Finlee 10 mg dispersible tablets

Patient Leaflet: Information for the User

Introduction

Patient Information Leaflet

Finlee 10 mg dispersible tablets

dabrafenib

Read the entire leaflet carefully before your child starts taking this medicine, because it contains important information.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for your child. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences any adverse effects, consult your doctor, pharmacist, or nurse, even if these are effects not listed in this leaflet. See section 4.
• The information in this leaflet is intended for you or your child, but throughout the leaflet it will refer to "your child".

Leaflet Contents

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

1. What Finlee is and what it is used for

Finlee is a medicine that contains the active substance dabrafenib.

It is used in combination with another medicine (trametinib oral solution) in children from 1 year of age to treat a type of brain tumour called glioma.

Finlee may be used in patients with:

• low-grade glioma
• high-grade glioma when the patient has received at least one course of radiation and/or chemotherapy.

Finlee is used to treat patients whose brain tumour has a specific mutation (change) in a gene called BRAF. This mutation causes the body to produce defective proteins, which in turn may lead to tumour development. Your doctor will assess for this mutation before starting treatment.

In combination with trametinib, Finlee targets these defective proteins and slows down or stops tumour progression. Also read the trametinib oral solution package leaflet.

2. What you need to know before starting Finlee

Do not give Finlee

• if your child is allergic to dabrafenib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to the doctor before starting Finlee. The doctor needs to know if your child:

• has eye problems, such as blockage of the veins supplying the eye (retinal vein occlusion) or swelling of the eye that may be due to fluid buildup (chorioretinopathy).
• has heart problems such as heart failure or issues with the way the heart beats.
• has or has ever had kidney problems.
• has or has ever had any liver problems.
• has or has ever had lung or breathing problems, such as difficulty breathing frequently accompanied by dry cough, shortness of breath, and fatigue.
• has or has ever had gastrointestinal problems such as diverticulitis (inflamed pouches in the colon) or metastases in the gastrointestinal tract.

Before your child starts taking Finlee, and during and after treatment, the doctor will perform checks to prevent complications.

Skin examination

Finlee may cause skin cancer. In general, these skin changes remain localized and can be removed surgically, and treatment with Finlee can continue uninterrupted. The doctor may examine your child’s skin before and regularly during treatment.

Check your child’s skin monthly during treatment and for 6 months after stopping this medicine. Tell the doctor as soon as possible if you notice any changes in your child’s skin such as a new wart, skin sore, or a red bump that bleeds or does not heal, or any change in the size or color of a mole.

Tumour lysis syndrome

If your child experiences the following symptoms, tell the doctor immediately, as this may be a potentially life-threatening condition: nausea, difficulty breathing, irregular heartbeat, muscle cramps, seizures, cloudy urine, reduced urine output, and fatigue. These may be caused by a group of metabolic complications that can occur during cancer treatment, due to the breakdown products of dying cancer cells (tumour lysis syndrome or TLS), and may lead to changes in kidney function (see also section 4).

Children under 1 year of age

The effects of Finlee in children under 1 year of age are unknown. Therefore, Finlee is not recommended for this age group.

Patients over 18 years of age

Information on treatment in patients over 18 years of age with glioma is limited; therefore, the doctor must evaluate continuation of treatment into adulthood.

Other medicines and Finlee

Before starting treatment, tell the doctor, pharmacist, or nurse if your child is taking, has recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription.

