dacomitinib monohydrate at a glance
Medicine class
Irreversible EGFR-family tyrosine kinase inhibitor
Licensed role
First-line monotherapy for EGFR-mutated, locally advanced or metastatic non-small-cell lung cancer in adults
Before treatment
An activating EGFR mutation must be confirmed using a validated test
Administration
Film-coated tablet swallowed whole with water, with or without food
What is dacomitinib monohydrate used for?
The selected UK product is licensed for:
First-line treatment, on its own, of adults with locally advanced or metastatic non-small-cell lung cancer whose tumour has an activating EGFR mutation.
How does dacomitinib monohydrate work?
Dacomitinib binds irreversibly to EGFR, HER2 and HER4 tyrosine kinases. In susceptible EGFR-mutated cancer cells, this blocks growth and survival signals, helping to slow tumour growth.
dacomitinib monohydrate preparations and strengths
Tablet
Route: Oral
Strengths: 15 mg, 30 mg, 45 mg
How to take dacomitinib monohydrate
Follow the oncology team's prescription. Swallow the film-coated tablet whole with water; it may be taken with or without food. Do not stop treatment or alter the prescribed amount without speaking to the team.
Tell the oncology team promptly if diarrhoea or rash begins, because early management is important.
Check with a pharmacist or oncology clinician before starting medicines for indigestion or heartburn.
Use caution when driving if tiredness or eye irritation occurs.
dacomitinib monohydrate side effects
Common or expected effects
- Diarrhoea
- Rash, itching, dry or cracked skin
- Sore or inflamed mouth and lips
- Nail changes
- Reduced appetite and weight loss
- Nausea or vomiting
- Dry, red or irritated eyes
- Hair loss
- Painful or reddened palms and soles
- Tiredness or weakness
- Changes in liver enzymes or blood potassium
Get urgent medical advice
- New or worsening breathlessness, cough or fever, which may indicate interstitial lung disease or pneumonitis
- Severe diarrhoea causing dehydration, kidney problems or low potassium
- Severe, rapidly worsening, peeling or extensively cracked skin reactions
- Yellow skin or eyes, dark urine or pale stools, suggesting liver injury
- Eye pain, marked redness, light sensitivity or vision change, which may indicate corneal inflammation
dacomitinib monohydrate in pregnancy
Dacomitinib should not be used during pregnancy because its mechanism and animal findings indicate potential fetal harm, while human pregnancy data are unavailable. People who could become pregnant should use effective contraception during treatment and for at least 17 days after it ends, and contact their specialist promptly if pregnancy occurs.
dacomitinib monohydrate while breastfeeding
Breastfeeding is not advised during treatment. It is unknown whether dacomitinib or its metabolites enter human milk, and serious effects in a breastfed child are possible; discuss feeding options with the oncology and maternity teams.
dacomitinib monohydrate interactions
The oncology team should review prescription, non-prescription and herbal products before and during treatment.
Proton pump inhibitors, such as omeprazole or rabeprazole
They raise stomach pH and can substantially reduce dacomitinib absorption, so concomitant use should be avoided.
Histamine-2 receptor antagonists
These require carefully separated administration from dacomitinib; obtain exact timing instructions from the oncology team.
Local antacids
These may be suitable alternatives to longer-acting acid suppression, but should still be checked with the oncology team.
Common questions about dacomitinib monohydrate
Answers are fully visible for fast scanning and source review.
What type of cancer is dacomitinib monohydrate used for?
It is licensed as first treatment for adults with locally advanced or metastatic non-small-cell lung cancer whose tumour has an activating EGFR mutation.
Why is an EGFR test needed?
Dacomitinib targets abnormal EGFR signalling, so a validated test is needed to confirm that the tumour carries a mutation likely to respond.
Is dacomitinib monohydrate chemotherapy?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.