Drug information of Dacomitinib


Dacomitinib is used to treat non-small cell lung cancer that has spread to other parts of the body.

Dacomitinib is given only if your tumor has a specific genetic marker (an abnormal "EGFR" gene).

Mechanism of effect

Dacomitinib is an irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor which has activity against EGFR/HER1, HER2, and HER4, as well as some EGFR-activating mutations (exon 19 deletion or exon 21 L858R substitution mutation). Dacomitinib also has activity against DDR1, EPHA6, LCK, DDR2, and MNK1 (in vitro).



Vss: 1,889 L


Hepatic, primarily via oxidation and glutathione conjugation; CYP2D6 is involved in the formation of O-desmethyl dacomitinib (active), and CYP3A4 contributes to the formation of minor oxidative metabolites


Feces: 79% (20% as parent drug); Urine: 3% (<1% as parent drug)

Time to Peak

~6 hours (range: 2 to 24 hours)

Half-Life Elimination

70 hours

Protein Binding


Drug indications

Labeled Indications

Non-small cell lung cancer, metastatic: First-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an approved test.


Usual Adult Dose for Non-Small Cell Lung Cancer

45 mg orally once a day until disease progression or unacceptable toxicity

Missed doses: If a dose is missed or vomited, do not make up the missed/vomited dose; administer the next dose as scheduled.

Side effects requiring immediate medical attention

Along with its needed effects, dacomitinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Drug contraindications

There are no contraindications listed in the US manufacturer's labeling.

Canadian labeling: Hypersensitivity to dacomitinib or any component of the formulation.

Side effects

Check with your doctor immediately if any of the following side effects occur while taking dacomitinib:

More common:

Blistering, crusting, irritation, itching, or reddening of the skin

body aches or pain

chest pain



cracked lips

cracked, dry, or scaly skin

deep cracks, grooves, or lines in the skin


difficulty in swallowing

ear congestion



itching, skin rash

loosening of the fingernails

loss of voice

nasal congestion

redness or soreness around the fingernails

redness, swelling, or pain of the skin

runny nose

scaling of the skin on the hands and feet


sore throat sores, ulcers, or white spots on the lips, tongue, or inside the mouth


tightness in the chest

tingling of the hands and feet

trouble breathing

ulceration of the skin

unusual tiredness or weakness


Less common:


decreased urination


dry mouth



increase in heart rate


loss of heat from the body

rapid breathing

sunken eyes


wrinkled skin

Side effects not requiring immediate medical attention

Some side effects of dacomitinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.


Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common:

Burning, dry, or itching eyes

change in taste


decreased appetite

decreased weight

discharge, excessive tearing

hair loss or thinning of hair

increased hair growth on the forehead, back, arms, and legs

lack or loss of strength

loss of taste


redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

trouble sleeping


Less common:

Eye redness, irritation, or pain

sacituzumab govitecan

Points of recommendation

You may need to have a negative pregnancy test before starting this treatment.

Do not use dacomitinib if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using dacomitinib and for at least 17 days after your last dose.

Do not breast-feed while using this medicine, and for at least 17 days after your last dose.

Tell your doctor if you have ever had:

  • frequent diarrhea; or
  • breathing problems (other than lung cancer).

Your doctor will perform a special test to make sure you have the correct tumor type to be treated with dacomitinib.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

If you vomit shortly after taking dacomitinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Drink plenty of liquids while you are taking dacomitinib.

Dacomitinib can cause severe diarrhea, which can be life-threatening if it leads to dehydration or infection.

If you have diarrhea while taking dacomitinib: Call your doctor right away. You may need to start taking anti-diarrhea medicine such as loperamide (Imodium) to quickly treat diarrhea.

Store at room temperature away from moisture and heat.

Dacomitinib can cause skin reactions. Use a skin moisturizer and avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Pregnancy level


Use is not recommended.

US FDA pregnancy category: Not assigned.


-Advise females of reproductive potential to use effective contraception during therapy and for at least 17 days after the final dose.

-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.

Breast feeding warning

No information is available on the use of this drug during breastfeeding. Because it is 98% bound to plasma proteins, the amount in milk is likely to be low; however, because of its potential toxicity in the breastfed infant and its half-life of 70 hours, the manufacturer recommends that breastfeeding be discontinued during therapy and for at least 17 days after.

Use should be avoided.

Excreted into human milk: Unknown

Excreted into animal milk: Data not available


-This drug can harm a nursing infant.

-Women should not breastfeed during therapy and for at least 17 days after.


Related drugs

vandetanib , tucatinib

Drug forms


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