Erlotinib functions as a first-line, monotherapy medicine that prevents further spreading of this type of cancer, in patients who have certain types of abnormal EGFR gene mutations. It is designed to be used before considering chemotherapy.
Another use of the medicine is for treating patients with cancer of the pancreas. It is used together with another drug, called Gemcitabine, for treating this type of cancer.
Erlotinib essentially works by blocking the activity of the epidermal growth factor receptor (EGRR). This is a protein found in cancer cells that causes the cells to divide, grow, and spread.
The drug is effective in patients with abnormal EGFR mutations, but can become resistant if used for long-term treatment.
The medicine is sold in the US under the brand name, Tarceva. It is supplied in the form of a tablet and is available to patients through a doctor's prescription only. It may be used to treat other types of cancers not discussed here.
The use of prescription medicines generally comes with potential risks and benefits. Since erlotinib can affect both the cancer cells and healthy cells of a patient and cause other unwanted adverse effects, your doctor may help you decide if it is right for you.
Tell your doctor if you have had an unusual or allergic reaction to this or other medicines; or allergic to inactive ingredients in this medicine. Also let your doctor know if you have any allergy to foods, preservatives, dyes or animals.
Give your doctor a list of all medications you are taking or plan to take. These include prescription and over-the-counter medicines (OTCs), vitamins, and nutritional supplements.
Certain medical conditions may affect the way the tablet works. It is important to let your doctor know if you are being or was recently treated with radiation therapy or chemotherapy, or had a recent medical or dental surgery.
The safety and efficacy of using this medicine in children have not been established.
There are no specific problems found that would limit the use of the medicine in elderly patients.
Tell your doctor if you are pregnant, may be pregnant or plan to become pregnant. Studies done in animals show a possible risk of harm to an unborn baby if erlotinib is used to treat a pregnant woman.
There is no specific information available that suggests the medicine can pass through breast milk and harm a breastfeeding infant.
If you are within any of the above risk groups, your doctor will determine treatment with erlotinib based on the potential benefits and risks involved and may take necessary precautions.
Side effects, hypersensitivity, or allergic reactions may occur from taking erlotinib. Some side effects are expected as the medicine begins to work in the body. Other effects are unwanted and may or may not require medical attention.
The following side effects may occur and need immediate medical attention. Call your doctor right away if you experience any of them.
Certain side effects which may occur tend to go away on their own as the body gets used to the medicine. They may require medical attention only if they become worse, bothersome or do not go away.
Tell your doctor if you experience any of them, as follows:
One or more of these side effects may occur, but not all of them may occur at once in one single patient. Some patients may experience other side effects not listed here.
Check with your doctor if you notice any unusual symptom that becomes bothersome or does not go away. You can ask your doctor or health care professional about ways to prevent or reduce side effects.
You may also call the FDA at 1-800-FDA-1088 to report side effects.
This drug is supplied as a tablet which should be taken only by mouth.
Since food tends to interfere with the absorption of the medicine in the body, you may be told to take your dose on an empty stomach (at least 1 hour before or 2 hours after a meal). Meals of grapefruit or grapefruit juice should be avoided.
Your dose will be set based on the condition you are being treated for. Your doctor will also decide the strength of the dose, time between each dose, and the duration of your treatment.
Take your dose exactly as you are told to and follow all other directions given to you by your doctor, pharmacist, and prescription label. Also read the patient information leaflet that comes with the medicine.
The recommended dosage is as follows.
For treating non-small cell lung cancer
Adults: Take 150 milligrams (mg) of the tablet, once a day by mouth. If necessary, your doctor may adjust your dose.
For treating cancer of the pancreas
Adults: Take 100 milligrams (mg) of the tablet, once a day by mouth. Take it together with Gemcitabine, as prescribed. If necessary, your doctor may adjust your dose.
If you missed a dose of your medicine, take it as soon as possible. However, if it is time to take the next dose, skip the missed dose and take the next dose as scheduled. Continue with the regular dosing schedule.
An extra dose should not be taken to make up for the missed dose. Also, remember to take your tablet on an empty stomach.
Call your doctor, 911 or the local poison control center at 1-800-222-1222, if you overdose on this drug. If the patient collapses or is not breathing, call 911.
Emergency medical attention is needed if you experience any of the following symptoms of overdose:
Food, alcohol, tobacco, and other medicines or medical problems may cause adverse interaction with erlotinib. Your doctor will use the information disclosed in your medical history to decide how to treat you.
The following interactions have been included in this guide due to their significance.
Food, alcohol, and tobacco
The medicine should not be used with the following foods:
The following substance should not be used during treatment because it can significantly reduce the effect of the medicine:
If the use of these foods or tobacco cannot be avoided, your doctor may need to change the dose of your medicine or how often take it. Your doctor may also give you special instructions on the use of other foods, or substances such as alcohol.
None of the medicines on the following list should be taken with erlotinib. They may interact and increase or reduce the effects of the cancer medication. Other medicines may cause an adverse interaction, but are not mentioned here.
When telling your doctor about all the medicines you use, remember to mention if you are using any of the following. Your doctor may decide that it is best to still treat you with the cancer medicine but may adjust your dose or how often you take one or more of your medicines.
If you must take any stomach ulcer or heartburn medicine such famotidine, cimetidine or ranitidine, take it at least 10 hours before or two hours after taking this cancer drug. Take antacids, such as Maalox, several hours before or after taking erlotinib.
Erlotinib should be used with caution in patients with the following medical conditions. Tell your doctor if you have (or have a history of) any of them, as the cancer drug can make these conditions worse.
To protect your health, your doctor may adjust the dose of your medicine and how often you take it.
The medicine should also be used with caution in patients who have the following condition. This condition slows down the removal of the drug from the body. The result may be a toxic level of the medicine in the body.
Your doctor may adjust the dose of your medicine and how often you take it to reduce the risk posed due to the liver disease.
Store the medicine in a closed container and at room temperature of about 20° to 25°C (68° to 77°F).
Keep away from heat, moisture, and direct light. Keep from extremely cold temperatures and freezing.
Keep out of the reach of children.
Throw away medicine that is expired or no longer needed.
Ask your healthcare professional or local waste disposal agency how to safely dispose of it.
Prior to 2013, erlotinib was used as an alternative treatment in patients with NSCLC who have certain types of abnormal epidermal growth factor receptor (EGFR) mutations. This was after other treatments had failed.
The US Food and Drug Administration (FDA) finally approved erlotinib as a first-line, monotherapy medicine for treating this condition. One of its primary values is that it helps to postpone the need for chemotherapy in these patients.
Erlotinib's secondary use is for the treatment of pancreatic cancer, when used along with another cancer medicine called Gemcitabine.
Despite its efficacy, the medicine can affect both the healthy cells and cancer cells of a patient. It may also worsen certain medical conditions present in patients undergoing treatment.
Additionally, long-term treatment may cause the body to become resistant to the medicine. This tends to occur after about 12 months of treatment, following another abnormal EGFR protein mutation.
Once the body stops responding to erlotinib, an alternative treatment is needed to prevent the cancer cells from spreading further.