TM Owner Pfizer
Vizimpro 15mg, 30mg, 45mg (dose 45mg) Tablet
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Indications & Clinical Uses
- Vizimpro is a film-coated tablet containing dacomitinib (as dacomitinib monohydrate), a kinase inhibitor that blocks the epidermal growth factor receptor (EGFR) family.
- It is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletion or exon 21 L858R substitution mutations,.
- The recommended dose is 45 mg taken orally once daily until the disease progresses or side effects become unacceptable.
- Tablets are made in 15 mg, 30 mg and 45 mg strengths; no 80 mg tablet exists.
- It is started and supervised by a cancer specialist.
- This information comes from the US prescribing information for Vizimpro (Pfizer).
Side Effects
- Very common (more than 20% of patients): diarrhoea (about 86%), rash (about 78%), paronychia (nail-fold infection), stomatitis (mouth sores), decreased appetite, dry skin, weight loss, hair loss (alopecia), cough and itching.
- Serious problems include severe or fatal interstitial lung disease or pneumonitis (0.5% of patients, 0.3% fatal), severe diarrhoea (grade 3 or 4 in 11%, 0.3% fatal) and severe skin reactions including rash (grade 3 or 4 in 21%).
- Vizimpro has no boxed warning in its US label.
- Report new or worsening cough, breathlessness, fever, persistent diarrhoea or severe skin reactions straight away.
- Your healthcare provider may pause or lower the dose.
Precautions & Warnings
- Vizimpro has no listed contraindications.
- Your healthcare provider will watch for lung, bowel and skin reactions and may reduce the dose or pause treatment.
- Vizimpro can cause fetal harm: use effective contraception during treatment and for at least 17 days after the last dose.
- Your tumour must have an EGFR mutation confirmed by a test before treatment.
- Report new or worsening cough, breathlessness, fever, severe diarrhoea or severe skin reactions promptly.
- Store at 20°C to 25°C (excursions 15°C to 30°C) in the original bottle.
- The label lists 15 mg, 30 mg and 45 mg tablets, so check your dose carefully.
Avoid Interactions
- Increased toxicity: avoid strong CYP2D6 substrates where small increases in level can cause serious or life-threatening toxicity.
- Strong CYP2D6 inhibitors only slightly raised dacomitinib exposure (about 6%) and are not considered clinically important.
- Reduced efficacy: avoid proton pump inhibitors (such as omeprazole) because they lower dacomitinib absorption.
- If you need an H2-receptor antagonist (such as famotidine), take Vizimpro at least 6 hours before or 10 hours after it.
- Locally acting antacids can be used.
- Tell your healthcare provider about all prescription, over-the-counter and herbal medicines and supplements before starting or stopping any medicine, because interacting medicines may need to be changed.
References
Frequently Asked Questions
Vizimpro (dacomitinib) is a once-daily tablet for first-line treatment of metastatic non-small cell lung cancer with an EGFR exon 19 deletion or exon 21 L858R mutation. Your tumour must be tested first. The recommended dose is 45 mg, and treatment is supervised by a cancer specialist.
Take Vizimpro (dacomitinib) 45 mg by mouth once a day until the cancer progresses or side effects become unacceptable. Your healthcare provider may lower or pause the dose, so do not change it yourself. Tablets come as 15 mg, 30 mg and 45 mg.
Vizimpro (dacomitinib) very commonly causes diarrhoea, rash, nail infections, mouth sores, poor appetite and dry skin. Report severe diarrhoea, severe skin reactions, or new cough or breathlessness at once, because lung inflammation can be fatal. It has no boxed warning.
Avoid proton pump inhibitors such as omeprazole with Vizimpro (dacomitinib), because they reduce absorption. Take it 6 hours before or 10 hours after H2 blockers. Avoid CYP2D6 substrate medicines with narrow safety margins. Antacids that act locally are acceptable. Tell your healthcare provider about all your medicines.
The Vizimpro (dacomitinib) label used here gives no specific missed-dose instruction, so ask your healthcare provider or pharmacist. Do not take extra tablets to make up a missed dose. Store the tablets at 20°C to 25°C in the original bottle.
Vizimpro (dacomitinib) can cause fetal harm, so it should not be used in pregnancy. Use effective contraception during treatment and for at least 17 days after your last dose. Tell your healthcare provider straight away if you become pregnant, and discuss pregnancy plans before starting.
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