NARRATOR:
BENLYSTA is indicated for patients aged 5 and older with active systemic lupus erythematosus, or SLE, or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus.
Please click the Important Safety Information tab to the left to watch or hear the Important Safety Information about BENLYSTA.
ON-SCREEN TEXT:
BENLYSTA: A DISEASE-MODIFYING TREATMENT FOR PATIENTS WITH LUPUS NEPHRITIS
BENLYSTA is indicated for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION
Previous anaphylaxis with BENLYSTA.
Please click the Important Safety Information tab to the left to watch or hear the Important Safety Information about BENLYSTA.
CHAPTER ONE: Who is at risk for lupus nephritis?
DR. PENDERGRAFT:
Hello, my name is Will Pendergraft. I’m a nephrologist specializing in autoimmune kidney disease in North Carolina.
Today, we’ll be talking about lupus nephritis and BENLYSTA. First let’s talk about GSK’s commitment to transparency and education.
ON-SCREEN TEXT:
DR. WILLIAM PENDERGRAFT
Nephrologist | World-Renowned Autoimmune Disease Expert
Paid consultant to GSK at the time of filming
DR. PENDERGRAFT:
GSK believes in transparent scientific dialogue, and I am a paid consultant to GSK. If you need more information about the use of BENLYSTA for treatment of lupus nephritis, please know that you can reach out to GSK to continue the conversation.
ON-SCREEN TEXT:
GSK’S COMMITMENT TO TRANSPARENCY AND EDUCATION
- We believe transparent scientific dialogue is in the interest of all those working to develop new medicines; it improves clinical practice and advances care for patients.
- Our goal in peer discussion, led by clinical experts, is to inform prescribers and caregivers about clinical data and relevant clinical experience relating to our innovative medicines.
- This program contains evidence-based, truthful, balanced information, and speakers may share clinical experience consistent with the FDA-approved label.
- GSK is committed to transparency of financial relationships with healthcare professionals.
FDA = Food and Drug Administration.
DR. PENDERGRAFT:
The kidneys are one of the major organs affected in patients with lupus. And up to 40% of these patients will develop lupus nephritis.
ON-SCREEN TEXT:
~40% of patients with SLE will develop lupus nephritis1*
* With or without biopsy-proven lupus nephritis.
SLE = systemic lupus erythematosus.
Reference: 1. Hanly JG, et al. Rheumatol. 2016;55:252-262.
DR. PENDERGRAFT:
The vast majority of patients who develop lupus nephritis do so within a few years of lupus diagnosis:
55% within 1 year
77% within 2 years
And 94% within 5 years
ON-SCREEN TEXT:
Majority of patients developed lupus nephritis in the first 5 years after SLE diagnosis1*
SLE diagnosis
1 year later 55%
2 years later 77%
5 years later 94%
ACR = American College of Rheumatology; SLE = systemic lupus erythematosus.
* Patients (≥16 years old) with SLE from the Oslo cohort (N=325) were followed from 1999 to 2008. Lupus nephritis was defined by the ACR criteria (proteinuria >0.5 g/24 hour and/or relevant casts in urine sediment). A patient who fulfilled the ACR criteria for lupus nephritis but did not have a renal biopsy available was defined as clinical lupus nephritis.
Reference: 1. Reppe Moe SE, et al. Lupus. 2019;28:818-825.
DR. PENDERGRAFT:
Several factors are associated with worse prognosis for patients with lupus nephritis, which include younger age at diagnosis, Black race, persistent hypertension, and delays in treatment and access to care.
ON-SCREEN TEXT:
Some patients with LN are at greater risk of developing ESKD1,2
Younger age at diagnosis
Black race
Persistent hypertension
Delay in treatment and access to care
ESKD = end-stage kidney disease; LN = lupus nephritis.
Reference: 1. Mok CC, et al. Int J Women’s Health. 2012;4:213-222. 2. Petri M, et al. J Rheumatol. 2020. pii: jrheum.191094.
DR. PENDERGRAFT:
Lupus nephritis is a severe manifestation of lupus and is a major risk factor for overall morbidity and mortality, regardless of treatment.
In fact, approximately 20% of patients with lupus nephritis will develop end-stage kidney disease in the 10 years after their lupus diagnosis.