Some medicines may affect how Finlee works, or make it more likely that your child will have side effects. Finlee may also affect how other medicines work. These include:

• medicines used for birth control (contraceptives) containing hormones, such as the pill, injections, or patches
• medicines used to thin the blood, such as warfarin and acenocoumarol
• medicines used to treat heart conditions, such as digoxin
• medicines used to treat fungal infections, such as itraconazole, voriconazole, and posaconazole
• medicines used to treat Cushing's disease, such as ketoconazole
• certain medicines called calcium channel blockers used to treat high blood pressure, such as diltiazem, felodipine, nicardipine, nifedipine, or verapamil
• medicines used to treat cancer, such as cabazitaxel
• certain medicines used to lower fat (lipids) in the blood, such as gemfibrozil
• certain medicines used to treat psychiatric conditions, such as haloperidol
• certain medicines called antibiotics, such as clarithromycin, doxycycline, and telithromycin
• certain medicines used to treat tuberculosis, such as rifampicin
• certain medicines used to lower cholesterol levels, such as atorvastatin and simvastatin
• certain medicines called immunosuppressants, such as cyclosporine, tacrolimus, and sirolimus
• certain medicines called anti-inflammatory agents, such as dexamethasone and methylprednisolone
• certain medicines used to treat HIV, such as ritonavir, amprenavir, indinavir, darunavir, delavirdine, efavirenz, fosamprenavir, lopinavir, nelfinavir, tipranavir, saquinavir, and atazanavir
• certain medicines used to help sleep, such as diazepam, midazolam, zolpidem
• certain medicines used for pain relief, such as fentanyl or methadone
• medicines used to treat seizures (epileptic fits), such as phenytoin, phenobarbital, primidone, valproic acid, or carbamazepine
• medicines called antidepressants such as nefazodone and St John's wort (Hypericum perforatum).

Talk to the doctor, pharmacist, or nurse if your child is taking any of these medicines (or if you are unsure). The doctor may consider adjusting the dose.

Pregnancy, breastfeeding and fertility

Pregnancy

• If your daughter is pregnant or thinks she might be pregnant, consult the doctor or nurse before using this medicine. Finlee could possibly harm the unborn baby.
• If your daughter becomes pregnant while taking this medicine, consult the doctor immediately.

Breastfeeding

It is not known whether Finlee passes into breast milk. If your daughter is breastfeeding or planning to breastfeed, she must inform the doctor. You, your daughter, and the doctor will decide whether to take Finlee or breastfeed.

Fertility

Finlee may reduce sperm count and it may not return to normal until after stopping treatment with Finlee.

Taking Finlee with trametinib oral solution: Trametinib may affect fertility in both males and females.

Before starting treatment with Finlee, talk to the doctor about options to improve the chances of your child being able to have children in the future.

Contraception

• If your daughter could become pregnant, she must use a reliable method of birth control (contraception) while taking Finlee in combination with trametinib oral solution and for at least 16 weeks after the last dose of Finlee and trametinib.
• Hormonal contraceptive methods (such as the pill, injections, or patches) may not be as effective when taking Finlee in combination with trametinib oral solution. Therefore, while taking this combination of medicines, another effective method of contraception must be used to prevent pregnancy. Consult the doctor or nurse.

Driving and using machines

Finlee may cause side effects that could affect your child’s ability to drive, ride a bicycle/motorcycle, use machines, or participate in other activities requiring alertness. If your child has vision problems or feels tired, weak, or lacks energy, they should avoid such activities.

A description of the side effects can be found in section 4. For more information, read the entire patient information leaflet.

If you are unsure, talk to the doctor, pharmacist, or nurse. Your child’s ability to perform such activities may also be affected by their illness, symptoms, or treatment.

Finlee contains potassium

This medicine contains less than 1 mmol (39 mg) of potassium per maximum daily dose; i.e., essentially “potassium-free”.

Finlee contains benzyl alcohol

This medicine contains <0.00078 mg of benzyl alcohol in each dispersible tablet.

Benzyl alcohol may cause allergic reactions.

Consult the doctor or pharmacist if your daughter is pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your daughter’s body and cause adverse effects (metabolic acidosis).

Consult the doctor or pharmacist if your child has liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your child’s body and cause adverse effects (metabolic acidosis).

3. How to administer Finlee

Follow exactly the administration instructions for this medicine given to you by the doctor, pharmacist, or nurse. If in doubt, consult again with the doctor, pharmacist, or nurse.

