Benlysta is a brand-name drug that’s prescribed for a certain type of lupus and lupus nephritis. Benlysta contains the active drug belimumab.

Benlysta is FDA-approved to treat:

Doctors prescribe Benlysta for people who are already taking standard treatments for their lupus, such as a steroid like prednisone.

Benlysta hasn’t been studied in people with severe active central nervous system lupus, which affects the central nervous system. Benlysta isn’t recommended as a treatment for this condition.

Drug details

You’ll find key information about Benlysta below.

Benlysta is available only as a brand-name medication. It’s a biologic drug that is not currently available in a generic or biosimilar form.

Biologic drugs are made from living cells. A biosimilar drug is very similar to a brand-name biologic drug. However, biologic drugs cannot be copied exactly because they’re made of living cells. A generic drug, on the other hand, is an exact copy of the active drug in a brand-name medication. Generic drugs are exact copies of brand-name medications that are made using chemicals in a lab.

Biosimilars may be available in a different form than the parent biologic drug. Biosimilar medications are considered to be as safe and effective as the original biologic drug.

Generics and biosimilars both tend to cost less than brand-name drugs.

Benlysta can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while using Benlysta. These lists do not include all possible side effects.

For more information on the possible side effects of Benlysta, refer to this article. You can also talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may bother you.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to report to the FDA a side effect you’ve had with Benlysta, you can do so through MedWatch.

Mild side effects

Mild side effects of Benlysta include:*

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or do not go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Benlysta. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Benlysta’s prescribing information.

Serious side effects

Serious side effects from Benlysta are not common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency phone number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms include:

  • Progressive multifocal leukoencephalopathy (a rare but very serious brain infection). Symptoms can include:
    • difficulty walking or coordinating your movements
    • vision loss
    • changes in your personality
    • trouble speaking
  • Allergic reaction.*
  • Serious infections.*
  • Depression or suicidal thoughts or behaviors.*

* For more information on these side effects, see “Side effect details” below.

Side effects in children

The form of Benlysta given by intravenous (IV) infusion is approved for use in children ages 5 years and older who have active SLE or active lupus nephritis. In clinical trials, children using Benlysta experienced the same side effects as adults using the drug (see above).

The form of the drug given by subcutaneous injection is not approved for use in children. Therefore, children will not experience injection site reactions, which are associated with the subcutaneous injection. However, they may still experience infusion reactions from receiving the drug through IV infusion.

Side effect details

You may wonder how often certain side effects occur with this drug or whether certain side effects pertain to it. Here’s some detail on certain side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after receiving Benlysta.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • difficulty breathing

Serious allergic reactions have occurred in people using Benlysta. In very rare cases, this has been fatal. Usually, people who have allergic reactions experience them within a few hours after treatment. However, in some cases, it may take time for symptoms to develop.

Call your doctor right away if you have a severe allergic reaction to Benlysta. Call 911 or your local emergency phone number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious infections

Although it is not common, developing serious infections is a possible side effect of Benlysta. And though rare, these infections have been fatal. Examples of serious infections include upper respiratory infections and urinary tract infections (UTIs).

Symptoms vary depending on the type of infection you have. For example, symptoms of a UTI may include:

  • a burning feeling when urinating
  • urinating more often than normal
  • blood in your urine

Before you start using Benlysta, be sure to tell your doctor if you have any severe or chronic (long lasting) infections. Your doctor will determine whether Benlysta is a safe treatment choice for you.

If you develop symptoms of an infection during Benlysta treatment, tell your doctor right away. They may have you stop receiving Benlysta until your infection goes away. Or they may decide to try a different treatment for your condition.

Hair loss

Hair loss is a rare side effect some people may experience while using Benlysta. In clinical trials, there were no reports of hair loss.

However, since the drug was approved, there were reports of three people experiencing hair loss while using Benlysta. The type of hair loss that was reported is called alopecia areata.

People with alopecia areata experience patchy hair loss, which can be on the scalp or other areas of the body. Alopecia areata is an autoimmune disease (as is lupus). It causes your immune system to attack your hair follicles, preventing your hair from growing properly.

It is unknown whether the hair loss reported in three people receiving Benlysta was caused by the drug. All three people experienced hair regrowth. Two of these people decided to stop receiving Benlysta because of hair loss.

If you are concerned about hair loss during your Benlysta treatment, talk with your doctor. They may be able to recommend ways to decrease this side effect. Or they may recommend a different medication to treat your systemic lupus erythematosus (SLE) or lupus nephritis.

Depression

Some people may experience depression during Benlysta treatment. In some cases, depression can be very serious* and may severely affect a person’s life.

Symptoms of depression include feeling sad or alone, feeling hopeless, or losing enthusiasm for activities that you used to enjoy. Sometimes, depression can lead to suicidal thoughts or behaviors. So it is important to talk with your doctor right away if you are experiencing symptoms of depression.

