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Manufacturer: Sigma Aldrich Fine Chemicals Biosciences MSQC11100UG

SILu™ MAb Adalimumab Stable-Isotope Labeled Monoclonal Antibody is a recombinant, stable isotope labeled, monoclonal antibody which incorporates [13C6, 15N4]-Arginine and [13C6, 15N2]-Lysine. Expressed in CHO cells, SILuMAb Adalimumab is designed to be used as an internal standard for analysis of Adalimumab in human serum. Each vial of SILuMAb Adalimumab contains the labeled antibody lyophilized from a solution of phosphate buffered saline. Vial content was determined by measuring A280 and using an extinction coefficient (E0.1%) of 1.4.
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Generic name: rituximab, rituximab-arrx, rituximab-pvvr, rituximab-abbs
Brand names: Rituxan , Riabni , Ruxience , Truxima
Dosage form: intravenous (infusion) injection
Drug classes: Antirheumatics , CD20 monoclonal antibodies
Medically reviewed by Nicole France, BPharm . Last updated on Apr 6, 2022.
Rituximab is a cancer drug that has revolutionized the treatment of non-Hodgkin lymphoma (NHL). It was first approved by the US Food and Drug Administration (FDA) in 1997.
Rituximab is a biological drug called a monoclonal antibody. It works by targeting a protein called CD20, which is found on a type of white blood cell called B cells. NHL and other conditions can affect B cells. It's not clear exactly how rituximab works, but it's known to recruit a patient's own immune system to attack and kill B cells.
Rituximab is available as Rituxan , the original version of rituximab. Biosimilars of rituximab are also available. Biosimilar versions of rituximab are highly similar to Rituxan and are designed to have the same effect on a person, but the biosimilars are not identical. Biosimilars of rituximab include:
The Rituxan brand of rituximab is a prescription medicine used to treat:
Rituxan is not indicated in children less than 2 years of age with GPA or MPA, in children less than 6 months of age with mature B-cell NHL and B-AL, or in children with conditions other than GPA, MPA, B-cell NHL and B-AL.
Biosimilar versions of rituximab are also used to treat some of the conditions listed above, but have not been approved to treat all of the same conditions.
Rituximab can cause serious side effects that can lead to death, including:
Before you or your child receive rituximab, tell your healthcare provider about all of your or your child's medical conditions, including if you or your child:
Rituximab can cause serious side effects, including:
Your healthcare provider will stop treatment with rituximab if you have severe, serious or life-threatening side effects.
The most common side effects of rituximab include:
In adult patients with GPA or MPA the most common side effects of rituximab also include:
In children with B-cell NHL or B-AL who receive rituximab with chemotherapy, the most common side effects include:
Other side effects with rituximab include:
These are not all of the possible side effects with rituximab.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken:
If you are not sure if your medicine is one listed above, ask your healthcare provider.
Tell your doctor if you are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to your or your child's unborn baby if you or your child receive rituximab during pregnancy.
Females who are able to become pregnant:
Tell your doctor if you are breastfeeding or plan to breastfeed. Rituximab may pass into your breast milk. Do not breastfeed during treatment and for 6 months after your or your child's last dose of rituximab.
Diluted rituximab (Rituxan) solutions for infusion may be stored refrigerated at 2°C to 8°C (36°F to 46°F) for 24 hours. Diluted rituximab solutions for infusion have been shown to be stable for an additional 24 hours at room temperature. However, since rituximab solutions do not contain a preservative, diluted solutions should be stored refrigerated (2°C to 8°C). No incompatibilities between rituximab and polyvinylchloride or polyethylene bags have been observed.
Rituxan: polysorbate 80, sodium chloride, sodium citrate dihydrate, and Water for Injection, USP.
Riabni: polysorbate 80, sodium chloride, sodium citrate dihydrate, and Water for Injection, USP. Hydrochloric acid is used to adjust the buffer solution pH.
Ruxience: edetate disodium dihydrate, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection, USP.
Truxima: polysorbate 80, sodium chloride, tri-sodium citrate dihydrate, and Water for Injection, USP.
Rituximab products are manufactured by the following companies:
In patients with hematological or blood cancers, including non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL), Rituxan’s success is measured in a number of ways. It is measured by looking at how long patients responded to treatment (median duration of response), how long they live without their disease progressing (progression-free survival) and how many patients respond to treatment (response rate).