ON-SCREEN TEXT:
~20% of patients with LN will develop ESKD in the 10 years after diagnosis1
ESKD = end-stage kidney disease; LN = lupus nephritis.
Reference: 1. Tektonidou MG, et al. Arthritis Rheumatol. 2016;68(6):1432-1441.
CHAPTER TWO: BENLYSTA: A targeted disease-modifier
DR. PENDERGRAFT:
BENLYSTA is targeted to modify the course of lupus and lupus nephritis.
BENLYSTA targets an underlying cause of lupus, positively impacts clinical outcomes for patients, and reduces progression of organ damage.
To learn more, click the link to review additional data.
ON-SCREEN TEXT:
BENLYSTA: A TARGETED DISEASE MODIFIER
Targets the underlying disease
- Designed to target BLyS, an underlying cause of lupus1,2
- Results in improved key serological markers linked to disease activity2,3*
(Button): MOA
Improved key clinical outcomes
- Reduced lupus disease activity, severe flares, and steroid dose2,4-6
- Achieved complete renal response2,7
- Improvements across organ systems, including skin, joint, and kidney2,8†‡
(Button): SLE
(Button): Lupus Nephritis
Reduction of organ damage progression
- Reduction in rate and risk of organ damage progression in lupus9‡
- Significantly reduced the risk of renal-related events or death in lupus nephritis2,7
(Button): Organ Damage
(Button): Medical Questions?
BLyS = B-lymphocyte stimulator protein; MOA = mechanism of action; SLE = systemic lupus erythematosus.
* The clinical relevance of these results has not been definitively established. † Studies were designed to evaluate efficacy in overall disease activity and were not powered to evaluate efficacy in specific organ domains. ‡ Results are descriptive.
References: 1. Stohl W, Hilbert DM. Nat Biotechnol. 2012;30(1):69-77. 2. BENLYSTA [package insert]. Durham, NC: GlaxoSmithKline; 2022. 3. Stohl W, Hiepe F, Latinis KM, et al. Arthritis Rheum. 2012;64(7):2238- 2337. 4. Navarra SV, Guzmán RM, Gallacher AE, et al. Lancet. 2011;377(9767):721-731. 5. Furie R, Petri M, Zamani O, et al. Arthritis Rheum. 2011;63(12):3918-3930. 6. Stohl W, Schwarting A, Okada M, et al. Arthritis Rheumatol. 2017;69(5):1016-1027. 7. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. 8. Data on File, GSK. 9. Urowitz MB, et al. Ann Rheum Dis. 2019;78:372-379.
CHAPTER THREE: BLISS-LN study design
DR. PENDERGRAFT:
BLISS-LN is the largest and longest Phase III trial of a biologic in lupus nephritis, with a duration of 104 weeks.
The unique aspect of BLISS-LN is that BENLYSTA was studied as an add-on to MMF or cyclophosphamide during both induction and maintenance phases of treatment.
ON-SCREEN TEXT:
BLISS-LN: the largest and longest Phase III trial of a biologic in lupus nephritis1
With a duration of 104 weeks
BENLYSTA IV 10 mg/kg was added to MMF or CYC
- During both induction and maintenance treatment
CYC = cyclophosphamide; MMF = mycophenolate mofetil.
Reference: 1. Data on File, GSK.
DR. PENDERGRAFT:
The BLISS-LN trial was a 104-week trial with mandatory steroid tapered to 10 mg/day or less at Week 24, and the primary endpoint (renal response) was measured at Week 104.
Additional secondary endpoints, including complete renal response and renal-related event or death, were also reported at Week 104.
448 patients with active lupus nephritis were randomized 1:1 to receive BENLYSTA IV at 10 mg/kg, or placebo, both in addition to standard therapy.
ON-SCREEN TEXT:
BLISS-LN STUDY DESIGN1,2
ON-SCREEN VISUAL – INFOGRAPHIC PRESENTING BLISS-LN STUDY DESIGN
Renal Response (RR) = Primary Efficacy Renal Response (PERR).
* Biopsy confirmed in the past 6 months (Class III, IV, and/or V).
CRR = complete renal response; ST = standard therapy.
References: 1. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. 2. Data on File, GSK.
DR. PENDERGRAFT:
Standard therapy included induction with either cyclophosphamide or mycophenolate mofetil, with high-dose steroids, plus either BENLYSTA or placebo.
