Benlysta (belimumab) is a prescription drug that’s used to help manage certain types of lupus in adults and some children. Benlysta comes in an intravenous (IV) infusion, prefilled syringe, or auto-injector pen.

Benlysta is used to help manage the following types of lupus in adults and certain children ages 5 years and older:

To learn more about Benlysta’s uses, see the “What is Benlysta used for?” section below.

Benlysta basics

Benlysta comes in two forms:

  • A powder that’s mixed into a liquid solution. This form is given by IV infusion (an injection into a vein over a period of time).
  • A liquid solution inside prefilled syringes or auto-injectors. This form is given as an injection under your skin.

Benlysta contains the active ingredient belimumab, which is a biologic medication. A biologic is made from parts of living organisms.

Benlysta is only available as a brand-name drug. It’s not available in a biosimilar form.

Biosimilars are like generic drugs. But unlike generics, which are made for nonbiologic drugs, biosimilars are made for biologic drugs.

Limitation of use

Benlysta has a limitation of use. It’s not known whether the drug is effective in people with severe active central nervous system lupus. This kind of lupus can affect your brain and spinal cord. If you have this condition, treatment with Benlysta is not recommended. Your doctor can recommend a different treatment option for you.

Like most drugs, Benlysta may cause mild or serious side effects. The lists below describe some of the more common side effects that Benlysta may cause. These lists don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

  • your age
  • other health conditions you have
  • other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Benlysta. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a list of some of the mild side effects that Benlysta can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Benlysta’s prescribing information.

Mild side effects of Benlysta that have been reported include:

  • fever
  • infection, such as the common cold or bronchitis
  • insomnia (trouble sleeping)
  • pain in your arms or legs
  • migraine
  • nausea
  • diarrhea
  • sore throat
  • injection site reactions or infusion-related reactions

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Benlysta can occur, but they aren’t common. If you have serious side effects from Benlysta, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Benlysta that have been reported include:

Allergic reaction

For some people, Benlysta can cause an allergic reaction.

In general, symptoms of allergic reaction can be mild or serious.

What might help?

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should keep taking Benlysta.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Benlysta, they may have you switch to a different treatment.

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Find answers below to some commonly asked questions about Benlysta.

Is Benlysta a chemotherapy drug?

No, Benlysta is not a chemotherapy drug. Benlysta belongs to a group of medications called monoclonal antibodies, which are biologics (drugs made from living cells).

Benlysta treats lupus by weakening a specific part of your immune system so that it doesn’t attack your body. This can help manage your lupus symptoms.

In comparison, chemotherapy drugs kill cells in your body that grow quickly. Although this often works to kill cancer cells, chemotherapy drugs also kill healthy cells that grow quickly. Because of this, chemotherapy drugs typically cause many side effects.

Benlysta works on a specific part of your immune system, so it causes fewer side effects than a chemotherapy drug.

What is Benlysta’s mechanism of action (how does it work)?

Lupus is an autoimmune condition that occurs when your body attacks its own cells.

Benlysta works by attaching to certain autoantibodies (proteins in your blood that attack your body). The drug reduces the number of autoantibodies you have, which can help manage your lupus symptoms.

Benlysta is used along with other drugs to treat your condition.

For more information on how Benlysta works, see this video on the Benlysta website, or talk with your doctor or pharmacist.

Are there side effects from stopping Benlysta treatment?

No, there haven’t been any side effects reported in people stopping Benlysta treatment. But it’s important to note that stopping your treatment may make symptoms of your condition return. This is because Benlysta helps manage these symptoms. Ending your treatment means the drug will stop working to manage your symptoms.

If you have other questions about ending your Benlysta treatment, talk with your doctor.

Does Benlysta cause weight gain or weight loss?

No, Benlysta shouldn’t cause weight gain or weight loss. These weren’t reported side effects during studies of the drug. But weight changes could be due to other factors during your lupus treatment.

