VANFLYTA 17.7 mg FILM-COATED TABLETS

2. What you need to know before you take VANFLYTA

Do not take VANFLYTA

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

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking VANFLYTA:

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

Monitoring during treatment with VANFLYTA

Blood tests

Your doctor will perform blood tests periodically during treatment with VANFLYTA to check 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 check your electrolytes more frequently if you have diarrhea or vomiting.

Electrocardiogram

Before and during treatment, your doctor will check your heart with an electrocardiogram (ECG) to make sure your heart is beating normally. ECGs will be performed weekly at the beginning and less frequently afterwards, 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

Older patients are at a higher risk of developing severe infections compared to younger patients, especially during the initial period of treatment. If you are over 65 years of age, you will be closely monitored for severe infections during induction.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age because there is not enough 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 take any other medicines, including those bought without a prescription, vitamins, antacids (medicines used for heartburn and stomach acid), and herbal supplements. This is because some medicines may affect the way VANFLYTA works.

In particular, the following medicines may increase the risk of side effects with VANFLYTA by increasing the 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 side effects (e.g., ritonavir) or reduce the effectiveness (e.g., efavirenz or etravirine) of VANFLYTA.

Medicines that prolong the QT interval

Taking VANFLYTA with other medicines that prolong the QT interval may further increase the risk of QT interval 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

Do not take VANFLYTA during pregnancy. This is because it may harm the fetus. Women of childbearing age should have a pregnancy test within 7 days before taking this medicine.

Women should use effective contraceptive methods during treatment with VANFLYTA and for at least 7 months after finishing treatment. Men should use effective contraceptive methods during treatment with VANFLYTA and for at least 4 months after finishing 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 finishing 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 men and women. You should discuss this with your doctor before starting treatment.

Driving and using machines

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

3. How to take VANFLYTA

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much VANFLYTA to take

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

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

Your doctor may tell you to start with a lower dose of one 17.7 mg tablet once a day if you are taking certain medicines.

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

Your doctor may temporarily stop your treatment or change your dose based on blood tests, side effects, or other medicines you may be taking.

Your doctor will stop treatment if you are going to have a stem cell transplant. Your doctor will tell 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 about the same time each day. This will help you remember to take your medicine.
• If you vomit after taking the medicine, do not take more tablets until the next scheduled dose.

How long to take VANFLYTA

Keep taking VANFLYTA for as long as your doctor tells you. Your doctor will regularly check your disease to see if the treatment is still working.

If you have any questions about how long to 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 the next dose at the usual time the next 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 make your disease worse. Do not stop taking your medicine unless your doctor tells you to.

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

4. Possible side effects

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

Serious side effects

Tell your doctor, pharmacist, or nurse immediately if you notice any of the following side effects:

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

Very common side 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 count);
• neutropenia (low neutrophil count, 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 (infections of the nose and throat);
• decreased appetite;
• epistaxis (nosebleeds);
• fungal infections;
• herpes infections;
• dyspepsia (indigestion);
• bacteremia (presence of bacteria in the blood).

Common side effects

(may affect up to 1 in 10 people)

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

Uncommon side effects

(may affect up to 1 in 100 people)

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through 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 VANFLYTA

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 is the last day of the month stated.

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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

VANFLYTA Composition

• The active ingredient 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.

Product Appearance and Package Contents

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

VANFLYTA 26.5 mg film-coated tablets (tablets) are yellow, round, and have the inscription “DSC 512” on one side, and are available in boxes containing 14 x 1, 28 x 1, or 56 x 1 film-coated tablets in aluminum/aluminum perforated 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

Other Sources of Information

Detailed information about this medication is available on the European Medicines Agency website: https://www.ema.europa.eu. There are also links to other websites about rare diseases and orphan medicines.