Maintenance therapy included azathioprine plus low-dose steroids, as part of the Euro-Lupus protocol, for those patients who received cyclophosphamide at induction, or MMF plus low-dose steroids, as part of the ALMS protocol, plus either BENLYSTA or placebo.
ON-SCREEN TEXT:
BLISS-LN STUDY DESIGN1
ON-SCREEN VISUAL – INFOGRAPHIC PRESENTING BLISS-LN STUDY DESIGN
Reference: 1. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128.
DR. PENDERGRAFT:
Renal response and complete renal response were endpoints that included measurements of eGFR and uPCR, and patients could not be a treatment failure.
ON-SCREEN TEXT:
DEFINING RENAL ENDPOINTS
A responder must meet all of the criteria listed1,2
ON-SCREEN VISUAL - TABLE PRESENTING RENAL ENDPOINT CRITERIA
For RR and CRR endpoints, response must be reproducible by a repeat measurement at a separate visit to be considered a responder.
* Treatment failure was defined as patients taking a protocol-prohibited or restricted medication, including corticosteroids above 10 mg/kg for treatment of a renal event after Week 24.
eGFR = estimated glomerular filtration rate; uPCR = urinary protein:creatinine ratio.
References: 1. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. 2. Data on File. GSK.
DR. PENDERGRAFT:
Time to renal-related event or death was a composite outcome that evaluated the prevention of renal-worsening events.
ON-SCREEN TEXT:
DEFINING RENAL ENDPOINTS
A responder must meet all of the criteria listed1,2
ON-SCREEN VISUAL - TABLE PRESENTING RENAL ENDPOINT CRITERIA
ESKD = end-stage kidney disease.
* Use of protocol-prohibited rescue medication such as prednisone above 10 mg/day after Week 24 for treatment of renal SLE-related disease activity or new immunosuppressants outside of the induction and maintenance regimens.
References: 1. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. 2. Data on File. GSK.
DR. PENDERGRAFT:
For more information, click the on-screen link that will take you to the detailed study design.
(Button): Study Design
CHAPTER FOUR: BLISS-LN key takeaways
DR. PENDERGRAFT:
Let’s review the key takeaways of the BLISS-Lupus Nephritis trial before we dive into each endpoint in greater detail.
In the BLISS-Lupus Nephritis trial, BENLYSTA demonstrated significant achievement of renal response and complete renal response endpoints.
In a descriptive analysis of another endpoint, patients treated with BENLYSTA had an increased likelihood of achieving and maintaining renal response through Week 104.
Treatment with BENLYSTA also significantly reduced the risk of renal-related events or death.
The safety profile of BENLYSTA in the BLISS-Lupus Nephritis trial was consistent with the known safety observed in BENLYSTA lupus trials.
ON-SCREEN TEXT:
- Significant achievement of renal response and complete renal response1,2
- Increased likelihood of achieving and maintaining renal response through Week 1042*
- Significant reduction in the risk of renal-related events or death1,2
- Safety profile consistent with the known safety observed in BENLYSTA lupus trials1,2
*Results are descriptive.
References: 1. BENLYSTA [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2021. 2. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128.
CHAPTER FIVE: The benefits of BENLYSTA
DR. PENDERGRAFT:
Significantly more patients treated with BENLYSTA achieved the primary endpoint renal response at Week 104.
43% of patients treated with BENLYSTA achieved renal response at Week 104 vs. only 32% of patients treated with standard therapy.
ON-SCREEN TEXT:
SIGNIFICANTLY MORE PATIENTS ON BENLYSTA ACHIEVED RENAL RESPONSE AT WEEK 1041,2
ON-SCREEN VISUAL - GRAPH PRESENTING RENAL RESPONSE AT WEEK 104
RR = renal response; ST = standard therapy.
References: 1. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. 2. Data on File. GSK.
DR. PENDERGRAFT:
Additionally, significantly more patients treated with BENLYSTA achieved the renal response at Week 52.
ON-SCREEN TEXT:
SIGNIFICANTLY MORE PATIENTS ON BENLYSTA ACHIEVED RENAL RESPONSE AT WEEK 521,2
ON-SCREEN VISUAL - GRAPH PRESENTING RENAL RESPONSE AT WEEK 52
RR = renal response; ST = standard therapy.
