Benlysta

Generic name: Belimumab
Drug class: Selective immunosuppressants

Usage of Benlysta

Benlysta is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Benlysta is used together with other medicines to treat active systemic lupus erythematosus (SLE). Benlysta helps decrease disease activity more than when the other medicines are used alone.

Benlysta is also used together with other lupus medicines to treat active lupus nephritis (lupus-related kidney inflammation).

Both the intravenous and suBCutaneous formulations of Benlysta are approved for use in adults with SLE and lupus nephritis. The intravenous formulation of Benlysta is approved for use in children at least 5 years old with SLE and lupus nephritis.

It is not known if Benlysta is safe and effective in people with severe active central nervous system lupus.

Benlysta side effects

Get emergency medical help if you have signs of an allergic reaction to Benlysta: hives, itching; feeling anxious or light-headed; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people have had serious or fatal allergic reactions to this medicine within hours or days after an injection. Tell your doctor right away if you have symptoms such as muscle pain, headache, tiredness, slow heartbeats, rash, itching, swelling in your face or throat, anxiety, nausea, trouble breathing, and feeling dizzy or light-headed.

You may get infections more easily, even serious or fatal infections. Stop using Benlysta and call your doctor right away if you have signs of infection such as:

  • skin sores, warmth, or redness;
  • cough with mucus, chest pain, shortness of breath;
  • cough with mucus;
  • pain or burning when you urinate;
  • urinating more than usual; or
  • bloody diarrhea.

    • Benlysta may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

    Also call your doctor at once if you have new or worsening depression, anxiety, mood or behavior changes, trouble sleeping, risk-taking behavior, or thoughts about hurting yourself or others.

    Common Benlysta side effects may include:

  • nausea, diarrhea;
  • fever, sore throat, runny or stuffy nose, cough;
  • pain, itching, redness, or swelling where an injection was given under the skin;
  • pain in your arms or legs;
  • headache, depressed mood; or
  • sleep problems (insomnia).

    • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Benlysta

    You should not use Benlysta if you are allergic to Belimumab.

    To make sure Benlysta is safe for you, tell your doctor if you have ever had:

  • an active or chronic infection;
  • depression or mental illness;
  • suicidal thoughts or actions;
  • cancer;
  • a drug allergy:
  • if you recently received a vaccine; or
  • if you are using cyclophosphamide, biologic medicines, or other monoclonal antibody medicines.

    • Belimumab may increase your risk of certain cancers by changing the way your immune system works. Ask your doctor about your individual risk.

    Some people have thoughts about suicide while using Benlysta. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

    Belimumab may affect the immune system of your baby if you use this medicine while you are pregnant. Use effective birth control to prevent pregnancy while you are using Benlysta and for at least 4 months after your last dose. Tell your doctor if you become pregnant.

    Belimumab may affect your baby's immune system, but having SLE during pregnancy may cause complications such as worsened lupus, eclampsia (dangerously high blood pressure), premature birth, miscarriage, or growth problems in the unborn baby. SLE in the mother may also cause lupus or heart problems to develop in the newborn. The benefit of treating SLE may outweigh any risks to the baby.

    If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Benlysta on the baby. Make sure any doctor caring for your newborn baby knows if you used Benlysta while you were pregnant.

    It may not be safe to breastfeed while using Benlysta. Ask your doctor about any risk.

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    How to use Benlysta

    Usual Adult Dose for Systemic Lupus Erythematosus:

    IV: 10 mg/kg IV over 1 hour at 2-week intervals for the first 3 doses and at 4-week intervals thereafter SUBCUTANEOUS: If transitioning from IV to subcutaneous administration, administer the first subcutaneous dose 1 to 4 weeks after the last IV dose: 200 mg subcutaneously once a week in the abdomen or thigh (preferably on the same day each week) Comments: -Consider premedication including an antihistamine, with or without an antipyretic, before the infusion. -Subcutaneous dosing is not based on weight. Use: Treatment of patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy

    Usual Adult Dose for Lupus Nephritis

    IV: 10 mg/kg IV over 1 hour at 2-week intervals for the first 3 doses and at 4-week intervals thereafter SUBCUTANEOUS: 400 mg (two 200-mg injections) once a week for 4 doses, then 200 mg once a week thereafter in the abdomen or thigh (preferably on the same day each week) A patient may transition from IV to subcutaneous administration any time after the patient completes the first 2 intravenous doses. If transitioning, administer the first subcutaneous dose of 200 mg 1 to 2 weeks after the last intravenous dose.

    Comments: -The 400 mg dose for active lupus nephritis requires administration of 2 autoinjectors or 2 prefilled syringes. -Consider premedication including an antihistamine, with or without an antipyretic, before the infusion. -Subcutaneous dosing is not based on weight.

