XPOVIO Film-coated tablet (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Karyopharm Therapeutics Inc.
Λέξεις κλειδιά
72237-101
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1. Indications and Usage
1.1 Multiple Myeloma XPOVIO in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies ...
2. Dosage and Administration
2.1 Recommended Dosage for Multiple Myeloma The recommended dosage of XPOVIO is 80 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity. Administer dexamethasone ...
3. Dosage Forms and Strengths
Tablets: 20 mg, blue, round, bi-convex, film-coated tablets with K20 debossed on one side and nothing on the other side.
4. Contraindications
None.
5. Warnings and Precautions
5.1 Thrombocytopenia XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia is the leading cause of dosage modifications <em>[see Adverse Reactions (6.1)] ...
6. Adverse Reactions
The following clinically significant adverse reactions are described in detail in other labeling sections: Thrombocytopenia <em>[see Warnings and Precautions (5.1)]</em>. Neutropenia <em>[see Warnings ...
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 ...
8.1. Pregnancy
Risk Summary Based on findings in animal studies and its mechanism of action <em>[see Clinical Pharmacology (12.1)]</em>, XPOVIO can cause fetal harm when administered to a pregnant woman. There are no ...
8.2. Lactation
Risk Summary There is no information regarding the presence of selinexor or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious ...
8.3. Females and Males of Reproductive Potential
XPOVIO can cause fetal harm when administered to a pregnant woman <em>[see Use in Specific Populations (8.1)]</em>. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior ...
8.4. Pediatric Use
The safety and effectiveness of XPOVIO have not been established in pediatric patients.
8.5. Geriatric Use
Of the 202 patients with multiple myeloma who received XPOVIO, 49% were 65 years of age and over, while 11% were 75 years of age and over. No overall difference in effectiveness was observed in patients ...
11. Description
Selinexor is a nuclear export inhibitor. Selinexor is (2<em>Z</em>)3{3-[3,5-bis(trifluoromethyl)phenyl]-1<em>H</em>-1,2,4-triazol-1-yl}<em>N</em>'(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white ...
12.1. Mechanism of Action
In nonclinical studies, selinexor reversibly inhibits nuclear export of tumor suppressor proteins (TSPs), growth regulators, and mRNAs of oncogenic proteins by blocking exportin 1 (XPO1). XPO1 inhibition ...
12.2. Pharmacodynamics
An increase in selinexor exposure was associated with an increase in the probability of dose modification and some adverse reactions. Cardiac Electrophysiology The effect of multiple doses of XPOVIO, up ...
12.3. Pharmacokinetics
Selinexor C<sub>max</sub> and AUC increased proportionally over a dose range from 3 mg/m<sup>2</sup> to 85 mg/m<sup>2</sup> (0.06 to 1.8 times the maximum approved recommended dose, based on 1.7 m<sup> ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with selinexor. Selinexor was not mutagenic in vitro in a bacterial reverse mutation (Ames) assay and was not clastogenic in either the in vitro cytogenetic ...
14. Clinical Studies
14.1 Relapsed or Refractory Multiple Myeloma The efficacy of XPOVIO plus dexamethasone was evaluated in STORM (KCP-330-012; NCT02336815). STORM was a multicenter, single-arm, open-label study of adults ...
16.1. How Supplied
XPOVIO (selinexor) are blue, round, bi-convex, and film-coated 20 mg tablets with K20 debossed on one side and nothing on the other side. Tablets are packaged in a child-resistant blister pack. Four blister ...
16.2. Storage and Handling
Store at or below 30°C (86°F).
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Dosing Instructions <em>[see Dosage and Administration (2)]</em> Instruct patients to take XPOVIO exactly as prescribed. ...