Lytgobi 4 mg comprimidos recubiertos con pelicula

Prospect: information for the patient

Lytgobi 4 mg film-coated tablets

futibatinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Lytgobi contains the active ingredient futibatinib, which belongs to a group of cancer medications called tyrosine kinase inhibitors. It blocks the action of a cell protein called the fibroblast growth factor receptor (FGFR), which helps regulate cell growth. Cancer cells may have an abnormal form of this protein.

By blocking the FGFR, futibatinib may prevent the growth of cancer cells.

Lytgobi is used alone (in monotherapy) to treat adults with bile duct cancer (also known as cholangiocarcinoma) that has spread or cannot be removed by surgery in patients who have already received previous treatment, and whose tumor has a specific type of "FGFR" anomaly.

Do not take Lytgobiif you are allergic to futibatinib or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lytgobi if:

• you have been told that you have high levels of phosphate in your blood (a condition known as hyperphosphatemia) according to the result of a blood test
• you have visual or eye problems, such as problems in the retina (layers of sensitive nerve tissue located at the back of the eye)

It is recommended to perform eye examinations:

• before starting treatment with Lytgobi
• 6 weeks later or at any time if visual or eye problems occur.

Lytgobi may cause serous retinal detachment (the retina detaches from its normal position). Symptoms include blurry vision, flashes of light in the field of vision (photopsia) and small dark shapes moving in the field of vision (floaters). Inform your doctor immediately if you experience any vision problems.

Lytgobi may cause high levels of phosphate in the blood and lead to the accumulation of minerals such as calcium in different tissues of the body. Your doctor may prescribe changes in diet, a phosphate-reducing treatment or a change or discontinuation of Lytgobi treatment as needed. Inform your doctor immediately if you experience painful skin lesions, any muscle cramps, numbness or tingling around the mouth or abnormal heart rhythm.

Lytgobi may harm the fetus during pregnancy. If you are fertile or your partner may have children, you must use an effective contraceptive during treatment and for 1 week after the last dose of Lytgobi. It is unknown whether Lytgobi reduces the effectiveness of contraceptive medications, and therefore barrier methods should be applied in addition to these medications to prevent pregnancy.

Children and adolescents

Lytgobi should not be administered to children or adolescents under 18 years of age. It is not known if it is safe and effective in this age group.

Other medications and Lytgobi

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication,

Particularly, you must inform your doctor if you are taking any of the following medications so that your doctor can decide if your treatment needs to be changed:

• itraconazole: a medication to treat fungal infections.
• clarithromycin: a medication to treat some infections
• rifampicin: a medication to treat tuberculosis and other infections.
• carbamazepine, phenytoin, phenobarbital: medications to treat epilepsy.
• efavirenz: a medication to treat HIV infection.
• digoxin: a medication to treat heart conditions.
• dabigatran: a medication to prevent blood clot formation.
• colchicine: a medication to treat gout attacks.
• rosuvastatin: a medication to treat high cholesterol.
• theophylline:a medication to treat respiratory problems.
• olanzapine:a medication to control symptoms of mental disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

• Pregnancy/Contraception - information for women

You should not become pregnant during treatment with Lytgobi because this medication may harm the fetus. You should have a pregnancy test before starting treatment, and women who may become pregnant should use effective contraceptive methods during treatment and for 1 week after the last dose of Lytgobi. Barrier methods should be applied as a second form of contraception to prevent pregnancy. Talk to your doctor about the most suitable contraceptive for you.

• Contraception - information for men

You should not father a child during treatment with Lytgobi because this medication may harm the fetus. You should use an effective contraceptive during treatment and for 1 week after the last dose of Lytgobi.

• Breastfeeding

Do not breastfeed during treatment with Lytgobi and for 1 week after the last dose. This is because it is unknown whether Lytgobi can pass into breast milk and, therefore, may harm the baby.

Driving and operating machinery

Lytgobi may cause side effects such as fatigue or visual disturbances. Do not drive or operate machinery if this happens.