If you have concerns about your mental health while using Benlysta, talk with your doctor before starting treatment. They will also monitor you for symptoms of depression or suicidal thoughts or behaviors during your Benlysta treatment.

* Depression may be considered serious if a person has thoughts of dying, hurting themself, or hurting others.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Find more links and local resources.

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Infusion or injection site reactions

Some people receiving Benlysta may experience infusion or injection site reactions after getting their dose. In some cases, these can be very serious. It’s important to watch for symptoms of a reaction while you are getting your medication and after you get your dose.

Infusion reactions

People receiving the drug by intravenous (IV) infusion may experience infusion reactions. Symptoms of infusion reactions include headache, nausea, and rash. In some cases, severe symptoms are possible. These include slow heart rate, muscle pain, and low blood pressure.

Your doctor may give you medications to decrease your risk of having an infusion reaction. However, it is not known for sure whether this is an effective way to decrease your risk of an infusion reaction.

If you do experience an infusion reaction, your doctor may decrease the speed of your infusion or may stop it altogether. Talk with your doctor about any infusion reactions you experience while using Benlysta. They can determine how serious these reactions are and can recommend ways to prevent the reactions from occurring.

Injection site reactions

People receiving Benlysta by subcutaneous injection may have a reaction at the injection site. These are called injection site reactions and may include symptoms such as pain, skin discoloration, or swelling.

Your doctor may give you medications to decrease your risk of having an injection site reaction. However, it is not known for sure whether this is an effective way to decrease your risk of an injection site reaction.

If you experience injection site reactions that bother you, talk with your doctor. They may be able to recommend ways to decrease these side effects.

Weight gain or weight loss (not side effects)

During clinical trials of Benlysta, weight changes, such as such as weight gain and weight loss, were not reported.

If you experience changes in your weight, talk with your doctor. Sometimes, changes in weight may be related to side effects from using Benlysta. For example, weight loss may be a symptom of a serious infection. Weight loss or weight gain may also be a symptom of depression.

If you notice any weight changes while receiving Benlysta, talk with your doctor. They can determine what is causing the change in your weight and suggest any steps you should take.

The Food and Drug Administration (FDA) approves prescription drugs such as Benlysta to treat certain conditions. Benlysta may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

To find out more about lupus, refer to this article list.

Benlysta for systemic lupus erythematosus

Benlysta is FDA-approved to treat a type of lupus called systemic lupus erythematosus (SLE). Doctors prescribe Benlysta for active SLE. If you have active lupus, it means you are having symptoms of the disease.

Benlysta is approved for use in people who are already taking standard treatments for their lupus, such as a steroid like prednisone.

With lupus, your immune system attacks your body. It can cause swelling in your organs and other tissues. Symptoms of lupus include:

  • a butterfly rash on your face
  • fever
  • fatigue
  • pain in your joints
  • headache
  • confusion
  • problems with organs, such as your kidneys not working properly

For this condition, Benlysta is approved for use in adults and in children ages 5 years and older.

Effectiveness for SLE

Clinical trials have shown that Benlysta is an effective medication for treating SLE. For information about these trials, see Benlysta’s prescribing information.

Benlysta for lupus nephritis

Benlysta is FDA-approved to treat a type of nephritis (kidney inflammation) that lupus causes. This condition is called lupus nephritis. Benlysta is used for active lupus nephritis. If you have active lupus nephritis, it means you are having symptoms of the disease.

Benlysta is approved for use in people who are already taking standard treatments, such as a steroid like prednisone, for their lupus nephritis.

With lupus, your immune system attacks your body. It can cause swelling in your organs, such as your kidneys. Symptoms of lupus nephritis can include:

For this condition, Benlysta is approved for use in adults and in children ages 5 years and older.

Effectiveness for lupus nephritis

Clinical trials have shown that Benlysta is an effective medication for treating lupus nephritis. For information about these trials, see Benlysta’s prescribing information.

Limitations of use

Benlysta hasn’t been studied in people with severe active central nervous system lupus, which affects the central nervous system. Benlysta isn’t recommended as a treatment for this condition.

Benlysta and children

The form of Benlysta given by intravenous (IV) injection is approved for use in children ages 5 years and older who have active SLE or active lupus nephritis. However, the form given by subcutaneous injection isn’t approved for children.

For more information, see the “Benlysta for systemic lupus erythematosus” and “Benlysta for lupus nephritis” sections above.

In addition to the uses listed above, Benlysta may be used off-label for other purposes. Off-label drug use is when a drug that’s approved for one or more uses is prescribed for a different one that’s not approved. Below is an example of an off-label use for Benlysta.

Benlysta for rheumatoid arthritis (off-label use)

Benlysta isn’t approved to treat rheumatoid arthritis (RA). But it may be used off-label for this condition.

One small study showed that Benlysta may have some benefit in treating RA. However, larger studies are still needed to confirm these results.

If you have additional questions about using Benlysta for RA, talk with your doctor. They’ll work to determine the best treatment plan for you.

