Vanflyta 17.7 mg film-coated tablets

Patient Information Leaflet

Introduction

Leaflet: Information for the patient

VANFLYTA 17.7 mg film-coated tablets
VANFLYTA 26.5 mg film-coated tablets
quizartinib

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet includes information on how to report side effects.

Read this entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally and must not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What VANFLYTA is and what it is used for

What VANFLYTA is

VANFLYTA contains the active substance quizartinib. It is a type of cancer medicine called a "protein kinase inhibitor". The medicine is used in combination with chemotherapy to treat adults who have acute myeloid leukaemia (AML, a type of blood cancer) with a mutation (change) in the FLT3 gene known as "FLT3-ITD". VANFLYTA may also be continued after a bone marrow transplant once patients have sufficiently recovered.

Your doctor will previously analyze your cancer cells for changes in the FLT3 gene to detect FLT3-ITD mutations and confirm that VANFLYTA is suitable for you.

How VANFLYTA works

In AML, the body produces a large number of defective white blood cells that do not mature into healthy cells. VANFLYTA works by blocking the action of certain proteins called "tyrosine kinases" in these defective cells. This slows down or stops the uncontrolled division and growth of the defective cells and helps immature cells to become normal cells.

2. What you need to know before starting VANFLYTA

Do not take VANFLYTA

• if you are allergic to quizartinib or to any of the other components of this medicine (listed in section 6). If you think you may be allergic, consult your doctor for advice;
• if you were born with a heart condition called "long QT syndrome" (abnormal electrical activity of the heart affecting rhythm);
• if you are breastfeeding (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take VANFLYTA:

• if you have or have had any heart problems, such as arrhythmia (abnormal heart rhythm), myocardial infarction (heart attack) within the previous 6 months, congestive heart failure (heart does not pump strongly enough), uncontrolled angina (chest pain), or uncontrolled hypertension (blood pressure too high);
• if you have ever been told that you have low levels of potassium or magnesium in your blood;
• if you are taking medicines that can prolong the QT interval (irregular heart rhythm; see "Other medicines and VANFLYTA");
• if you are taking strong CYP3A inhibitors (see "Other medicines and VANFLYTA");
• if you have ever had fever, cough, chest pain, shortness of breath, fatigue, or pain when urinating.

Monitoring during treatment with VANFLYTA

Blood tests

Your doctor will perform periodic blood tests during treatment with VANFLYTA to monitor your blood cells (white blood cells, red blood cells, and platelets) and electrolytes (salts such as sodium, potassium, magnesium, calcium, chloride, and bicarbonate in the blood). Your doctor will monitor your electrolytes more frequently if you develop diarrhea or vomiting.

Electrocardiogram (ECG)

Before and during treatment, your doctor will check your heart with an electrocardiogram (ECG) to ensure your heart is beating normally. ECGs will be performed weekly at the beginning and less frequently later, as determined by your doctor. Your doctor will check your heart more frequently if you are taking other medicines that prolong the QT interval (see "Other medicines and VANFLYTA").

Infections in patients over 65 years of age

Elderly patients are at higher risk of developing very serious infections compared to younger patients, especially during the initial period of treatment. If you are over 65 years old, you will be closely monitored for serious infections during induction.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as there is insufficient information on its use in this age group.

Other medicines and VANFLYTA

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines, vitamins, antacids (medicines used for heartburn and acid indigestion), and herbal supplements. This is because some medicines may affect how VANFLYTA works.

In particular, the following medicines may increase the risk of adverse effects with VANFLYTA by increasing levels of this medicine in the blood:

• certain medicines used to treat fungal infections, such as itraconazole, posaconazole, or voriconazole;
• certain antibiotics, such as clarithromycin or telithromycin;
• nefazodone, a medicine used to treat major depression.

The following medicines may reduce the effectiveness of VANFLYTA:

• certain medicines used to treat tuberculosis, such as rifampicin;
• certain medicines used to treat seizures or epilepsy, such as carbamazepine, primidone, phenobarbital, or phenytoin;
• some medicines used to treat prostate cancer, such as apalutamide and enzalutamide;
• mitotane, a medicine used to treat symptoms of adrenal gland tumors;
• bosentan, a medicine used to treat high blood pressure in the lungs (pulmonary arterial hypertension);
• St. John’s wort (Hypericum perforatum), a herbal product used for anxiety and mild depression.

Certain medicines used to treat HIV may increase the risk of adverse effects (e.g., ritonavir) or reduce the effectiveness (e.g., efavirenz or etravirine) of VANFLYTA.

Medicines that prolong the QT interval

Taking VANFLYTA together with other medicines that prolong the QT interval may further increase the risk of QT prolongation. Medicines that prolong the QT interval include antifungal azoles, ondansetron, granisetron, azithromycin, pentamidine, doxycycline, moxifloxacin, atovaquone, prochlorperazine, and tacrolimus.

Pregnancy, breastfeeding and fertility

Pregnancy

You must not take VANFLYTA during pregnancy. This is because it may harm the unborn baby. Women of childbearing potential should have a pregnancy test within 7 days before taking this medicine.

Women must use effective contraception during treatment with VANFLYTA and for at least 7 months after stopping treatment. Men must use effective contraception during treatment with VANFLYTA and for at least 4 months after stopping treatment.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

Breastfeeding

Do not breastfeed during treatment with VANFLYTA and for at least 5 weeks after stopping treatment. This is because it is unknown whether VANFLYTA is excreted in breast milk (see "Do not take VANFLYTA").

