Description
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.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dacomitinib in the elderly.
Breastfeeding
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.
Drug Interactions
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
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.
- For non-small cell lung cancer:
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
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
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.
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