As with all medications, the cost of Benlysta can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll have to get Benlysta autoinjectors (for subcutaneous injections) at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to ensure safe and effective use.

You will typically receive your Benlysta intravenous (IV) infusions at a doctor’s office, infusion center, or hospital. But sometimes, a home health nurse may administer them at your home. A healthcare professional will usually obtain any medication they give you at your home. If you’re receiving Benlysta by IV infusion and you have questions about purchasing the medication, talk with your doctor or pharmacist.

Before approving coverage for Benlysta, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you will need to get prior authorization for Benlysta, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Benlysta, or if you need help understanding your insurance coverage, help is available.

GSK, the manufacturer of Benlysta, offers two options, the Benlysta Gateway and Benlysta Copay programs, that may help lower your cost of the drug. For more information and to find out if you are eligible for support, call 877-423-6597 or visit the Benlysta website.

Biosimilar version

Benlysta is a biologic drug. It is not currently available in biosimilar form.

Biologic drugs are made using living cells. It’s not possible for drug companies to produce exact copies of these drugs. A biosimilar drug is a very similar version of the parent brand-name biologic drug. However, it’s not identical. Biosimilar drugs are made to treat the same conditions as their parent drug. They are considered to be as safe and effective as the parent drug. Biosimilars also tend to cost less than brand-name drugs.

The Benlysta dosage your doctor prescribes will depend on several factors. These include:

  • your weight*
  • the form of Benlysta you receive
  • other medical conditions you may have

Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

For more information about Benlysta’s dosage, refer to this article.

* Doses are determined by your weight in kilograms, such as 10 milligrams per kilogram (mg/kg) of body weight.

Drug forms and strengths

Benlysta comes in these two forms:

  • A powder that’s mixed with liquid to form a solution. This form is given as an intravenous (IV) infusion into a vein. (An infusion is an injection into your vein that’s slowly dripped in over time.) Benlysta powder comes in vials containing either 120 milligrams (mg) or 400 mg of the drug.
  • A solution inside prefilled syringes and autoinjectors. This form is given as a subcutaneous injection. The syringe or autoinjector contains 200 mg of the drug.

Dosage for lupus

The Benlysta dosage for treating systemic lupus erythematosus (SLE) or lupus nephritis varies with the form of the drug.

IV infusion

For Benlysta given by IV infusion, your dose is based on your body weight. The normal dose is 10 mg/kg of weight. As an example, the dose for someone who weighs 68 kg (about 150 pounds [lb]) would be 680 mg. It usually takes about an hour to receive the dose by infusion. You’ll get your dose in a doctor’s office, infusion center, or hospital.

When you first start receiving Benlysta by IV infusion, you’ll get a dose every 2 weeks. After the first three doses, you’ll only need to get a dose once every 4 weeks.

When a drug’s dosage is higher at the start of treatment, it’s called a loading dose. A loading dose is used to quickly get the drug into your body at levels high enough for it to begin working to treat your condition. Without a loading dose, Benlysta would take a long time to start working.

Your doctor may give you medications before the infusion to lower your risk of having an infusion reaction. These are called premedications, and they may include drugs such as diphenhydramine (Benadryl) and acetaminophen (Tylenol). These medications may help prevent infusion reactions, such as a rash or fever.

During the infusion, a healthcare professional will monitor you for reactions to the drug. If you have a reaction, they will pause or stop the infusion to treat the reaction.

Subcutaneous injection

A subcutaneous injection is an injection given under the skin. The dosage for Benlysta given this way is not based on your weight. Instead, it’s based on the condition you are using Benlysta to treat. This form of Benlysta is only approved for adults.

If you receive Benlysta by subcutaneous injection, you’ll likely get your first dose at a doctor’s office, infusion center, or hospital. This is to make sure you do not experience any serious reactions to the injection. After that, your doctor may teach you or your caregiver how to give the injection at home. The manufacturer’s website has a video and step-by-step instructions that also explain how to inject Benlysta.

You’ll inject Benlysta into your abdomen or thigh. You should rotate the injection site (change the area where you give yourself the injection) each week to prevent scar tissue from forming. Also, do not inject your dose into areas that are red, bruised, or tender.

Talk with your doctor if you are interested in getting Benlysta injections at home.

Subcutaneous injection for SLE

For SLE, your dose is 200 mg injected under your skin once per week.

Subcutaneous injection for lupus nephritis

For lupus nephritis, your dose is 400 mg injected under your skin once per week for 4 weeks. (You’ll use either two prefilled syringes or two prefilled autoinjectors for each dose.)

You’ll then receive 200 mg each week.

Pediatric dosage

The only approved form of Benlysta for children is that given by intravenous (IV) infusion. It’s approved for use in children ages 5 years and older.

For children using Benlysta, the dose is based on their body weight. The usual dose is 10 mg/kg of weight. For example, a dose for a child who weighs 20 kg (about 44 lb) would be 200 mg. It usually takes about an hour to receive the dose by infusion. Children will get their dose in a doctor’s office, infusion center, or hospital.

