XOSPATA Tablet (2019)
Βιβλιογραφική αναφορά
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Astellas Pharma US, Inc.
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1. Indications and Usage
Relapsed or Refractory Acute Myeloid Leukemia XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) ...
2. Dosage and Administration
2.1 Patient Selection Select patients for the treatment of AML with XOSPATA based on the presence of FLT3 mutations in the blood or bone marrow <em>[see Clinical Studies (14)]</em>. 2.2 Recommended Dosage ...
3. Dosage Forms and Strengths
Tablets: 40 mg as light yellow, round-shaped, film-coated tablets debossed with the Astellas logo and 235 on the same side.
4. Contraindications
XOSPATA is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. Anaphylactic reactions have been observed in clinical trials <em>[see Adverse Reactions (6) and Description ...
5. Warnings and Precautions
5.1 Differentiation Syndrome Of 319 patients treated with XOSPATA in the clinical trials, 3% experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation ...
6. Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Differentiation syndrome <em>[see Boxed Warning and Warnings and Precautions (5.1)]</em> Posterior reversible ...
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 ...
7. Drug Interactions
7.1 Effect of Other Drugs on XOSPATA Combined P-gp and Strong CYP3A Inducers Concomitant use of XOSPATA with a combined P-gp and strong CYP3A inducer decreases gilteritinib exposure which may decrease ...
8.1. Pregnancy
Risk Summary Based on findings from animal studies <em>(see Data)</em> and its mechanism of action, XOSPATA can cause fetal harm when administered to a pregnant woman <em>[see Clinical Pharmacology (12.1)] ...
8.2. Lactation
Risk Summary There are no data on the presence of gilteritinib and/or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Following administration of radiolabeled ...
8.3. Females and Males of Reproductive Potential
Pregnancy testing Pregnancy testing is recommended for females of reproductive potential within seven days prior to initiating XOSPATA treatment <em>[see Use in Specific Populations (8.1)]</em>. Contraception ...
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
Of the 319 patients in clinical studies of XOSPATA, 43% were age 65 years or older, and 13% were 75 years or older. No overall differences in effectiveness or safety were observed between patients age ...
11. Description
Gilteritinib is a tyrosine kinase inhibitor. The chemical name is 2-Pyrazinecarboxamide, 6-ethyl-3-[[3-methoxy-4-[4-(4-methyl-1-piperazinyl)-1-piperidinyl] phenyl] amino]5[(tetrahydro-2<em>H</em>-pyran-4-yl) ...
12.1. Mechanism of Action
Gilteritinib is a small molecule that inhibits multiple receptor tyrosine kinases, including FMS-like tyrosine kinase 3 (FLT3). Gilteritinib demonstrated the ability to inhibit FLT3 receptor signaling ...
12.2. Pharmacodynamics
In patients with relapsed or refractory AML administered gilteritinib 120 mg, substantial (>90%) inhibition of FLT3 phosphorylation was rapid (within 24 hours after first dose) and sustained, as characterized ...
12.3. Pharmacokinetics
The following pharmacokinetic parameters were observed following administration of gilteritinib 120 mg once daily, unless otherwise specified. Gilteritinib exposure (C<sub>max</sub> and AUC<sub>24</sub> ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been performed with gilteritinib. Gilteritinib was not mutagenic in a bacterial mutagenesis (Ames) assay and was not clastogenic in a chromosome aberration test assay in ...
13.2. Animal Toxicology and/or Pharmacology
In the 13-week oral repeated dose toxicity studies in rats and dogs, target organs of toxicity included the eye and kidney.
14. Clinical Studies
14.1 Relapsed or Refractory Acute Myeloid Leukemia The efficacy of XOSPATA was assessed in the ADMIRAL Trial (NCT02421939), which included adult patients with relapsed or refractory AML having a FLT3 ITD, ...
16.1. How Supplied
XOSPATA (gilteritinib) 40 mg tablets are supplied as light yellow, round-shaped, film-coated tablets debossed with the Astellas logo and 235 on the same side. XOSPATA tablets are available in the following ...
16.2. Storage and Handling
Store XOSPATA tablets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep in original container until dispensed. Protect ...
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Differentiation Syndrome Advise patients of the risks of developing differentiation syndrome as early as 2 days after the ...