Have you considered BENLYSTA for your patients?

BENLYSTA can be used in appropriate patients with lupus nephritis who are experiencing active disease despite treatment with standard therapy.

Do these patients* seem familiar to you?

Learn how BENLYSTA may make a difference for patients* with lupus nephritis.

Meet Jonathan*

A patient with lupus nephritis receiving initial therapy

Meet Carla*

A patient with lupus nephritis receiving initial therapy

Meet Chloe*

A pediatric patient with lupus nephritis

  • *Hypothetical patient profiles. May not be representative of all BENLYSTA patients.

Jonathan*

A 38-year-old patient with a 6-year history of lupus symptoms; correctly diagnosed 4 years ago. Subsequently diagnosed with lupus nephritis 6 months ago.

“You may get to a point at times when you think you can’t go on or you can’t handle it anymore, but I promise you, you can.”

Jonathan’s initial lupus manifestations and lab values

  • Synovitis (6)
  • uPCR 2.5 g/day
  • Renal-biopsy confirmed Class IV LN (10)
  • Anti-dsDNA antibodies (6)

Jonathan’s initial treatment

Lupus

  • HCQ 400 mg/day + prednisone 15 mg/day + MTX 15 mg/week

 

Lupus nephritis (initial therapy)

  • BENLYSTA IV + MMF 3 g/day + HCQ 400 mg/day + prednisone 20 mg/day

 

Lupus nephritis (maintenance therapy)

  • BENLYSTA SC + MMF 3 g/day + HCQ 400 mg/day + prednisone 7.5 mg/day

Jonathan’s concerns for his lupus nephritis diagnosis

“Since getting this new diagnosis, I can’t lie, I have been scared. I learned that lupus nephritis can even lead to worse complications, and I don’t want that.”

— Jonathan

Jonathan’s experience on BENLYSTA

“After my diagnosis, my doctor expressed concern about preserving my kidney function and recommended we start BENLYSTA. I have started taking the weekly injections using the BENLYSTA Autoinjector. So far, I really appreciate the at-home convenience of it. It’s easier to fit into my busy schedule.”

— Jonathan

  • * Hypothetical patient profile. May not be representative of all BENLYSTA patients.
  • EULAR/ACR 2019 criteria score for SLE classification.
  • ACR = American College of Rheumatology; anti-dsDNA = anti-double–stranded DNA; EULAR = European Alliance of Associations for Rheumatology; HCQ = hydroxychloroquine; IV = intravenous; LN = lupus nephritis; MMF = mycophenolate mofetil; MTX = methotrexate; SC = subcutaneous; SLE = systemic lupus erythematosus; uPCR = urine protein:creatinine ratio.

BENLYSTA may help your patients like Jonathan preserve their kidney function.

Carla*

A 44-year-old patient with a 7-year history of lupus symptoms; correctly diagnosed 5 years ago. Subsequently diagnosed with lupus nephritis 3 years ago.

“I was scared about what having lupus nephritis meant, not only for me, but also for my family. My main concern is always my kids. I cannot imagine not being able to fulfill the role of being their mom.”

Carla’s initial lupus manifestations and lab values

  • Synovitis (6)
  • Leukopenia (3)
  • eGFR of 85 mL/min/1.73 m2
  • Active urinary sediment
  • Proteinuria <3 g/g
  • Renal-biopsy confirmed Class III LN (10)

Carla’s initial treatment

Lupus

  • HCQ 200 mg/day + prednisone 20 mg/day

 

Lupus nephritis (initial therapy)

  • BENLYSTA IV + MMF 3 g/day + HCQ 200 mg/day + prednisone 40 mg/day

 

Lupus nephritis (maintenance therapy)

  • BENLYSTA IV + MMF 3 g/day + HCQ 200 mg/day + prednisone 5 mg/day

Carla’s concerns for her lupus nephritis diagnosis

“When my symptoms started impacting the time I spent with my family, I knew I had to do something. I’m happy to know that there is a treatment for lupus nephritis that has the potential to help reduce my symptoms so I can focus on what is important to me.”

