Qinlock 50 mg comprimidos

Prospect: information for the user

QINLOCK 50 mg tablets

ripretinib

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospect. See section 4.

QINLOCK is a cancer medication that contains the active ingredient ripretinib, a protein kinase inhibitor. Protein kinase inhibitors are used to treat cancer by interrupting the activity of certain proteins involved in the growth and

propagation of cancer cells.

QINLOCK is used to treatadultswithgastrointestinal stromal tumor (GIST), a rare type ofdigestive system cancer that includes the stomach and intestineand that:

• has spread to other parts of the body or cannot be removed by surgery;
• has been treated with at least three previous cancer medications, including imatinib.

If you have any doubts about how QINLOCK works or why you have been prescribed this medication, consult your doctor.

Do not take QINLOCKif you areallergic to ripretinibor toany of the other ingredientsin this medication (listed in section 6).

Warnings and precautions

Before takingQINLOCK, consult your doctor or pharmacist if you have or have had:

• High blood pressure. Your doctor will monitor your blood pressure before and during treatment with QINLOCK and may prescribe a medication to treat hypertension if necessary.

-Heart disease. Your doctor may perform additional tests to evaluate your heart function before and during treatment with QINLOCK.

• Liver or kidney problems.

When takingQINLOCK, consult your doctor or pharmacist in the following cases:

-If you notice redness, pain, swelling, or blisters on the palms of your hands or the soles of your feet. This is a skin condition called palmoplantar erythrodysesthesia syndrome (SEPP). Your doctor may continue treatment, change the dose, or discontinue treatment until your condition improves (see section 4).

-If you notice unexpected changes in your skin, such as a new mole, an open wound, or a red, bleeding, or non-healing bump, or a change in the size or color of a mole. QINLOCK may increase the risk of certain types of skin cancer (see section 4). Your doctor will examine your skin when you start treatment with QINLOCK and regularly during treatment. It is essential to have your skin examined regularly.

• If you have recent surgery wounds that are not healing as expected.

QINLOCK may affect wound healing. Your doctor may decide to temporarily discontinue treatment with QINLOCK a few days before surgery and until the wound has healed after surgery. Your doctor will decide when to restart treatment with QINLOCK. It is essential to inform your doctor if you have any upcoming surgeries planned.

-If you feel tired, lack breath, notice prominent veins in your neck, or experience swelling in your abdomen, ankles, or calves while taking QINLOCK; these may be symptoms of heart failure (see section 4).

-If your skin or eyes become more sensitive to sunlight or other light sources. Do not expose yourself to direct sunlight, sunlamps, or other sources of ultraviolet radiation while taking this medication. Wear protective clothing and apply sunscreen with a high protection factor when exposed to intense sunlight.

Important information for men and women about contraception

QINLOCK may cause harm to the fetus.Do not become pregnantwhile taking QINLOCK. Use an effective contraceptive method during treatment and for at least 1 week after the last dose of QINLOCK if you are a fertile woman or a man with a fertile female partner. If you use hormonal contraceptives, add a barrier method (such as condoms). See the section on "Contraception, pregnancy, breastfeeding, and fertility."

Children and adolescents

Do not administer this medication to children and adolescents under 18 years of age, as the administration of this medication has not been studied in this age group.

Other medications and QINLOCK

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

QINLOCK may affect the mechanism of action of some medications. Additionally, some medications may affect the mechanism of action of QINLOCK.

Particularly,inform your doctorif you are taking any of the following medications:

-Medications used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, or voriconazole)

• Medications used to treat bacterial infections (such as erythromycin, clarithromycin, or rifampicin)
• Medications used to treat HIV (such as ritonavir, efavirenz, or etravirine)

-Medications used to treat epilepsy or seizures (such as phenytoin, carbamazepine, or phenobarbital)

• Medications used to treat irregular heartbeats (such as digoxin)

-Medications used to prevent stroke or harmful blood clots (such as dabigatran etexilate)

• Medications used to lower high cholesterol (such as rosuvastatin)

-Medications used to lower blood sugar or treat diabetes (such as repaglinide or metformin)

