Pronunciation:

dak-oh-MI-ti-nib

Brand Names:

• Vizimpro

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Dacomitinib is used to treat non-small cell lung cancer that has spread (metastatic) with an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation gene. Your doctor will use a test to check for the mutation before you receive this medicine.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dacomitinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dacomitinib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Desipramine
• Dexlansoprazole
• Duloxetine
• Esomeprazole
• Flecainide
• Fluoxetine
• Imipramine
• Lansoprazole
• Mexiletine
• Nortriptyline
• Omeprazole
• Pantoprazole
• Pimozide
• Rabeprazole
• Tamoxifen
• Thioridazine
• Trimipramine
• Valbenazine
• Vortioxetine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Lung or breathing problems (eg, interstitial lung disease, pneumonitis)—Use with caution. May make this condition worse.

• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Take this medicine at least 6 hours before or 10 hours after using an antacid or H2 blocker (eg, cimetidine, ranitidine).

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For non-small cell lung cancer:
    • Adults—45 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking a dose, take the next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment with this medicine and for at least 17 days after the last dose to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

Cancer medicines can cause diarrhea, nausea, vomiting, or stomach pain in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Apply moisturizer and avoid overexposing your skin to sunlight. Always use sunscreen or sun blocking lotions and wear protective clothing and hats while you are using this medicine.

Side Effects of This Medicine:

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

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

More common

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

body aches or pain

chest pain

chills

cough

cracked lips

cracked, dry, or scaly skin

deep cracks, grooves, or lines in the skin

diarrhea

difficulty in swallowing

ear congestion

fever

headache

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

sneezing

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

swelling

tightness in the chest

tingling of the hands and feet

trouble breathing

ulceration of the skin

unusual tiredness or weakness

Less common

Confusion

decreased urination

dizziness

dry mouth

fainting

fever

increase in heart rate

lightheadedness

loss of heat from the body

rapid breathing

sunken eyes

thirst

wrinkled skin

Some side effects 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

constipation

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

nausea

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

trouble sleeping

vomiting

Less common

Eye redness, irritation, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.