your next dose at your regularly scheduled time or continue weekly dosing based on the new day injected. In case you are not sure when to inject Benlysta, call your healthcare provider. Do not use 2 doses on the same day to make up for a missed dose.

Take this medication exactly as prescribed by your doctor.

If injected into the vein:

• The dose your doctor recommends may be based on your weight.
• The recommended dose of Benlysta is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.

If injected under the skin:

• 200 mg once weekly.

If you use too much Benlysta, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Benlysta is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

• Store autoinjectors and prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
• Keep Benlysta and all other medications out of the reach of children. 
• Keep Benlysta autoinjectors and prefilled syringes in the original package until time of use to protect from light.
• Do not shake. Keep away from heat.
• Do not use and do not place back in the refrigerator if left out at room temperature for more than 12 hours.
• Safely throw away medicine that is out of date or no longer needed.