20 mg, 30 mg, 40 mg, 50 mg film-coated tablets
afatinib

1. What GIOTRIF is and what it is used for

GIOTRIF is a medicine that contains the active substance afatinib. It works by blocking the activity of a group of proteins called the ErbB family, (including EGFR [epidermal growth factor receptor or ErbB1], HER2 [ErbB2], ErbB3, and ErbB4). These proteins are involved in the growth and spread of cancer cells, and can be affected by changes ( mutations ) in the genes that produce them. By blocking the activity of these proteins, this drug inhibits the growth and spread of cancer cells.

This medicine is used alone to treat adult patients with a specific type of lung cancer (non-small cell lung cancer ):

  • identified by a change ( mutation ) in the EGFR gene. GIOTRIF can be prescribed to you as your first cancer treatment or if your previous chemotherapy has been insufficient.
  • of squamous cell carcinoma if previous cancer treatment has been insufficient.

2. What you need to know before using GIOTRIF

Do not use GIOTRIF

– if you are allergic to afatinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using this medicine:

  • if you are a woman, have low body weight (less than 50 kg) or have kidney problems. If you meet any of these, you may need to be checked more closely by your doctor as the side effects may be more pronounced.
  • if you have a history of inflammation of the lungs (interstitial lung disease).
  • if you have liver problems. Your doctor may need to test your liver function. Treatment with this drug is not recommended if you have a severe liver disease.
  • if you have previously had eye problems such as very dry eyes, inflammation of the transparent layer at the end of the eye (cornea) or sores in the front of the eye or if you wear contact lenses.
  • if you have had heart problems in the past. Your doctor may need to check you more closely.

Contact your doctor immediately when using this medicine:

  • if you get diarrhea. Treatment at the first sign of diarrhea is important.
  • if you get a rash. Early treatment of skin rash is important.
  • if you experience shortness of breath, or shortness of breath that suddenly worsens, possibly also with cough and fever. This may mean that you have an inflammation of the lungs (interstitial lung disease), which can be life-threatening.
  • if you get severe pain in the stomach or intestines, fever, chills, nausea, vomiting or stiff or swollen abdomen, as these may be symptoms of a rupture of the stomach or intestinal wall (“gastrointestinal perforation”). Also tell your doctor if you have a history of gastrointestinal ulcers or a diverticular disease or if you are being treated with anti-inflammatory drugs ( NSAIDs ) (used to relieve pain and swelling) or steroids (used for inflammation and allergies ), as this may increase the risk.
  • if you develop acute or worsening redness and pain in the eye, increased tear flow, blurred vision and / or photosensitivity. You may need emergency care.

See also section 4 “Possible side effects”.

Children and young people

GIOTRIF has not been studied in children or adolescents. Do not give this medicine to children or adolescents under 18 years of age.

Other medicines and GIOTRIF

Tell your doctor or pharmacist if you have recently taken or might take any other medicines. This also applies to herbal medicines and over-the-counter medicines.

The following medicines may increase the blood level of GIOTRIF and thus increase the risk of side effects if taken before the GIOTRIF tablet. These medicines should therefore be taken as far away as possible in time from GIOTRIF. This preferably means 6 hours (for medicines taken twice daily) or 12 hours (for medicines taken once daily) before or after GIOTRIF:

  • Ritonavir, ketoconazole (excluding shampoo ), itraconazole, erythromycin, nelfinavir, saquvinavir, all of which are used to treat different types of infections .
  • Verapamil, quinidine , amiodarone used to treat heart disease.
  • Ciclosporin A, tacrolimus, a medicine that affects your immune system.

The following medicines may reduce the effect of GIOTRIF:

  • Carbamazepine, phenytoin , phenobarbital, used in the treatment of seizures.
  • St. John’s wort ( Hypericum perforatum ), an herbal remedy for treating mild depression and mild anxiety.
  • Rifampicin, an antibiotic used to treat tuberculosis .

Talk to your doctor if you are unsure when to take these medicines.

GIOTRIF in turn can increase blood levels of other medicines, such as:

  • Sulfasalazine used to treat inflammation / infection.
  • Rosuvastatin is used to lower cholesterol levels .

Talk to your doctor before taking these medicines with GIOTRIF.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Avoid getting pregnant during your treatment with this medicine. If you could become pregnant, use reliable contraception during treatment, and for at least 1 month after taking the last dose of one of GIOTRIF. This is because there may be a risk that an unborn baby may be harmed by the medicine.

If you become pregnant during your treatment with this medicine, tell your doctor immediately. Your doctor will decide whether or not to continue treatment.

If you are planning to become pregnant after taking the last dose of one of these medicines, you should consult a doctor as your body may still contain some of the medicine.

Breast-feeding

Do not breastfeed if you are being treated with this medicine as the risk to the newborn cannot be ruled out.

Driving and using machines

If you experience side effects that affect your vision ( redness and/or irritation in the eye, dry eyes, increased tear flow, photosensitivity) or that affect your concentration and ability to react, you should not drive or use machines before the side effect disappears (see section 4. side effect ar).

GIOTRIF contains lactose

This medicine contains a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use GIOTRIF

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

The recommended dose is 40 mg every day.

Your doctor may need to adjust the dose one (increase or decrease) depending on how well you tolerate this medicine.

When to take GIOTRIF

  • It is important to take this medicine without food
  • Take this medicine at least 1 hour before meals, or
  • If you have already eaten, wait at least 3 hours before taking this medicine.
  • Take this medicine once a day at about the same time each day. This makes it easier to remember to take the medicine.
  • The tablet should not be broken, chewed or crushed.
  • Swallow the tablet whole with a glass of water (not carbonated).