• Medications used to treat rheumatoid arthritis and severe intestinal inflammation

(such as sulfasalazine)

• Medications used to treat cancer (such as paclitaxel or irinotecan)
• Medications used to prevent organ rejection (such as cyclosporine and tacrolimus)

-Medications used to treat low platelet counts in the blood (such as eltrombopag)

• Medications used to treat muscle spasms (such as tizanidine)
• Medications used to alleviate anxiety before procedures (such as midazolam)

-Herbal preparations used to treat depression and anxiety containing St. John's Wort (Hypericum perforatum)

QINLOCK with food and drinks

The juice ofgrapefruitmay alter the amount of QINLOCK in your body. Do not drink grapefruit juice or eat grapefruit during treatment with this medication.

Contraception, pregnancy, breastfeeding, and fertility

Contraception

Both fertile women and men should use effective contraceptive methods during treatment and for at least 1 week after completing treatment. If you use hormonal contraceptives, add a barrier method (such as condoms). See the section on "Contraception, pregnancy, breastfeeding, and fertility."

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, do not take this medication unless your doctor has decided that treatment with QINLOCK is clearly necessary. Consult your doctor or pharmacist before starting this medication.

Do not become pregnantwhile receiving treatment with QINLOCK.

If you are a male patient with a partner who is pregnant or may become pregnant, use a barrier method (such as condoms) during treatment and for at least 1 week after completing treatment. This medication may harm the fetus.

If you are a male patient and your female partner becomes pregnant during treatment with QINLOCK, inform your doctor immediately.

Fertile women should perform pregnancy tests before starting treatment with QINLOCK and during treatment.

Breastfeeding

Do not breastfeed your childwhile taking QINLOCK or for at least 1 week after completing treatment, as this medication may causeserious adverse effectsin your child. Inform your doctor if you are breastfeeding or plan to do so.

Fertility

QINLOCK may affect fertility in men and women. Consult your doctor before starting treatment with QINLOCK.

Driving and operating machinery

QINLOCK does not directly affect your ability to drive or operate machinery. If you feel unwell or extremely tired while receiving treatment with QINLOCK, do not drive or operate machinery until you feel safe to do so.

QINLOCK contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

QINLOCK will be prescribed to you by an experienced cancer treatment doctor. Follow exactly the administration instructions for this medication as indicated by your doctor.

If you are unsure, consult your doctor or pharmacist again.

The recommended daily dose isthree 50 mg tablets (150 mg) once a day.Take the tablets at thesame time every daywith or without food. Swallow the tablets whole with a glass of water; do not crush, break, or chew them. Do not take any tablet that is broken, cracked, or otherwise damaged, as the effects of taking a non-intact tablet are unknown.

If you need to take other medications at the same time as QINLOCK, your doctor may change your dose to three 50 mg tablets (150 mg) twice a day.

Generally, you will take QINLOCK as long as you benefit from it and do not experience unacceptable side effects (see section 4); however, your doctor may reduce the dose or decide to temporarily or permanently interrupt or suspend treatment if necessary.

If you have kidney problems or severe liver problems

While being treated with QINLOCK, your doctor will closely monitor your renal or hepatic function.

If you take more QINLOCK than you should

If you have accidentally taken an excessive number of tablets,seek urgent medical attention.

If you forget to take QINLOCK

What to do if you forget to take this medication depends on the time when you remember the missed dose. If:

• 8 hours or less (4 hours or less for 150 mg twice a day) have passed since the scheduled time, take the missed dose as soon as you remember. Then, take the next dose at the usual time.
• More than 8 hours (more than 4 hours for 150 mg twice a day) have passed since the scheduled time, omit the missed dose. Then, take the next dose at the usual time.

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

If you vomit when taking QINLOCK

If you vomit after taking this medication,do nottake an additional dose; continue as usual. Take the next dose of tablets the next day at the usual time and inform your doctor if you have vomited.