Lytgobi contains lactose and sodium

This medication contains lactose (found in milk or dairy products). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

Lytgobi treatment should be initiated by an experienced doctor in the diagnosis and treatment of bile duct cancer. Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is

5 Lytgobi 4 mg tablets (20 mg of futibatinib in total) taken orally once a day. Your doctor will adjust the dose or discontinue treatment as necessary.

Administration Form

Swallow the tablet whole with a glass of water at the same time every day. Lytgobi can be taken with food or between meals. The tablets should be swallowed whole to ensure the complete dose is taken.

Treatment Duration

Take Lytgobi for the time indicated by your doctor.

If you take more Lytgobi than you should

Inform your doctor immediately if you have taken more Lytgobi than you should have.

If you forget to take Lytgobi

• If you forget to take a dose of Lytgobi within 12 hours or less, take the missed dose as soon as you remember.
• If you forget to take a dose of Lytgobi more than 12 hours, skip the missed dose. Take the next dose at the usual time.
• Do not take a double dose of Lytgobi if you experience vomiting. Take the next dose at the scheduled time.
• Do not take a double dose to compensate for missed doses.

If you discontinue treatment with Lytgobi

Do not stop taking Lytgobi without consulting your doctor, as discontinuation may reduce the effectiveness of treatment.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediatelyifyou experience any of the serious side effects listed below. The side effects listed below are frequent (can affect up to 1 in 10 people).

• Migraine
• Intestinal obstruction

Other side effects

Consult your doctor if you experience any other side effect. These may occur with the following frequencies:

Very frequent(can affect more than 1 in 10 people)

• High or low phosphate concentrations observed in blood tests
• Low sodium concentrations observed in blood tests
• Nail separation from the nail bed, poor nail formation, change in nail color
• Constipation
• Diarrhea
• Dry mouth
• Vomiting
• Abdominal pain
• Hair loss (alopecia)
• Feeling of fatigue or weakness
• Dry skin
• High levels of liver enzymes observed in blood tests
• Nausea
• Inflammation of the mouth lining (stomatitis)
• Loss of appetite
• Dry eyes
• Redness, swelling, peeling, or pain on palpation, mainly in the hands or feet (hand-foot syndrome)
• Alterations in taste
• Muscle pain
• Joint pain

Frequent(can affect up to 1 in 10 people)

• Eye problems, such as eye inflammation or corneal inflammation (front part of the eye), blurred vision, sudden appearance of small dark shapes moving in the visual field (floaters), and flashes of light in the visual field (photopsia).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Lytgobi Composition

• The active ingredient is futibatinib.

Each film-coated tablet contains 4 mg of futibatinib.

• The other components are:

Core of the tablet: maize starch, crospovidone, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate (see section 2, “Lytgobi contains lactose and sodium”)

Film coating: hypromellose, macrogol, and titanium dioxide

Binder: magnesium stearate

Appearance of Lytgobi and contents of the package

Lytgobi 4 mg is presented as round, white, film-coated tablets, engraved with relief on one face with "4MG" and "FBN" on the other face.

Lytgobi tablets are presented in blisters in a sealed carton that contains treatment for 7 days, as follows:

• Daily dose of 20 mg: each carton contains 35 tablets (5 tablets once a day).
• Daily dose of 16 mg: each carton contains 28 tablets (4 tablets once a day).
• Daily dose of 12 mg: each carton contains 21 tablets (3 tablets once a day).

Marketing Authorization Holder

Taiho Pharma Netherlands B.V.

Barbara Strozzilaan 201

1083HN Amsterdam

Netherlands

Responsible Person

PCI Pharma Services (Millmount Healthcare Limited)

Block 7, City North Business Campus

Stamullen, Co. Meath, K32 YD60

Ireland

Last update of this leaflet: {MM/AAAA}

This medicine has been authorized under a «conditional approval».

This type of approval means that more information is expected to be obtained about this medicine. The European Medicines Agency will review the new information about this medicine at least once a year and this leaflet will be updated as necessary.

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.

This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.