Erlotinib Krka

Leaflet attached to the packaging: patient information

Erlotinib Krka, 25 mg, film-coated tablets

Erlotinib Krka, 100 mg, film-coated tablets

Erlotinib Krka, 150 mg, film-coated tablets

Erlotinib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Erlotinib Krka and what is it used for
• 2. Important information before taking Erlotinib Krka
• 3. How to take Erlotinib Krka
• 4. Possible side effects
• 5. How to store Erlotinib Krka
• 6. Contents of the packaging and other information

1. What is Erlotinib Krka and what is it used for

Erlotinib Krka contains the active substance erlotinib. Erlotinib Krka is a medicine used to treat patients with cancer. The mechanism of action of the medicine involves inhibiting the activity of a protein called the epidermal growth factor receptor (EGFR). This protein is involved in the process of growth and spread of cancer cells. Erlotinib Krka is indicated for adult patients. This medicine may be prescribed to patients with advanced non-small cell lung cancer. It may be used as a first-line treatment or when the disease has not changed significantly after first-line chemotherapy, provided that the tumor cells have specific EGFR mutations. Erlotinib Krka may also be used when previous chemotherapy has not stopped the progression of the disease. This medicine may also be prescribed in combination with another medicine called gemcitabine to patients with pancreatic cancer with metastases.

2. Important information before taking Erlotinib Krka

When not to take Erlotinib Krka

• -if the patient is allergic to erlotinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• -if the patient is taking other medicines that may increase or decrease the level of erlotinib in the blood, or affect its action (e.g., antifungal medicines such as ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St. John's Wort, or proteasome inhibitors), they should consult their doctor. In some cases, these medicines may reduce the effectiveness or increase the side effects of Erlotinib Krka. In such cases, the doctor may need to modify the treatment. The doctor may advise the patient to stop taking these medicines while taking Erlotinib Krka.

if the patient is taking anticoagulant medicines (medicines that help prevent blood clots or thrombosis, e.g., warfarin), Erlotinib Krka may increase the risk of bleeding. In such cases, the patient should consult their doctor, who will need to regularly perform blood tests to monitor the patient's condition.

• -if the patient is taking statins (medicines used to lower cholesterol levels in the blood), Erlotinib Krka may increase the risk of muscle disease caused by statins, which can rarely lead to severe muscle damage (rhabdomyolysis) causing kidney damage. The patient should consult their doctor.
• -if the patient wears contact lenses and/or has previously had eye problems, such as severe dry eye, keratitis, or corneal ulcers, they should inform their doctor.

See also "Other medicines and Erlotinib Krka" below. The patient should inform their doctor:

• -if they experience sudden difficulty breathing with cough or fever, as they may need to take other medicines and stop taking Erlotinib Krka;
• -if they experience diarrhea, as they may need to take an anti-diarrheal medicine (e.g., loperamide);
• -immediately, if they experience severe or persistent diarrhea, nausea, loss of appetite, or vomiting, as they may need to stop taking Erlotinib Krka and may need to be treated in a hospital;
• -if they have ever had liver problems. Erlotinib may cause serious liver problems, and some cases may be fatal. The doctor may perform blood tests while the patient is taking this medicine to monitor liver function;
• -if they experience severe abdominal pain, increased acne, or skin peeling. They may need to temporarily stop or permanently discontinue treatment;
• -if they experience sudden or worsening eye redness and pain, increased tearing, blurred vision, and/or sensitivity to light, they should immediately inform their doctor or nurse, as they may need urgent treatment (see "Possible side effects");
• -if they are taking statins and experience muscle pain of unknown cause, tenderness, weakness, or muscle cramps. In such cases, the doctor may temporarily stop or permanently discontinue treatment.

