SARCLISA Concentrate solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
sanof-aventis U.S. LLC
Λέξεις κλειδιά
0024-0654 0024-0656
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1. Indications and Usage
SARCLISA is 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 ...
2. Dosage and Administration
2.1 Recommended Dosage Administer pre-infusion medications <em>[see Dosage and Administration (2.2)]</em>. SARCLISA should be administered by a healthcare professional, with immediate access to emergency ...
3. Dosage Forms and Strengths
SARCLISA is a clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particulates available as: Injection: 100 mg/5 mL (20 mg/mL) in a single-dose vial Injection: ...
4. Contraindications
SARCLISA is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients <em>[see Warnings and Precautions (5.1)]</em>.
5. Warnings and Precautions
5.1 Infusion-Related Reactions Infusion-related reactions have been observed in 39% of patients treated with SARCLISA <em>[see Adverse Reactions (6.1)]</em>. All infusion-related reactions started during ...
6. Adverse Reactions
The following clinically significant adverse reactions from SARCLISA are also described in other sections of the labeling: Infusion-Related Reactions <em>[see Warnings and Precautions (5.1)]</em> Neutropenia ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...
7. Drug Interactions
7.1 Laboratory Test Interference Interference with Serological Testing SARCLISA, an anti-CD38 antibody, may interfere with blood bank serologic tests with false positive reactions in indirect antiglobulin ...
8.1. Pregnancy
Risk Summary SARCLISA can cause fetal harm when administered to a pregnant woman. The assessment of isatuximab-irfc-associated risks is based on the mechanism of action and data from target antigen CD38 ...
8.2. Lactation
Risk Summary There are no available data on the presence of isatuximab-irfc in human milk, milk production, or the effects on the breastfed child. Maternal immunoglobulin G is known to be present in human ...
8.3. Females and Males of Reproductive Potential
Pregnancy Testing With the combination of SARCLISA with pomalidomide, refer to the pomalidomide labeling for pregnancy testing requirements prior to initiating treatment in females of reproductive potential. ...
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
Of the total number of subjects in clinical studies of SARCLISA, 53% (306 patients) were 65 and over, while 14% (82 patients) were 75 and over. No overall differences in safety or effectiveness were observed ...
10. Overdosage
There is no known specific antidote for SARCLISA overdose. In the event of overdose of SARCLISA, monitor the patients for signs or symptoms of adverse effects and take all appropriate measures immediately. ...
11. Description
Isatuximab-irfc, a CD38-directed cytolytic antibody, is a chimeric immunoglobulin G1 (IgG1) monoclonal antibody (mAb). Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) ...
12.1. Mechanism of Action
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. Isatuximab-irfc induces apoptosis ...
12.2. Pharmacodynamics
In multiple myeloma patients treated with SARCLISA combined with pomalidomide and dexamethasone, a decrease in absolute counts of total NK cells (including inflammatory CD16<sup> + low</sup> CD56<sup> ...
12.3. Pharmacokinetics
Following the administration of isatuximab-irfc at the recommended dose and schedule, the steady state isatuximab-irfc mean (CV ) predicted maximum plasma concentration (C<sub>max</sub>) was 351 µg/mL ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity and genotoxicity studies have not been conducted with isatuximab-irfc. Fertility studies have not been conducted with isatuximab-irfc.
14. Clinical Studies
ICARIA-MM The efficacy and safety of SARCLISA in combination with pomalidomide and low-dose dexamethasone (Isa-Pd) were evaluated in ICARIA-MM (NCT02990338), a multicenter, multinational, randomized, open-label, ...
16.1. How Supplied
SARCLISA (isatuximab-irfc) injection is a clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particulates, supplied as follows: One 100 mg/5 mL single-dose ...
16.2. Storage and Handling
16.2 Storage Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze. Do not shake. 16.3 Handling and Disposal Discard unused portion of solution. ...
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Infusion-Related Reaction Instruct patients to immediately report any occurrence of symptoms occurring within 24 hours ...