Lytgobi

Package leaflet: Information for the patient

Lytgobi 4 mg film-coated tablets

futibatinib
▼This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Lytgobi is and what it is used for

Lytgobi contains the active substance futibatinib, which belongs to a group of anticancer medicines called tyrosine kinase inhibitors. It blocks the action of a protein in the cell called fibroblast growth factor receptor (FGFR), which helps regulate cell growth. Cancer cells may have an abnormal form of this protein. By blocking FGFR, futibatinib is able to prevent the growth of these tumor cells.
Lytgobi is used alone (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 prior treatment and whose tumor has a specific type of abnormal "FGFR".

2. What you should know before taking Lytgobi

Do not take Lytgobi if you are allergic to futibatinib or to any of the other ingredients of this
medicinal product (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Lytgobi if:

• You have been told that you have high levels of phosphate in your blood (a condition known as hyperphosphataemia), based on blood test results
• You have vision or eye problems, such as issues with the retina (layers of nerve tissue at the back of the eye that are sensitive to light)

Ophthalmological examinations are recommended:

• Before starting treatment with Lytgobi
• 6 weeks after starting treatment, or at any time if you experience vision or eye problems.

Lytgobi may cause severe retinal detachment (the retina pulls away from its normal position).
Symptoms include blurred vision, flashes of light in the visual field (photopsia), and small dark spots moving across the visual field (floaters). Inform your doctor immediately if you
experience any visual symptoms.
Lytgobi may increase phosphate levels in the blood and may lead to accumulation of minerals, including calcium, in various body tissues. Your doctor may adjust your diet, prescribe phosphate-lowering therapy, or modify or discontinue treatment with Lytgobi, if necessary. Inform your doctor immediately if you experience painful skin lesions, muscle cramps, numbness or tingling around the mouth, or irregular heartbeat.
Lytgobi may harm an unborn child. If you are a woman of childbearing potential, or if your partner is of reproductive age, you must use an effective method of contraception during treatment and for at least 1 week after the last dose of Lytgobi. Since it is not known whether Lytgobi reduces the effectiveness of contraceptive medication, barrier methods must be used in addition to such medication to prevent pregnancy.
Children and adolescents
Lytgobi must not be administered to children or adolescents under 18 years of age. Its efficacy and safety have not been established in this age group.
Other medicines and Lytgobi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking any of the following medicines, inform your doctor so that they can decide whether your treatment needs to be adjusted:

• Itraconazole: a medicine used to treat fungal infections
• Clarithromycin: medicines used to treat certain infections
• Rifampicin: a medicine used to treat tuberculosis or certain other infections
• Carbamazepine, phenytoin, phenobarbital: medicines used to treat epilepsy
• Efavirenz: a medicine used to treat HIV infection
• Digoxin: a medicine used to treat heart conditions
• Dabigatran: a medicine used to prevent blood clots
• Colchicine: a medicine used to treat gout attacks
• Rosuvastatin: a medicine used to treat high cholesterol
• Theophylline: a medicine used to treat respiratory problems
• Olanzapine: a medicine used to manage symptoms of mental health disorders

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy/Contraception – information for women
You must not become pregnant during treatment with Lytgobi, as this medicine may harm the unborn child. A pregnancy test must be performed before starting treatment, and women who are able to become pregnant must use an effective method of contraception during treatment and for 1 week after the last dose of Lytgobi. To prevent pregnancy, barrier methods should be used as a second method of contraception.
Discuss with your doctor which contraceptive method is most suitable for you.
Contraception – information for men
You must not father a child during treatment with Lytgobi, as this medicine may harm the unborn child. You must use an effective method of contraception during treatment and for at least 1 week after the last dose of Lytgobi.
Breastfeeding
Do not breastfeed during treatment with Lytgobi and for at least 1 week after the last dose. This is because it is not known whether Lytgobi passes into breast milk and could therefore harm the infant.
Driving and using machines
Lytgobi may cause adverse effects such as fatigue or visual disturbances. If this occurs, do not drive or operate machinery.
Lytgobi contains lactose and sodium
This medicinal product contains lactose (found in human milk or dairy products). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Lytgobi

Treatment with Lytgobi must be initiated by a physician experienced in the diagnosis and treatment of bile duct cancer. Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose:
5 tablets of Lytgobi 4 mg (20 mg futibatinib in total), taken orally once daily. Your doctor may adjust the dose or interrupt treatment, if necessary.