See also section 4 "Possible side effects". Liver or kidney disease It is not known whether the action of Erlotinib Krka may be affected in patients with impaired liver or kidney function. The use of this medicine is not recommended in patients with severe liver or kidney disease. Glucuronyl transferase conjugation disorders, such as Gilbert's syndrome The doctor should exercise caution in patients with glucuronyl transferase conjugation disorders, such as those with Gilbert's syndrome. Smoking Patients taking Erlotinib Krka are advised to stop smoking, as smoking may decrease the level of the medicine in the blood.

Children and adolescents

Erlotinib Krka has not been studied in patients under 18 years of age. The use of this medicine is not recommended in children and adolescents.

Other medicines and Erlotinib Krka

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Erlotinib Krka with food and drink

Erlotinib Krka should not be taken with food. See also section 3 "How to take Erlotinib Krka".

Pregnancy and breastfeeding

Pregnancy should be avoided while taking Erlotinib Krka. Female patients who may become pregnant should use appropriate contraceptive methods during treatment and for at least 2 weeks after taking the last tablet. If a patient becomes pregnant while taking Erlotinib Krka, they should immediately inform their doctor, who will decide whether treatment can be continued. Breastfeeding should be avoided while taking Erlotinib Krka and for at least 2 weeks after taking the last tablet. In pregnancy, during breastfeeding, or if pregnancy is planned, the patient should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Erlotinib Krka has not been studied for its potential impact on the ability to drive or operate machines. It is very unlikely that this treatment will affect the ability to drive or operate machines.

Erlotinib Krka contains lactose and sodium

If the patient has been diagnosed with an intolerance to certain sugars, they should contact their doctor before taking Erlotinib Krka. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Erlotinib Krka

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The tablet should be taken at least one hour before a meal or at least two hours after a meal. The usual dose of Erlotinib Krka is 150 mg once daily for non-small cell lung cancer. For pancreatic cancer with metastases, the usual dose of Erlotinib Krka is 100 mg once daily. Erlotinib Krka is given in combination with another medicine called gemcitabine. The doctor may adjust the dose of Erlotinib Krka in increments of 50 mg. To allow for different dosing schedules, Erlotinib Krka is available in tablets of 25 mg, 100 mg, and 150 mg.

Taking a higher dose of Erlotinib Krka than recommended

The patient should immediately contact their doctor or pharmacist. The side effects may be more severe, and the doctor may stop the treatment.

Missing a dose of Erlotinib Krka

If the patient misses one or more doses of Erlotinib Krka, they should contact their doctor or pharmacist as soon as possible. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Erlotinib Krka

Erlotinib Krka should be taken daily for as long as the doctor recommends. In case of doubts about the treatment, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Erlotinib Krka can cause side effects, although not everybody gets them. If the patient experiences any of the side effects listed, they should contact their doctor as soon as possible. In some cases, the doctor may reduce the dose of Erlotinib Krka or stop the treatment:

• -Diarrhea and vomiting (very common: may affect more than 1 in 10 people). Persistent and severe diarrhea may lead to low potassium levels in the blood and kidney problems, especially if the patient is receiving other types of chemotherapy at the same time. If the patient experiences more severe or persistent diarrhea, they should immediately contact their doctor, as they may need to be treated in a hospital.
• -Eye irritation due to conjunctivitis and keratitis (very common: may affect more than 1 in 10 people), conjunctivitis, and keratitis (common: may affect up to 1 in 10 people).
• -Inflammation of the lung tissue, called interstitial lung disease (uncommon in the European population and common in the Japanese population: may affect up to 1 in 100 people in the European population and up to 1 in 10 people in the Japanese population). This disease may also be related to the natural progression of the underlying disease and in some cases may be fatal. If the patient experiences symptoms such as sudden difficulty breathing with cough or fever, they should immediately contact their doctor, as these may be signs of this disease. The doctor may decide to permanently stop Erlotinib Krka treatment.
• -Perforation of the digestive tract (uncommon: may affect up to 1 in 100 people). The patient should inform their doctor if they experience severe abdominal pain. They should also inform their doctor if they have a history of stomach ulcers or diverticulitis, as these conditions may increase the risk of perforation of the digestive tract.
• -In rare cases, liver inflammation has been observed (may affect up to 1 in 1,000 people). Symptoms may include general malaise, with or without possible jaundice (yellowing of the skin and eyes), dark urine, nausea, vomiting, and abdominal pain. In rare cases, liver failure has been observed. It can lead to death. If blood tests indicate severe changes in liver function, the doctor may advise stopping the treatment.

