Gilotrif
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.
What is Gilotrif (afatinib)?
What is Gilotrif (afatinib) used for?
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
How Gilotrif (afatinib) works
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.
Drug facts
Side effects of Gilotrif (afatinib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Diarrhea (up to 96%)
- Rash or acne-like bumps on the skin (up to 90%)
- Painful sores in the mouth or throat (up to 71%)
- Nail infection (up to 58%)
- Higher liver enzyme levels (up to 54%)
- Kidneys not working as well (49%)
- Low white blood cell counts (up to 38%)
- Dry skin (up to 31%)
- Low potassium levels (up to 30%)
- Loss of appetite (up to 25%)
- Nausea (up to 21%)
- Itchy skin (up to 21%)
Less Common Side Effects
- Weight loss
- Nose bleed
- Bladder infection
- Vomiting
- Cracked, swollen, or irritated lips
- Fever
- Runny nose
- Pink eye
Gilotrif (afatinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious skin reactions: painful rash, blisters, peeling skin
- Lung problems: cough, fever, trouble breathing, shortness of breath, chest - pain
- Serious liver problems: tiredness, loss of appetite, nausea or vomiting, dark urine, right-side stomach pain, easy bruising or bleeding, or yellowing of the eyes or skin
- Tearing of the stomach or intestines: fever, chills, severe stomach pain, bloated stomach, nausea, vomiting
- Severe diarrhea
The following Gilotrif (afatinib) side effects have also been reported
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.
Pros and cons of Gilotrif (afatinib)
Pros
- Taken by mouth
- Taken once daily
- Can be taken as a single medication for NSCLC
Cons
- Must take on empty stomach
- Raises risk for nail infections
- Commonly causes diarrhea and skin problems that can be serious
Pharmacist tips for Gilotrif (afatinib)
- 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.
Common questions about Gilotrif (afatinib)
You should take Gilotrif (afatinib) as instructed by your provider. The length of your Gilotrif (afatinib) treatment depends on several factors, including how well the medication is working to treat your cancer, and how well you tolerate it. Don’t stop receiving Gilotrif (afatinib) without first discussing it with your provider.
No. Chemotherapy is a term used for cancer medications that kill cancer cells in your body. Gilotrif (afatinib) isn’t a chemotherapy medication. Rather, it’s a type of targeted anticancer treatment that works more specifically to target cancer cells.
Yes. In clinical trials, most people experienced diarrhea with Gilotrif (afatinib). In severe cases, the diarrhea led to serious kidney problems. Tell your provider right away if you have diarrhea because they can let you know if you need more medical attention. If the symptoms are mild to moderate, your provider can give you tips to manage the diarrhea at home. For example, you can stay hydrated so you don’t lose too much bodily fluid (dehydration). You can try eating bland foods that are easier on your stomach. Your provider can also prescribe medications, such as loperamide (Imodium A-D) to try to ease the symptoms. Get medical help right away if the diarrhea doesn't get better after 2 days, or if you have other symptoms, such as high fevers or bloody stools.
Gilotrif (afatinib) shouldn't be taken during pregnancy, because animal studies showed that it can cause harm to your unborn baby. If you’re able to become pregnant, you should use birth control while taking Gilotrif (afatinib) and for 2 weeks after the last dose. Let your provider know right away if you become pregnant while taking this medication.
You should avoid breastfeeding while taking Gilotrif (afatinib) and for 2 weeks after your last dose. It isn’t known if Gilotrif (afatinib) can pass into breast milk nor what effects the medication has on nursing infants if it does. To be safe, it's best to not give your baby breastmilk during and soon after Gilotrif (afatinib) treatment. If you have questions about Gilotrif (afatinib) and breastfeeding, talk with your provider. They can recommend other ways to feed your baby, such as with baby formula.
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Risks and warnings for Gilotrif (afatinib)
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.
Diarrhea
- 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.
Skin reactions
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.
Lung problems
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).
Liver problems
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.
Tearing of the stomach or intestines
- 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).
Eye problems
- 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.
Harm to unborn baby
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.
Gilotrif (afatinib) dosage
Typical dosage for Gilotrif (afatinib)
- 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.
Interactions between Gilotrif (afatinib) and other drugs
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.
- Amiodarone
- Apalutamide
- Capmatinib
- Carbamazepine
- Carvedilol
- Clarithromycin
- Cobicistat
- Conivaptan
- Cyclosporine
- Dronedarone
- Erythromycin
- Flibanserin
- Fosphenytoin
- Itraconazole
- Ketoconazole
- Lapatinib
- Phenytoin
- Quinidine
- Ranolazine
- Rifampin
- Ritonavir
- St John's Wort
- Telaprevir
- Tipranavir
- Vemurafenib
- Verapamil
What are alternatives to Gilotrif (afatinib)?
