Jeselhy Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Pimitespib

Indications/Uses

GI stromal tumor that has progressed after cancer chemotherapy including but not limited to imatinib, sunitinib, regorafenib.

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Dosage/Direction for Use

160 mg once daily for 5 consecutive days, followed by 2 days off, & repeat. Dose reduction: 1st-level reduction: 120 mg daily. 2nd-level reduction: 80 mg daily. 3rd-level reduction: 40 mg daily.

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Overdosage

View Jeselhy overdosage for action to be taken in the event of an overdose.

Administration

Should be taken with food: Not to be taken 1 hr before & 2 hr after meal.

Contraindications

History of hypersensitivity.

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Special Precautions

Serious renal disorders resulting from dehydration due to diarrhoea; adverse drug reactions of duodenal ulcer & intra-abdominal haemorrhage. Eye disorder. Carefully monitor electrolytes & consider fluid replacement to prevent dehydration & electrolyte shift. Ensure early detection of ocular reactions including early ophthalmologic consultation of any persistent or vision-reducing ocular symptoms. Consider possibility of decrease in reproductive function. Women of childbearing potential & men whose partner is of childbearing potential should use appropriate contraception during & for appropriate period after end of treatment. Pregnancy. Not to breastfeed while on treatment.

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Use In Pregnancy & Lactation

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Adverse Reactions

Night blindness; diarrhoea, nausea; malaise; increased blood creatinine; decreased appetite; taste disorder; renal impairment. Anaemia; blurred vision, visual impairment; vomiting; liver disorder; increased ALT & AST; rash. Hypothyroidism; retinal vein occlusion, retinopathy, acquired colour blindness; abdominal discomfort & pain, dry mouth, dyspepsia, enterocolitis, stomatitis, intra-abdominal & duodenal ulcer haemorrhage; oedema, pyrexia; pneumonia, cystitis; decreased platelet count, increased blood bilirubin, blood alkaline phosphatase & LDH, decreased wt & blood P; hypokalaemia, dehydration; proteinuria, dysuria; dysphonia; alopecia, pruritus, acneiform dermatitis, eczema, maculo-papular rash.

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Drug Interactions

May alter conc & activity w/ P-gp & BCRP inhibitors or inducers. May increase conc of midazolam; metformin; P-gp, BCRP & OATP1B1 substrates.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Jeselhy detailed prescribing information

Storage

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Description

View Jeselhy description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Cytotoxic Chemotherapy

ATC Classification

L01X - OTHER ANTINEOPLASTIC AGENTS ; Used in the treatment of cancer.

Thai FDA Category

Presentation/Packing

Form

Jeselhy FC tab 40 mg

Packing/Price

4 × 10's

Jeselhy

Manufacturer:

Taiho Pharmaceutical

Distributor:

DKLL

Marketer:

DKLL