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Renflexis
Overview
What is Renflexis?
Infliximab-abda, the active ingredient in RENFLEXIS, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions) specific for human tumor necrosis factor-alpha (TNFα). It has a molecular weight of approximately 149.1 kilodaltons. Infliximab-abda is produced by a recombinant cell line cultured and is purified by a series of steps that includes measures to inactivate and remove viruses.
RENFLEXIS (infliximab-abda) for Injection is supplied as a sterile, white, lyophilized powder for intravenous infusion. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the resulting pH is approximately 6. Each mL contains 10 mg infliximab-abda, dibasic sodium phosphate heptahydrate (0.12 mg), monobasic sodium phosphate monohydrate (0.63 mg), polysorbate 80 (0.05 mg), and sucrose (50 mg). No preservatives are present.
What does Renflexis look like?
What are the available doses of Renflexis?
For injection: 100 mg of lyophilized infliximab-abda in a 20 mL vial for intravenous infusion. ()
What should I talk to my health care provider before I take Renflexis?
How should I use Renflexis?
RENFLEXIS is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.
RENFLEXIS is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease.
The recommended dose of RENFLEXIS is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohn's disease or fistulizing Crohn's disease. For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue RENFLEXIS in these patients.
What interacts with Renflexis?
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What are the warnings of Renflexis?
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What are the precautions of Renflexis?
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What are the side effects of Renflexis?
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What should I look out for while using Renflexis?
RENFLEXIS at doses > 5 mg/kg should not be administered to patients with moderate to severe heart failure. In a randomized study evaluating infliximab in patients with moderate to severe heart failure (New York Heart Association [NYHA] Functional Class III/IV), infliximab treatment at 10 mg/kg was associated with an increased incidence of death and hospitalization due to worsening heart failure .
RENFLEXIS should not be re-administered to patients who have experienced a severe hypersensitivity reaction to infliximab products. Additionally, RENFLEXIS should not be administered to patients with known hypersensitivity to inactive components of the product or to any murine proteins.
What might happen if I take too much Renflexis?
Single doses up to 20 mg/kg of infliximab have been administered without any direct toxic effect. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
How should I store and handle Renflexis?
Store between 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Each RENFLEXIS (infliximab-abda) for Injection 100 mg vial is individually packaged in a carton.Each single dose vial contains 100 mg of lyophilized infliximab-abda for final reconstitution volume of 10 mL.Each RENFLEXIS (infliximab-abda) for Injection 100 mg vial is individually packaged in a carton.Each single dose vial contains 100 mg of lyophilized infliximab-abda for final reconstitution volume of 10 mL.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Infliximab products neutralize the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors. Infliximab products do not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα. Biological activities attributed to TNFα include: induction of pro-inflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other liver proteins, as well as tissue degrading enzymes produced by synoviocytes and/or chondrocytes. Cells expressing transmembrane TNFα bound by infliximab products can be lysed or . Infliximab products inhibit the functional activity of TNFα in a wide variety of bioassays utilizing human fibroblasts, endothelial cells, neutrophils, B and T-lymphocytes and epithelial cells. The relationship of these biological response markers to the mechanism(s) by which infliximab products exert their clinical effects is unknown. Anti-TNFα antibodies reduce disease activity in the cotton-top tamarin colitis model, and decrease synovitis and joint erosions in a murine model of collagen-induced arthritis. Infliximab products prevent disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFα, and when administered after disease onset, allow eroded joints to heal.
Non-Clinical Toxicology
RENFLEXIS at doses > 5 mg/kg should not be administered to patients with moderate to severe heart failure. In a randomized study evaluating infliximab in patients with moderate to severe heart failure (New York Heart Association [NYHA] Functional Class III/IV), infliximab treatment at 10 mg/kg was associated with an increased incidence of death and hospitalization due to worsening heart failure .RENFLEXIS should not be re-administered to patients who have experienced a severe hypersensitivity reaction to infliximab products. Additionally, RENFLEXIS should not be administered to patients with known hypersensitivity to inactive components of the product or to any murine proteins.
Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. However, the application of these data to other barbiturates appears valid and warrants serial blood level determinations of the relevant drugs when there are multiple therapies.
Patients treated with infliximab products are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death.
Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF-blockers. Patients have frequently presented with disseminated rather than localized disease.
Treatment with RENFLEXIS should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection. The risks and benefits of treatment should be considered prior to initiating therapy in patients:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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