When a child first starts receiving an IV infusion of Benlysta, they’ll get a dose every 2 weeks. After the first three doses, they’ll only need to get a dose once every 4 weeks.

When a drug’s dosage is higher at the start of treatment, it’s called a loading dose. A loading dose is used to quickly get the drug into your body at levels high enough for it to begin working to treat your condition. Without a loading dose, Benlysta would take a long time to start working.

The child’s doctor may give them medications before the infusion to lower their risk of having an infusion reaction. These are called premedications, and they may include drugs such as diphenhydramine (Benadryl) and acetaminophen (Tylenol). These medications may help prevent infusion reactions, such as a rash or fever.

During the infusion, a healthcare professional will monitor the child for reactions to the drug. If the child has a reaction, the healthcare professional will pause or stop the infusion to treat the reaction.

What if I miss a dose?

If you miss your appointment to get your intravenous (IV) dose of Benlysta, call your doctor right away. They will probably have you schedule another appointment as soon as possible so that you do not have an interruption in your treatment.

If you’re receiving Benlysta by subcutaneous injection and you miss your dose, call your doctor or pharmacist. They will usually recommend that you take your dose as soon as you remember. Depending on your situation, they may recommend continuing your dose on your regular dosing days. Or they may recommend changing your dosing days so that you do not get two doses too close together.

You should never take two doses on the same day to try to make up for a missed dose. Doing so could raise your risk of serious side effects.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Benlysta is meant to be used as a long-term treatment. If you and your doctor determine that Benlysta is safe and effective for you, you will likely take it long term.

The Food and Drug Administration (FDA) has approved Benlysta to treat:

What happens with lupus

Lupus is an autoimmune disease, which means that it affects your immune system. (Your immune system protects your body against infection and disease.) For more information about SLE and lupus nephritis, see the “Benlysta for lupus” section above.

If you have active lupus, it means you’re having symptoms of the disease.

Benlysta is approved for use in people who are already taking standard treatments for their lupus, such as a steroid like prednisone.

What Benlysta does

Benlysta belongs to a group of medications called monoclonal antibodies. These are biologic drugs made from immune system cells. Specifically, Benlysta is a B-lymphocyte stimulator-specific blocker. B-lymphocyte stimulators produce autoantibodies, which are proteins in your blood that attack your body.

By blocking those B-lymphocyte stimulators, Benlysta decreases the amount of autoantibodies you have. Having fewer autoantibodies can help relieve your lupus symptoms.

How long does it take to work?

Benlysta will start working after your first dose. However, it may take a few doses before you notice improvements in your lupus symptoms.

Never stop using Benlysta without first talking with your doctor. If you want to stop using the drug because of negative side effects, your doctor can determine the best way to end your treatment. They may also prescribe a different medication for you to take instead.

Here are answers to some frequently asked questions about Benlysta.

Is Benlysta a chemotherapy drug?

No, Benlysta isn’t a chemotherapy drug. It’s a type of drug called a monoclonal antibody (a biologic drug made from immune system cells).

People with lupus have an immune system that attacks their body. Benlysta works by weakening the immune system, which can help relieve lupus symptoms.

Chemotherapy drugs kill cells in the body that grow rapidly. Cancer cells are usually fast-growing cells, so they’re affected by chemotherapy. However, some healthy cells (like hair cells) are also fast growing. Chemotherapy can also affect these growing healthy cells, which is why chemotherapy drugs can cause many side effects.

Because Benlysta works in a specific part of your immune system, it may cause fewer side effects than a chemotherapy drug.

Can I take antibiotics with Benlysta?

There are no known drug interactions between Benlysta and antibiotics. However, because Benlysta can weaken your immune system, you should not receive it while you have a serious infection. Your doctor may monitor you more closely if you have an infection and are using Benlysta.

If your infection is serious, your doctor may temporarily stop your Benlysta treatment until the infection goes away. You may be able to restart the medication once your infection has cleared.

If you currently have any infections, talk with your doctor before you start treatment with Benlysta. Your doctor will treat your infection before you start Benlysta treatment.

If I’m having surgery, can I still use Benlysta?

Yes, you can still receive Benlysta if you’re having surgery. There are no recommendations about stopping treatment for surgery.

Some biologic drugs may weaken your immune system. This can make it harder for you to heal after a major surgery. However, there isn’t a high risk of this side effect with Benlysta, even though it can weaken your immune system. Be sure to talk with your doctor about all medications you take before your surgery.

Does Benlysta help with fatigue from lupus?

Yes. Benlysta can help relieve your lupus symptoms, including fatigue. Clinical trials have shown that people receiving Benlysta may have significantly less fatigue compared with people receiving a placebo (a treatment with no active drug).

It’s important to note that reactions to the drug may vary depending on the person. Talk with your doctor about how Benlysta may help relieve your symptoms of lupus, including fatigue.

