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Benlysta

Last reviewed on RxList: 1/12/2021
Benlysta Side Effects Center

What Is Benlysta?

Benlysta (belimumab) is a monoclonal antibody indicated for the treatment of adult patients with active systemic lupus erythematosus (SLE). Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.

What Are Side Effects of Benlysta?

Common side effects of Benlysta include:

Tell your doctor if you have any serious side effects, including:

  • mental/mood/behavior changes (such as new or worsening depression, anxiety, thoughts of suicide, or thoughts about hurting yourself or others),
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling,
  • wheezing, chest tightness, trouble breathing, or
  • signs of cancer (such as fever, night sweats, unusual tiredness, unexplained weight loss, swollen glands, and unusual lumps or growths).

Benlysta can cause serious and sometimes fatal side effects such as infections, and heart problems.

Dosage for Benlysta

The recommended dosage regimen for Benlysta is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.

What Drugs, Substances, or Supplements Interact with Benlysta?

Formal drug interaction studies have not been performed with Benlysta.

Benlysta During Pregnancy and Breastfeeding

Before you receive Benlysta, tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Benlysta will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with Benlysta. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Benlysta passes into your breast milk. You and your healthcare provider should decide if you will receive Benlysta or breastfeed. You should not do both.

Additional Information

Our Benlysta (belimumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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Benlysta Consumer Information

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

Some side effects may occur during the injection. Tell your caregiver if you feel anxious, nauseated, light-headed, itchy, or have trouble breathing, severe headache, or skin redness and swelling.

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

  • fever, chills;
  • cough with mucus;
  • pain or burning when you urinate;
  • urinating more than usual; or
  • bloody diarrhea.

Belimumab 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;
  • wheezing, chest tightness, trouble breathing; or
  • chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common side effects may include:

  • nausea, diarrhea;
  • fever, sore throat, runny or stuffy nose, cough;
  • pain, itching, redness, or swelling where the injection was given;
  • 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.

Read the entire detailed patient monograph for Benlysta (Belimumab)

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Lupus Symptoms, Rash, and Treatment See Slideshow
Benlysta Professional Information

SIDE EFFECTS

The following have been observed with BENLYSTA and are discussed in detail in the Warnings and Precautions section:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience With Intravenous Administration

Adults

The data described in Table 1 reflect exposure to BENLYSTA administered intravenously plus standard therapy compared with placebo plus standard therapy in 2,133 adult patients in 3 controlled trials (Trials 1, 2, and 3). Patients received BENLYSTA plus standard therapy at doses of 1 mg/kg (n = 673), 4 mg/kg (n = 111; Trial 1 only), or 10 mg/kg (n = 674), or placebo plus standard therapy (n = 675) intravenously over a 1-hour period on Days 0, 14, 28, and then every 28 days. In 2 of the trials (Trial 1 and Trial 3), treatment was given for 48 weeks, while in the other trial (Trial 2) treatment was given for 72 weeks [see Clinical Studies]. Because there was no apparent dose-related increase in the majority of adverse events observed with BENLYSTA, the safety data summarized below are presented for the 3 intravenous doses pooled, unless otherwise indicated; the adverse reaction table displays the results for the recommended intravenous dose of 10 mg/kg compared with placebo.

The population had a mean age of 39 years (range: 18 to 75), 94% were female, and 52% were white. In these trials, 93% of patients treated with BENLYSTA plus standard therapy reported an adverse event compared with 92% treated with placebo plus standard therapy.

The most common serious adverse events were serious infections (6.0% and 5.2% in the groups receiving BENLYSTA and placebo plus standard therapy, respectively), some of which were fatal [see WARNINGS AND PRECAUTIONS].

The most commonly reported adverse events, occurring in ≥5% of patients in clinical trials were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.

The proportion of patients who discontinued treatment due to any adverse reaction during the controlled clinical trials was 6.2% for patients receiving BENLYSTA plus standard therapy and 7.1% for patients receiving placebo plus standard therapy. The most common adverse reactions resulting in discontinuation of treatment (≥1% of patients receiving BENLYSTA or placebo) were infusion reactions (1.6% BENLYSTA and 0.9% placebo), lupus nephritis (0.7% BENLYSTA and 1.2% placebo), and infections (0.7% BENLYSTA and 1.0% placebo).

