Gilotrif

Name: Gilotrif

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Brand names

  • Gilotrif®

Manufacturer

  • Boehringer Ingelheim Pharmaceuticals, Inc.

Gilotrif Usage

Take Gilotrif exactly as your doctor tells you to take it. 
  • Your doctor will tell you how many Gilotrif tablets to take and when to take them. Do not change your dose or stop Gilotrif  unless your doctor tells you to. 
  • Take Gilotrif on an empty stomach at least 1 hour before a meal or 2 hours after a meal. 
  • If you miss a dose of Gilotrif, take it as soon as you remember. If it is within 12 hours of your next dose, skip the dose and just take your next dose at your regular time. 
  • Do not take 2 doses of Gilotrif at the same time. 

 

What should I avoid while taking afatinib?

Avoid exposure to sunlight or tanning beds. Afatinib can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Afatinib Dimaleate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

20 mg (of afatinib)

Gilotrif

Boehringer Ingelheim

30 mg (of afatinib)

Gilotrif

Boehringer Ingelheim

40 mg (of afatinib)

Gilotrif

Boehringer Ingelheim

Proper Use of Gilotrif

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Take this medicine on an empty stomach at least 1 hour before or 2 hours after a meal.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For metastatic non-small cell lung cancer:
      • Adults—40 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not take this medicine if it has been more than 12 hours since you missed your last dose. Do not take 2 doses at the same time.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Gilotrif

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 2 weeks after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if diarrhea occurs while taking this medicine. You may need medicines to help manage or prevent the diarrhea.

Skin reactions (eg, acne, rash, or skin redness) may occur while you are using this medicine. Check with your doctor right away if you develop severe skin reactions, such as blistering or peeling of the skin, or severe rash. Also, avoid overexposing your skin to sunlight. Always use sunscreen or sun blocking lotions and wear protective clothing and hats while you are using this medicine.

Check with your doctor right away if you start having breathing problems, shortness of breath, a cough, chest pain, fever, or chills. These could be symptoms of a serious lung problem.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately if you have vision changes, such as blurred vision, difficulty reading, or eye pain, irritation, or swelling, during or after treatment. Your doctor may want you to have your eyes checked by an eye doctor. Also, tell your doctor if you wear contact lenses.

Check with your doctor right away if you have trouble breathing, cough, fast or uneven heartbeat, rapid weight gain, swelling of your ankles or legs, or unusual tiredness or weakness.

Talk with your doctor before using this medicine if you plan to have children. This medicine may cause infertility in men and women (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Uses of Gilotrif

  • It is used to treat lung cancer.

How do I store and/or throw out Gilotrif?

  • Store in the original container at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Indications and usage

EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer

Gilotrif is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14.1)].

Limitation of Use: The safety and efficacy of Gilotrif have not been established in patients whose tumors have other EGFR mutations [see Clinical Studies (14.1)].

1.2 Previously Treated, Metastatic Squamous NSCLC

Gilotrif is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy [see Clinical Studies (14.2)].

Drug interactions

Effect of P-glycoprotein (P-gp) Inhibitors and Inducers
Concomitant taking of P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with Gilotrif can increase exposure to afatinib [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

Concomitant taking of P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John’s wort) with Gilotrif can decrease exposure to afatinib [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

Use in specific populations

Pregnancy

Risk Summary
Based on findings from animal studies and its mechanism of action, Gilotrif can cause fetal harm when administered to a pregnant woman. There are no available data on the use of Gilotrif in pregnant women. Administration of afatinib to pregnant rabbits during organogenesis at exposures approximately 0.2 times the exposure in humans at the recommended dose of 40 mg daily resulted in embryotoxicity and, in rabbits showing maternal toxicity, increased abortions at late gestational stages [see Data]. Advise a pregnant woman of the potential risk to a fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data
Animal Data
In an embryo-fetal development study in rabbits, administration of afatinib to pregnant animals at doses of 5 mg/kg (approximately 0.2 times the exposure by AUC at the recommended human dose of 40 mg daily) or greater during the period of organogenesis caused increased post-implantation loss, and in animals showing maternal toxicity, abortion at late gestational stages. In the same study, at the high dose level of 10 mg/kg (approximately 0.7 times the exposure by AUC at the recommended human dose of 40 mg daily), there were reduced fetal weights, and increases in the incidence of runts, as well as visceral and dermal variations. In an embryo-fetal development study in rats, there were skeletal alterations consisting of incomplete or delayed ossifications and reduced fetal weight at a dose of 16 mg/kg (approximately twice the exposure based on AUC at the recommended human dose of 40 mg daily).

