Dacomitinib oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of dacomitinib.
Drugs List
Therapeutic Indications
Uses
Locally advanced/metastatic Non-Small Cell Lung Cancer (NSCLC)
Dacomitinib is indicated as a monotherapy for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
Dosage
Adults
45mg once daily.
Patients with Hepatic Impairment
Severe (Child-Pugh class C) hepatic impairment 30mg once daily
Increase of the dose to 45mg once daily may be considered after at least 4 weeks based on individual safety and tolerability.
Additional Dosage Information
Advise patients to take their dose at approximately the same time each day. If the patient vomits or misses a dose, an additional dose should not be taken and the next prescribed dose should be taken at the usual time the next day.
Dose modification
First dose reduction: 30mg
Second dose reduction: 15mg
Diarrhoea
Grade 1 diarrhoea: no dose modification required. Initiate treatment with anti-diarrhoeal product at first onset of diarrhoea.
Grade 2 diarrhoea: if not improved to grade 1 within 24 hours while using anti-diarrhoeal products and adequate oral fluid intake, withhold dacomitinib treatment until recovery to grade 1, then resume at the same dose level or consider a reduction of 1 dose level.
Grade 3 diarrhoea: withhold dacomitinib. Treat with anti-diarrhoeal products and adequate oral fluid intake or intravenous fluids or electrolytes as appropriate until recovery to grade 1, then resume at a reduction of 1 dose level.
Skin-related adverse reactions
Grade 1 rash or erythematous skin conditions: no dose modification required. Initiate treatment.
Grade 1 exfoliative skin conditions: no dose modification required. Initiate treatment.
Grade 2 rash, erythematous or exfoliative skin condition: no dose modification required. Initiate treatment or provide additional treatment. If condition persists for 72 hours despite treatment, withhold dacomitinib until recovery to grade 1, then resume at the same dose level or consider a reduction of 1 dose level.
Grade 3 rash, erythematous or exfoliative skin condition: withhold dacomitinib. Initiate or continue treatment and/or provide additional treatment until recovery to grade 1, then resume at a reduction of 1 dose level.
Other
Grade 1 or 2 toxicity: no dose modification required.
Grade 3 or greater toxicity: withhold until recovery to grade 2, then resume with a reduction of 1 dose level.
Contraindications
Children under 18 years
Breastfeeding
Galactosaemia
Haemodialysis
Pregnancy
Renal impairment - creatinine clearance below or equal to 30ml/minute
Precautions and Warnings
Glucose-galactose malabsorption syndrome
Lactose intolerance
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Reduce dose in patients with severe hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Anti-diarrhoeals may be required during treatment
Avoid H2 antagonists 10 hours before or 2 hours after dose
Confirm EGFR mutation status of tumour prior to treatment
Maintain adequate hydration during therapy
Restore electrolyte & fluid balance in case of dehydration
Treatment to be initiated and supervised by a specialist
Contains lactose
Advise patient on concurrent use of proton pump inhibitors
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Monitor for signs and symptoms of interstitial lung disease
Monitor for signs and symptoms of pneumonitis
Monitor hepatic function periodically
Patients with new pulmonary symptoms should be investigated
Advise patient to report any symptoms of interstitial lung disease
Diarrhoea to be managed with electrolyte/fluids+high dose loperamide
Discontinue treatment if interstitial lung disease develops
Suspend treatment if pneumonitis is suspected
Discontinue if treatment related pneumonitis is diagnosed
Interrupt treatment and/or reduce dose for any grade 3 toxicity
Interrupt treatment if severe elevation of transaminases occurs
Suspend treatment if grade 2 diarrhoea occurs
Suspend treatment if interstitial lung disease is suspected
Female: Contraception required during and for 17 days after treatment
Advise patient on appropriate sun protection methods
Advise patient that the use of topical moisturisers may be necessary
Advise patient to avoid exposure to sunlight and UV rays during treatment
Pregnancy and Lactation
Pregnancy
Dacomitinib is contraindicated during pregnancy.
The manufacturer recommends that dacomitinib should not be used during pregnancy. Animal studies have shown limited effects on reproductive toxicity, however, based on its mechanism of action dacomitinib may cause foetal harm. Patients taking dacomitinib during pregnancy or who become pregnant while taking dacomitinib should be apprised of the potential hazard to the foetus.
Lactation
Dacomitinib is contraindicated during breastfeeding.
The manufacturer recommends that mothers should be advised against breastfeeding whilst receiving treatment with dacomitinib. It is unknown whether dacomitinib is excreted in human breast milk, so a risk to the child can not be excluded.
Side Effects
Alanine aminotransferase increased
Alopecia
Aspartate aminotransferase increased
Asthenia
Conjunctivitis
Decreased appetite
Dehydration
Diarrhoea
Dry skin
Dysgeusia
Fatigue
Hypertrichosis
Hypokalaemia
Interstitial lung disease
Keratitis
Nail disorders
Nausea
Palmar-Plantar Erythrodysaesthesia syndrome
Pruritus
Rash
Skin exfoliation
Skin fissures
Stomatitis
Vomiting
Weight loss
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: December 2020
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Vizimpro 15mg film-coated tablets. Pfizer Ltd. Revised August 2021. Summary of Product Characteristics: Vizimpro 30mg film-coated tablets. Pfizer Ltd. Revised August 2021. Summary of Product Characteristics: Vizimpro 45mg film-coated tablets. Pfizer Ltd. Revised August 2021.
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