isatuximab fda label

1. The combination of isatuximab-irfc with pomalidomide is contraindicated in pregnant women because pomalidomide may cause birth defects and death of the unborn child. Administration 2.5 . If symptoms improve, restart isatuximab-irfc infusion at half of the initial infusion rate, with supportive care as needed, and closely monitor patients. Neutropenia (reported as laboratory abnormality) occurred in 96% of patients and grade 3-4 neutropenia occurred in 85% of patients treated with isatuximab-irfc, pomalidomide, and dexamethasone (Isa-Pd). mg = milligrams (2) The Daily Value decrease for folate/folic acid only applies to foods/supplements containing folic acid or a mixture of folic acid and naturally occurring folate. FDA has not reviewed this information prior to posting on this website. 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. 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) Recommended Dosing 2.2 . 20% DV or more of a nutrient per serving is considered high. mcg RAE = micrograms of retinol activity equivalents 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. 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.

<< The Lows and Highs of Percent Daily Value on the New Nutrition Facts Label. All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. The %DV is how much a nutrient in a single serving of an individual packaged food or dietary supplement contributes to your daily diet. Isatuximab-irfc may cause fetal immune cell depletion and decreased bone density. For patients with grade 1 or 2 reactions, interrupt isatuximab-irfc infusion and provide appropriate medical support. 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. 2.1 Dosage . Higher in dietary fiber, vitamin D, calcium, iron, and potassium. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . 1. For foods/supplements containing only the synthetic form of vitamin E, the DV increased. Read on to find out what’s new with the Daily Value and % Daily Value. 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%.

After binding to its target, the antibody can prompt myeloma cells to die (by a programmed cell death process called apoptosis) and also can engage the … Isatuximab-irfc is an antineoplastic agent. 2020 Mar.

The most common severe signs and symptoms included hypertension and dyspnea.1, To decrease the risk and severity of infusion-related reactions, premedicate patients prior to isatuximab-irfc infusion with dexamethasone, acetaminophen, H2-receptor antagonists, and diphenhydramine hydrochloride; dexamethasone is considered to be both a premedication and a part of the combination chemotherapy regimen. Consider phenotyping prior to starting isatuximab-irfc treatment. Use in Cancer. ABO/RhD typing was not affected by isatuximab-irfc treatment.

Isatuximab-irfc is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 148 kDa. Medically reviewed by Drugs.com.

So, the %DV may be different on some of your favorite products or supplements. See 17 for PATIENT COUNSELING INFORMATION and FDA approved patient labeling. The BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase 3 clinical trial of isatuximab in patients with RRMM.

The Nutrition Facts label on packaged foods and drinks has been updated to make it easier for you to make informed choices.

Advise patients to report suspected or known pregnancies.

For foods/supplements containing only naturally occurring folate, the original and updated Daily Values are the same. 500 mg/25 mL (20 mg/mL) solution in single-dose vial.

With the exception of the patient with myelodysplastic syndrome, patients were able to continue isatuximab-irfc treatment. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. 5% DV or less of a nutrient per serving is considered low. Select one or more newsletters to continue. Isatuximab-irfc was granted orphan drug designation. 2.2 Instructions for Preparation and Administration . No overall differences in safety or effectiveness were observed between subjects 65 and over and younger subjects, and other reported clinical experience has not identified differences in responses between the adults 65 years and over and younger patients, but greater sensitivity of some older individuals cannot be ruled out.1, The most common adverse reactions (in ≥20% of patients) were neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, and diarrhea.1, The most common hematology laboratory abnormalities (in ≥80% of patients) were anemia, neutropenia, lymphopenia, and thrombocytopenia.1.

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Refer to pomalidomide prescribing information for additional information.1, With the combination of isatuximab-irfc with pomalidomide, refer to the pomalidomide labeling for pregnancy testing requirements prior to initiating treatment in females of reproductive potential.1, Isatuximab-irfc can cause fetal harm when administered to a pregnant woman.

The .gov means it’s official.Federal government websites often end in .gov or .mil. For the nutrients with DVs that are going down, the %DVs may go up. Featured. (See 21 CFR part 207.) Under FDA's laws and regulations, FDA does not pre-approve labels for food products. Defer administration of live vaccines to neonates and infants exposed to isatuximab-irfc in utero until a hematology evaluation is completed.1, Animal Data: Mice that were genetically modified to eliminate all CD38 expression (CD38 knockout mice) had reduced bone density which recovered 5 months after birth. Pomalidomide is only available through a REMS program.1. Advise female patients of reproductive potential to use effective contraception during treatment and for at least 5 months after the last dose of isatuximab-irfc. The labels are also available on the National Library of Medicine's DailyMed web site. Instructions for Downloading Viewers and Players. The device labeling has been reformatted to make it easier to read but its content has not been altered nor verified by FDA. Revised: [MM/YYYY] FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . full prescribing information warning: fatal infusion reactions, tumor lysis syndrome (tls), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (pml) 100 mg/5 mL (20 mg/mL) solution in single-dose vial.

Drugs marked "unapproved medical gas", "unapproved homeopathic" or "unapproved drug other" on this Web site have not been evaluated by FDA for safety and efficacy and their labeling has not been approved.

Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more. Class: Antineoplastic Agents g = grams Refer to the pomalidomide prescribing information on use during pregnancy. Dosage.

The addition of isatuximab to pomalidomide–dexamethasone significantly improves progression-free survival in patients with relapsed and refractory multiple myeloma. 1. In patients with a positive indirect antiglobulin test, blood transfusions were administered without evidence of hemolysis. Use %DV to determine if a serving of the food is high or low in an individual nutrient. Interaction highlights: Please see product labeling for drug interaction information. For more information see 21 CFR 101.9(c). The BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase 3 clinical trial of isatuximab in patients with RRMM. Permanently discontinue isatuximab-irfc therapy if a grade 3 or higher infusion-related reaction occurs and institute appropriate medical management.1, Isatuximab-irfc may cause neutropenia. Sarclisa (isatuximab) INTRAVENOUS prescribing information. 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. Maternal immunoglobulin G is known to be present in human milk. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Isatuximab-ifrc was approved by the FDA based on results from the ICARIA-MM trial. 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.

Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) using a fed-batch production process. DVs are the recommended amounts of nutrients to consume or not to exceed each day. For a complete list of the Daily Values for all nutrients, check out the Reference Guide below.

For the nutrients with DVs that are going up, the %DVs may go down. See below for a side-by-side comparison of the information on the original and new Nutrition Facts labels. Advise pregnant women of the potential risk to a fetus.