Lactation

Risk Summary
There are no data on the presence of afatinib in human milk or its effects on the breastfed infant or on milk production. Afatinib was present in the milk of lactating rats [see Data]. Because of the potential for serious adverse reactions in nursing infants from Gilotrif, advise a lactating woman not to breastfeed during treatment with Gilotrif and for 2 weeks after the final dose.

Data
Afatinib was present in the milk of lactating rats at concentrations 80 and 150 times higher than those found in plasma at 1 and 6 hours after administration.

Females and Males of Reproductive Potential

Contraception
Females
Gilotrif can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with Gilotrif, and for at least 2 weeks after the last dose of Gilotrif [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].

Infertility
Based on results from an animal fertility study, Gilotrif may reduce fertility in females and males of reproductive potential. It is not known if the effects on fertility are reversible [see Nonclinical Toxicology (13.1)].

Pediatric Use

Safety and effectiveness of Gilotrif in pediatric patients have not been established.

Geriatric Use

Study 1 did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

In Study 2, 53% of the 398 patients randomized to receive afatinib were 65 years of age or older and 11% were 75 years or older. In an exploratory subgroup analysis of Study 2, the hazard ratio for overall survival in patients less than 65 years old was 0.68 (95% CI: 0.55, 0.85) and in patients 65 years or older was 0.95 (95% CI: 0.76, 1.19). No overall differences in safety were observed between patients 65 years and older and younger patients.

Renal Impairment

Patients with severe renal impairment have a higher exposure to afatinib than patients with normal renal function. Administer Gilotrif at a starting dose of 30 mg once daily in patients with severe renal impairment. Adjustments to the starting dose of Gilotrif are not necessary in patients with mild or moderate renal impairment. Dosing recommendations for patients with eGFR <15 mL/min/1.73 m2 or on dialysis cannot be provided as Gilotrif has not been studied in these patient populations [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].

Hepatic Impairment

Gilotrif has not been studied in patients with severe (Child Pugh C) hepatic impairment. Adjustments to the starting dose of Gilotrif are not necessary in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Closely monitor patients with severe hepatic impairment and adjust Gilotrif dose if not tolerated [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

What is Gilotrif?

Gilotrif (afatinib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Gilotrif is used to treat a certain type of non-small cell lung cancer that has spread to other parts of the body.

Gilotrif is used for this condition only if your tumor has a specific genetic marker for which your doctor will test.

Gilotrif is also used to treat squamous non-small cell lung cancer that has spread to other parts of the body after other cancer medicine has been tried without successful treatment.

For the Consumer

Applies to afatinib: oral tablet

Along with its needed effects, afatinib (the active ingredient contained in Gilotrif) 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 while taking afatinib:

More common
  • Bloody or cloudy urine
  • burning, dry, or itching eyes
  • diarrhea
  • difficult, burning, or painful urination
  • discharge or excessive tearing
  • fever
  • 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
Less common
  • Cough
  • difficult breathing

Get emergency help immediately if any of the following symptoms of overdose occur while taking afatinib:

Symptoms of overdose
  • Abdominal or stomach pain
  • dizziness
  • headache
  • lack or loss of strength
  • nausea
  • vomiting

Some side effects of afatinib 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
  • canker sores
  • chapped, red, or swollen lips
  • decreased appetite
  • decreased weight
  • dry skin
  • itching skin or rash
  • loosening of the fingernails
  • nosebleeds
  • pimples
  • redness or soreness around the fingernails
  • runny nose
  • 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

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