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

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

Severe side effects

Seek medical attention immediatelyif you experience any of the followingsevere side effects

(see section 2):

• Skin problems(known as SEPP)

The syndrome of erythromelalgia palmoplantar (SEPP) is a very common side effect when taking this medicine. If you develop:

•redness, pain, swelling, or blisters on the palms of your hands or the soles of your feet,

Your doctor may continue treatment, change the dose, or stop treatment until your condition improves.

• Hypertension

Hypertension is a very common side effect when taking this medicine. If you develop:

•headache, dizziness, or a feeling of dizziness, which may be symptoms of hypertension,

Your doctor may change your dose or stop treatment until your condition improves.

• Cardiac problems (heart failure)

Heart failure is a common side effect when taking this medicine. If:

• You feel very tired, lack breath, and have swollen feet or ankles, which may be symptoms of cardiac problems.

Consult your doctor or pharmacistif you have:

• Skin cancer

Treatment with QINLOCK may cause certain types of skin cancer, such as 'cutaneous squamous cell carcinoma' and 'melanoma'. Inform your doctor if you notice any unexpected changes in your skin during treatment, such as a new wart, an open wound, or a

bloody or non-healing red bump, or a change in the size or color of a mole. Your doctor will examine your skin when you start treatment with QINLOCK and regularly during treatment (see section 2).

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

• Nausea
• Constipation
• Diarrea
• Vomiting
• Joint pain
• Headache
• Dyspnea
• Blood tests that show an increase in bilirubin levels, a substance produced by the liver
• Blood tests that show an increase in lipase levels, an enzyme involved in digestion
• Blood tests that show a decrease in phosphate levels
• Tiredness
• Hair loss
• Muscle pain or cramps
• Weight loss
• Muscle spasms
• Dry skin
• Back pain
• Cough
• Swelling of hands and shins
• Pain in hands or feet
• Itching
• Non-cancerous skin lesions

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

• Mouth sores
• Abdominal pain
• Affection of peripheral nerves (numbness and tingling in hands and feet, burning, stabbing, or shooting pain in affected areas, loss of balance and coordination, and muscle weakness, especially in the feet)
• Skin reactions such as peeling and inflammation of the skin, a characteristic skin rash characterized by a flat, red area of skin covered with small bumps or acne
• Abnormal results in liver tests (possible liver damage revealed by blood tests)
• Depression
• Underactive thyroid gland
• Weakness
• Chest pain
• Fast heart rate

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the bottle label, after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging and keep the bottle perfectly closed to protect it from light and moisture.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation. Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help to protect the environment.

Dispose of the packaging and medications that you no longer need.

Protect the environment.

Composition of QINLOCK

• The active ingredient is ripretinib. Each tablet contains 50 mg of ripretinib.

-The other components are crospovidone (E1202), acetate succinate of hypromellose, lactose monohydrate, magnesium stearate (E470b), microcrystalline cellulose (E460) and hydrated colloidal silica (E551) (see section 2 "QINLOCK contains lactose").

Appearance of the product and contents of the packaging

QINLOCK tablets are white to off-white, oval-shaped and have the inscription "DC1" on one side.

Each bottle is child-resistant and contains 30 or 90 tablets and a desiccant. The bottles are provided with an aluminum/polyethylene (PE) safety cap. The desiccant is a humidity-absorbing material contained in a small container to protect the tablets from moisture. Always keep the desiccant inside the bottle and do not ingest it.

Only some packaging sizes may be commercially available.

Marketing Authorization HolderDeciphera Pharmaceuticals (Netherlands) B.V. Atrium Building 4th Floor

Strawinskylaan 3051

1077ZX, Amsterdam

Netherlands

Responsible for manufacturing

Deciphera Pharmaceuticals (Netherlands) B.V. Atrium Building 4th Floor

Strawinskylaan 3051

1077ZX, Amsterdam

Netherlands

For more information about this medication, please contact the marketing authorization holder:

Deciphera Pharmaceuticals (Netherlands) B.V.,NL Tel/ Tél/ Te?/ Tlf/ Τηλ/ Sími/ Puh: 08006333435

Email:[email protected]

Last review date of this leaflet: February 2023

Detailed information about thismedication is available on the European Medicines Agency website:http://www.ema.europa.euhttp://www.ema.europa.eu.