Why would my doctor recommend Benlysta infusions instead of subcutaneous injections?

Benlysta can be given in two ways: as an intravenous (IV) infusion or as a subcutaneous injection. Both treat your lupus. However, your doctor may recommend one over the other based on your specific situation.

There may be pros and cons to each option, depending on what’s important to you. IV infusions of Benlysta must be given in a doctor’s office, infusion center, or hospital. However, after your first few doses, you only need to get a dose of Benlysta every 4 weeks. In comparison, people who are prescribed the subcutaneous injection need to receive it once per week.

If you receive Benlysta by IV infusion, you’re only at risk of an infusion reaction once per month. However, if you receive Benlysta by subcutaneous injection, you may be at risk of injection reactions each week.

Talk with your doctor about whether IV infusions or subcutaneous injections of Benlysta are best for you. They can discuss the benefits and risks of each with you.

How can I keep track of my injection sites while using Benlysta?

If you’re receiving Benlysta by subcutaneous injection, it’s very important that you keep track of where you’re injecting the drug each week. This is because you should rotate the injection site (change the area where you give yourself the injection) each week to prevent scar tissue from forming. You should also not inject into areas that are bruised or tender.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

You might also consider keeping a journal to track when you take your doses as well as any symptoms you may be having. You can record how you’re feeling and any notes or questions for your doctor. This is helpful to bring to your doctor appointments so that you can discuss any side effects you’re experiencing and whether the drug is helping your symptoms.

Will I have side effects if I stop using Benlysta?

No, Benlysta shouldn’t cause any side effects when you stop using it. However, while you’re using Benlysta, your lupus symptoms may decrease. Once you stop treatment with the drug, symptoms of your condition (such as tiredness, rash, or joint pain) may come back.

Talk with your doctor if you have questions or concerns about ending your Benlysta treatment.

Benlysta can be given in two ways: as an intravenous (IV) infusion or as a subcutaneous injection. An IV infusion is an injection into your vein that’s slowly dripped in over time. A subcutaneous injection is given under your skin.

By IV infusion

The Benlysta form used for IV infusion comes as a powder that’s mixed with liquid to make a solution. The solution is given by infusion into a vein. This form can be used in adults and in children ages 5 years and older.

If you’re receiving Benlysta by IV infusion, you’ll likely need to get your medication at a doctor’s office, infusion center, or hospital. It usually takes about an hour to get your full dose of Benlysta by infusion. Your doctor or nurse will mix the medication before they give you the dose. During the infusion, a healthcare professional will monitor you for reaction to the drug. If you have a reaction, they will pause or stop the infusion to treat the reaction.

You may also be able to receive Benlysta as an IV infusion at home from a home health nurse. Talk with your doctor if you’re interested in learning more about this option.

By subcutaneous injection

Benlysta also comes in a syringe or autoinjector that already has the liquid medication in it. This form is given as a subcutaneous injection and is approved for use in adults only.

If you receive Benlysta by subcutaneous injection, in most cases you’ll get your first dose at a doctor’s office, infusion center, or hospital. This is to make sure you don’t experience any serious reactions to the injection. After that, your doctor may teach you or your caregiver how to give the injection at home. The manufacturer’s website has a video and step-by-step instructions that also explain how to inject Benlysta.

You’ll inject Benlysta into your abdomen or thigh. You should rotate the injection site (change the area where you give yourself the injection) each week to prevent scar tissue from forming. Also, don’t inject your dose into areas that are red, bruised, or tender.

Talk with your doctor if you’re interested in using the Benlysta injections at home.

When to receive your dose

If you are receiving Benlysta by IV infusion, you will likely get a dose every 2 weeks for the first three doses of your treatment. After that, you will only need to get one dose every 4 weeks.

If you are receiving a subcutaneous injection of the drug, you will take one dose every week. You should inject your dose on the same day each week. This is so you always have about the same amount of medication in your body.

To help make sure you do not miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

It is unknown whether Benlysta is safe to use during pregnancy.

Monoclonal antibodies, such as belimumab (the active drug in Benlysta), may affect the immune system of a fetus exposed to the drug.

In animal studies, there was no increased risk of harm to the fetus when a pregnant animal received Benlysta.

Although there was no higher risk of harm to a fetus, these animal studies did show weakened immune systems of offspring born to animals receiving Benlysta. However, their immune systems returned to previous levels within 3 to 12 months after birth. It’s important to note that animal studies do not always reflect what will happen in humans.

There are also risks to a pregnant person’s health if lupus is left untreated. You should only use Benlysta during pregnancy if the benefits outweigh the risks.

Pregnancy registry

There is a pregnancy registry for Benlysta that collects information on whether the drug affects pregnancy. If you become pregnant during Benlysta treatment, you or your doctor can sign you up for the registry by calling 877-311-8972.

It is unknown whether Benlysta is safe to use during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Benlysta.

For more information about using Benlysta during pregnancy, see the “Benlysta and pregnancy” section above.

