Trade Name : Gilotrif™

Generic Name : Afatinib

Gilotrif™is the trade name for the generic drug Afatinib. In some cases, health care professionals may use the generic name Afatinib when referring to the trade drug name Gilotrif™.

Drug Type:

Gilotrif™ is a targeted therapy. Gilotrif™ is classified as a Tyrosine Kinase inhibitor; Epidermal Growth Factor Receptor (EGFR) inhibitor. (For more detail, see "How this drug works," below.)

What Gilotrif Is Used For:

Gilotrif™ is used to treat metastatic non-small cell lung cancer (NSCLC) that has certain EGFR mutations (exon 19 deletions or exon 21 substitution) as detected by an FDA-approved test.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Gilotrif Is Given:

• Gilotrif™ is a pill, taken by mouth
• Take Gilotrif™ on an empty stomach at least 1 hour before or 2 hours after a meal.
• Swallow Gilotrif™ tablets whole with at least 8 ounces of water. Do not crush or dissolve tablets.
• Do not change your dose or stop Gilotrif™ unless your health care provider tells you to.

If you miss a dose and your next dose is due in:

• Less than 12 hours, take your next dose at the normal time. Do not make up the next dose.
• 12 hours or more, take the missed dose as soon as you remember. Take your next dose at the normal time.
• Do not take more than 1 dose of Gilotrif™ at one time. Call your health care provider and go to the emergency room right away if you take too much.
• Store at room temperature (68° F to 77° F); keep medication in original bottle; protect from high humidity, moisture and light.
• Keep out of reach from children and pets.
• Safely throw away any Gilotrif™ that is out of date or unused (ask your provider for directions on how to discard the medication).
• The amount of Gilotrif™ that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact Gilotrif™ dosage and schedule.

Side Effects:

Important things to remember about the side effects of Gilotrif™:

• Most people will not experience all of the Gilotrif™ side effects listed.
• Gilotrif™ side effects are often predictable in terms of their onset, duration, and severity.
• Gilotrif™ side effects are almost always reversible and will go away after therapy is complete.
• Gilotrif™ side effects may be quite manageable. There are many options to minimize or prevent the side effects of Gilotrif™.

The following side effects are common (occurring in greater than 30%) for patients taking Gilotrif™ :

• Diarrhea
• Acneiform eruption (group of skin conditions resembling acne)
• Mouth sores
• Paronychia (infection of nails)
• Dry mouth

These are less common side effects (occurring in 10-29%) for patients receiving Gilotrif™:

• Decreased appetite
• Itching
• Weight loss
• Nose bleeds
• Cystitis (bladder infection)
• Cheilitis (inflammation of the lips)
• Fever
• Hypokalemia (low potassium)
• Conjunctivitis (pink eye)
• Rhinorrhea (runny nose)
• Elevated liver enzymes

Not all side effects are listed above. Some that are rare (occurring in less than about 10 percent of patients) are not listed here. Always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° C or higher, chills)
• Shortness of breath, cough or trouble breathing
• Chest pain or feeling that your heart is pounding or racing (palpitations)

The following symptoms require medical attention, but are not an emergency. Contact your doctor or health care provider within 24 hours of noticing any of the following:

• Diarrhea (4-6 episodes in a 24-hour period).
• Nausea (interferes with ability to eat and unrelieved with prescribed medication).
• Vomiting (vomiting more than 4-5 times in a 24 hour period).
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness.
• Skin or the whites of your eyes turn yellow
• Urine turns dark or brown (tea color)
• Decreased appetite
• Pain on the right side of your stomach
• Bleed or bruise more easily than normal
• Any skin or nail changes (rash, itching, severe dryness, blisters, nail infection, inflammation of the lips, etc.)
• Cough with or without mucus
• Mouth sores
• Pain or burning with urination
• Eye inflammation, watering, redness, pain, blurred vision, light sensitivity
• Extreme fatigue (unable to carry on self-care activities)
• Swelling of your ankles, feet or legs
• Sudden weight gain

Always inform your doctor or health care provider if you experience any unusual symptoms.

Precautions:

• Before starting Gilotrif™ treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• While taking Gilotrif™, do not receive any kind of immunization or vaccination without your doctor’s approval.
• Limit your time in the sun. Gilotrif™ can make your skin sensitive to sunlight. Severe sunburn, rash or worsening acne can occur with too much exposure. Remember to use sunscreen and wear a hat and clothes that cover as much of your skin as possible while taking Gilotrif™.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
• For both men and women: Barrier methods of contraception, such as condoms, are recommended during therapy and for at least 2 weeks after treatment is complete. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking Gilotrif™.

Self-Care Tips:

• While taking Gilotrif™, drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• Wash your hands often and after taking each dose of Gilotrif™.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• To help treat/prevent mouth sores while taking Gilotrif™, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
• Use an electric razor and a soft toothbrush to minimize bleeding.
• Avoid contact sports or activities that could cause injury.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals while taking Gilotrif™.
• Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
• Eat foods that may help reduce diarrhea-see managing side effects - diarrhea
• Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing. Gilotrif™ may make you more sensitive to the sun and you may sunburn more easily.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely while you are taking Gilotrif™. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition while being treated with Gilotrif™.
• If you experience symptoms or side effects while being treated with Gilotrif™, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your doctor while you are taking afatinib to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor the function of your organs (such as your kidneys and liver) as well as other side effects.

How Gilotrif Works:

Gilotrif™ is not a traditional chemotherapy drug but one of what are termed "targeted therapies." Targeted therapy is the result of years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. These are small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors in this way are also known as monoclonal antibodies. Angiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Gilotrif™ is designed to block tumor cell growth in several ways. Gilotrif™ blocks the activating sites (called tyrosine kinases) of several proteins within the cell. These proteins are most likely to stimulate cancer growth when the tumor contains an EGFR gene mutation. By blocking these targets, it is hoped the cancer will shrink.

Research continues to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this web site is meant to be helpful and educational, but is not a substitute for medical advice.

Chemocare.com is designed to provide the latest information about chemotherapy to patients and their families, caregivers and friends. For information about the 4th Angel Mentoring Program visit www.4thangel.org