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Gilotrif (Generic Afatinib)

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Why is this medication prescribed?

When non-small cell lung cancer has progressed to neighboring tissues or to other organs, it can be treated with afatinib. Afatinib belongs to the kinase inhibitors drug family. It functions by impeding the action of a certain naturally occurring chemical that might be required to promote the growth of cancer cells.

How should this medicine be used?

Afatinib is available as an oral tablet. Once daily, it is typically taken on an empty stomach, at least one hour before or two hours after a meal or snack. Afatinib should be taken every day at about the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Administer afatinib exactly as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

If you encounter severe side effects with afatinib, your doctor may decide to temporarily or permanently stop your therapy or reduce the dosage. Discuss your feelings regarding your treatment with your doctor.

Afatinib should still be used even if you feel OK. Avoid stopping afatinib use without first consulting your physician.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking afatinib,

  • If you have an allergy to afatinib, any other drugs, or any of the ingredients in afatinib tablets, inform your doctor and pharmacist right away. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any prescription and over-the-counter drugs, vitamins, and dietary supplements you are currently taking or intend to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); certain antifungal medications such as itraconazole (Sporanox) and ketoconazole (Nizoral); cyclosporine (Gengraf, Neoral, Sandimmune); erythromycin (E.E.S., Erythrocin, other brands); some anti-HIV drugs like nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); some anti-seizure drugs like carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin); verapamil (Calan, Covera, Isoptin, Verelan), tacrolimus (Prograf), rifampin (Rimactane, Rifadin, in Rifater), and quinidine (in Nuedexta). Tell your doctor about all of the medications you are taking, including any that may not appear on this list, as many additional drugs may interact with afatinib. Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • Inform your doctor if you have or have ever had any of the following conditions: Asian ancestry; lung or breathing issues (other than lung cancer); dry eyes; heart issues; liver or kidney illness; or any other medical condition. If you wear contact lenses, let your doctor know as well.
  • If you are pregnant or plan to become pregnant, let your doctor know. While taking afatinib and for at least two weeks after finishing your therapy, you shouldn’t get pregnant. Consult your physician about birth control options you can take while undergoing therapy. Call your doctor right away if you find out you’re expecting while taking afatinib. The fetus could suffer from afatinib.
  • Inform your doctor if you are nursing a baby. When taking afatinib, breastfeeding is not advised.
  • Make a plan to limit your time spent in the sun and to use sunscreen, sunglasses, and protective clothes. Your skin could become sun-sensitive if you take afatinib. During your afatinib treatment, you run a higher chance of developing a rash or acne if you are exposed to sunlight.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If you missed a dose and you have less than 12 hours until your next dose, omit the missing dose and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Afatinib might have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Lips that are chapped, swollen, or have ulcers in the corners of their mouths
  • Itchy or dry skin
  • Reduced appetite
  • Nail fungus
  • Acne
  • A nosebleed

Some adverse effects can be very harmful. Call your doctor right away if you see any of these signs or any of those in the IMPORTANT WARNING section and stop taking afatinib immediately:

  • Diarrhea
  • Dehydration symptoms including a dry mouth, dark urine, less sweating, dry skin, and othersreduced urination
  • Swelling of the hands, feet, ankles, lower legs, or arms
  • Rash
  • Skin irritation, rashes, peeling, or blisters
  • Breathing challenges
  • Respiration difficulty
  • Heartbeat that is erratic, fast, or hammering
  • Rapid weight increase
  • Cough
  • Fever
  • Excessive tiredness
  • Pain in the right upper part of the stomach
  • Unusual bruising or bleeding
  • Nausea
  • Fever
  • Extreme fatigue
  • Stomach ache in the right upper portion
  • Significant bruising or bleeding
  • Nausea
  • Vmiting
  • Eyes or skin that have a yellow tint
  • Dark feces
  • Teary, painful, or swollen eyes
  • Vision changes that occur suddenly, including blurry vision
  • Responsiveness to light

Other negative effects of afatinib are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at or by phone at 1-800-332-1088 if you have a serious side event.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. It should not be kept in the bathroom. Store it at room temperature and away from light, excessive heat, and moisture.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the easiest approach to get rid of your medication. To find out about take-back programs in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back program, see the FDA’s Safe Disposal of Medicines website at for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose symptoms could include:

  • Nausea
  • Vomiting
  • Weakness
  • Dizziness
  • Headache
  • Abdominal pain

What other information should I know?

Keep all of your appointments with your physician and the lab. To determine how well your body is responding to afatinib, your doctor will request a few lab tests.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Gilotrif®
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