Fruzaqla: detailed information

Patient Information Leaflet

FRUZAQLA 1 mg hard capsules, 5 mg hard capsules

fruquintinib
This medicine is subject to additional monitoring. This will allow any new safety information to be identified quickly. 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 this leaflet carefully before 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What FRUZAQLA is and what it is used for
What you need to know before taking FRUZAQLA
How to take FRUZAQLA
Possible side effects
How to store FRUZAQLA
Contents of the pack and other information

1. What FRUZAQLA is and what it is used for

FRUZAQLA contains the active substance fruquintinib, a type of anticancer medicine called a kinase inhibitor.
FRUZAQLA is used to treat adult patients with colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic). It is used in cases where other treatments have not worked or are not suitable for you.
How FRUZAQLA works
Cancer cells need new blood vessels to grow. FRUZAQLA prevents tumours from forming new blood vessels, thereby slowing down the growth and spread of cancer.
If you have any questions about how this medicine works or why it has been prescribed for you, speak with your doctor, pharmacist, or nurse.

2. What you should know before taking FRUZAQLA

Do not take FRUZAQLA

if you are allergic to fruquintinib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking FRUZAQLA or at any time during treatment if you have any of the following conditions:

High blood pressure. Your doctor must ensure that your blood pressure is under control before starting and during treatment with this medicine.
Any bleeding problems. Inform your doctor if you have or have ever had bleeding problems, or if you are taking warfarin, acenocoumarol, or other medicines to thin the blood and prevent blood clots.
Severe stomach and intestinal problems caused by a hole in the intestinal wall (known as gastrointestinal perforation). If you experience severe stomach or intestinal problems, contact your doctor immediately.
Kidney problems (indicated by the presence of protein in the urine).
Any skin problems, which may include redness, pain, swelling, or blisters on the palms of the hands or soles of the feet.
Recent severe and persistent headache, visual disturbances, seizures, or changes in mental status (such as confusion, memory loss, or disorientation). If you or someone close to you notices any of these changes, contact your doctor immediately.
An open wound or if you have recently undergone or are scheduled to undergo a surgical procedure. FRUZAQLA may affect the wound healing process.
Recent blood clot problems in veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.

Your doctor may prescribe additional medicines to prevent more serious complications and reduce symptoms. Your doctor may delay the next dose of FRUZAQLA or discontinue treatment with FRUZAQLA.
Children and adolescents
FRUZAQLA is not intended for use in children and adolescents for the treatment of colon or rectal cancer that has spread to other parts of the body.
Other medicines and FRUZAQLA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor or pharmacist if you are taking medicines used to treat tuberculosis or certain other infections, such as rifampicin.
Pregnancy
FRUZAQLA has not been studied in pregnant women. Due to its mechanism of action, FRUZAQLA must not be used during pregnancy unless absolutely necessary, as it may cause harm to the fetus. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss with you the potential risks associated with taking this medicine during pregnancy.
Contraception in women
Women of childbearing potential must use highly effective contraceptive methods during treatment and for at least 2 weeks after the last dose of FRUZAQLA. Speak to your doctor to determine the most appropriate contraceptive methods for you.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. It is not known whether FRUZAQLA passes into breast milk; therefore, the risk to newborns/infants cannot be ruled out. You must not breastfeed during treatment with this medicine and for at least 2 weeks after the last dose. Consult your doctor to discuss the best way to feed your baby during this period.
Driving and using machines
FRUZAQLA has a minor influence on the ability to drive and use machines. You may feel tired after taking FRUZAQLA. Do not drive or operate tools or machinery if you experience symptoms that affect your ability to concentrate or react.
FRUZAQLA contains
Tartrazine (E102) and sunset yellow FCF/orange yellow S (E110) only in the 1 mg capsules. These are dyes that may cause allergic reactions.
Allura red AC (E129) only in the 5 mg capsules. This is a dye that may cause allergic reactions.