For example, some people may take a corticosteroid drug such as prednisone (Rayos) along with Benlysta. Corticosteroids can cause weight gain.

On the other hand, you could experience weight loss if you develop an infection during your Benlysta treatment.

Weight changes can also be due to changes in mood, such as depression. (Depression is a side effect of Benlysta.)

If you have unexplained weight gain or weight loss during your Benlysta treatment, talk with your doctor.

Is hair loss a side effect of Benlysta?

It’s unlikely that you’ll experience hair loss from using Benlysta. In studies, hair loss wasn’t a side effect reported by people using the drug.

But there have been some reports of hair loss after Benlysta was approved for use. It’s important to note that the hair loss was reversible in each case. This means it wasn’t a permanent side effect.

If you have concerns about hair loss during your Benlysta treatment, talk with your doctor.

Is Benlysta used for rheumatoid arthritis?

At this time, Benlysta is not approved by the Food and Drug Administration (FDA) to treat rheumatoid arthritis (RA). Benlysta is only approved to treat active systemic lupus erythematosus and active lupus nephritis.

In some cases, your doctor may prescribe Benlysta off-label to treat RA. (Off-label is when your doctor prescribes a drug for a different use than it was FDA approved for.)

It’s currently not known whether Benlysta may be safe and effective for people with RA. More research is needed into the drug’s use for this condition.

If you’re interested in receiving Benlysta for RA, talk with your doctor to see if it may be a safe treatment option for you.

Costs of prescription drugs can vary depending on many factors. These factors may include what your insurance plan covers and which pharmacy you use.

If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You may also qualify for the Benlysta Gateway services or the Benlysta Copay Program.

You can check out this article to learn more about saving money on prescriptions.

Benlysta is used in adults and in children ages 5 years and older with one of the following conditions:

Lupus is an autoimmune condition that occurs when your body attacks its own cells.

Benlysta works by attaching to certain autoantibodies (proteins in your blood that attack your body). The drug reduces the number of autoantibodies you have, which can help manage your lupus symptoms.

Benlysta is used along with other drugs to treat your condition.

Benlysta has a limitation of use. It’s not known whether the drug is effective in people with severe active central nervous system lupus. This kind of lupus can affect your brain and spinal cord. If you have this condition, receiving Benlysta is not recommended. Your doctor can recommend a different treatment option for you.

Benlysta for systemic lupus erythematosus

Benlysta is used to treat active systemic lupus erythematosus (SLE). This condition causes inflammation throughout your body. It can also affect joints and organs such as your brain, lungs, or kidneys.

Symptoms of SLE may include:

  • rash on your cheeks or nose
  • fever
  • pain in your joints
  • fatigue (low energy)

Benlysta for lupus nephritis

Benlysta is also used to treat active lupus nephritis. This is a complication of lupus that specifically affects your kidneys. Symptoms of lupus nephritis may include:

  • blood in your urine
  • swelling of your hands or feet
  • high blood pressure
  • foamy urine

Your doctor will recommend the dosage of Benlysta that’s right for you. Below are commonly used dosages, but your doctor will determine the dosage you receive. If you use a subcutaneous form of Benlysta and you self-inject, always use the dosage that your doctor prescribes. For more information about Benlysta’s dosage, see this article.

Forms and strengths

Benlysta is available in two forms:

  • A powder that’s mixed into a liquid solution. This form is given by intravenous (IV) infusion (an injection into your vein over a period of time). The powder comes in two strengths: 120 milligrams (mg) and 400 mg.
  • A liquid solution inside prefilled syringes or auto-injectors. This form is given as a subcutaneous injection (an injection under your skin) and comes in one strength: 200 mg per milliliter (mL).

Recommended dosages

See below for the recommended dosages for each form of Benlysta.

Dosage for Benlysta IV infusion

If you receive Benlysta through IV infusions, you’ll get doses at your doctor’s office, an infusion suite, or a hospital.

