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29 Cards in this Set

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Benlysta indication
BENLYSTA® (belimumab) is indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy
Limitation of use
The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations
Benlysta dose
The recommended dosage regimen is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.
Dosing premeds recommendations
Prior to dosing with BENLYSTA, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions
Infusion of Benlysta
1.The diluted solution of BENLYSTA should be administered by intravenous infusion only, over a period of 1 hour
Dosage form and strength
Single‑use vials of belimumab lyophilized powder for injection:
•120 mg per vial
•400 mg per vial
Benlysta contraindication
BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab
List warning and precautions
Mortality (14% B vs 6% placebo)
Serious Infections (6% vs 5.2%)(avoid pts with chronic infections)
Death due to serious infections (0.3% vs 0.1%)
Malignancy
Hypersensitivity reactions13% vs 11%
Anaphylaxis 0.6% vs 0.4%
Infusion reactions 17% vs 15%
Depression 16% vs 12%
Immunization recommendations
Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established
Concominant use with other biologics or CTX
BENLYSTA has not been studied in combination with other biologic therapies, including B-cell targeted therapies, or intravenous cyclophosphamide. Therefore, use of BENLYSTA is not recommended in combination with biologic therapies or intravenous cyclophosphamide.
Benlysta clinical trial summary
The data described below reflect exposure to BENLYSTA plus standard of care compared with placebo plus standard of care in 2133 patients in 3 controlled studies. Patients received BENLYSTA at doses of 1 mg/kg (N=673), 4 mg/kg (N=111; Trial 1 only), or 10 mg/kg (N=674) or placebo (N=675) intravenously over a 1-hour period on Days 0, 14, 28, and then every 28 days. In two of the studies (Trial 1 and Trial 3), treatment was given for 48 weeks, while in the other study (Trial 2) treatment was given for 72 weeks
Top 5 AEs observed in all 3 clinical trials
There was no apparent dose-related increase in the majority of adverse events observed with BENLYSTA:
Nausea 15% vs 12%
Diarrhea 12% vs 9%
Pyrexia 10% vs 8%
Nasopharyngitis 9% vs 7%
Bronchitis 9% vs 5%
Immunogenicity
In Trials 2 and 3, 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
Drug interactions
Formal drug interaction studies have not been performed with BENLYSTA. In clinical trials of patients with SLE, BENLYSTA was administered concomitantly with other drugs, including corticosteroids, antimalarials, immunomodulatory and immunosuppressive agents (including azathioprine, methotrexate, and mycophenolate), angiotensin pathway antihypertensives, HMG-CoA reductase inhibitors (statins), and NSAIDs without evidence of a clinically meaningful effect of these concomitant medications on belimumab pharmacokinetics
Pregnancy category
Pregnancy Category C
Nursing recommendations
It is not known whether BENLYSTA is excreted in human milk or absorbed systemically after ingestion. However, belimumab was excreted into the milk of cynomolgus monkeys. Because maternal antibodies are excreted in human breast milk, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of breastfeeding to the infant and the importance of the drug to the mother
Race
In Trial 2 and Trial 3, response rates for the primary endpoint were lower for black subjects in the BENLYSTA group relative to black subjects in the placebo group [see Clinical Studies (14)]. Use with caution in black/African-American patients
Benlysta description
BENLYSTA (belimumab) is a human IgG1λ monoclonal antibody specific for soluble human B lymphocyte stimulator protein (BLyS, also referred to as BAFF and TNFSF13B
Benlysta MOA
BENLYSTA is a BLyS-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. BENLYSTA does not bind B cells directly, but by binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Benlysta half life
Terminal half-life (t½, days)
19.4
Trial 1 description
Trial 1 enrolled 449 patients and evaluated doses of 1, 4, and 10 mg/kg BENLYSTA plus standard of care compared with placebo plus standard of care over 52 weeks in patients with SLE. Patients had to have a SELENA-SLEDAI score of ≥4 at baseline and a history of autoantibodies (anti-nuclear antibody (ANA) and/or anti-double-stranded DNA (anti-dsDNA), but 28% of the population was autoantibody negative at baseline. The co-primary endpoints were percent change in SELENA-SLEDAI score at Week 24 and time to first flare over 52 weeks
Trial 2 & 3 description
Trials 2 and 3 were randomized, double-blind, placebo-controlled trials in patients with SLE that were similar in design except duration - Trial 2 was 76 weeks duration and Trial 3 was 52 weeks duration. Eligible patients had active SLE disease, defined as a SELENA-SLEDAI score ≥6, and positive autoantibody test results at screening. Patients were excluded from the study if they had ever received treatment with a B-cell targeted agent or if they were currently receiving other biologic agents. Intravenous cyclophosphamide was not permitted within the previous 6 months or during study. Trial 2 was conducted primarily in North America and Europe. Trial 3 was conducted in South America, Eastern Europe, Asia, and Australia.
Trial 2 & 3 end points
Week 52 compared with baseline:

•≥4-point reduction in the SELENA-SLEDAI score, and
•no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores, and
•no worsening (<0.30-point increase) in Physician's Global Assessment (PGA) score
Trial 2 & 3 results
In both Trials 2 and 3, the proportion of SLE patients achieving an SRI response, as defined for the primary endpoint, was significantly higher in the BENLYSTA 10 mg/kg group than in the placebo group in both studies. The effect on the SRI was not consistently significantly different for the BENLYSTA 1mg/kg group relative to placebo in both trials.
Effect on concominant steroid treatment
In Trial 2 and Trial 3, 46% and 69% of patients, respectively, were receiving prednisone at doses > 7.5 mg/day at baseline. The proportion of patients able to reduce their average prednisone dose by at least 25% to ≤7.5 mg/day during Weeks 40 through 52 was not consistently significantly different for BENLYSTA relative to placebo in both trials. In Trial 2, 17% of patients receiving BENLYSTA 10 mg/kg and 19% of patients receiving BENLYSTA 1 mg/kg achieved this level of steroid reduction compared with 13% of patients receiving placebo. In Trial 3, 19%, 21%, and 12% of patients receiving BENLYSTA 10 mg/kg, BENLYSTA 1 mg/kg, and placebo, respectively, achieved this level of steroid reduction.
Effect on severe SLE flares
The probability of experiencing a severe SLE flare, as defined by a modification of the SELENA Trial flare criteria which excluded severe flares triggered only by an increase of the SELENA-SLEDAI score to >12, was calculated for both Trials 2 and 3. The proportion of patients having at least 1 severe flare over 52 weeks was not consistently significantly different for BENLYSTA relative to placebo in both trials. In Trial 2, 18% of patients receiving BENLYSTA 10 mg/kg and 16% of patients receiving BENLYSTA 1 mg/kg had a severe flare compared with 24% of patients receiving placebo. In Trial 3, 14%, 18%, and 23% of patients receiving BENLYSTA 10 mg/kg, BENLYSTA 1 mg/kg and placebo, respectively, had a severe flare.
How is supplied
--120 mg belimumab in a 5-mL single-use vial NDC 49401-101-01
--400 mg belimumab in a 20-mL single-use vial NDC 49401-102-01
How is stored
Store vials of BENLYSTA refrigerated between 2° to 8°C (36° to 46°F). Vials should be protected from light and stored in the original carton until use. Do not freeze. Avoid exposure to heat. Do not use beyond the expiration date.
Advice for patients
Patients should be given the Medication Guide for BENLYSTA and provided an opportunity to read it prior to each treatment session. It is important that the patient's overall health be assessed at each infusion visit and any questions resulting from the patient's reading of the Medication Guide be discussed.