— Carla

Carla’s experience on BENLYSTA

“A few months back, my doctor started me on BENLYSTA through IV injections. Later, I was offered the option to switch to the BENLYSTA Autoinjector. The at-home convenience of it was really appealing. Since starting treatment with BENLYSTA, my symptoms have improved. Over time, my lab results have shown increased eGFR, which means that my kidney function has been improving, and my doctor is hopeful that I may be able to achieve renal remission.”

— Carla

  • * Hypothetical patient profile. May not be representative of all BENLYSTA patients.
  • EULAR/ACR 2019 criteria score for SLE classification.
  • Renal remission is defined here as complete renal response (CRR) and was a secondary endpoint in the 104-week BLISS-LN study.
  • BLISS-LN = Belimumab International Study in Lupus Nephritis; eGFR = estimated glomerular filtration rate.

Is renal remission possible for Carla? You may be able to help your patients like her.

Chloe*

A 10-year-old patient with a 3-year history of lupus symptoms; correctly diagnosed 2 years ago. Subsequently diagnosed with lupus nephritis a year ago.

“Even though I’m a little nervous about seeing new doctors, I know they’re trying to help me get better. When I feel better, I can play with my dog, and that is my favorite thing to do.”

Chloe’s initial lupus manifestations and lab values

  • Rash (4) and fatigue
  • Arthritis (6)
  • Proteinuria 3 g/day (4)

Chloe’s initial treatment

Lupus

  • HCQ 200 mg/day + prednisone 15 mg/day + MTX 15 mg/week

 

Lupus nephritis (initial therapy)

  • BENLYSTA IV + MMF 2 g/day + prednisone 40 mg/day

 

Lupus nephritis (maintenance therapy)

  • BENLYSTA IV + MMF 1.5 g/day + HCQ 200 mg/day + prednisone 7.5 mg/day

Parent concerns while on initial treatment

“I’m scared about what lupus nephritis means for her, but we are determined to stay strong.”

— Chloe’s mother

Chloe’s experience on BENLYSTA

Chloe’s parents worry each time she experiences a kidney flare, because they know that the more it happens, it brings her closer to the possibility of severe implications.

 

When the doctor mentioned BENLYSTA infusions a year ago and explained how it may help preserve her kidney function, Chloe’s parents were a bit nervous, but optimistic for what it could mean for her. They wanted nothing more than for their child to feel better. They have been hopeful since their daughter began infusions with BENLYSTA.

  • * Hypothetical patient profile. May not be representative of all BENLYSTA patients.
  • EULAR/ACR 2019 criteria score for SLE classification.

Help your patients like Chloe receive the care
they need with BENLYSTA.

Learn more

How to start a patient on BENLYSTA

BENLYSTA can help you and your patients access BENLYSTA.

Efficacy for lupus nephritis

BENLYSTA improved key clinical outcomes for appropriate patients.

Looking to identify patients with lupus?
We may be able to help.

Indication & Safety Info

Indication

Important Safety Information

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.

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 suspected, immunosuppressant therapy, including BENLYSTA, must be suspended until PML is excluded. If confirmed, stop immunosuppressant therapy, including BENLYSTA.

 

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.

 

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: Available data do not support the safety and efficacy of concomitant use of BENLYSTA with rituximab in patients with SLE. An increased incidence of serious infections and post-injection systemic reactions in patients receiving BENLYSTA concomitantly with rituximab compared to patients receiving BENLYSTA alone has been observed. The safety and efficacy of BENLYSTA concomitantly with other biologic therapies, including B-cell-targeted therapies, have not been established. Caution should be exercised if BENLYSTA is administered in combination with other biologic therapies.

 

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.

 

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 refer patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/.

 

Please see full Prescribing Information and Medication Guide for BENLYSTA.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249, or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.