Table 1 lists adverse reactions, regardless of causality, occurring in at least 3% of patients with SLE who received BENLYSTA 10 mg/kg plus standard therapy and at an incidence at least 1% greater than that observed with placebo plus standard therapy in 3 controlled studies (Trials 1, 2, and 3).

Table 1. Incidence of Adverse Reactions Occurring in at Least 3% of Adult Patients Treated with BENLYSTA 10 mg/kg plus Standard Therapy and at Least 1% More Frequently than in Patients Receiving Placebo plus Standard Therapy

Preferred Term BENLYSTA
10 mg/kg + Standard Therapy
(n = 674)
%
Placebo + Standard Therapy
(n = 675)
%
Nausea 15 12
Diarrhea 12 9
Pyrexia 10 8
Nasopharyngitis 9 7
Bronchitis 9 5
Insomnia 7 5
Pain in extremity 6 4
Depression 5 4
Migraine 5 4
Pharyngitis 5 3
Cystitis 4 3
Leukopenia 4 2
Gastroenteritis viral 3 1

Pediatric Patients

The safety of BENLYSTA administered intravenously plus standard therapy (n = 53) compared with placebo plus standard therapy (n = 40) was evaluated in 93 pediatric patients (Trial 4). The adverse reactions observed were consistent with those observed in adults [see Clinical Studies].

Clinical Trials Experience With Subcutaneous Administration In Adults

The data described below reflect exposure to BENLYSTA administered subcutaneously plus standard therapy compared with placebo plus standard therapy in 836 patients in a controlled trial (Trial 5). In addition to standard therapy, patients received BENLYSTA 200 mg (n = 556) or placebo (n = 280) (2:1 randomization) once weekly for up to 52 weeks [see Clinical Studies].

The overall population had a mean age of 39 years (range: 18 to 77), 94% were female, and 60% were white. In the trial, 81% of patients treated with BENLYSTA plus standard therapy reported an adverse event compared with 84% treated with placebo plus standard therapy. The proportion of patients who discontinued treatment due to any adverse reaction during the controlled clinical trial was 7.2% of patients receiving BENLYSTA plus standard therapy and 8.9% of patients receiving placebo plus standard therapy.

The safety profile observed for BENLYSTA administered subcutaneously plus standard therapy was consistent with the known safety profile of BENLYSTA administered intravenously plus standard therapy, with the exception of local injection site reactions.

Injection Site Reactions

In the clinical study for BENLYSTA administered subcutaneously, the frequency of injection site reactions was 6.1% (34/556) for patients receiving BENLYSTA plus standard therapy and 2.5% (7/280) for patients receiving placebo plus standard therapy. These injection site reactions (most commonly pain, erythema, hematoma, pruritus, and induration) were mild to moderate in severity. The majority (94%) did not necessitate discontinuation of treatment.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of BENLYSTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to belimumab with the incidence of antibodies in other studies or to other products may be misleading.

In Trials 2 and 3 (intravenous dosing in adults), anti-belimumab antibodies were detected in 4 of 563 (0.7%) patients receiving BENLYSTA 10 mg/kg and in 27 of 559 (4.8%) patients receiving BENLYSTA 1 mg/kg. The reported frequency for the group receiving 10 mg/kg may underestimate the actual frequency due to lower assay sensitivity in the presence of high drug concentrations. Neutralizing antibodies were detected in 3 patients receiving BENLYSTA 1 mg/kg. Three patients with anti-belimumab antibodies experienced mild infusion reactions of nausea, erythematous rash, pruritus, eyelid edema, headache, and dyspnea; none of the reactions was life-threatening. In Trial 4 (intravenous dosing in pediatric patients), there was no formation of anti-belimumab antibodies in 53 patients receiving BENLYSTA 10 mg/kg plus standard therapy during the 52-week placebo-controlled period. In Trial 5 (subcutaneous dosing in adults), there was no formation of anti-belimumab antibodies in 556 patients receiving BENLYSTA 200 mg during the 52-week placebo-controlled period.

The clinical relevance of the presence of anti-belimumab antibodies is not known.

The data reflect the percentage of patients whose test results were positive for antibodies to belimumab in specific assays.

Read the entire FDA prescribing information for Benlysta (Belimumab)

QUESTION

Lupus is an infection. See Answer
Related Resources for Benlysta

Read the Benlysta User Reviews »

© Benlysta Patient Information is supplied by Cerner Multum, Inc. and Benlysta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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