Belimumab

Belimumab treats an immune system disease, lupus. Can increase your chance of getting an infection. Tell your doctor if you notice any signs of infection such as a fever.

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Belimumab Cautionary Labels

Uses of Belimumab

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

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Belimumab Brand Names

Belimumab may be found in some form under the following brand names:

  • Benlysta

Belimumab Drug Class

Belimumab is part of the drug class:

  • Selective immunosuppressants

Side Effects of Belimumab

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

The most common side effects of belimumab 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 belimumab. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Belimumab Interactions

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.

Belimumab Precautions

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

Belimumab can cause serious side effects. Some of these side effects may cause death. It is not known if belimumab causes these serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while receiving belimumab. 1. Infections. Symptoms of an infection can include:

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

2. Heart Problems. Symptoms of heart problems can include:

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

3. Mental health problems and suicide. Symptoms of mental health problems can include:

  • 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. Belimumab 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 belimumab 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

Your healthcare provider will watch you closely while you are receiving belimumab and after your infusion for signs of a reaction. 6. Progressive multifocal leukoencephalopathy (PML). PML is a serious and life-threatening brain infection. Your chance of getting PML may be higher if you take medications that weaken your immune system, including belimumab. PML can result in death or severe disability. If you notice any new or worsening medical problems such as those below, tell your healthcare provider right away:

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

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

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

Belimumab Food Interactions

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 belimumab there are no specific foods that you must exclude from your diet when receiving belimumab.

Inform MD

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

  • are allergic to belimumab or to any of its ingredients
  • think you have an infection or have infections that keep coming back. You should not receive belimumab 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 belimumab, 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 belimumab will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with belimumab.
  • If you become pregnant while receiving belimumab, 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 belimumab passes into your breast milk. You and your healthcare provider should decide if you will receive belimumab or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine.

Belimumab and Pregnancy

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 belimumab will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with belimumab.

  • If you become pregnant while receiving belimumab, talk to your healthcare provider about enrolling in the belimumab 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.

Belimumab and Lactation

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

Belimumab Usage

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 belimumab 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 belimumab.
  • Your healthcare provider will tell you how often you should receive belimumab.
  • Your healthcare provider may give you medicines before you receive belimumab to help reduce your chance of having a reaction. A healthcare provider will watch you closely while you are receiving belimumab 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 belimumab, 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 belimumab 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 belimumab, call your healthcare provider. Do not use 2 doses on the same day to make up for a missed dose.

Belimumab Dosage

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 belimumab 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.

Belimumab Overdose

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

If belimumab 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.

Other Requirements

  • Store autoinjectors and prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
  • Keep belimumab and all other medications out of the reach of children.
  • Keep belimumab 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.
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