Dosage

The doctor will determine the correct dose of Finlee based on your child's body weight.

The doctor will decide whether your child needs to take a lower dose depending on any adverse effects experienced.

How to administer

Read the instructions for use at the end of this leaflet for more information on how to prepare and administer the dispersible tablet solution.

• Administer Finlee twice daily. Giving Finlee at the same time every day will help you remember when to administer the medicine. Doses of Finlee should be given approximately 12 hours apart. Oral trametinib solution is taken only once daily. Administer oral trametinib either with the morning or the evening dose of Finlee.
• Administer Finlee on an empty stomach, at least 1 hour before or 2 hours after a meal, which means:
  • after taking Finlee, your child must wait at least 1 hour before eating.
  • after eating, your child must wait at least 2 hours before taking Finlee.
  • if necessary, breastfeeding and/or formula feeding may be given on demand.

If you give more Finlee than you should

If you give too much Finlee, contact the doctor, pharmacist, or nurse immediately. If possible, show them the Finlee packaging and the leaflet.

If you forget to give Finlee

If less than 6 hours have passed since the missed dose, give the dose as soon as you remember.

If 6 hours or more have passed since the missed dose, do not make up for the missed dose. Give the next dose at the usual time and then continue administering Finlee at the regular times.

Do not give a double dose to make up for missed doses.

If your child vomits after taking Finlee

If your child vomits after taking Finlee, do not give another dose until the next scheduled dose.

If you interrupt treatment with Finlee

Give Finlee for as long as the doctor has instructed. Do not stop treatment unless instructed by the doctor.

If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Stop giving this medicine and seek urgent medical attention if your child has any of the following symptoms:

• coughing up blood, blood in the urine, vomiting blood or vomit that looks like "coffee grounds", passing red stools or black, tarry stools. These may be signs of bleeding.
• fever (temperature of 38°C or higher).
• chest pain or difficulty breathing, sometimes with fever or cough. These may be signs of pneumonitis or inflamed lungs (interstitial lung disease).
• blurred vision, loss of vision, or other changes in vision. These may be signs of retinal detachment.
• redness of the eyes, eye pain, increased sensitivity to light. These may be signs of uveitis.
• unexplained muscle pain, muscle cramps or muscle weakness, dark urine. These may be signs of rhabdomyolysis.
• severe abdominal pain. This may be a sign of pancreatitis.
• fever, swollen lymph nodes, bruising, or rash occurring at the same time. These may be signs of a condition in which the immune system produces too many infection-fighting cells, which can cause various symptoms (hemophagocytic lymphohistiocytosis).
• nausea, difficulty breathing, irregular heartbeat, muscle cramps, seizures, cloudy urine, reduced urine output, and fatigue. These may be signs of a condition caused by rapid breakdown of cancer cells, which in some people can be fatal (tumor lysis syndrome or TLS).
• reddish spots on the trunk, circular or target-like, with or without central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These may be signs of serious skin rashes, which can be life-threatening and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), widespread rash, fever, and enlarged lymph nodes (DRESS).

Other possible adverse effects

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

• Headache
• Dizziness
• Cough
• Diarrhea, feeling unwell (nausea), discomfort (vomiting), constipation, stomach pain
• Skin problems such as rash, acne-like rash, dry or itchy skin, skin redness
• Wart-like growths (cutaneous papilloma)
• Skin infection under the nails
• Pain in arms, legs, or joints
• Lack of energy or feeling weak or tired
• Weight gain
• Upper respiratory tract infections with symptoms such as sore throat and nasal congestion (nasopharyngitis)
• Increased liver enzymes in blood tests
• Low levels of white blood cells (neutropenia, leucopenia)
• Low levels of red blood cells (anemia)

Common (may affect up to 1 in 10 people)