Method of administration
Swallow the tablet whole with a glass of water, at approximately the same time each day. Lytgobi may be taken with or without food. The tablets must be swallowed whole to ensure the full dose is administered.

Duration of treatment
Take Lytgobi for as long as prescribed by your doctor.

If you take more Lytgobi than you should
If you have taken more Lytgobi than prescribed, inform your doctor immediately.

If you forget to take Lytgobi
If you miss a dose of Lytgobi by 12 hours or less, take the missed dose as soon as you remember.
If you miss a dose of Lytgobi by more than 12 hours, skip the missed dose and take the next dose at your regular scheduled time.
Do not take a double dose of Lytgobi if you vomit; take the next dose at your usual time.
Do not take a double dose to make up for a missed dose.

If you stop taking Lytgobi
Do not stop taking Lytgobi without first discussing it with your doctor, as this may reduce the effectiveness of the treatment.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the serious side effects listed below, inform your doctor immediately.
The following side effects listed below are common (may affect up to 1 in 10 people):

• Migraine
• Intestinal obstruction

Other side effects
If you experience any other side effects, consult your doctor. These may occur with the following frequencies:
Very common (may affect more than 1 in 10 people)

• High or low phosphate levels detected in blood tests
• Low sodium levels observed in blood tests
• Nails separating from the nail bed, poor nail formation, change in nail colour
• Constipation
• Diarrhoea
• Dry mouth
• Vomiting
• Abdominal pain
• Hair loss (alopecia)
• Feeling of tiredness or weakness
• Dry skin
• Elevated liver enzyme levels observed in blood tests
• Nausea
• Inflammation of the lining of the mouth (stomatitis)
• Decreased appetite
• Dry eyes
• Redness, swelling, peeling or tenderness, mainly on the hands or feet (hand-foot syndrome)
• Altered sense of taste
• Muscle pain
• Joint pain

Common (may affect up to 1 in 10 people)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lytgobi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lytgobi contains

• The active substance is futibatinib. Each film-coated tablet contains 4 mg of futibatinib.
• The other components are: Tablet core: maize starch, crospovidone, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate (see section 2, "Lytgobi contains lactose and sodium") Coating: hypromellose, macrogol, and titanium dioxide Polishing agent: magnesium stearate

Description of the appearance of Lytgobi and package contents
Lytgobi 4 mg is supplied as white, round, film-coated tablets, printed with "4MG" on one side and "FBN" on the other.
Lytgobi tablets are packaged in sealed blister packs within a folded carton providing a 7-day supply as follows:

• Dose of 20 mg daily: each carton contains 35 tablets (5 tablets once daily).
• Dose of 16 mg daily: each carton contains 28 tablets (4 tablets once daily).
• Dose of 12 mg daily: each carton contains 21 tablets (3 tablets once daily).

Marketing Authorisation Holder
Taiho Pharma Netherlands B.V.
Barbara Strozzilaan 201
1083HN Amsterdam
The Netherlands

Manufacturer
PCI Pharma Services (Millmount Healthcare Limited)
Block 7, City North Business Campus
Stamullen, Co. Meath, K32 YD60
Ireland

This medicinal product has been granted a conditional marketing authorisation.
This means that additional data on this medicinal product are required.
The European Medicines Agency will review new information on this medicinal product at least annually, and this package leaflet will be updated as necessary.

Further information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.