    Use: Treatment of adult patients with active lupus nephritis who are receiving standard therapy

    Usual Pediatric Dose for Systemic Lupus Erythematosus:

    5 years and older: 10 mg/kg IV over 1 hour at 2-week intervals for the first 3 doses and at 4-week intervals thereafter Comments: -Subcutaneous dosing not been evaluated and is not approved for patients younger than 18 years. -Consider premedication including an antihistamine, with or without an antipyretic, before the infusion. Use: Treatment of patients 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy

    Usual Pediatric Dose for Lupus Nephritis

    5 years and older: 10 mg/kg IV over 1 hour at 2-week intervals for the first 3 doses and at 4-week intervals thereafter

    Comments: -Subcutaneous dosing not been evaluated and is not approved for patients younger than 18 years. -Consider premedication including an antihistamine, with or without an antipyretic, before the infusion.

    Use: Treatment of patients 5 years and older with active lupus nephritis who are receiving standard therapy

    Warnings

    Some people have had serious or fatal allergic reactions to Benlysta within hours or days after an injection. Tell your doctor right away if you have symptoms such as headache, anxiety, rash, itching, swelling in your face or throat, nausea, trouble breathing, and feeling dizzy or light-headed.

    Belimumab affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, cough with mucus, skin sores, warmth or redness under your skin, increased urination, or burning when you urinate.

    Report any new or worsening mental health symptoms to your doctor, such as: depression, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others.

    What other drugs will affect Benlysta

    Other drugs may interact with belimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

    Popular FAQ

    Benlysta starts working from your very first injection/infusion, but it may take up to 8 weeks before you notice an improvement in some symptoms, and from 4 to 8 months before the full effects at resolving fatigue, joint, and muscle pain are seen. Once an improvement is seen these effects usually persist long term. Benlysta is a long-term medication and as long as you are tolerating it well, it is important to persist with dosing for several months to see if it works for you.

    Yes, the Benlysta copay program that may lower your costs to as little as $0 if you qualify. You can contact GSK and the Benlysta Cares Support Team at 1-877-4-BENLYSTA (1-877-423-6597) Monday to Friday, 8 AM to 8 PM ET, to learn if you are eligible.

    Yes, Benlysta can cause an allergic reaction, but serious and life-threatening allergic reactions are uncommon. Approximately 13% of people will experience a mild to moderate hypersensitivity (allergic) reaction on the day they get their Benlysta infusion. This is an exaggerated or inappropriate response by our immune system to Benlysta, which can also occur with other medications. Symptoms include low blood pressure, swelling under the skin (angioedema), urticaria (hives), other rashes, itch, and shortness of breath. Anaphylaxis, a very serious, life-threatening reaction, has only been reported in 0.6% of people receiving Benlysta (9 people experienced anaphylaxis out of 1458 people who were given it). People may also experience an infusion reaction on the day they get their Benlysta infusion, and sometimes it is difficult to tell if this is a true infusion reaction or a hypersensitivity reaction, because there is an overlap of signs and symptoms. 17% of people experienced mild to moderate infusion reactions (251 out of 1458 people receiving Benlysta) and the most common symptoms include a headache, nausea, and skin reactions. Serious infusion reactions have been reported in 0.5% of people receiving Benlysta and symptoms include a slow heartbeat, muscle aches, headache, rash, urticaria, and low blood pressure. Hypersensitivity reactions, infusion reactions, and serious allergic reactions such as anaphylaxis can occur when Benlysta is given subcutaneously or by intravenous infusion. The risk of hypersensitivity reactions is greatest with the first two doses of Benlysta, although the risk should be considered for every administration. Reactions are more likely to occur within a few hours of administration, but delayed reactions have been reported. Allergic reactions to Benlysta are more likely to occur in those with a history of multiple drug allergies or significant hypersensitivity, but appear less common in people who have received premedication to reduce the risk of an infusion/allergic reaction. You should seek immediate medical attention if you develop any signs or symptoms of a hypersensitivity reaction such as itchy skin, low blood pressure, muscle aches, nausea, swelling under the skin (angioedema), urticaria (hives), other rashes, or shortness of breath.

    It may take up to 6 or 7 months for Benlysta injections to work because it takes time for Benlysta to reduce the activity of autoreactive B-lymphocytes that contribute to inflammation that causes lupus symptoms. Trials that investigated Benlysta were not designed to measure when Benlysta started to work, but in those trials, most people responded within 7 months. Blog sites and support groups suggest most people start to notice an improvement within 4 to 5 months. Benlysta is a long-term treatment.

    Benlysta helps lupus by reducing disease activity and flares and decreasing the need for steroid medications by up to 25%. Benlysta works for lupus by binding to a substance called BLyS, which helps B cells to survive for longer. When Benlysta is attached to BLyS, BLyS can no longer bind to and stimulate autoreactive B cells. Autoreactive B cells are overactive B cells that attack normal tissue causing inflammation instead of just producing antibodies as normal B cells do. B cells are a type of lymphocyte, and an important part of our immune system and people with Lupus develop too many autoreactive B cells.

    An infusion of Benlysta takes approximately 1 hour, but you may need to go into the place you are getting your infusion from for a short time before to receive any premedication you may need, and stay for a short time after to monitor for any infusion reactions.