References: 1. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. 2. Data on File. GSK.
DR. PENDERGRAFT:
Significantly more patients treated with BENLYSTA achieved complete renal response at Week 104.
ON-SCREEN TEXT:
SIGNIFICANTLY MORE PATIENTS ON BENLYSTA ACHIEVED COMPLETE RENAL RESPONSE AT WEEK 1041,2
ON-SCREEN VISUAL - GRAPH PRESENTING COMPLETE RENAL RESPONSE AT WEEK 104
CRR = complete renal response; ST = standard therapy.
References: 1. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. 2. Data on File. GSK.
DR. PENDERGRAFT:
Treatment with BENLYSTA significantly reduced the incidence of renal-related events or death.
ON-SCREEN TEXT:
BENLYSTA REDUCED RISK OF RENAL-RELATED EVENTS OR DEATH AT ANY TIME UP TO WEEK 1041,2*
ON-SCREEN VISUAL - GRAPH PRESENTING REDUCED RISK OF RENAL-RELATED EVENTS OR DEATH AT ANY TIME UP TO WEEK 104
ST = standard therapy.
* When excluding deaths (BENLYSTA=1, ST=2), the percentage of patients with a renal-related event was 15% vs 27%, respectively (HR=0.51; 95% CI: 0.34, 0.78).
References: 1. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. 2. Data on File. GSK.
DR. PENDERGRAFT:
BENLYSTA significantly reduced the risk of a renal-related event or death for patients with lupus nephritis, and this composite endpoint is driven mostly by the “renal worsening” category.
ON-SCREEN TEXT:
INDIVIDUAL BREAKDOWN OF THE FIRST-OCCURRING RENAL-RELATED EVENTS (n)1*
ON-SCREEN VISUAL - GRAPH PRESENTING INDIVIDUAL BREAKDOWN OF THE FIRST-OCCURRING RENAL-RELATED EVENTS
Results are descriptive for individual events.
ESKD = end-stage kidney disease; ST = standard therapy.
* Use of protocol-prohibited rescue medication such as prednisone above 10 mg/day after Week 24 for treatment of renal SLE-related disease activity or new immunosuppressants outside of the induction and maintenance regimens.
Reference: 1. Data on File. GSK.
CHAPTER SIX: Safety profile
DR. PENDERGRAFT:
The safety of BENLYSTA has been studied in 8 clinical trials.
Refer to the table for the adverse events specific to the BLISS-LN trial.
ON-SCREEN TEXT:
BENLYSTA: ESTABLISHED SAFETY PROFILE ACROSS 8 CLINICAL TRIALS1*
Adverse reactions (BLISS-LN)
ON-SCREEN VISUAL - TABLE PRESENTING ADVERSE REACTIONS (BLISS-LN)
Serious infections occurred in 14% of patients receiving BENLYSTA + ST and in 17% of patients receiving placebo + ST.
Fatal infections occurred in 0.9% (2/224) of patients receiving BENLYSTA + ST and in 0.9% (2/224) of patients receiving placebo + ST.
AE = adverse event; AZA = azathioprine; CYC = cyclophosphamide; IP = investigational product;
LN = lupus nephritis; MMF = mycophenolate mofetil; SAE = serious adverse event; ST = standard therapy.
* Adult Phase II, BLISS-76, BLISS-52, EMBRACE, BLISSLN, PLUTO, BLISS-SC, and BASE. † Includes all deaths that occurred during the double-blind phase including off-treatment. ‡ Developed fatal SAEs while on study treatment while death may have occurred at any time thereafter. § Fatal SAEs occurred after the on-treatment period.
Reference: 1. Data on File. GSK.
DR. PENDERGRAFT:
The adverse reactions observed in the BLISS-LN trial were consistent with the known safety profile of BENLYSTA administered intravenously plus standard therapy in patients with lupus.
ON-SCREEN TEXT:
BENLYSTA: ESTABLISHED SAFETY PROFILE ACROSS 8 CLINICAL TRIALS1*
Adverse reactions (Adult Phase II, BLISS-52, AND BLISS-76)
In ≥3% of patients treated with BENLYSTA IV 10 mg/kg + ST and ≥1% more frequently than in patients receiving placebo + ST.
