Vizimpro Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings 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

Dacomitinib

Indications/Uses

1st-line treatment in adults w/ locally advanced or metastatic NSCLC w/ epidermal growth factor receptor (EGFR)-activating mutations.

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Dosage/Direction for Use

45 mg once daily until disease progressions or unacceptable toxicity occurs. Recommended dose modification for adverse reactions 1st dose reduction: 30 mg once daily. 2nd dose reduction: 15 mg once daily.

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Overdosage

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

Administration

May be taken with or without food: Take at the same time each day.

Contraindications

Hypersensitivity.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Vizimpro detailed prescribing information

Special Precautions

Discontinue use if ILD/pneumonitis occurs. Diarrhea; rash, erythematous & exfoliative skin conditions. Increased hepatotoxicity & transaminases. Limit sun exposure. Galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Concomitant use of medicinal products metabolised by CYP2D6. Avoid concomitant use w/ PPIs. May affect ability to drive & use machines. Severe hepatic & renal impairment; patients requiring haemodialysis. Women of childbearing potential should use effective contraception during & at least 17 days after last dose. Not to be used during pregnancy. Lactation. Paed <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Decreased appetite, hypokalaemia; conjunctivitis; diarrhoea, stomatitis, vomiting, nausea; rash, palmar-plantar erythrodysaesthesia syndrome, skin fissures, dry skin, pruritus, nail disorder, alopecia; fatigue, asthenia; increased transaminase, decreased wt. Dehydration; dysgeusia; keratitis; ILD; skin exfoliation, hypertrichosis.

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Drug Interactions

Decreased C_max, AUC_0-96h& AUC_inf w/ rabeprazole. Concomitant use w/ PPIs. Increased mean exposure of dextromethorphan. Co-administration w/ strong CYP2D6 inhibitors. Inhibited P-gp activity, BCRP & cation transporter.

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Caution For Usage

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

Storage

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Description

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Action

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MIMS Class

Targeted Cancer Therapy

ATC Classification

L01EB07 - dacomitinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.

Thai FDA Category

Presentation/Packing

Form

Vizimpro FC tab 15 mg

Packing/Price

3 × 10's

Vizimpro

dacomitinib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

Pfizer