If you are breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.

Fertility

VANFLYTA may reduce fertility in both men and women. You should discuss this with your doctor before starting treatment.

Driving and using machines

It is unlikely that VANFLYTA will affect your ability to drive or use machines.

3. How to take VANFLYTA

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

How much VANFLYTA to take

Your doctor or pharmacist will tell you exactly how much VANFLYTA you should take. Do not change the dose or stop taking VANFLYTA without first speaking to your doctor.

Generally, you will start by taking 35.4 mg (two 17.7 mg tablets) once daily for 2 weeks during each chemotherapy cycle. The maximum recommended dose is 53 mg once daily.

Your doctor may instruct you to start with a lower dose of one 17.7 mg tablet once daily if you are taking certain medications.

After chemotherapy is completed, your doctor may change your dose to one 26.5 mg tablet once daily for 2 weeks, and then increase your dose to 53 mg (two 26.5 mg tablets) once daily, depending on how you respond to VANFLYTA.

Your doctor may temporarily interrupt your treatment or adjust your dose based on blood tests, side effects, or other medications you may be taking.

Your doctor will stop treatment if you are undergoing a stem cell transplant. Your doctor will advise you when to stop taking the medicine and when to restart it.

Taking this medicine

• Take VANFLYTA by mouth, with or without food.
• Take VANFLYTA at approximately the same time each day. This will help you remember to take your medicine.
• If you vomit after taking the medicine, do not take another tablet until the time of your next dose.

How long to take VANFLYTA

Continue taking VANFLYTA for as long as your doctor has instructed. Your doctor will periodically monitor your disease to check that the treatment is still effective.

If you have any questions about how long you should take VANFLYTA, consult your doctor or pharmacist.

If you take more VANFLYTA than you should

If you accidentally take more tablets than you should, or if someone else accidentally takes your medicine, consult a doctor immediately or go to the hospital and take this leaflet with you. Medical treatment may be necessary.

If you forget to take VANFLYTA

If you forget to take VANFLYTA, take it as soon as possible on the same day. Take your next dose at the usual time the following day.

Do not take an extra dose (two doses on the same day) to make up for missed doses.

If you stop taking VANFLYTA

Stopping treatment with VANFLYTA may cause your condition to worsen. Do not stop taking your medicine unless your doctor tells you to.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Serious adverse effects

Inform your doctor, pharmacist, or nurse immediately if you notice any of the following serious adverse effects:

• feeling dizzy, lightheaded, or faint. These could be signs of a heart problem called “long QT interval” (abnormal electrical activity of the heart affecting the rhythm);
• fever, cough, chest pain, shortness of breath, fatigue, or pain when urinating. These could be signs of an infection or febrile neutropenia (low white blood cell count with fever).

Very common adverse effects

(may affect more than 1 in 10 people)

• increased alanine aminotransferase (abnormal liver enzyme results);
• thrombocytopenia (low platelet count in the blood);
• anemia (low red blood cell levels);
• neutropenia (low levels of neutrophils, a type of white blood cell);
• diarrhea;
• nausea (feeling sick);
• abdominal pain (stomach pain);
• headache;
• vomiting;
• edema (swelling of the face, arms, and legs);
• upper respiratory tract infections (nose and throat infections);
• decreased appetite;
• epistaxis (severe nosebleeds);
• fungal infections;
• herpes infections;
• dyspepsia (indigestion);
• bacteremia (presence of bacteria in the blood).

Common adverse effects

(may affect up to 1 in 10 people)

• pancytopenia (low levels of all types of blood cells).

Uncommon adverse effects

(may affect up to 1 in 100 people)

• cardiac arrest (heart stops beating);
• ventricular fibrillation (dangerous, irregular, and uncoordinated contractions of the lower chambers of the heart).

Reporting of adverse effects

If you experience any adverse effect, consult your 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 listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of VANFLYTA

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 the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or if there are any signs of tampering with the closure.

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

6. Contents of the pack and other information

Composition of VANFLYTA

• The active substance is quizartinib.

VANFLYTA 17.7 mg: Each film-coated tablet contains 17.7 mg of quizartinib (as dihydrochloride).

VANFLYTA 26.5 mg: Each film-coated tablet contains 26.5 mg of quizartinib (as dihydrochloride).

• The other components are:

VANFLYTA 17.7 mg:

Tablet core: hydroxypropylbetadex, microcrystalline cellulose, magnesium stearate. Coating: hypromellose, talc, triacetin, titanium dioxide.

VANFLYTA 26.5 mg:

Tablet core: hydroxypropylbetadex, microcrystalline cellulose, magnesium stearate. Coating: hypromellose, talc, triacetin, titanium dioxide.

Appearance of the product and contents of the pack

VANFLYTA 17.7 mg film-coated tablets (tablets) are white, round tablets with the imprint “DSC 511” on one side, and are available in cartons containing 14 x 1 or 28 x 1 film-coated tablets in perforated aluminum/aluminum unit dose blisters.

VANFLYTA 26.5 mg film-coated tablets (tablets) are yellow, round tablets with the imprint “DSC 512” on one side, and are available in cartons containing 14 x 1, 28 x 1 or 56 x 1 film-coated tablets in perforated aluminum/aluminum unit dose blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48

81379 Munich

Germany

Manufacturer

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

More information on this medicinal product is available upon request by contacting 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. There are also links to other websites on rare diseases and orphan medicinal products.