This dose is expected to be the same regardless of which condition the drug is used to treat. Your doctor or another healthcare professional will mix the appropriate amount of Benlysta powder with a liquid solution before giving it to you.

A typical dose of Benlysta is 10 mg per kilogram (kg) of body weight. You’ll get this dose every 2 weeks for your first three doses. Then, you’ll receive a dose every 4 weeks.

Each Benlysta infusion usually lasts about 1 hour.

Dosage for Benlysta subcutaneous injection

If you’re prescribed the Benlysta auto-injector or prefilled syringe, you’ll likely inject a dose once weekly. Children weighing less than 40 kg or 88 pounds (lb) may receive a dose every 2 weeks.

In most cases, your doctor can show you or a caregiver how to inject the drug at home.

The dosage of Benlysta’s subcutaneous forms depends on certain factors, including your age and the condition it’s used to treat.

Dosage for active systemic lupus erythematosus (SLE)

Benlysta is approved to treat active SLE in adults and children ages 5 years and older. For adults, the dosage is 200 mg per week.

For children, the dosage is based on weight. If your child weighs 15 to 40 kg (33 to 88 lb), they’ll receive 200 mg of Benlysta every 2 weeks. If they weigh more than 40 kg (88 lb), their dose is the same as for adults: 200 mg per week.

It’s important to note that the auto-injector pen is the only subcutaneous form of Benlysta that’s approved for children. For children ages 10 years and younger, Benlysta must be given by a caregiver or a healthcare professional.

Dosage for active lupus nephritis

Benlysta prefilled syringes and auto-injector pens are approved to treat active lupus nephritis in adults. For this use, the typical dosage is 400 mg per week for 4 weeks. After this, you’ll receive 200 mg per week for the rest of your treatment with Benlysta.

It’s important to note that only the intravenous form of Benlysta is approved to treat active lupus nephritis in children.

Questions about Benlysta’s dosing

Below are some common questions about Benlysta’s dosing.

What if I miss a dose of Benlysta? If you miss your appointment for the IV infusion form of Benlysta, call your doctor’s office as soon as possible to reschedule. If you miss your dose of the subcutaneous form of Benlysta, inject it as soon as you remember.

Then, you can continue with your usual dosage schedule or adjust your schedule based on when you took the missed dose. For example, if you usually inject on Mondays but took your missed dose on Tuesday, you can either inject your next dose the following Monday or switch to Tuesdays. If you miss a dose of Benlysta and need help determining when to give your next dose, talk with your doctor or pharmacist.

Will I need to use Benlysta long term? Yes, Benlysta is typically a long-term treatment. If you and your doctor determine that Benlysta is effective for you, they’ll usually recommend the drug long term.

How long does it take for Benlysta to work? Benlysta begins to work as soon as you get your first dose of medication. But you may not notice changes in your lupus symptoms until you’ve had a few doses. If you have questions about what to expect from your Benlysta treatment, talk with your doctor.

Your doctor will explain how Benlysta will be given to you. They’ll also explain how much you’ll be given and how often.

In some cases, you or a caregiver may be able to inject your dose of Benlysta at home. In that case, your doctor can explain how to inject Benlysta. They’ll also explain how much to inject and how often. Be sure to follow your doctor’s instructions.

Using Benlysta

Benlysta comes in two forms:

See below for details.

By IV infusion

If you receive Benlysta through IV infusions, you’ll likely get doses at your doctor’s office, an infusion suite, or a hospital. In some cases, you may be able to have a healthcare professional come to your home for Benlysta administration.

Your doctor may prescribe some medications to take before the Benlysta infusion. These medications may help reduce the risk of infusion reactions and allergic reactions from Benlysta.

The infusion time (how long your Benlysta infusion will take) is about 1 hour. Benlysta comes as a powder that your doctor will mix into a liquid solution.

The IV infusion form of Benlysta can be used in both adults and children.