For females using Benlysta

If you can become pregnant, you may wish to prevent pregnancy while using Benlysta. It is unknown whether Benlysta is safe for pregnant females* to use. Therefore, if you wish to prevent pregnancy, you should use an effective form of birth control, such as birth control pills, during your treatment. You’ll also need to use birth control for at least 4 months after your last dose of Benlysta.

For males using Benlysta

The manufacturer of Benlysta has not provided birth control recommendations for males* who are using the medication. If you’re sexually active with someone who could become pregnant, talk with your doctor about your birth control needs.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

It is unknown whether Benlysta is safe to use while breastfeeding. In animal studies, Benlysta did pass into breast milk. However, animal studies do not always predict what will happen in humans.

If you are currently breastfeeding, talk with your doctor before starting Benlysta treatment.

Other drugs are available that can treat systemic lupus erythematosus (SLE) or lupus nephritis. Some may be a better fit for you than others. If you are interested in finding an alternative to Benlysta, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for SLE

Examples of other drugs that may be prescribed to treat SLE include:

Alternatives for lupus nephritis

Examples of other drugs that may be prescribed to treat lupus nephritis include:

  • azathioprine (Imuran)
  • corticosteroids, such as prednisone
  • cyclophosphamide
  • mycophenolate mofetil (CellCept)

You may wonder how Benlysta compares with other medications that are prescribed for similar uses. Here we look at how Benlysta and Plaquenil are alike and different.

Ingredients

The active drug in Benlysta is belimumab. The active drug in Plaquenil is hydroxychloroquine.

Uses

Here is a list of conditions that the Food and Drug Administration (FDA) has approved Benlysta and Plaquenil to treat.

  • Benlysta and Plaquenil are both FDA-approved to treat:
    • Systemic lupus erythematosus (SLE). This is a type of lupus. Doctors prescribe Benlysta to treat SLE in people who are already taking standard treatments for their SLE. It can be used in adults and in children who are ages 5 years or older. For treating SLE, Plaquenil is approved for use in adults only.
  • Benlysta is also FDA-approved to treat:
    • Lupus nephritis. This condition is a type of kidney inflammation that is caused by lupus. Doctors prescribe Benlysta to treat lupus nephritis in adults who are already receiving standard treatments for their condition.
  • Plaquenil is also FDA-approved to treat:

Drug forms and administration

Benlysta comes in two forms:

  • A powder that’s mixed with liquid to form a solution. This form is given as an intravenous (IV) infusion and can be used in adults and in children ages 5 years and older. You will receive this form every 2 weeks for the first three doses. After that, you receive it once every 4 weeks.
  • A solution inside prefilled syringes and autoinjectors. This form is given as a subcutaneous injection and is approved for use in adults only. You will receive this form of Benlysta once every week.

Plaquenil is available as an oral tablet that you take either once or twice per day.

Side effects and risks

Benlysta and Plaquenil have some similar side effects and others that differ. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Benlysta, with Plaquenil, or with both drugs (when taken individually).

  • Can occur with Benlysta:
    • infection, such as the common cold or bronchitis (a type of lung infection)
    • pain in your arms or legs
    • infusion or injection site reactions, such as skin discoloration and pain
    • fever
    • migraine
  • Can occur with Plaquenil:
    • muscle pain
    • dizziness
    • abdominal pain
    • vomiting
    • decreased appetite or weight loss
  • Can occur with both Benlysta and Plaquenil:

Serious side effects

These lists contain examples of serious side effects that can occur with Benlysta, with Plaquenil, or with both drugs (when taken individually).

Effectiveness

Benlysta and Plaquenil have different FDA-approved uses, but they’re both used to treat SLE.

These drugs have not been directly compared in clinical trials. However, trials have found both Benlysta and Plaquenil to be effective for treating SLE.

Benlysta is usually used in combination with standard treatments for SLE. Therefore, Benlysta may be used with Plaquenil.

Costs

The actual price you will pay for Benlysta or Plaquenil depends on your insurance plan, your location, and the pharmacy you use.

Benlysta and Plaquenil are both brand-name drugs. There is a generic form of Plaquenil called hydroxychloroquine. There is no biosimilar drug available for Benlysta. A biosimilar is a drug that’s similar to a biologic. Benlysta is a biologic drug, which means it’s made from living cells. Generics, on the other hand, are made with chemicals in a lab.

Brand-name medications usually cost more than generics or biosimilars.

Like Plaquenil (above), CellCept has uses similar to those of Benlysta. Here’s a comparison of how these drugs are alike and different.

Ingredients

The active drug in Benlysta is belimumab. The active drug in CellCept is mycophenolate mofetil.

Uses

The Food and Drug Administration (FDA) has approved Benlysta to treat active systemic lupus erythematosus (SLE). This is a type of lupus. Doctors prescribe Benlysta to treat SLE in people who are already taking standard treatments for their SLE. It can be used in adults and in children who are ages 5 years or older.