• Frequent urination with pain or burning sensation (urinary tract infection)
• Skin effects including skin infection (cellulitis), inflammation of hair follicles in the skin, inflamed and peeling skin (generalized exfoliative dermatitis), thickening of the outer layer of skin (hyperkeratosis)
• Decreased appetite
• Low blood pressure (hypotension)
• High blood pressure (hypertension)
• Shortness of breath
• Mouth ulcers or mouth pain, mucosal inflammation
• Inflammation of the fatty layer under the skin (panniculitis)
• Unusual hair loss or thinning hair
• Redness, pain in hands and feet (hand-foot syndrome)
• Muscle spasms
• Chills
• Allergic reaction (hypersensitivity)
• Dehydration
• Vision problems including blurred vision
• Slowed heart rate (bradycardia)
• Fatigue, discomfort in the chest, dizziness, palpitations (reduced ejection fraction)
• Swelling of tissues (edema)
• Muscle pain (myalgia)
• Fatigue, chills, sore throat, joint or muscle pain (flu-like illness)
• Abnormal test results related to creatine phosphokinase, an enzyme found mainly in the heart, brain, and skeletal muscle
• Increased blood sugar levels
• Low levels of sodium or phosphate in blood
• Decreased platelet count in blood (cells that help blood to clot)
• Increased sensitivity of the skin to sunlight

Uncommon (may affect up to 1 in 100 people)

• Irregular heartbeat (atrioventricular block)
• Inflammation of the intestines (colitis)
• Cracked skin
• Night sweats
• Excessive sweating
• Raised, painful, red to dark purple skin spots or sores appearing mainly on arms, legs, face, and neck, with fever (signs of acute febrile neutrophilic dermatosis)

In addition to the adverse effects described above, the following adverse effects have so far only been reported in adult patients, although they could also occur in children:

• nerve problems that may cause pain, loss of sensation, or tingling in the hands and feet and/or muscle weakness (peripheral neuropathy)
• dry mouth
• kidney failure
• benign skin tumor (acrochordon)
• inflammatory disease affecting mainly the skin, lungs, eyes, and lymph nodes (sarcoidosis)
• inflammation of the kidneys
• hole (perforation) in the stomach or intestines
• inflammation of the heart muscle that may cause difficulty breathing, fever, palpitations, and chest pain
• skin reactions localized at tattoos
• worsening of adverse effects due to radiation

Reporting of adverse effects

If your child experiences any type of adverse effect, consult a doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Finlee

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

Do not use this medicine after the expiry date stated on the label of the bottle and on the outer packaging, after EXP. The expiry date refers to the last day of the month indicated.

Administer the solution no later than 30 minutes after the tablets have dissolved.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Finlee

• The active substance is dabrafenib. Each dispersible tablet contains dabrafenib mesilate equivalent to 10 mg of dabrafenib.
• The other components are: mannitol (E 421), microcrystalline cellulose (E 460), crospovidone (E 1202), hypromellose (E 464), potassium acesulfame (E 950) (see section 2), magnesium stearate (E 470b), artificial berry flavour (maltodextrin, propylene glycol [E 1520], artificial flavours, triethyl citrate [E 1505], benzyl alcohol [E 1519] [see section 2]) and colloidal anhydrous silica (E 551).

Description of the product and contents of the container

Finlee 10 mg dispersible tablets are white to slightly yellow, round, 6 mm in diameter, marked with a "D" on one side and "NVR" on the other.

The bottles are made of white plastic with screw caps made of plastic.

The bottles also contain a cylindrical silica gel desiccant container. These desiccants must be left inside the bottle and must not be ingested.

Finlee 10 mg dispersible tablets are available in packages containing 1 or 2 bottles (210 or 420 dispersible tablets) and 2 dosing cups.

Marketing Authorization Holder

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526, Ljubljana
Slovenia

Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57
1000, Ljubljana
Slovenia

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes 764
08013 Barcelona
Spain

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

DIRECTIONS FOR USE