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Generic Name: Belimumab be-LIM’ue-mab be-LIM-ue-mab.

Names of Brands: Benlysta, Benlysta Autoinjector
Dosage Formats: Intravenous powder for injection (120 mg, 400 mg) Subcutaneous solution (200 mg/mL).
Drug Class: Selective immunosuppressants.

What is Belimumab?

Belimumab is used in conjunction with other drugs to combat active systemic lupus erythematosus (SLE) in children and adults who are at least 5 years old. Beliumumab can also be employed to manage kidney issues (active lupus nephritis) in patients with SLE who are on other lupus medications. Belimumab is not recommended for people with active SLE, which affects the central nervous system (brain, nerves, and spinal cord). Belimumab could be used for additional reasons not mentioned in this medication guide.

Side effects of Belimumab

Contact a medical professional immediately. If you are experiencing symptoms that are warning signs of an allergic reaction, such as itching, hives, feeling nervous or lightheaded, trouble breathing, or swelling of your lips, tongue, throat, or face.

There have been cases of severe and fatal reactions to belimumab in the days or hours after an injection. Talk to your doctor when you experience symptoms that include muscle pain, headaches, fatigue, slow heartbeats, and itching. swelling of your throat or face, nausea, anxiety, and trouble breathing. You may also be feeling lightheaded or dizzy. It is possible that you will contract infections more often, including severe or fatal infections. Stop using belimumab and contact your doctor as soon as you begin to show symptoms or warning signs of infection, like:

  • Fever, chills.
  • Skin lesions, warmth, or redness.
  • Cough with mucus, chest pains, shortness of breath.
  • Burning or pain during urination.
  • More frequently urinating than usual.
  • Bloody diarrhea.

Belimumab could cause a severe brain infection, which could result in disability or even death. Consult your physician right away if you are experiencing difficulties with speech, thinking, vision, or movement. These symptoms may begin gradually and then get worse. Make sure to contact your doctor whenever you notice any new or deteriorating depression or anxiety, changes in your mood or behavior, trouble sleeping, risk-taking behavior, or thoughts of damaging yourself or others.

Common side effects of belimumab include:

  • Nausea, diarrhea.
  • The fever may be accompanied by a sore throat, stuffy or runny nose, throat tightness, fever.
  • Redness, itching, pain, or swelling when the injection was made beneath the skin.
  • The pain in your arms and legs.
  • Depression, headache.
  • Sleep problems (insomnia).

This isn't a complete list of all the possible adverse side effects. Others could happen. Contact your doctor for advice regarding medical effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.


Certain people have experienced severe reactions to the drug within a few hours or days following the injection. Tell your doctor immediately if you experience symptoms like a headache or anxiety, itching, rashes, or swelling of your throat or face, nausea, breathing problems, difficulty breathing, or feeling lightheaded or dizzy. Belimumab can affect the immune system. It can cause infections more often, or even fatal or serious infections. Call your doctor if you are suffering from chills, fever, or coughs with mucus. skin redness or sores under your skin; an increase in frequency of urination; or burning when you go to the bathroom. Inform your doctor about any new or more severe mental health problems that require treatment, such as mood or behavioral changes, sleeplessness, or fears of harming yourself or others.

Before you take this drug.

Belimumab should not be used if you have an allergy to it.

Inform your doctor if you have ever suffered from:

  • An active or chronic illness.
  • Mental illness or depression.
  • Suicidal thoughts, actions, or thoughts.
  • Cancer.
  • A drug allergy.
  • If you've recently received vaccinations.
  • If you're taking cyclophosphamide, biologic medications, or other monoclonal anti-body medicines.

Belimumab can increase your chance of developing certain cancers by changing the way that your immune system functions. Consult your physician about your risk.

Many people are contemplating suicide after taking belimumab. Your physician will examine your progress every few appointments. Family members or other caregivers should be aware of any changes in your symptoms or mood. Belimumab can impact the body's immune system in your child in the event that you are using belimumab when you are expecting. Use effective birth control to stop the birth of your child while taking belimumab for at least four months following the last dose. Inform your doctor in the event that you become pregnant. Belimumab could impact your baby's immune system; however, the presence of SLE during pregnancy can cause problems such as a worsening of eclampsia and lupus (dangerously high blood pressure), as well as miscarriage, preterm birth, or growth issues for the baby that is still in utero. A mother's SLE could also trigger lupus or heart issues in the infant. The benefits of treating SLE could outweigh the risks for the infant.

If you're pregnant and you are a registered mother, your name could be included on the pregnancy registry to monitor how belimumab affects you and the baby. It is important that the healthcare professional caring for your infant baby be aware that you used belimumab when you were pregnant. It might not be safe to breastfeed while taking this medication. Consult your doctor about any potential risks.

How to take belimumab?

Follow the directions on the prescription label and go through all medication guides or instruction sheets. Your doctor may change the dosage. Make sure you take the medicine precisely.

Belimumab is injected as an injection into the vein, generally every 2 to 4 weeks. The healthcare professional will administer the injection. The medication should be administered slowly, and the infusion may take up to an hour to be completed. In adult patients, belimumab could be injected beneath the skin, typically once a week, every day of the week. Your healthcare professional can instruct you on the proper use of the medicine on your own. Don't inject this medication into skin that is swollen, red, tender, or hard.

If you administer injections at home, you must read and follow the instructions for use that come with your prescription. Talk to your pharmacist or doctor for clarification if you aren't sure about the instructions. Only inject when you are prepared to administer it. Don't use any medicine that appears cloudy, changes color, or contains particles. Consult your pharmacist about new medications.

You might also be prescribed additional medications to avoid severe reactions or allergic reactions. Use these medications as long as your physician has prescribed them. Keep the already-filled syringe as well as the injector pen in the original container within the fridge. Avoid freezing or exposing yourself to heat or light. Don't shake the medicine.

The syringe or the pen for injection should be taken out of the refrigerator and allowed to cool to room temperature for 30 minutes prior to injecting the dose. Don't use any medicine that has been stored at room temperature for more than twelve hours. Don't put it back in the refrigerator. Consult your pharmacist about a new medication. The syringe, or pen for injection, is designed for only one use. Dispose of it after just one use, regardless of whether there's still medicine within. Get rid of used needles and syringes, as well as injection pens, inside an impervious to puncture "sharps" container. Make sure you follow local or state laws regarding the disposal of the container. Keep it out of pets' and children's reach.

What happens if I miss a dose?

Take the medication immediately after you remember. You can restart the weekly schedule on the new day for injections or go back to your usual injection schedule. Don't use two injections on the same day. Consult your doctor for the appropriate instructions in the event that you don't make the appointment for the intravenous injection of belimumab.

What happens if I overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help line toll-free at 1-800-222-1222.

What should be avoided?

Avoid being around those with illnesses or who suffer from infections. Contact your doctor right away in the event of symptoms of an infection.

Don't receive a "live" vaccine while using belimumab. The vaccine might not function as effectively and could not completely protect you from illness. The live vaccines are measles, rubella, mumps (MMR), and rotavirus. yellow fever, typhoid, varicella (chickenpox), zoster (shingles), and the nasal virus (influenza) vaccination.

Interaction with other drugs

Other medications can affect belimumab, such as prescription and non-prescription medicines, vitamins, and herbal products. Inform your physician about your current medications as well as any medications you are about to start or stop taking.