Benlysta is also approved to treat active lupus nephritis. This condition is a type of kidney inflammation that’s caused by lupus. Doctors prescribe Benlysta to treat lupus nephritis in adults who are already receiving standard treatments for the condition.

CellCept is FDA-approved to prevent organ rejection in people receiving an organ transplant. Specifically, it can be used in people who had kidney, heart, or liver transplants.

Although it’s not FDA-approved to treat people with lupus, CellCept is included in the European Alliance of Associations for Rheumatology (EULAR) guidelines for treating SLE. So doctors may prescribe it off-label to treat this condition.

Drug forms and administration

Benlysta comes in two forms:

  • A powder that’s mixed with liquid to form a solution. This form is given as an intravenous (IV) infusion and can be used in adults and in children ages 5 years and older. You will receive it once every 2 weeks for the first three doses. After that, you will receive it once every 4 weeks.
  • A solution inside prefilled syringes and autoinjectors. This form is given as a subcutaneous injection and is approved for use in adults only. You will receive this form once every week.

CellCept comes as an oral tablet, an oral capsule, an oral suspension, and an IV infusion. Because this medication isn’t FDA-approved for treating SLE, there is no approved dosing schedule for it.

Side effects and risks

Benlysta and CellCept have some similar side effects and others that differ. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Benlysta, with CellCept, or with both drugs (when taken individually).

  • Can occur with Benlysta:
    • infusion or injection site reactions, such as skin discoloration or pain
  • Can occur with CellCept:
    • vomiting
    • low amount of white blood cells
    • abdominal pain
  • Can occur with both Benlysta and CellCept:
    • diarrhea
    • infections
    • nausea
    • fever
    • pain, such as in your arms or legs
    • migraine episode or headache

Serious side effects

These lists contain examples of serious side effects that can occur with Benlysta, with CellCept, or with both drugs (when taken individually).

* CellCept has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Effectiveness

Benlysta and CellCept have different FDA-approved uses, but they are both used to treat people with SLE.

These drugs have not been directly compared in clinical trials. However, trials have found Benlysta to be effective for treating SLE. Also, Benlysta and CellCept are both recommended in EULAR treatment guidelines for SLE.

Costs

The actual price you’ll pay for Benlysta or CellCept depends on your insurance plan, your location, and the pharmacy you use.

Benlysta and CellCept are both brand-name drugs. There is a generic form of CellCept called mycophenolate mofetil. There is no biosimilar drug available for Benlysta. A biosimilar is a drug that is similar to a biologic. Benlysta is a biologic drug, which means it’s made from living cells. Generics, on the other hand, are made with chemicals in a lab.

Brand-name medications usually cost more than generics or biosimilars.

There are no known interactions between Benlysta and alcohol. However, you will take other drugs in combination with Benlysta to treat your systemic lupus erythematosus (SLE) or lupus nephritis.

Some of these drugs may interact with alcohol. For example, people taking methotrexate (Trexall) should not drink alcohol. This is because methotrexate and alcohol may both affect your liver. Drinking alcohol while taking methotrexate could cause serious side effects.

If you drink alcohol, talk with your doctor about how much (if any) is safe to consume during your treatment.

Benlysta is not known to interact with other medications. It is also not known to interact with supplements or certain foods. However, this drug may interact with certain vaccines.

Before starting Benlysta treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Benlysta and vaccines

Benlysta can interact with certain vaccines, called live vaccines, and cause them to not work or not work as well. Therefore, you should not get any live vaccines within 30 days before starting Benlysta or while using the drug.

Live vaccines contain a small amount of the virus or bacterium that the vaccine is trying to protect against. Because Benlysta may weaken your immune system, your body may not be able to fight the viruses or bacteria in live vaccines. This means that the vaccines may cause you to become sick.

Your doctor will have you wait 30 days to start your treatment if you get a live vaccine before using Benlysta. Your doctor can also help make sure you’re up to date on vaccines you may need before your Benlysta treatment.

Examples of live vaccines include:

Inactive vaccines

It is possible that Benlysta may also make inactive vaccines less effective. These are vaccines without live viruses or bacteria in them, so they can’t make you sick. However, inactive vaccines need your immune system to work properly for them to protect you. Because Benlysta can weaken your immune system, it may prevent inactive vaccines from being effective.

Examples of inactive vaccines include:

Talk with your doctor about any vaccines you may need before you start Benlysta treatment. They can help you catch up on any vaccines you may need before starting treatment.

Benlysta is approved to be used with other medications to treat systemic lupus erythematosus (SLE) and lupus nephritis.

In clinical trials, people took Benlysta with:

Your doctor will likely prescribe other medications in combination with Benlysta to treat systemic lupus erythematosus (SLE) and lupus nephritis.

