Drug Interaction:
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.
The effect of belimumab on the pharmacokinetics of other drugs has not
been evaluated
Indication:
BENLYSTA (belimumab) for injection, for intravenous use only
Initial U.S. Approval: 2011
Drug Name- Benlysta
Active Ingredient - Belimumab
To treat patients with active, autoantibody-positive lupus (systemic lupus
erytematosus) who are receiving standard therapy , including corticosteroids,
antimalarials
Indication-
To treat patients with active, autoantibody-positive lupus (systemic lupus
erytematosus) who are receiving standard therapy , including corticosteroids,
antimalarials
Approved by FDA on 09-3-2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
Common adverse reactions (5%) in clinical trials were: nausea, diarrhea, pyrexia,
nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine,
and pharyngitis.
Contra-Indications:
CONTRAINDICATIONS
Previous anaphylaxis to belimumab.
WARNINGS AND PRECAUTIONS
Mortality: There were more deaths reported with BENLYSTA than with placebo
during the controlled period of clinical trials.
Serious Infections: Serious and sometimes fatal infections have been reported in
patients receiving immunosuppressive agents, including BENLYSTA.
Use with caution in patients with chronic infections.
Consider interrupting BENLYSTA therapy if patients develop a new infection during
BENLYSTA treatment.
Hypersensitivity Reactions, Including Anaphylaxis: Serious and fatal reactions
have been reported. BENLYSTA should be administered by healthcare providers
prepared to manage anaphylaxis. Monitor patients during and for an appropriate
period of time after administration of BENLYSTA.
Depression: Depression and suicidality have been reported in BENLYSTA studies.
Patients should be instructed to contact their healthcare provider if they experience
new or worsening depression, suicidal thoughts or other mood changes.
Immunization: Live vaccines should not be given concurrently with BENLYSTA.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated
for the treatment of adult patients with active, autoantibody-positive,
systemic lupus erythematosus who are receiving standard therapy.
Limitations 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.
DOSAGE AND ADMINISTRATION
Recommended dosage regimen is 10 mg/kg at 2-week intervals for the
first 3 doses and at 4-week intervals thereafter. Reconstitute, dilute and
administer as an intravenous infusion only, over a period of 1 hour.
Consider administering premedication for prophylaxis against infusion
reactions and hypersensitivity reactions
DOSAGE FORMS AND STRENGTHS
Single-use vials of belimumab lyophilized powder:
120 mg per vial
400 mg per vial
Patient Information:
PATIENT COUNSELING INFORMATION
Advice for the Patient
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.
Mortality:
Patients should be advised that more patients receiving BENLYSTA in the main
clinical trials died than did patients receiving placebo treatment
Serious Infections:
Patients should be advised that BENLYSTA may decrease their ability to
fight infections.
Patients should be asked if they have a history of chronic infections and if they
are currently on any therapy for an infection should be instructed to tell their
healthcare provider if they develop signs or symptoms of an infection.
Hypersensitivity/Anaphylactic and Infusion Reactions:
Educate patients on the signs and symptoms of anaphylaxis, including wheezing,
difficulty breathing, peri-oral or lingual edema, and rash.
Patients should be instructed to immediately tell their healthcare provider
if they experience symptoms of an allergic reaction during or after the
administration of BENLYSTA
Depression:
Patients should be instructed to contact their healthcare provider
if they experience new or worsening depression, suicidal thoughts or other
mood changes
Immunizations:
Patients should be informed that they should not receive live vaccines while taking
BENLYSTA. Response to vaccinations could be impaired by BENLYSTA
Pregnancy and Nursing Mothers:
Patients should be informed that BENLYSTA has not been studied in pregnant women
or nursing mothers so the effects of BENLYSTA on pregnant women or nursing
infants are not known.
Patients should be instructed to tell their healthcare provider if they are pregnant,
become pregnant, or are thinking about becoming pregnant
. Patients should be instructed to tell their healthcare provider if they plan to
breastfeed their infant
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
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.
2 Pharmacokinetics
The pharmacokinetic parameters are based on population parameter estimates
which are specific to the patients who received belimumab 10 mg/kg in the Trials
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category C.
There are no adequate and well-controlled clinical studies using
BENLYSTA in pregnant women. Immunoglobulin G (IgG) antibodies,
including BENLYSTA, can cross the placenta.
Because animal reproduction studies are not always predictive of human
response, BENLYSTA should be used during pregnancy only if the
potential benefit to the mother justifies the potential risk to the fetus.
Women of childbearing potential should use adequate contraception during
treatment with BENLYSTA and for at least 4 months after the final treatment.
2. Breast Feeding
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.
3. Pediatric Use
Safety and effectiveness of BENLYSTA have not been established in children.
4. Geriatric Use
Clinical studies of BENLYSTA did not include sufficient numbers of subjects
aged 65 or over to determine whether they respond differently from younger
subjects. Use with caution in elderly patients.
Manufacturer Details