3. How to take FRUZAQLA

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Recommended dose
The recommended dose is 5 milligrams (mg), taken once daily at approximately the same time each day for 21 days, followed by 7 days off (no medicine). This constitutes one treatment cycle.
Depending on your response to treatment and any possible side effects, your doctor may ask you to switch to a lower dose or to temporarily or permanently stop treatment.
How to take FRUZAQLA

Take FRUZAQLA with or without food.
Swallow the capsule whole with water or another beverage.
Do not chew, dissolve, or open the capsules, as the potential effects of taking a non-intact capsule are not known.
If you have or think you may have difficulty swallowing the capsules whole, speak to your doctor before starting treatment.

How long to take FRUZAQLA
Your doctor will monitor you regularly. You may continue taking FRUZAQLA normally for as long as it remains effective and side effects are acceptable.
If you take more FRUZAQLA than you should
Inform your doctor immediately if you have taken more than the prescribed dose. Medical assistance may be required, and your doctor may instruct you to stop taking FRUZAQLA.
If you forget to take FRUZAQLA
If less than 12 hours remain before your next scheduled dose, skip the missed dose and take the next dose as planned.
If more than 12 hours remain before your next scheduled dose, take the missed dose and then take the next dose as scheduled.
If you vomit after taking FRUZAQLA, do not take a replacement capsule. Continue your treatment by taking the next dose at the usual time.
Before stopping treatment with FRUZAQLA
Do not stop taking this medicine unless your doctor tells you to. If you have any questions about using 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. The following side effects may occur with this medicine:
Serious side effects
Tell your doctor immediately if you experience any of the following serious side effects.
High blood pressure
Tell your doctor if you experience any of the following symptoms:

severe headache
mental confusion or dizziness
confusion
severe chest pain

Bleeding
FRUZAQLA may cause serious bleeding in the digestive system such as stomach, throat, rectum, or intestine. Seek medical help immediately if you have any of the following symptoms:

blood in stool or black stools
blood in urine
stomach pain
coughing/vomiting blood

Serious stomach and intestinal problems due to gastrointestinal perforation
Treatment with FRUZAQLA may lead to gastrointestinal perforation.
Seek immediate medical help if you have any of the following symptoms:

coughing/vomiting blood
severe stomach (abdominal) pain or stomach pain that does not go away
red or black stools

Reversible swelling of the brain (reversible posterior encephalopathy syndrome)
Seek immediate emergency medical help and contact your doctor if you have any of the following symptoms:

headache
confusion
seizures
changes in vision

Other side effects
Tell your doctor, pharmacist, or nurse if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

reduced number of platelets (cells that help blood to clot), detected in blood tests (thrombocytopenia), which may cause bruising or bleeding
reduced activity of the thyroid gland (hypothyroidism), which may cause tiredness, weight gain, and changes in skin and hair
weight loss and decreased appetite (anorexia)
high blood pressure (hypertension)
voice changes or hoarseness (dysphonia)
frequent bowel movements or loose stools (diarrhea)
painful or dry mouth, mouth sores or ulcers (stomatitis)
increased liver enzymes in blood tests, including aspartate aminotransferase and alanine aminotransferase
increased bilirubin in blood (abnormal liver function test)
redness, pain, blisters, and swelling of the palms of the hands or soles of the feet (palmar-plantar erythrodysesthesia)
pain in bones, muscles, chest, or neck (musculoskeletal discomfort)
joint pain (arthralgia)
protein in urine (proteinuria)
weakness, lack of strength and energy, excessive tiredness (asthenia/fatigue)

Common (may affect up to 1 in 10 people):

lung infection (pulmonary infection)
infection of nose and throat (upper respiratory tract)
bacterial infection
reduced white blood cells in blood tests (leukopenia), which may increase the risk of infection
reduced neutrophils (a type of white blood cell) in blood tests (neutropenia), which may increase the risk of infection
decreased potassium levels in blood tests (hypokalemia)
nosebleeds (epistaxis)
sore throat
bleeding in the digestive system such as stomach, rectum, or intestine (gastrointestinal hemorrhage)
hole in the stomach (gastrointestinal perforation)
increased pancreatic enzymes in blood tests (which may be a sign of pancreatic problems)
toothache, gum or lip pain (oral pain)
skin rashes
mouth ulcers (mucosal inflammation)

