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Xpovio

Xpovio

Manufacturer:

Catalent

Distributor:

DKSH
Concise Prescribing Info
Contents
Selinexor
Indications/Uses
In combination w/ bortezomib & dexamethasone for adults w/ multiple myeloma who have received at least 1 prior therapy. In combination w/ dexamethasone for adults w/ multiple myeloma who have received at least 4 prior therapies whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents & anti-CD38 monoclonal Ab w/ demonstrated disease progression on last therapy.
Dosage/Direction for Use
In combination w/ bortezomib & dexamethasone 100 mg once wkly on day 1 of each wk based on 35-day cycle. Max: 70 mg/m2/dose. Bortezomib: 1.3 mg/m2 SC once wkly on day 1 of each wk for 4 wk followed by 1 wk off. Dexamethasone: 20 mg PO twice wkly on days 1 & 2 of each wk. In combination w/ dexamethasone 80 mg + dexamethasone 20 mg PO on days 1 & 3 of each wk.
Administration
May be taken with or without food: Swallow whole, do not crush/chew/break/divide.
Contraindications
Special Precautions
Thrombocytopenia; neutropenia; GI toxicity eg, nausea, vomiting, diarrhoea; wt loss; anorexia; cataract; tumour lysis syndrome. May cause confusional state & dizziness. Maintain adequate fluid & caloric intake throughout treatment; consider IV hydration. Provide prophylactic concomitant treatment w/ 5-HT3 antagonist &/or other anti-nausea agents before & during treatment. Assess CBC & Na at baseline, during treatment & as clinically indicated; monitor more frequently during 1st 2 mth of treatment. May affect ability to drive & use machines. May impair female & male fertility. Women of childbearing potential & male patients of reproductive potential should use effective contraception or abstain from sexual activity during & for at least 1 wk after last dose. Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue lactation during & for at least 1 wk after last dose. Childn <18 yr.
Adverse Reactions
Pneumonia, URTI; thrombocytopenia, anaemia, neutropenia; decreased appetite; insomnia; dizziness, headache; blurred vision; cough; nausea, diarrhoea, vomiting, constipation; fatigue, pyrexia, asthenia; decreased wt. Sepsis; leukopenia, lymphopenia; hyponatraemia, hypocalcaemia, hypophosphataemia, hyperkalaemia, hypomagnesaemia, dehydration; confusional state; dysgeusia, peripheral neuropathy, syncope, balance disorder, ageusia; tachycardia; hypotension; dyspnoea, epistaxis; dyspepsia, dry mouth, abdominal pain, flatulence; alopecia, night sweats, pruritus; cataract; hypercreatinaemia; acute kidney injury; general physical health deterioration, malaise; increased AST & ALT; fall. In combination w/ bortezomib & dexamethasone: Bronchitis, nasopharyngitis. Lower resp tract infection; amnesia; vertigo; contusion. In combination w/ dexamethasone: Hyperglycaemia, hypokalaemia. Bacteraemia; febrile neutropenia; hyperamylasaemia, hyperuricaemia, hyperlipasaemia; delirium, hallucination; taste & cognitive disorder, attention & gait disturbance, memory & visual impairment; abdominal discomfort; muscle spasms; chills; increased blood alkaline phosphatase.
Drug Interactions
Decreased exposure w/ strong CYP3A4 inducer.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XX66 - selinexor ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Xpovio FC tab 20 mg
Packing/Price
16's;20's;24's;32's
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