Belimumab
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]
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Overview
Belimumab is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Belimumab FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Belimumab in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Belimumab in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Belimumab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Belimumab in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Belimumab in pediatric patients.
Contraindications
There is limited information regarding Belimumab Contraindications in the drug label.
Warnings
There is limited information regarding Belimumab Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Belimumab Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Belimumab Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Belimumab Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Belimumab in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Belimumab in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Belimumab during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Belimumab in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Belimumab in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Belimumab in geriatric settings.
Gender
There is no FDA guidance on the use of Belimumab with respect to specific gender populations.
Race
There is no FDA guidance on the use of Belimumab with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Belimumab in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Belimumab in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Belimumab in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Belimumab in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Belimumab Administration in the drug label.
Monitoring
There is limited information regarding Belimumab Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Belimumab and IV administrations.
Overdosage
There is limited information regarding Belimumab overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Belimumab Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Belimumab Mechanism of Action in the drug label.
Structure
There is limited information regarding Belimumab Structure in the drug label.
Pharmacodynamics
There is limited information regarding Belimumab Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Belimumab Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Belimumab Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Belimumab Clinical Studies in the drug label.
How Supplied
There is limited information regarding Belimumab How Supplied in the drug label.
Storage
There is limited information regarding Belimumab Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Belimumab Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Belimumab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Belimumab Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Belimumab Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
Template:Drugbox-mab Belimumab (registered name LymphoStat-B), is a fully human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-Lymphocyte stimulator (BLys), also known as B cell activation factor of the TNF family (BAFF). It is being developed by Human Genome Sciences Inc. and GlaxoSmithKline. BLyS is a protein necessary for the maturation of B lymphocytes.
Interaction of BLyS with B lymphocytes
BLyS (also known as BAFF) plays a key role in B lymphocyte differentiation, survival and activation.[1] Three membrane receptors are concerned:
- BCMA (B cell maturation antigen)
- TACI (transmembrane activator and calcium modulator and cyclophylin ligand interactor)
- BAFF-R (also known as BR3)
These receptors are not present in early B cell precursors or in pre-B cells (stage at which CD20 receptors appear). They are present in primary mature B cells and in mature B cells (in this last stage, CD20 receptors have disappeared).
BLyS is secreted, sometimes under the influence of interferon-gamma, by a variety of cells: monocytes and macrophages, bone marrow stromal cells, astrocytes, synoviocytes during rheumatoid arthritis, salivary epithelial cells during Sjögren's syndrome, astrocytes in certain glioblastomas.
Lymphocyte apoptosis is decreased because stimulation of BAFF-R and BCMA increases levels of Bcl-2 (a key anti-apoptotic mediator). Stimulation of all 3 receptors increases intranuclear levels of NF kappa B, active on differentiation and proliferation.
BLyS is not the only activator of B lymphocytes. APRIL (a proliferation activating ligand) also plays a key role[2], but is only active on BCMA and TACI.
Mechanism of action of belimumab
Belimumab is a monoclonal antibody that binds to BlyS. It is possible that belimumab binds essentially to circulating soluble BlyS, therefore not inducing an antibody-dependent cellular cytotoxicity that could be expected from a IgG1-type antibody. Nevertheless, it does reduce the number of circulating B cells, but seemingly less, and for less time, than anti-CD20 monoclonals (this impression was given at the June 2007 European League against Rheumatism symposium). Only comparative trials will clarify this impression.
Diseases with B lymphocyte hyperactivity
B lymphocyte hyperactivity is known in malignant and non-malignant diseases.
Among the malignant diseases (B cell malignancies):
Among the non-malignant diseases:
- Multiple sclerosis
- Rheumatoid arthritis
- Systemic lupus erythematosus - It is in this last field that Belimumab is the most advanced (2 phase 3 trials ongoing, with regulatory filing possibly in 2010).
Other drugs addressing B lymphocyte hyperactivity
Atacicept is a recombinant fusion protein built with the extracellular ligand binding portion of TACI. It blocks activation of TACI by April and BLyS. It is being developed by Zymogenetics and Serono/Merck KgaA. Early stage trials are ongoing in B cell malignancies (Multiple Myeloma), Systemic Lupus Erythematosus and Rheumatoid arthritis.[3]
BR3-Fc is a recombinant fusion protein built with the extracellular ligand-binding portion of BAFF-R. It blocks activation of this receptor by BLys. It is in early stage development by Biogen and Genentech.[3]
Anti-CD20 monoclonals: Rituximab is approved. Ocrelizumab, Ofatumumab and 3rd generation anti CD20 monoclonals are being developed.[3]
References
- Bossen C, Schneider P (2006). "BAFF, APRIL and their receptors: structure, function and signaling". Semin. Immunol. 18 (5): 263–75. doi:10.1016/j.smim.2006.04.006. PMID 16914324.
- ↑ Crowley JE, Treml LS, Stadanlick JE, Carpenter E, Cancro MP (2005). "Homeostatic niche specification among naïve and activated B cells: a growing role for the BLyS family of receptors and ligands". Semin. Immunol. 17 (3): 193–9. doi:10.1016/j.smim.2005.02.001. PMID 15826824.
- ↑ Schneider P (2005). "The role of APRIL and BAFF in lymphocyte activation". Curr. Opin. Immunol. 17 (3): 282–9. doi:10.1016/j.coi.2005.04.005. PMID 15886118.
- ↑ 3.0 3.1 3.2 Healthvalue.net. "Hyperactive B lymphocytes: Therapies" Last accessed June 19, 2007.