Your doctor will explain how the IV infusions will be given to you and what to expect at your appointments. If you have other questions about the IV infusions, talk with your doctor before starting treatment.

By subcutaneous injection

If you use the subcutaneous form of Benlysta, you’ll likely receive your first injection at your doctor’s office. Then, they can show you or a caregiver how to give injections at home.

The recommended injection sites for Benlysta are your belly or thigh. You should rotate the spot where you inject the drug for each dose to help prevent an injection site reaction, such as pain or itching. Do not inject the drug into skin that’s bruised, discolored, tender, or hard.

The subcutaneous form of Benlysta can be used in adults with active systemic lupus erythematosus and active lupus nephritis. It can also be used in children with active systemic lupus erythematosus. Children with active lupus nephritis will receive the drug through IV infusions.

If you have other questions about how to inject Benlysta, talk with your doctor or pharmacist. And if you use an auto-injector to administer Benlysta, the drugmaker’s website has a video explaining how to give yourself injections.

Accessible medication containers and labels

If it’s hard for you to read the label on your prescription, tell your doctor or pharmacist. Certain pharmacies may provide medication labels that:

  • have large print
  • use braille
  • contain a code you can scan with a smartphone to change the text into audio

Your doctor or pharmacist may be able to recommend a pharmacy that offers these options if your current pharmacy doesn’t.

Using Benlysta with other drugs

You’ll use Benlysta along with other medications to treat your lupus. This may include:

Before you start your Benlysta treatment, your doctor will help determine the best treatment plan for you.

Questions about using Benlysta

Below are some common questions about using the subcutaneous form of Benlysta.

  • Should I eat food before injecting Benlysta? You can give your dose of Benlysta with or without food.
  • Is there a best time of day to take Benlysta? No, there isn’t a best time of day to inject your dose of Benlysta. Benlysta can be used at any time of day, but you should give your dose on the same day each week.
Questions for your doctor

You may have questions about Benlysta and your treatment plan. It’s important to discuss all your concerns with your doctor.

Here are a few tips that might help guide your discussion:

  • Before your appointment, write down questions such as:
    • How will Benlysta affect my body, mood, or lifestyle?
  • Bring someone with you to your appointment if doing so will help you feel more comfortable.
  • If you don’t understand something related to your condition or treatment, ask your doctor to explain it to you.

Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So don’t be afraid to ask questions or offer feedback on your treatment.

Some important things to discuss with your doctor when considering treatment with Benlysta include:

  • your overall health
  • any medical conditions you may have

Additionally, tell your doctor if you’re taking any medications. This is important because some medications can interfere with Benlysta.

These and other considerations to discuss with your doctor are described below.

Interactions

Taking a medication with certain vaccines, foods, and other things can affect how the medication works. These effects are called interactions.

Before using Benlysta, be sure to tell your doctor about all medications you take, including prescription and over-the-counter types. Also describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Benlysta.

For information about drug-condition interactions, see the “Warnings” section below.

Interactions with drugs or supplements

There currently aren’t any medications or supplements known to interact with Benlysta. But this doesn’t mean drug interactions with Benlysta won’t be recognized in the future. For example, new medications may be approved that interact with Benlysta.

For this reason, you should still tell your doctor and pharmacist about any medications you take besides Benlysta. This way, they can check for any new interactions during your treatment.

Other interactions

You should not receive any live vaccines during your Benlysta treatment or in the 30 days before you start treatment.

Live vaccines contain a small amount of the virus that they protect against. Benlysta works by weakening your immune system, so your body may not be able to fight the virus in a live vaccine. This could make you sick.

Examples of live vaccines include:

Benlysta may also make inactive (non-live) vaccines less effective. These vaccines don’t contain a live virus, so they won’t make you sick. But receiving them during your Benlysta treatment could make them less effective.

Examples of inactive vaccines include:

Before starting treatment with Benlysta, talk with your doctor about any vaccines that you may need. In some cases, they may recommend that you get a certain vaccine before starting Benlysta treatment.