Uncommon (may affect up to 1 in 100 people):

reversible swelling of the brain (reversible posterior encephalopathy syndrome)
stomach area pain, nausea, vomiting, and fever, which may be symptoms of pancreas inflammation (pancreatitis)
severe pain in the upper right or central abdomen, nausea and vomiting, which may be symptoms of gallbladder inflammation (cholecystitis)
delayed wound healing

Not known (frequency cannot be estimated from the available data):

sudden, severe pain in the abdomen, chest, or back, which may be a symptom of aortic wall tear (aortic dissection)

Reporting of side effects
If you get any side effects, 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 FRUZAQLA

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 on the label of the
vial after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture.
Keep the vial tightly closed.
Do not dispose of any medicine 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 other information

What FRUZAQLA contains
FRUZAQLA 1 mg hard capsules

The active substance is fruquintinib. Each hard capsule contains 1 mg of fruquintinib.
The other components are:
- Capsule contents: maize starch, microcrystalline cellulose (E460), talc (E553b)
- Capsule shell: gelatin, titanium dioxide (E171), tartrazine (E102), sunset yellow FCF/orange yellow S (E110)
- Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide, black iron oxide (E172).

FRUZAQLA 5 mg hard capsules

The active substance is fruquintinib. Each hard capsule contains 5 mg of fruquintinib.
The other components are:
- Capsule contents: maize starch, microcrystalline cellulose (E460), talc (E553b)
- Capsule shell: gelatin, titanium dioxide (E171), allura red AC (E129), brilliant blue FCF (E133)
- Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide, black iron oxide (E172).

Description of the appearance of FRUZAQLA and contents of the pack
FRUZAQLA 1 mg hard capsules (approximately 16 mm in length) are white with a yellow cap, printed with “HM013” above “1mg”.
FRUZAQLA 5 mg hard capsules (approximately 19 mm in length) are white with a red cap, printed with “HM013” above “5mg”.
Each bottle contains 21 hard capsules and a desiccant. The desiccant is a moisture-absorbing material placed in a small container to protect the capsules from moisture.
Keep the desiccant in the bottle. Do not swallow the desiccant.

Marketing Authorization Holder
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland

Manufacturer
Takeda Ireland Limited
Bray Business Park
Kilruddery
Co. Wicklow
A98 CD36
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: +32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]

България Luxembourg/Luxemburg
Такеда България ЕООД Takeda Belgium NV
Тел.: +359 2 958 27 36 Tél/Tel: +32 2 464 06 11
[email protected] [email protected]

Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: +420 234 722 722 Tel.: +36 1 270 7030
[email protected] [email protected]

Danmark Malta
Takeda Pharma A/S Drugsales Ltd
Tlf.: +45 46 77 10 10 Tel: +356 21419070
[email protected] [email protected]

Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: +49 (0)800 825 3325 Tel: +31 20 203 5492
[email protected] [email protected]

Eesti Norge
Takeda Pharma OÜ Takeda AS
Tel: +372 6177 669 Tlf: +47 800 800 30
[email protected] [email protected]

Ελλάδα Österreich
Takeda ΕΛΛΑΣ Α.Ε. Takeda Pharma Ges.m.b.H.
Tηλ: +30 210 6387800 Tel: +43 (0) 800-20 80 50
[email protected] [email protected]

España Polska
Takeda Farmacéutica España, S.A. Takeda Pharma Sp. z o.o.
Tel: +34 917 90 42 22 Tel.: +48223062447
[email protected] [email protected]

France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél: +33 1 40 67 33 00 Tel: +351 21 120 1457
[email protected] [email protected]

Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: +385 1 377 88 96 Tel: +40 21 335 03 91
[email protected] [email protected]

Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba
Tel: 1800 937 970 d.o.o.
[email protected] Tel: +386 (0) 59 082 480
[email protected]

Ísland Slovenská republika
Vistor hf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 (2) 20 602 600
[email protected] [email protected]

Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: +39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]

Κύπρος Sverige
A.POTAMITIS MEDICARE LTD Takeda Pharma AB
Τηλ: +357 22583333 Tel: 020 795 079
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Takeda Latvia SIA Takeda UK Ltd
Tel: +371 67840082 Tel: +44 (0) 3333 000 181
[email protected] [email protected]

Additional sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.