ON-SCREEN VISUAL - TABLE PRESENTING ADVERSE REACTIONS (Adult Phase II, BLISS-52, AND BLISS-76)
ST = standard therapy.
* Adult Phase II, BLISS-76, BLISS-52, EMBRACE, BLISS-LN, PLUTO, BLISS-SC, and BASE.
Reference: 1. BENLYSTA [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2021.
CHAPTER SEVEN: Case study: a patient with lupus nephritis
DR. PENDERGRAFT:
Let’s explore a hypothetical patient case study.
Ashley is 34 years old, recently diagnosed with lupus nephritis, and diagnosed with lupus 4 years ago.
Her lupus treatment included an anti-malarial and corticosteroids.
Recently, Ashley presented with proteinuria of 2.4 g and an active urinary sediment with the renal biopsy that confirmed Class III + V lupus nephritis.
ON-SCREEN TEXT:
MEET ASHLEY*
- 34 years old
- Recently diagnosed with lupus nephritis
~2 MONTHS AGO, PRESENTED WITH THE FOLLOWING:
- Proteinuria 2.4 g/24 hours
- Active urinary sediment
- Renal biopsy confirmed Class III + V LN
CYC = cyclophosphamide
* Hypothetical patient profile. May not be representative of all BENLYSTA patients.
DR. PENDERGRAFT:
Ashley’s doctor began therapy with IV cyclophosphamide, followed by IV pulse methylprednisolone and then oral prednisone.
Ashley is an example of a patient who is currently receiving cyclophosphamide, and BENLYSTA can be considered for adult patients as an add-on to standard therapies.
ON-SCREEN TEXT:
MEET ASHLEY*
INDUCTION THERAPY
- CYC 500 mg IV, every 2 weeks
- 3 IV pulses of methylprednisolone 750 mg/pulse
– Followed by oral prednisone 1 mg/kg/day
CYC = cyclophosphamide
* Hypothetical patient profile. May not be representative of all BENLYSTA patients.
CHAPTER EIGHT: BENLYSTA dosing options
DR. PENDERGRAFT:
BENLYSTA offers dosing options for your patients with lupus nephritis. It can be given as an IV infusion, or by subcutaneous injection.
For more information, please click the on-screen link that will take you to the detailed BENLYSTA dosing information.
ON-SCREEN TEXT:
BENLYSTA AUTOINJECTOR FOR LUPUS NEPHRITIS
Start
2 x 200 mg for the first 4 doses, once per week,* for 4 weeks
Stay
200 mg once per week
BENLYSTA is approved as an SC injection in patients aged ≥18 with SLE or LN. BENLYSTA IV use is approved for patients aged ≥5 years with SLE or LN.
* The 400-mg dose requires administration of 2 autoinjectors (2 x 200 mg). The dose is given via subcutaneous injection in the abdomen or thigh. When the 400-mg dose is administered at the same site, it is recommended that the 2 individual 200-mg injections be administered at least 5 cm (approximately 2 inches) apart.1
Reference: 1. BENLYSTA [package insert]. Durham, NC: GlaxoSmithKline; 2022.
(Button): See the full dosing information
CHAPTER NINE: Important Safety Information
NARRATOR:
BENLYSTA is indicated for patients aged 5 and older with active systemic lupus erythematosus or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus.
ON-SCREEN TEXT:
INDICATION
BENLYSTA is indicated for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus.
NARRATOR:
And now, Important Safety Information about BENLYSTA.
BENLYSTA should not be administered to patients with a history of previous anaphylaxis with BENLYSTA.
Serious and sometimes fatal infections have been reported and occurred more frequently with BENLYSTA. Use caution in patients with severe or chronic infections, and consider interrupting therapy in patients with a new infection.
Cases of JC virus-associated progressive multifocal leukoencephalopathy, or PML, resulting in neurological deficits, including fatal cases, have been reported. If progressive multifocal leukoencephalopathy is confirmed, consider stopping immunosuppressant therapy, including BENLYSTA.
ON-SCREEN TEXT:
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION
Previous anaphylaxis with BENLYSTA.
WARNINGS AND PRECAUTIONS
Serious Infections: Serious and sometimes fatal infections have been reported and occurred more frequently with BENLYSTA. Use caution in patients with severe or chronic infections, and consider interrupting therapy in patients with a new infection.
Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported. If PML is confirmed, consider stopping immunosuppressant therapy, including BENLYSTA.
NARRATOR:
Acute hypersensitivity reactions, including anaphylaxis and death, and infusion-related reactions have been reported. Generally, reactions occurred within hours of the infusion but may occur later, including in patients who have previously tolerated BENLYSTA. Non-acute hypersensitivity reactions (including rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Monitor patients during and after treatment and be prepared to manage anaphylaxis and infusion-related reactions. Be aware of the risk of hypersensitivity reactions, which may present as infusion-related reactions. Discontinue immediately in the event of a serious reaction. With intravenous administration, if an infusion reaction develops, slow or interrupt the infusion.
ON-SCREEN TEXT:
IMPORTANT SAFETY INFORMATION (CONT’D)
WARNINGS AND PRECAUTIONS (CONT’D)
Hypersensitivity Reactions (Including Anaphylaxis):
Acute hypersensitivity reactions, including anaphylaxis and death, and infusion-related reactions have been reported. Generally, reactions occurred within hours of the infusion but may occur later, including in patients who have previously tolerated BENLYSTA. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Monitor patients during and after treatment and be prepared to manage anaphylaxis and infusion-related reactions. Be aware of the risk of hypersensitivity reactions, which may present as infusion-related reactions. Discontinue immediately in the event of a serious reaction. With intravenous administration, if an infusion reaction develops, slow or interrupt the infusion.
NARRATOR:
Depression and suicidality were reported in patients receiving BENLYSTA. Before adding BENLYSTA, assess patients’ risk of depression and suicide and monitor them during treatment. Instruct patients or caregivers to contact their HCP if they experience new or worsening depression, suicidal thoughts/behavior, or other mood changes.
There is an increased risk of malignancies with the use of immunosuppressants. The impact of BENLYSTA on the development of malignancies is unknown.
Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.
BENLYSTA has not been studied and is not recommended in combination with other biologic therapies, including B-cell targeted therapies.
ON-SCREEN TEXT:
IMPORTANT SAFETY INFORMATION (CONT’D)
WARNINGS AND PRECAUTIONS (CONT’D)
Depression and Suicidality: Depression and suicidality were reported in patients receiving BENLYSTA. Before adding BENLYSTA, assess patients’ risk of depression and suicide and monitor them during treatment. Instruct patients/caregivers to contact their HCP if they experience new/worsening depression, suicidal thoughts/behavior, or other mood changes.
Malignancy:There is an increased risk of malignancies with the use of immunosuppressants. The impact of BENLYSTA on the development of malignancies is unknown.
Immunization: Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.
Use With Biologic Therapies: BENLYSTA has not been studied and is not recommended in combination with other biologic therapies, including B-cell targeted therapies.
NARRATOR:
The most common serious adverse reactions in adult SLE clinical trials were serious infections; some were fatal. The most common adverse reactions (greater than or equal to 5%) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reactions (with the subcutaneous injection).
Adverse reactions reported in clinical trials with SLE pediatric patients (aged 5 years or older) and adult patients with lupus nephritis were consistent with those observed in adult SLE trials.
ON-SCREEN TEXT:
IMPORTANT SAFETY INFORMATION (CONT’D)
ADVERSE REACTIONS
The most common serious adverse reactions in adult SLE clinical trials were serious infections; some were fatal. The most common adverse reactions (≥5%) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reactions (subcutaneous injection).
Adverse reactions reported in clinical trials with SLE pediatric patients (≥5 years) and adult patients with lupus nephritis were consistent with those observed in adult SLE trials.
NARRATOR:
There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for at least 4 months after the final treatment.
HCPs are encouraged to register patients, and pregnant women are encouraged to enroll themselves, in the Pregnancy Registry by calling 1-877-681-6296.
ON-SCREEN TEXT:
IMPORTANT SAFETY INFORMATION (CONT’D)
USE IN SPECIFIC POPULATIONS
Pregnancy: There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for ≥4 months after the final treatment.
Pregnancy Registry: HCPs are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-681-6296.
To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing information, including Medication Guide, at BENLYSTAHCP.com.
Trademarks are owned by or licensed to the GSK group of companies.
©2022 GSK or licensor. BELVID220040 August 2022 Produced in USA.
