LYTGOBI 4 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lytgobi 4 mg Film-Coated Tablets

futibatinib

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Lytgobi and what is it used for
2. What you need to know before you take Lytgobi
3. How to take Lytgobi
4. Possible side effects
5. Storage of Lytgobi
6. Contents of the pack and other information

1. What is Lytgobi and what is it used for

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

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

Lytgobi is used alone (as monotherapy) to treat adults with cancer of the bile ducts (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 abnormal "FGFR".

2. What you need to know before you take Lytgobi

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking Lytgobi if:

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

Eye examinations are recommended:

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

Lytgobi may cause serous retinal detachment (the retina moves out of its normal position). Symptoms include blurred vision, flashes of light in the field of vision (photopsia), and small dark shapes moving in the field of vision (floaters). Tell your doctor immediately if you have 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, phosphate-reducing treatment, or a change or discontinuation of treatment with Lytgobi if necessary. Tell your doctor immediately if you experience painful skin lesions, any muscle cramp, numbness or tingling around the mouth, or an abnormal heartbeat.

Lytgobi may harm the unborn baby. If you are a woman of childbearing potential or your partner may have children, you must use effective contraception during treatment and up to 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.

• Pregnancy/Contraception - Information for Women

You must not become pregnant during treatment with Lytgobi because this medicine may harm the baby. A pregnancy test must be performed before starting treatment, and women who may become pregnant must use effective contraceptive methods during treatment and up to 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 must not father a child during treatment with Lytgobi because this medicine may harm the baby. You must use effective contraception during treatment and up to 1 week after the last dose of Lytgobi.

• Breast-feeding

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

Driving and using machines

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

Lytgobi contains lactose and sodium

This medicine contains lactose (found in milk or milk products). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Lytgobi

Treatment with Lytgobi should be initiated by a doctor with experience in the diagnosis and treatment of bile duct cancer. Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is

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

Method of administration

Swallow the tablet whole with a glass of water at the same time each day. Lytgobi can be taken with or without food. The tablets should be swallowed whole to ensure that the full dose is taken.

Duration of treatment

Take Lytgobi for the duration indicated by your doctor.

If you take more Lytgobi than you should

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

If you forget to take Lytgobi

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

If you stop taking Lytgobi

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

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

4. Possible side effects

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

Tell your doctor immediatelyif you experience any of the following serious side effects. The following side effects are common (may affect up to 1 in 10 people).

• Migraine
• Intestinal obstruction

Other side effects

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

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

• high or low phosphate levels observed in blood tests
• low sodium levels observed in blood tests
• separation of the nails from the nail bed, poor nail formation, change in nail color
• constipation
• diarrhea
• dry mouth
• vomiting
• abdominal pain
• hair loss (alopecia)
• feeling of tiredness or weakness
• dry skin
• high levels of liver enzymes observed in blood tests
• nausea
• inflammation of the lining of the mouth (stomatitis)
• decreased appetite
• dry eye
• redness, swelling, scaling, or pain on palpation, mainly on the hands or feet (palmar-plantar erythrodysesthesia syndrome)
• taste disturbances
• muscle pain
• joint pain

Common(may affect up to 1 in 10 people)

• Eye problems, such as inflammation of the eyes or cornea (the 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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lytgobi

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 and blister after "EXP". The expiry date refers to the last day of the month shown.

No special storage conditions are required.

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 protect the environment.

6. Contents of the pack and other information

Composition of Lytgobi

• The active substance is futibatinib.

Each film-coated tablet contains 4 mg of futibatinib.

• The other ingredients are:

Tablet core: corn 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

Binding agent: magnesium stearate

Appearance of Lytgobi and pack contents

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

Lytgobi tablets are presented in blisters in a sealed carton containing 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 authorisation holder

Taiho Pharma Netherlands B.V.

Barbara Strozzilaan 201

1083HN Amsterdam

Netherlands

Manufacturer

PCI Pharma Services (Millmount Healthcare Limited)

Block 7, City North Business Campus

Stamullen, Co. Meath, K32 YD60

Ireland

Date of last revision of this leaflet: {MM/YYYY}

This medicine has been authorised with a "conditional approval".

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

Other sources of information

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

The leaflet for this medicine can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.