erlotinib
Erlotinib (Tarceva) is an oral medication used to treat non-small cell lung cancer (NSCLC) and pancreatic cancer. It’s a type of targeted anticancer treatment. Erlotinib (Tarceva) is a recommended treatment option for certain adults, but can commonly cause bothersome skin rashes and diarrhea.
What is Erlotinib (Tarceva)?
What is Erlotinib (Tarceva) used for?
- Metastatic non-small cell lung cancer (NSCLC) in certain adults
- Advanced, unresectable, or metastatic pancreatic cancer, in combination with gemcitabine (Gemzar)
How Erlotinib (Tarceva) works
Erlotinib (Tarceva) is a tyrosine kinase inhibitor. It blocks certain proteins from attaching to a specific target on cells called the epidermal growth factor receptor (EGFR). EGFR is found on both healthy and cancer cells, and is important for cell growth. Cancer cells usually have more EGFR proteins than noncancerous cells. When EGFR is blocked by erlotinib (Tarceva), cancer cells can’t grow and spread as well.
Drug facts
Side effects of Erlotinib (Tarceva)
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
- Rash (up to 85%)
- Diarrhea (up to 62%)
- Loss of appetite (up to 52%)
- Extreme tiredness (52%)
- Cough (48%)
- Difficulty breathing (up to 45%)
- Nausea (33%)
- Infection (24%)
Less Common Side Effects
- Dry skin
- Back pain
- Chest pain
- Itching
- Nail changes or infection
- Joint pain
- Muscle pain
- Eye inflammation (pink eye)
Erlotinib (Tarceva) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Stroke: severe headaches, visual changes, sudden confusion, weakness on one side of the body, dizziness, trouble speaking or walking
- Serious lung problems: extreme tiredness, dry cough, trouble catching your breath (especially after an activity), fast and shallow breathing, chest discomfort
- Kidney problems: blood in the urine, painful urination, dark urine
- Liver damage: dark urine, right-sided stomach pain, yellowing of the eyes or skin, tiredness, loss of appetite, nausea, vomiting
- Damage to the gut: fevers, chills, nausea, vomiting, feeling bloated, intense stomach pain
- Severe skin reactions: painful blisters, skin wounds, peeling skin, painful sores in your mouth or around your eyes
- Serious bleeds: bleeding or bruising that doesn’t stop or go away, large amount of bleeding, blood in the urine, throwing up blood, bloody or black and tarry stool
The following Erlotinib (Tarceva) 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
Burning, tingling, numbness or pain in the hands, arms, feet, or legs
cough or hoarseness
diarrhea (severe)
difficult or labored breathing
fever or chills
lower back or side pain
painful or difficult urination
rash (severe)
sensation of pins and needles
stabbing chest pain
tightness in the chest
Rare
Bloody or black, tarry stools
blurred vision
chest pain or discomfort
convulsions (seizures)
eye irritation or redness
inability to speak
pain or discomfort in the arms, jaw, back, or neck
severe stomach pain
slurred speech
sudden, severe chest pain
sudden, severe headache
sudden, severe weakness in the arm or leg on one side of the body
sweating
vision changes
vomiting of blood or material that looks like coffee grounds
Incidence not known
Agitation
blistering, peeling, or loosening of the skin
bloody nose
burning feeling in the chest or stomach
burning upper abdominal or stomach pain
confusion
dark-colored urine
darkening of the skin
decreased urine output
general feeling of tiredness or weakness
headache
increased thirst
irregular heartbeat
lethargy
light-colored stools
loss of appetite
mood changes
muscle pain or stiffness
muscle twitching
nausea or vomiting
rapid weight gain
red skin lesions, often with a purple center
sores, ulcers, or white spots in the mouth or on the lips
stomach pain, continuing
stupor
swelling of the face, ankles, or hands
tenderness in the stomach area
trouble breathing
unusual tiredness or weakness
yellow eyes or 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
Acid or sour stomach
belching
blemishes on the skin
bloated or full feeling
bone pain
burning, dry, or itching eyes
diarrhea (mild)
difficulty with moving
dizziness
excess air or gas in the stomach or intestines
excessive tearing
fear
feeling sad or empty
feeling unusually cold
headache
indigestion
irritability
itching skin
joint pain
loss of interest or pleasure
nervousness
passing gas
rash, mild
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
shivering
stomach discomfort, upset, or pain
swelling
swelling or inflammation of the mouth
swollen joints
thinning of the hair
tiredness
trouble or inability to sleep
trouble with concentrating
Less common
Loosening of the fingernails
redness or soreness around the fingernails
Incidence not known
Brittle and loose nails
discharge, excessive tearing
increased hair growth, especially on the face
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 Erlotinib (Tarceva)
Pros
- Only taken once a day
- Taken by mouth, so good for people who don't like needles
- Recommended treatment option for NSCLC and pancreatic cancer in certain adults
- More precise in the way it targets cancer cells, compared to traditional chemotherapy
Cons
- Must be taken on an empty stomach
- Not recommended during pregnancy or breastfeeding
- Commonly causes acne-like skin rashes
Pharmacist tips for Erlotinib (Tarceva)
- Take erlotinib (Tarceva) on an empty stomach, at least 1 hour before or 2 hours after food.