GIOTRIF should be taken by mouth. If you have problems swallowing the tablet, you can dissolve it in a glass of water (not carbonated). Do not use any other liquid. Drop the tablet into the water without crushing it, stirring occasionally until the tablet has dissolved into very small particles, it may take up to 15 minutes. Drink the liquid immediately. To be sure that you have ingested all the medicine, refill the glass with water and drink from it.

If you are unable to swallow and have a gastric tube, your doctor may suggest that you receive the medicine through the tube.

If you use more GIOTRIF than you should 

Contact your doctor or pharmacist immediately. You may experience increased side effects and your doctor may need to stop your treatment and give you care.

If you forget to use GIOTRIF

  • If there are more than 8 hours left until the next scheduled dose , take the missed dose as soon as you remember.
  • If there are less than 8 hours left until the next scheduled dose , skip the missed dose . Then take the next dose at the usual time. Then continue to take your tablets regularly as usual.

Do not take a double dose (two tablets at the same time instead of one) to make up for a forgotten dose.

If you stop using GIOTRIF

Do not stop using this medicine without first consulting a doctor. It is important to continue taking this medicine every day for as long as your doctor prescribes it for you. If you do not take this medicine as your doctor advised, your cancer may start to grow again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, GIOTRIF can cause side effects, although not everybody gets them.

Contact your doctor immediately if you get any of the following serious side effects. In some cases, your doctor may need to stop your treatment and reduce your dose or stop the treatment:

  • Diarrhea (very common side effect , may affect more than 1 in 10 people).Diarrhea lasting more than 2 days or severe diarrhea can lead to dehydration (common side effect , may affect up to 1 in 10 people), low levels of potassium in the blood (common) and impaired kidney function (common). Diarrhea can be treated. At the first sign of diarrhea: drink plenty of fluids, contact a doctor immediately and start treatment with a suitable medicine that counteracts diarrhea as soon as possible. You must have access to medicines that prevent diarrhea before using GIOTRIF.
  • Skin rash (very common).It is important to treat skin rashes early. Contact a doctor if you get a rash. If the treatment for the rash does not work or if the rash becomes severe (eg blisters and flaking of the skin), you should contact your doctor immediately, as your doctor may need to end your treatment with GIOTRIF. Skin rashes may occur or worsen in areas exposed to the sun. Protective clothing and the use of sunscreen are recommended.
  • Inflammation of the lungs (uncommon side effect , may affect up to 1 in 100 people) called “interstitial lung disease”.Contact your doctor immediately if you experience shortness of breath, or sudden worsening of shortness of breath, possibly also with a cough or fever.
  • Eye irritation or inflammationIrritation or inflammation of the eye may occur (conjunctivitis / dry eyes is common and keratitis ( corneal inflammation ) is uncommon). Contact a doctor if you develop acute or worsening eye problems such as pain or redness in the eye or dry eyes.

Contact your doctor as soon as possible if you experience any of the side effects listed above.

The following side effects have also been reported:

Very common side effects is (can occur in more than 1 in 10):

  • Sores and inflammation in the mouth
  • Nail infection
  • Loss of appetite
  • Nasal blood
  • Nausea
  • Vomiting
  • Itching
  • Dry skin

Common side effects are (may affect up to 1 in 10):

  • Pain, redness , swelling or flaking of the skin on the hands or feet
  • Increased level of liver enzymes ( aspartate aminotransferase and alanine aminotransferase ) in blood samples.
  • Inflammation of the bladder wall with a burning sensation when urinating and urgent need to urinate frequently ( cystitis , cystitis )
  • Abnormal taste experience ( dysgeusia )
  • Stomach pain, stomach upset, heartburn
  • Inflammation of the lips
  • Weight loss
  • Runny nose
  • Muscle spasms
  • Fever
  • Nail problem

Less common side effects are (may affect up to 1 in 100):

  • Inflammation of the pancreas ( pancreatitis )
  • Occurrence of a rupture in the stomach or intestinal wall ( gastrointestinal perforation )

Rare side effects are (may affect up to 1 in 1000):

  • Severe blistering or flaking of skin (may indicate Stevens-Johnson syndrome and toxic epidermal necrolysis )

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store GIOTRIF

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, sachet, and blister after EXP. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

20 mg

  • The active substance is afatinib. Each film-coated tablet contains 20 mg of afatinib (as dimaleate).
  • The other ingredients are lactose monohydrate , microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400, titanium dioxide (E171), talc (E553bat), polysor .

30 mg, 40 mg, 50 mg

  • The active substance is afatinib. Each film-coated tablet contains 30 mg, 40 mg or 50 mg of afatinib (as dimaleate).
  • The other ingredients are lactose monohydrate , microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400, titanium dioxide (E171), talc (E553bat), polysor , indigo carmine (E132) aluminum lacquer.

What the medicine looks like and contents of the pack

GIOTRIF 20 mg film-coated tablets are off-white and round. They are embossed with the code “T20” on one side and the Boehringer Ingelheim company symbol on the other side.

GIOTRIF 30 mg film-coated tablets are dark blue and round. They are embossed with the code “T30” on one side and the Boehringer Ingelheim company symbol on the other side

GIOTRIF 40 mg film-coated tablets are light blue and round. They are embossed with the code “T40” on one side and the Boehringer Ingelheim company symbol on the other side.

GIOTRIF 50 mg film-coated tablets are dark blue and oval. They are embossed with the code “T50” on one side and the Boehringer Ingelheim company symbol on the other side.

GIOTRIF film-coated tablets are supplied in packs containing 1, 2, or 4 perforated unit dose blisters. Each blister contains 7 x 1 film-coated tablets and is packaged in an aluminum bag along with a bag of desiccant that should not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

Boehringer Ingelheim France

100-104 Avenue de France

75013 Paris

France

Muhammad Nadeem

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