Gilotrif (afatinib) is an oral medication used to treat certain types of non-small cell lung cancer (NSCLC) that has spread. It’s used on its own to treat NSCLC, so you typically don’t have to take other anticancer medications with it. Gilotrif (afatinib) is conveniently taken by mouth once a day. But it commonly causes diarrhea and skin reaction, which can be serious.
Non-small cell lung cancer (NSCLC) in people with:
Metastatic NSCLC that have non-resistant mutations in the EGFR gene
Metastatic squamous NSCLC that’ve gotten worse after receiving platinum therapy
In certain types of NSCLC, there are changes (or mutations) in the epithelial growth factor receptor (EGFR) gene. EGFR is found in both normal and cancer cells. But cancer cells usually have more EGFR proteins than normal cells. This can cause cancer cells to grow more quickly than normal cells.
Gilotrif (afatinib) is a kinase inhibitor that works by attaching to these EGFR proteins. When it does, the proteins can’t continue to send signals for cancer cells to grow. This means cancer cells can’t grow and spread as well.
Source: DailyMed
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
Bloody or cloudy urine
burning, dry, or itching eyes
difficult, burning, or painful urination
discharge or excessive tearing
frequent urge to urinate
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
redness, swelling, or pain of the skin
scaling of the skin on the hands and feet
tingling of the hands and feet
ulceration of the skin
Get emergency help immediately if any of the following symptoms of overdose occur:
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
Blemishes on the skin
chapped, red, or swollen lips
decreased appetite
decreased weight
itching skin or rash
loosening of the fingernails
nosebleeds
redness or soreness around the fingernails
scaling, redness, burning, pain, or other signs of inflammation of the lips
sores, ulcers, or white spots on the lips or tongue or inside the mouth
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.
Taken by mouth
Taken once daily
Can be taken as a single medication for NSCLC
Must take on empty stomach
Raises risk for nail infections
Commonly causes diarrhea and skin problems that can be serious
Take Gilotrif (afatinib) on an empty stomach (1 hour before or 2 hours after a meal). Swallow the tablet whole so that the medication works properly. Don’t cut, chew, or crush the tablet.
If you miss a dose of Gilotrif (afatinib) and you still have more than 12 hours before your next dose, you can take your missed dose. If you have less than 12 hours until your next dose, don’t take another dose. In this case, just skip the missed dose and take your next dose at the normally scheduled time.
People taking Gilotrif (afatinib) who spend time in the sun can be at higher risk of developing skin reactions. Where possible, limit the amount of time you spend in the sunlight. To protect your skin when outside, use sunscreen or clothes that cover your skin.
Gilotrif (afatinib) commonly causes diarrhea. Let your provider know right away if you experience diarrhea because they can let you know whether you need more medical attention. It’s important to drink enough water and electrolytes if you experience diarrhea so you don’t become dehydrated or have kidney damage.
Taking Gilotrif (afatinib) might impact your ability to have children (fertility). If you have concerns about this, talk to your provider.
Ask your provider or pharmacist about the best way to handle and throw away Gilotrif (afatinib) safely. Anticancer medications can be very harmful to people who handle or come into contact with them.
Gilotrif (afatinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Kidney problems
Gilotrif (afatinib) causes diarrhea in most people, typically within 6 weeks of starting this medication. Sometimes, diarrhea can be life-threatening because it can lead to serious loss of fluids and electrolytes (dehydration). If you develop any diarrhea, let your provider know right away so they can let you know if you need immediate medical attention. Depending on how severe the diarrhea, your provider might ask you stop taking Gilotrif (afatinib) for a little while or lower your dose. Your provider might also have you take an anti-diarrhea medication, such as loperamide (Imodium A-D), until the diarrhea has stopped for at least 12 hours.
Gilotrif (afatinib) commonly causes skin reactions, such as rash, itchy skin, and acne-like bumps. Though rare, some people have also experienced more serious reactions, such as painful blisters, peeling of the skin, and hand-foot syndrome. If you develop a skin reaction with Gilotrif (afatinib) , your provider might have you stop taking Gilotrif (afatinib) for a little while or lower your dose. In serious cases, they might have you stop taking Gilotrif (afatinib). Let your provider know right away if you notice a rash, peeling or blistering of the skin, or blisters in your mouth.
Rarely, Gilotrif (afatinib) can cause serious lung problems, like interstitial lung disease (ILD). If you have breathing problems, your provider might tell you to stop taking Gilotrif (afatinib) while they figure out what’s causing these problems. If they find that you have ILD caused by Gilotrif (afatinib), your provider will probably tell you to stop taking this medication. Let your provider know if you develop any new or worsening breathing problems (e.g., dry cough, trouble breathing, or fever).
Gilotrif (afatinib) can raise the level of certain liver enzymes in your body, which might lead to liver problems. You’ll need to get regular blood tests done while taking this medication to make sure that your liver is healthy. If you develop any severe liver problems, your provider might have you stop taking Gilotrif (afatinib). Let your provider know if you experience tiredness, loss of appetite, nausea or vomiting, dark urine, right-side stomach pain, easy bruising or bleeding, or yellowing of the eyes or skin, as these can be symptoms of liver problems.
Risk factors: Older adults | Taking medications that raise the risk for stomach or intestine damage | Stomach ulcers or inflamed intestine
Though rare, some people people who took Gilotrif (afatinib) during clinical trials have reported tears or damage in the stomach or intestines. The risk for stomach tears is higher if you’re also taking medications that can cause damage to your stomach (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids). If you experience a stomach tear, your provider will have you stop taking Gilotrif (afatinib). Let your provider know right away if you experience any severe stomach pain while taking Gilotrif (afatinib).
Risk factors: Severe dry eye | Redness and swelling of the cornea (clear layer on the outside of the eye) | Wearing contact lens
Some people reported cornea redness and swelling while receiving Gilotrif (afatinib) treatment. These problems made them more sensitive to light, and led to watery eyes, blurry vision, and eye pain. Let your provider know if you experience any of these eye problems. They might have you stop taking Gilotrif (afatinib) while they figure out what’s causing these problems.
Gilotrif (afatinib) hasn’t been studied during human pregnancies, but animal studies show that it can cause harm to unborn babies and to pregnant mothers. If you're able to become pregnant, you should use birth control while receiving Gilotrif (afatinib) and for at least 2 weeks after your last dose. Let your provider know right away if you become pregnant during this time.
The typical dose is 40 mg taken by mouth once daily.
Your dose might be different if you’re also taking medications that can interact with Gilotrif (afatinib) or have severe kidney problems.
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.
Non-small cell lung cancer (NSCLC) in people with:
Metastatic NSCLC that have non-resistant mutations in the EGFR gene
Metastatic squamous NSCLC that’ve gotten worse after receiving platinum therapy
Metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations
Metastatic non-small cell lung cancer (NSCLC) in certain adults
Advanced, unresectable, or metastatic pancreatic cancer, in combination with gemcitabine (Gemzar)
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