- Avoid grapefruit and grapefruit juice while taking erlotinib (Tarceva). They can raise the levels of the medication in your body and cause more side effects. If you do choose to eat grapefruit or drink grapefruit juice, let your provider know because they might need to lower your dose of erlotinib (Tarceva).
- Protect your skin from the sun and and try to avoid other sources of ultraviolet (UV) rays, such as tanning beds, when you’re taking erlotinib (Tarceva). Sun and UV rays can worsen the skin side effects that this medication can cause. If you’re going to be outside, be sure to wear sunscreen with at least sun protective factor (SPF) 15 and protective clothing, such as long sleeves, pants, hats, and sunglasses.
- Tell your provider and pharmacist about all the medications you take, including supplements and over-the-counter medications, so they can help you check for interactions. For example, medications like ketoconazole and clarithromycin (Biaxin) can raise erlotinib (Tarceva) levels in your body and put you at higher risk for sid effects. Medications like omeprazole (Prilosec) or carbamazepine (Tegretol) might cause erlotinib (Tarceva) to not work as well in treating your cancer. Before starting any new medications, make sure your provider knows you're taking erlotinib (Tarceva).
- Smoking can lower the levels of erlotinib (Tarceva) in your body and affect how well it works to treat your cancer. Let your provider know if you currently smoke, as you might need to take a higher dose of this medication and be monitored more closely. If you're interested in quitting, talk to your provider about the different options.
- If you’re able to become pregnant, use birth control, such as birth control pills or condoms, while taking erlotinib (Tarceva) and for at least 1 month after your last dose. It’s possible for the medication to cause harm to an unborn baby.
- Ask your provider about the best way to handle and throw away erlotinib (Tarceva) safely. Anticancer medications can be very harmful to people who handle or come into contact with them. You should store the medication up and away, so children and pets won’t be able to reach it.
Common questions about Erlotinib (Tarceva)
Erlotinib (Tarceva) is one of the recommended options for metastatic NSCLC, which is lung cancer that has spread to other parts of the body. It's specifically for NSCLC with tumors that have certain epidermal growth factor receptor (EGFR) mutations. Your provider will test your tumor to see if you have these mutations before starting you on this medication.
Erlotinib (Tarceva) fights cancer by blocking EGFR. This prevents or slows cancer cell growth. But the problem is that EGFR isn’t only found on cancer cells, but also on healthy cells, especially skin cells. So as a side effect, erlotinib (Tarceva) also affects cell growth in these healthy cells. Specifically, it can trigger an immune response, which can cause changes to your skin, such as rashes and inflammation. This medication can also affect how well your skin holds moisture, which might lead to dryness and cracking. Let your provider know right away if you experience any painful blisters, skin wounds, peeling skin, painful sores in your mouth or around your eyes. These can be signs of a more serious skin reaction and your provider might need to stop your erlotinib (Tarceva) treatment.
You should take erlotinib (Tarceva) as instructed by your provider. How long you take erlotinib (Tarceva) therapy depends on several factors, including how well the medication is working to treat your cancer and how well you tolerate the side effects. Don’t stop taking erlotinib (Tarceva) without first discussing with your provider.
Let your provider know if you have liver problems. You might be able to receive erlotinib (Tarceva) treatment if your provider thinks the benefits outweigh the risk of side effects. This is because erlotinib (Tarceva) can cause liver problems, even in people with healthy livers. Your provider might order blood work to check your liver health regularly, especially if you already have liver problems. In addition, because this medication is broken down by the liver, your body might have a harder time getting rid of it if you have liver problems. As a result, you might be at higher risk for side effects, such as skin rash, diarrhea, and lung problems. Let your provider know right away if you experience symptoms of liver problems, such as fatigue, stomach pain, or yellowing of the skin or whites of the eyes.
Talk with your provider if you’re pregnant or thinking about becoming pregnant. Erlotinib (Tarceva) hasn’t been well-studied in human pregnancies, but animal studies show that it will likely cause harm to your unborn baby. If you’re a female who’s able to have babies, you should use birth control while taking erlotinib (Tarceva) and for 1 month after the last dose. Let your provider know right away if you become pregnant while taking erlotinib (Tarceva).
Erlotinib (Tarceva) isn’t recommended in people who are breastfeeding. This medication hasn’t been studied in nursing mothers, so it’s not known whether or not it can pass through breastmilk or cause harm to nursing infants. But in the case that erlotinib (Tarceva) can pass through breastmilk, it can put nursing infants at risk for serious skin, lung, or kidney side effects. Because of these potential risks, it’s recommended that you avoid breastfeed during erlotinib (Tarceva) treatment and for 2 weeks after your last dose. Talk with your provider if you have any questions about breastfeeding while taking erlotinib (Tarceva).
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Risks and warnings for Erlotinib (Tarceva)
Erlotinib (Tarceva) 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.
