In the three-drug arm, isatuximab 10 mg/kg was administered weekly for 4 weeks, then every 2 weeks. The drug labeling on this Web site may not be the labeling on currently distributed products or identical to the labeling that is approved. The BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase 3 clinical trial of isatuximab in patients with RRMM. Isatuximab is an IgG1-derived monoclonal antibody directed against CD38. Isatuximab-irfc is available in the following dosage form(s) and strength(s): Injection: 1. Administration 2.5 . full prescribing information warning: fatal infusion reactions, tumor lysis syndrome (tls), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (pml) Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Over a median follow-up of 20.7 months, treatment with the triplet regimen was associated with a 47% reduction in the risk of progression or death, compared with the two-drug regimen (hazard ratio [HR] = 0.531; 99% CI 0.318-0.889; p=0.007). For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. For the nutrients with DVs that are going down, the %DVs may go up. As a result, you may need to consume more or less of a certain food, beverage or dietary supplement in order to meet the DVs or the recommended amounts.
The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA). Featured. First, let’s look at how Daily Value (DV) and Percent Daily Value (%DV) work together. Isatuximab-irfc is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells. The assessment of isatuximab-irfc-associated risks is based on the mechanism of action and data from target antigen CD38 knockout animal models.
For foods/supplements containing only naturally occurring folate, the original and updated Daily Values are the same. Brands: Sarclisa. 2020 Mar. So, the %DV may be different on some of your favorite products or supplements. The Nutrition Facts label must list total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, and certain vitamins and minerals. Revised: [MM/YYYY] FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . 100 mg/5 mL (20 mg/mL) solution in single-dose vial. Monitor patients with neutropenia for signs of infection. The labels are also available on the National Library of Medicine's DailyMed web site. FDA label information for this drug is available at DailyMed.
American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 1. If you ate one serving of the product, you would have met 10% of your need for that nutrient in a day and could consume other foods or supplements to get the other 90%.
Isatuximab is a monoclonal antibody designed to target the CD38 protein, which is found in most multiple myeloma cells.
Maternal immunoglobulin G is known to be present in human milk. If an emergency transfusion is required, non–cross-matched ABO/RhD-compatible RBCs can be given as per local blood bank practices.1, Isatuximab-irfc is an IgG kappa monoclonal antibody that can be incidentally detected on both serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein.
2.2 Instructions for Preparation and Administration .
The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor verified by FDA. Injection, solution, concentrate, for IV infusion only.
FDA’s final decision about whether to approve isatuximab is expected by April 30, 2020, according to a press release.
You can search for labels by drug name and link to the Library’s information resources about marketed drugs. Pomalidomide is only available through a REMS program.1, Clinical Considerations: Immunoglobulin G1 monoclonal antibodies are known to cross the placenta.
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Last updated on Mar 9, 2020. Isatuximab-irfc inhibits the ADP-ribosyl cyclase activity of CD38. (See 21 CFR part 207.) << The Lows and Highs of Percent Daily Value on the New Nutrition Facts Label. IU = international units, An official website of the United States government, : For example, the DV for sodium has been updated from 2,400mg to 2,300mg. For example, the DV for total fat has been updated from 65g to 78g. ICARIA-MM was an open-label, multicenter, randomized, phase 3 trial that enrolled patients with R/R MM with previous treatment with lenalidomide and any proteasome inhibitor (bortezomib, carfilzomib, or ixazomib). 20% DV or more of a nutrient per serving is considered high.
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary: Premedicate with dexamethasone, acetaminophen, H2-receptor antagonists, and diphenhydramine hydrochloride 15–60 minutes prior to start of infusion.1 Dexamethasone is considered to be both a premedication and a part of the combination chemotherapy regimen.1, The recommended dosage of isatuximab-irfc is 10 mg/kg as an intravenous infusion on days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle; administer in combination with pomalidomide and dexamethasone until disease progression or unacceptable toxicity.1, See Full Prescribing Information for instructions on preparation and administration.1, Patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.1, Infusion-related reactions have been observed in 39% of patients treated with isatuximab-irfc.
Similarly, the Supplement Facts label is required to list the same nutrients as the Nutrition Facts label when any of these nutrients are found in the supplement in an amount considered to be greater than zero.
FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . Consider the use of antibiotics and antiviral prophylaxis during treatment. The target action date for the FDA decision is April 30, 2020. Isatuximab-irfc is a CD38-directed cytolytic antibody indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.1. Dosage. Animal reproduction toxicity studies have not been conducted with isatuximab-irfc.
The most common symptoms of an infusion-related reaction included dyspnea, cough, chills, and nausea. It is used in combination with pomalidomide and dexamethasone to treat adults who have already received at least two therapies, including lenalidomide and a proteasome inhibitor.
For foods/supplements containing only the synthetic form of vitamin E, the DV increased. Medically reviewed by Drugs.com. DVs are the recommended amounts of nutrients to consume or not to exceed each day. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.1, The combination of isatuximab-irfc and pomalidomide is contraindicated in pregnant women because pomalidomide may cause birth defects and death of the unborn child. Premedication 2.3 . For the nutrients with DVs that are going up, the %DVs may go down. That means that a packaged food with 36g of total fat in one serving (previously 55% DV) now has 46% DV.
Isatuximab-ifrc was approved by the FDA based on results from the ICARIA-MM trial. Based on its mechanism of action, isatuximab-irfc may cause depletion of fetal CD38-positive immune cells and decreased bone density. 1. The device labeling and other device-specific information on this website have been voluntarily submitted to the FDA by device manufacturers. mcg RAE = micrograms of retinol activity equivalents See below for a side-by-side comparison of the information on the original and new Nutrition Facts labels. No dose reductions of isatuximab-irfc are recommended.1, Second primary malignancies were reported in 3.9% of patients in the isatuximab-irfc, pomalidomide and dexamethasone (Isa-Pd) arm and in 0.7% of patients in the pomalidomide and dexamethasone (Pd) arm, and consisted of skin squamous cell carcinoma (2.6% of patients in the Isa-Pd arm and in 0.7% of patients in the Pd arm), breast angiosarcoma (0.7% of patients in the Isa-Pd arm) and myelodysplastic syndrome (0.7% of patients in the Isa-Pd arm). 3 DOSAGE FORMS AND STRENGTHS 5% DV or less of a nutrient per serving is considered low. Isatuximab is an important new treatment option for the management of relapsed and refractory myeloma, particularly for patients who become refractory to lenalidomide and a proteasome inhibitor. Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Higher in dietary fiber, vitamin D, calcium, iron, and potassium. g = grams Isatuximab-irfc induces apoptosis of tumor cells and activation of immune effector mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). 500 mg/25 mL (20 mg/mL) solution in single-dose vial.
The device labeling has been reformatted to make it easier to read but its content has not been altered nor verified by FDA. 1. Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) using a fed-batch production process.
Please be aware of the following when using information from this Web site: The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA). mg = milligrams
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