It’s recommended that you avoid using Benlysta with the biologic drug rituximab (Rituxan). In a clinical trial, an increase in side effect frequency was reported when these drugs were used in combination. Otherwise, Benlysta hasn’t been studied for use with other biologic drugs. It is unknown whether Benlysta is safe to use in combination with these medications. Be sure to tell your doctor about any other medications you’re taking before your Benlysta treatment.

Benlysta with premedications

If you are receiving Benlysta by IV injection, your doctor may have you take premedications before your infusion. Examples of premedications include diphenhydramine (Benadryl) and acetaminophen (Tylenol). These medications may be given to prevent infusion reactions, such as a rash or fever.

Talk with your doctor about any premedications you should take before your first dose of Benlysta.

This drug comes with several precautions. Before starting Benlysta treatment, talk with your doctor about your health history. Benlysta may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Current infections: If you have an infection, your doctor will treat the infection before you start using Benlysta. This is because Benlysta may weaken your immune system, which can make it harder for your body to fight off the infection. Be sure to tell your doctor about any infections you have before you start Benlysta treatment.
  • History of depression or suicidal thoughts or behaviors: Benlysta may raise your risk of depression or suicidal thoughts or behaviors. If you have a history of depression or suicidal thoughts or behaviors, you may have an increased risk of symptoms worsening. Talk with your doctor if you have any history of depression or suicidal thoughts. Your doctor may monitor you more often while you’re receiving Benlysta to be sure that your symptoms don’t worsen or come back.
  • Recent vaccinations: You should not get any live vaccines within 30 days before starting Benlysta or while using the drug. Live vaccines contain a small amount of the virus or bacterium that the vaccine is meant to protect against. Because Benlysta may weaken your immune system, your body may not be able to fight the viruses or bacteria in live vaccines. This means that the vaccines may cause you to become sick. If you get a live vaccine before starting Benlysta treatment, your doctor will have you wait 30 days before receiving your first dose of Benlysta. Your doctor can also help make sure you are up to date on any vaccines you may need before your Benlysta treatment.
  • History of cancer: It is unknown whether Benlysta may increase your risk of developing cancer. Because the drug may weaken your immune system, it is possible that it may increase your cancer risk. However, clinical trials have not shown an increased risk. If you have a history of cancer, tell your doctor before you start Benlysta treatment. They may monitor you more closely to make sure your cancer is not coming back.
  • Taking other biologic medications: It’s recommended that you avoid using Benlysta with the biologic drug rituximab (Rituxan). In a clinical trial, an increase in side effect frequency was reported when these drugs were used in combination. Otherwise, Benlysta has not been studied along with other biologic medications (such as monoclonal antibodies). Therefore, it is unknown whether the drug is safe for people taking these other treatments. If you’re taking other biologic drugs, talk with your doctor before starting Benlysta. They may recommend a different medication to treat your systemic lupus erythematosus (SLE) or lupus nephritis.
  • Allergic reaction: If you’ve had an allergic reaction to Benlysta or any of its ingredients, you should not receive Benlysta. Ask your doctor which other medications are better options for you.
  • Pregnancy: It is unknown whether Benlysta is safe to receive during pregnancy. For more information, see the “Benlysta and pregnancy” section above.
  • Breastfeeding: It is unknown whether Benlysta is safe to receive while breastfeeding. For more information, see the “Benlysta and breastfeeding” section above.

Note: For more information about the potential negative effects of Benlysta, see the “Benlysta side effects” section above.

Using more than the recommended dosage of Benlysta can lead to serious side effects.

Do not use more Benlysta than your doctor recommends.

Overdose symptoms

Overdose symptoms in people who took too much Benlysta were similar to the side effects of Benlysta.

In clinical trials, people received doses of 20 milligrams (mg) per kilogram (kg) of body weight (double the recommended dose). There was no increased risk of side effects. Also, reported side effects were no different or worse than normal side effects in people who took the recommended dose of Benlysta.

What to do in case of overdose

If you give yourself injections of Benlysta at home and you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 (or your local emergency phone number) or go to the nearest emergency room right away.

When you get Benlysta from the pharmacy, the pharmacist will add an expiration date to the label on the box. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about how to correctly dispose of it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Benlysta vials, syringes, or autoinjectors should be stored in the refrigerator at 36–46°F (2–8°C). They should be kept in their original carton so that the medication is protected from light. Benlysta shouldn’t be frozen or exposed to heat. You also shouldn’t shake Benlysta.

Benlysta vials, syringes, or autoinjectors may be stored at room temperature (up to 86°F [30°C]) for up to 12 hours. They should be protected from light. Do not use it if it has been left at room temperature for more than 12 hours. If it is left out for more than 12 hours, do not put it back in the refrigerator. Instead, throw it away.

Disposal

Right after you have used a syringe, needle, or autoinjector, dispose of it in an FDA-approved sharps disposal container. This helps prevent others, including children and pets, from taking the drug by accident or harming themselves with the needle. You can buy a sharps container online or ask your doctor, pharmacist, or health insurance company where to get one.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

Disclaimer: Medical News Today 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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