Warnings

Benlysta may not be right for you if you have certain medical conditions. These are known as drug-condition interactions. Other factors may also affect whether Benlysta is a good treatment option for you.

Talk with your doctor about your health history before you use Benlysta. Factors to consider include those described below.

Mood problems, such as depression or suicidal thoughts or behaviors: Benlysta may cause changes in your mood, including depression or suicidal thoughts or behaviors. If you’ve experienced these issues before, tell your doctor before starting Benlysta treatment. They may monitor you more often for changes in your mood throughout your treatment. In some cases, they may recommend a different treatment option for you.

Recent vaccines: Before starting Benlysta, talk with your doctor about any recent vaccines you’ve received or may need. Some vaccines interact with Benlysta, so your doctor may recommend updating your vaccines before starting treatment. For more details about Benlysta and vaccines, see the “Other interactions” section above.

Cancer: It’s not known whether Benlysta may raise your risk of cancer. But because the drug may weaken your immune system, treatment with Benlysta could raise your risk of cancer. If you’ve had cancer previously, tell your doctor before using Benlysta. They may monitor you more closely during your treatment.

Taking other biologic drugs or monoclonal antibodies: Benlysta is a biologic drug (made from living cells) and belongs to a group of drugs called monoclonal antibodies. Before starting Benlysta treatment, tell your doctor if you’re taking any other biologic drugs or monoclonal antibodies. This is because it’s not known whether it’s safe to use Benlysta with these drugs. Your doctor can determine the best treatment plan for you.

Allergic reaction: If you’ve had an allergic reaction to Benlysta or any of its ingredients, your doctor will likely not prescribe Benlysta. Ask them what other medications are better options for you.

Infections: Before starting Benlysta treatment, tell your doctor if you have an active or reoccurring infection. Benlysta may weaken your immune system. If you already have an infection, using Benlysta could cause it to become worse. In this case, your doctor will treat your infection before starting Benlysta.

Benlysta and alcohol

There aren’t any known interactions between Benlysta and alcohol. But both alcohol and Benlysta may cause nausea. Combining the two may increase your risk of experiencing nausea.

In addition, you’ll use Benlysta along with other medications to treat your condition. Certain other treatments may interact with alcohol.

If you drink alcohol, talk with your doctor about how much (if any) may be safe to drink with your treatment plan.

Pregnancy and breastfeeding

It’s not known whether it’s safe to use Benlysta during pregnancy.

At this time, it isn’t known whether Benlysta may raise the risk of problems with fetal development (also known as birth defects) or pregnancy loss. If you can become pregnant, your doctor may recommend using birth control during your treatment due to these risks. You’ll continue using birth control for at least 4 months after your last dose of Benlysta.

Because Benlysta affects your immune system, the drug can also weaken the immune system in a fetus. It’s important to note that untreated lupus may cause risks during pregnancy. Your doctor can determine how to treat your lupus during your pregnancy.

It’s also not known whether Benlysta is safe to use while breastfeeding. This is because it’s not known whether the drug passes into breast milk or what effects it may have on a breastfed child.

If you’re pregnant or breastfeeding, or planning to become pregnant or to breastfeed, talk with your doctor about the best treatment options for you.

Do not use more Benlysta than your doctor prescribes. Using more than this can lead to serious side effects.

What to do in case you use too much Benlysta

Call your doctor if you think you’ve injected too much Benlysta. You can also call 800-222-1222 to reach America’s Poison Centers or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number. Or go to the nearest emergency room.

If you still have questions or concerns about using Benlysta, talk with your doctor or pharmacist. Questions that you may want to ask include:

  • If Benlysta doesn’t work for me, can my dose be increased?
  • Which form of Benlysta would be better for me?
  • Do I have a higher risk of side effects due to the other medications I take?
  • What should I do if I become pregnant during my Benlysta treatment?

To get information on different conditions and tips for improving your health, subscribe to any of Healthline’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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