Severe lung or breathing problems
Though rare, some people taking erlotinib (Tarceva) have experienced a serious lung problem called interstitial lung disease (ILD). This is a condition where scars appear on the lungs. People have reported symptoms of ILD anywhere from 5 days to 9 months after starting treatment. Tell your provider right away if you have new or worsening breathing trouble, chest pain or discomfort, dry cough, or fever. You might have to pause or stop treatment with erlotinib (Tarceva) while your provider figures out the cause.
Kidney or liver damage
- Risk factors: History of liver problems | Not having enough fluids in your body
Erlotinib (Tarceva) can cause rare, but serious kidney problems. Your provider will monitor your kidney health regularly through lab work during treatment. If you develop kidney problems, your provider might pause erlotinib (Tarceva) until your kidney gets better. Talk to your provider if you notice any changes in how often you urinate (more or less) or any blood in your urine so they can check for kidney issues.
Erlotinib (Tarceva) can also cause rare, but possibly life-threatening liver problems. Your provider will monitor your liver health regularly through lab work while you’re taking erlotinib (Tarceva). If you develop liver problems, your provider might stop your erlotinib (Tarceva) treatment. Let your provider know if you experience tiredness, loss of appetite, nausea or vomiting, dark urine, right-side stomach pain, or yellowing of the eyes or skin, as these can be signs of liver problems.
Tears in the lining of the gut
- Risk factors: Taking certain medications that can raise your risk for stomach tears | History of stomach ulcers or other gut problems
While extremely rare, erlotinib (Tarceva) can cause tears in the lining of the stomach, intestines, or bowel (gastrointestinal perforation). These problems can be serious and life-threatening. They’re more likely to happen if you’re also taking medications that can affect how new blood vessels are made, corticosteroids, NSAIDs, or taxane chemotherapy. If you develop a tear in the lining of your gut, you’ll have to stop taking erlotinib (Tarceva). Seek medical help right away if you experience severe stomach pain, fever, chills, nausea, or vomiting.
Severe skin problems
Erlotinib (Tarceva) can cause skin problems, including pus-filled blisters, dry or cracking skin, nail changes, and excessive hair growth anywhere on the body. In rare cases, it can cause severe skin reactions or infections, which can be life-threatening. Tell your provider immediately if you develop painful blisters, skin wounds, or peeling skin, as these are signs of a serious skin reaction that requires medical attention.
Stroke
Though rare, a few people who took erlotinib (Tarceva) during clinical trials experienced blood clots in the brain that’ve led to a stroke. Call 911 or seek immediate medical help if you experience severe headache, sudden confusion, weakness on one side of your body, or trouble speaking or walking.
Eye problems
Erlotinib (Tarceva) can cause you to have less tears, dry eyes, abnormal eyelash growth, and inflammation of the eye tissue. In rare cases, these can lead to serious problems. Tell your provider right away if you have eye pain or vision changes while taking erlotinib (Tarceva).
Serious bleeding in people taking warfarin (Coumadin)
You’re at higher risk of bleeding if you take warfarin (Coumadin) along with erlotinib (Tarceva). Your provider will monitor you regularly through blood tests (international normalized ratio, or INR test) to make sure your warfarin (Coumadin) dose is safe. Get immediate medical attention if you notice signs of bleeds, such as blood in your urine, have bright red or dark, tarry "coffee ground" stool, or can't stop bleeding from a wound.
Harm to unborn baby
Based on animal studies, erlotinib (Tarceva) might harm an unborn baby or raise the risk for miscarriage (pregnancy loss). Because of these risks, if you’re a female who can get pregnant, you should use birth control while taking erlotinib (Tarceva) and for 1 month after the last dose. Let your provider know right away if you become pregnant during this time.
Erlotinib (Tarceva) dosage
Typical dosage for Erlotinib (Tarceva)
- NSCLC: The typical dose is 150 mg by mouth once daily, on an empty stomach.
- Pancreatic cancer: The typical dose is 100 mg by mouth once daily, on an empty stomach. Erlotinib (Tarceva) is usually taken in combination with gemcitabine (Gemzar).
Interactions between Erlotinib (Tarceva) 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.
- Acenocoumarol
- Amiodarone
- Boceprevir
- Carbamazepine
- Cimetidine
- Ciprofloxacin
- Clarithromycin
- Cobicistat
- Conivaptan
- Dexlansoprazole
- Enzalutamide
- Esomeprazole
- Famotidine
- Fosphenytoin
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Lansoprazole
- Lopinavir
- Lumacaftor
- Mitotane
- Nefazodone
- Nelfinavir
- Nizatidine
- Omeprazole
- Pantoprazole
- Phenobarbital
- Phenprocoumon
- Phenytoin
- Posaconazole
- Rabeprazole
- Ranitidine
- Rifabutin
- Rifampin
- Rifapentine
- Ritonavir
- Saquinavir
- St John's Wort
- Telaprevir
- Telithromycin
- Voriconazole
- Warfarin
What are alternatives to Erlotinib (Tarceva)?
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