Very common side effects(may affect more than 1 in 10 people):

• -Rash, which may appear or worsen on skin exposed to sunlight. Patients who are exposed to sunlight may be advised to use protective clothing and/or sunscreens (e.g., containing minerals)
• -Infections
• -Loss of appetite, weight loss
• -Depression
• -Headache, numbness or tingling of the skin
• -Difficulty breathing, cough
• -Nausea
• -Mouth irritation
• -Abdominal pain, indigestion, and bloating
• -Abnormal liver blood test results
• -Itching
• -Fatigue, fever, chills

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

• -Dry skin
• -Hair loss
• -Nosebleeds
• -Gastrointestinal bleeding
• -Inflammatory reactions around the nails
• -Folliculitis
• -Acne
• -Skin cracking
• -Kidney failure (when taking Erlotinib Krka off-label in combination with chemotherapy)

Uncommon side effects(may affect up to 1 in 100 people):

• -Kidney inflammation
• -Excess protein in the urine (proteinuria)
• -Changes in eyelashes
• -Excessive hair growth on the body and face
• -Excessive skin pigmentation
• -Changes in eyebrows
• -Brittle and fragile nails

Rare side effects(may affect up to 1 in 1,000 people):

• -Redness or pain on the palms of the hands or soles of the feet (palmar-plantar erythrodysesthesia syndrome)

Very rare side effects(may affect up to 1 in 10,000 people):

• -Cases of perforation or ulceration of the cornea
• -Severe skin reactions, including Stevens-Johnson syndrome
• -Uveitis

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Erlotinib Krka

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated. The medicine should be stored in the original blister pack to protect it from moisture. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Erlotinib Krka contains

• -The active substance of the medicine is erlotinib. Erlotinib Krka, 25 mg, film-coated tablets Each film-coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Krka, 100 mg, film-coated tablets Each film-coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Krka, 150 mg, film-coated tablets Each film-coated tablet contains 150 mg of erlotinib (as erlotinib hydrochloride).
• -The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, hypromellose 240 mPas, sodium lauryl sulfate, croscarmellose sodium (type A), calcium silicate, magnesium stearate in the tablet core, and hypromellose 6 mPas, type 2910, propylene glycol, titanium dioxide (E 171), talc, iron oxide red (E 172) (only for 100 mg tablets), and iron oxide yellow (E 172) (only for 25 mg and 100 mg tablets) in the tablet coating. See section 2 "Erlotinib Krka contains lactose and sodium".

What Erlotinib Krka looks like and contents of the pack

Erlotinib Krka, 25 mg, film-coated tablets (tablets) Light yellow, round, slightly biconvex film-coated tablets with beveled edges, with "25" engraved on one side. Tablet dimensions: diameter approximately 6 mm. Erlotinib Krka, 100 mg, film-coated tablets (tablets) Light orange-pink, round, slightly biconvex film-coated tablets with beveled edges, with "100" engraved on one side. Tablet dimensions: diameter approximately 11 mm. Erlotinib Krka, 150 mg, film-coated tablets (tablets) White to almost white, round, biconvex film-coated tablets with beveled edges, with "150" engraved on one side. Tablet dimensions: diameter approximately 12 mm. Erlotinib Krka is available in blisters containing 30 film-coated tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Manufacturer: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia KRKA-FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia For more information, the patient should contact the representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Tel. 22 57 37 500 Date of last revision of the leaflet:01.08.2024