Rituxan treatment improves outcomes in certain patients with NHL. Adding Rituxan alongside standard therapies enhances the response patients have to treatment and improves overall outcomes, including increasing the time patients live for without experiencing a progression of their disease.
Rituxan helps to improve overall survival in certain patients with CLL and also helps to increase the time patients live for without experiencing disease progression. Adding Rituxan alongside standard therapy enhances the response patients have to therapy. Continue reading
Rituximab infusion reactions are caused primarily by cytokine release in the body. Cytokines are immune system proteins in the body that help to fight infections but can cause an inflammatory response. Infusion reactions may cause hives, itching, shortness of breath, chest pain or dizziness and are a very common side effect of treatment with rituximab (Rituxan). Continue reading
Treatment with Rituxan (rituximab) successfully improves patient outcomes in patients with rheumatoid arthritis including reducing symptoms, reducing levels of fatigue and disability, and increasing health-related quality of life. It also slows the progression of structural damage in joints. Continue reading
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Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 6 July 2022), Cerner Multum™ (updated 27 July 2022), ASHP (updated 1 July 2022) and others.
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Volumes 1044–1045 , 15 February 2017 , Pages 166-176
Stable isotope labeled universal monoclonal antibody (SILuMab)
© 2017 Elsevier B.V. All rights reserved.
We report the application of a liquid chromatography-tandem mass spectrometry (LC–MS/MS) bioanalytical method for the determination of a recombinant human immunoglobulin G1 (hIgG1), NVSMAb-1, in rat serum. A stable isotopically labeled universal monoclonal antibody (SILuMab), instead of stable isotopically labeled surrogate peptide, was employed as the internal standard. The internal standard was added to the sample matrix in the first step of the sample preparation process, which involved protein precipitation and pellet digestion. The digestion of the resulting pellet with trypsin was performed prior to analysis of surrogate peptides of both NVSMAb-1 and SILuMab using LC–MS/MS. Precipitation reagents (1% TCA in IPA, 75% MeOH and 14% PEG) and digestion conditions (50 °C for 2 h and 60 °C for 0.5 h) were evaluated by monitoring LC–MS/MS responses of GPS and VVS in the resulting sample extracts. Overall, the use of 1% TCA in IPA appeared to be more effective as compared to 75% methanol in protein precipitation and removal of unwanted matrix components, e.g., albumin, and more appealing than 14% PEG as it avoided additional steps that are necessary to remove PEG or reduce PEG to a negligible level. The yield (LC–MS/MS response) of GPS is less sensitive than VVS to the changes of digestion conditions (time and temperature). The results obtained using SILuMab over SIL surrogate peptide as the internal standard appeared unaffected by the suboptimal sample processing method. For the current assay, surrogate peptide GPSVFPLAPSSK (GPS) was selected as surrogate peptide over VVSVLTVLHQDWLNGK (VVS) for quantitative analysis of NVSMAb-1. The optimal chromatographic separation was achieved on a Waters Cortecs C18 (100 × 2.1 mm, 2.7 μm) column using gradient elution with a total cycle time of approximately 8 min. The mobile phases were water containing 0.1% formic acid (mobile phase A) and acetonitrile containing 0.1% formic acid (mobile phase B). The current method was validated for specificity, sensitivity, matrix effect, recovery, linearity, accuracy and precision, dilution integrity, and stability. The validated assay dynamic range was 10–5000 μg/mL using 20 μL of rat serum. The accuracy and precision for the LLOQs (10 μg/mL) were within ±6.0% bias and ≤6.5% CV, respectively. From the intra-day and inter-day assay performance evaluations, the precision of the other QC sample (30, 300, 2500 and 3750 μg/mL) results were ≤6.8% CV and the accuracy within ±4.8% bias, respectively. Additional assessment of incurred sample reanalysis (ISR) was conducted to demonstrate the ruggedness and robustness of the assay method. The validated method was successfully implemented in support of a toxicity study in rats administered 30, 150 and 750 mg/kg/week intravenous infusion and 150 mg/kg/week subcutaneous injection of NVSMAb-1.
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Copyright © 2022 Elsevier B.V. or its licensors or contributors. ScienceDirect® is a registered trademark of Elsevier B.V.
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