    Before using the Benlysta autoinjector on your own, get training from your healthcare provider. When you are ready to inject your Benlysta autoinjector, remove one sealed tray containing an autoinjector from the refrigerator and peel back the film of the tray and remove the autoinjector. Check the expiration date on the autoinjector and do not use it if the expiration date has passed. Look in the inspection window and check that the Benlysta solution is colorless to slightly yellow in color. Do not use it if the solution looks cloudy, discolored, or has particles. It is normal to see one or more air bubbles in the solution. Place the Benlysta autoinjector on a flat surface and allow it to come to room temperature. Do not warm the autoinjector in any other way, such as by putting it in the microwave, hot water, or direct sunlight. Choose an injection site. This could be your stomach area (but not within 2 inches of your belly button) or the top outer area of your thigh. If you need 2 injections to complete your dose, leave at least 2 inches between each injection. Do not inject into the same site each time or in areas where the skin is tender, bruised, red, or hard. Wipe the injection site with an alcohol swab and allow it to dry. Wash your hands. Remove the Ring Cap by pulling or twisting it off in either a clockwise or counterclockwise direction. Hold the autoinjector comfortably so that you can see the Inspection Window while you are giving the injection. This allows you to see that the purple indicator is moving while you are injecting and that it stops when the dose is complete. Hold the autoinjector straight over your injection site at a 90-degree angle. Make sure the Gold Needle Guard is flat on the skin. Firmly press the autoinjector all the way down onto the injection site and hold it in place. This will insert the needle and start the injection. You may hear a “first click” at the start of the injection and see the purple indicator moving through the Inspection Window. Hold the autoinjector down until the purple indicator stops moving. You may hear a “second click”. It may take up to 15 seconds to complete the injection. When the injection is complete, lift the autoinjector from the injection site and throw it away in a sharps container.

    Although hair loss is not listed as a side effect in the product information for Benlysta, at least 3 people have reported hair loss as a side effect since the drug has been approved. The type of hair loss reported in these 3 people taking Benlysta was alopecia areata, symptoms include patchy hair loss on the scalp or other areas of the body, which is an autoimmune condition (like lupus). All 3 cases resolved but 2 out of 3 people stopped taking Benlysta.

    Although weight gain is not listed as a side effect of Benlysta in the product information, a phase IV clinical study that analyzed side effect information from 14,100 people who had taken Benlysta reported weight gain as a side effect for 2.87% of them (404 people). Weight gain is more likely in females aged 50 to 59 years who have been taking Benlysta for 1 - 6 months. Weight gain can also be a side effect of other conditions, such as depression, and if you experience changes in your weight, you should talk with your doctor

    Although hair loss is not listed as a side effect in the product information for Benlysta, at least 3 people have reported hair loss as a side effect since the drug has been approved. The type of hair loss reported in these 3 people taking Benlysta was alopecia areata, symptoms include patchy hair loss on the scalp or other areas of the body, which is an autoimmune condition (like lupus). All 3 cases resolved but 2 out of 3 people stopped taking Benlysta.

    Benlysta starts working from your very first injection/infusion, but it may take up to 8 weeks before you notice an improvement in some symptoms, and from 4 to 8 months before the full effects at resolving fatigue, joint, and muscle pain are seen. Once an improvement is seen these effects usually persist long term. Benlysta is a long-term medication and as long as you are tolerating it well, it is important to persist with dosing for several months to see if it works for you.

    Benylsta does stop inflammation by reducing the activity of certain white blood cells called autoreactive B-cells that produce antibodies that attack healthy cells. This reduces the inflammation that causes the symptoms of lupus.

    Yes, Benlysta does help with fatigue although it may take 4 to 8 months before symptoms of fatigue resolve or reduce.

    Yes, the Benlysta copay program that may lower your costs to as little as $0 if you qualify. You can contact GSK and the Benlysta Cares Support Team at 1-877-4-BENLYSTA (1-877-423-6597) Monday to Friday, 8 AM to 8 PM ET, to learn if you are eligible.

    An infusion of Benlysta takes approximately 1 hour, but you may need to go into the place you are getting your infusion from for a short time before to receive any premedication you may need, and stay for a short time after to monitor for any infusion reactions.

    Benlysta works by attaching to a specific protein, called B-lymphocyte stimulator (BLyS), preventing it from binding to its receptors on B cells. BLyS is important for the growth and development of B cells, and B cells have a crucial role in the development of lupus. Certain B cells, called autoreactive B-cells, stay in the body for longer than they should, producing autoantibodies that target important cellular components, such as DNA, causing disease flares. By binding to BLyS, Benlysta prevents the survival of B-cells and their differentiation into immunoglobulin-producing plasma cells. Benlysta is a biologic therapy, not a steroid. It may be called a B-cell depleting therapy or a selective immunosuppressant.

    Benlysta is an injectable medicine approved to treat children 5 years of age and older and adults with systemic lupus erythematosus (SLE) and active lupus nephritis (lupus-related kidney inflammation) who are receiving other lupus medicines. Lupkynis is only approved by the FDA to treat lupus nephritis in adults and comes as an oral capsule taken by mouth twice per day. Continue reading

    Although weight gain is not listed as a side effect of Benlysta in the product information, a phase IV clinical study that analyzed side effect information from 14,100 people who had taken Benlysta reported weight gain as a side effect for 2.87% of them (404 people). Continue reading

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