QINLOCK 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

QINLOCK 50 mg tablets

ripretinib

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What QINLOCK is and what it is used for

QINLOCK is a cancer medicine that contains the active substance ripretinib, a kinase inhibitor. Kinase inhibitors are used to treat cancer by blocking the action of certain proteins involved in the growth and spread of cancer cells.

QINLOCK is used to treat adultswith gastrointestinal stromal tumor (GIST), a rare type of digestive tract cancer that includes the stomach and intestineand:

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

If you have any questions about how QINLOCK works or why it has been prescribed for you, ask your doctor.

2. What you need to know before you take QINLOCK

Do not take QINLOCKif you are allergic to ripretinibor to any of the other ingredientsof this medicine (listed in section 6).

Warnings and precautions

Before taking QINLOCK, tell your doctor or pharmacist if you have or have had:

• High blood pressure. Your doctor will check your blood pressure before and during treatment with QINLOCK and may give you a medicine to treat high blood pressure if necessary.

• Heart problems. Your doctor may perform additional tests to assess your heart function before and during treatment with QINLOCK.
  • Liver or kidney problems.

When taking QINLOCK, tell 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 problem called palmar-plantar erythrodysesthesia syndrome (PESS). Your doctor may continue treatment, change the dose, or interrupt treatment until your condition improves (see section 4).

• If you notice unexpected changes in your skin, such as a new wart, an open sore, or a red lump that bleeds or does not heal, 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 routinely during treatment. It is important that you have your skin checked regularly.

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

QINLOCK may affect the way wounds heal. Your doctor may decide to temporarily interrupt 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 important that you inform your doctor if you have any planned surgery in the future.

• If you feel tired, short of breath, notice prominent veins in your neck, or have swelling in your abdomen, ankles, or legs 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 forms of light. Do not expose yourself to direct sunlight, sunlamps, or other sources of ultraviolet radiation while taking this medicine. You should wear protective clothing and apply sunscreen with a high protection factor when exposed to intense sunlight.

Important information for males and females on contraception

QINLOCK may harm the fetus. Do notbecome pregnant while 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 female of childbearing potential or a male with a female partner of childbearing potential. If you use hormonal contraceptives, add a barrier contraceptive (such as condoms). See section on "Contraception, pregnancy, breastfeeding, and fertility".

Children and adolescents

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

Other medicines and QINLOCK

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

QINLOCK may affect the way some medicines work. Additionally, some medicines may affect the way QINLOCK works.

In particular, tell your doctorif you are taking any of the following medicines:

• medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, or voriconazole)
  • medicines used to treat bacterial infections (such as erythromycin, clarithromycin, or rifampicin)
  • medicines used to treat HIV (such as ritonavir, efavirenz, or etravirine)

• medicines used to treat epilepsy or seizures (such as phenytoin, carbamazepine, or phenobarbital)
  • medicines used to treat irregular heartbeats (such as digoxin)

• medicines used to prevent stroke or harmful blood clots (such as dabigatran etexilate)
  • medicines used to lower high cholesterol (such as rosuvastatin)

• medicines used to lower blood sugar or treat diabetes (such as repaglinide or metformin)
  • medicines used to treat rheumatoid arthritis and severe intestinal inflammation

(such as sulfasalazine)

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

• medicines used to treat low platelet counts in the blood (such as eltrombopag)
  • medicines used to treat muscle spasms (such as tizanidine)
  • medicines used to relieve anxiety before procedures (such as midazolam)

• herbal preparations used to treat depression and anxiety that contain St. John's Wort (Hypericum perforatum)

QINLOCK with food and drinks

Grapefruit juice may change the amount of QINLOCK in your body. It is not recommended to drink grapefruit juice or eat grapefruit during treatment with this medicine.

Contraception, pregnancy, breastfeeding, and fertility

Contraception

Both females of childbearing potential and males must use effective contraceptive methods during treatment and for at least 1 week after the end of treatment. If you use a hormonal contraceptive, you should add a barrier method (such as condoms).

Pregnancy

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

Do notbecome pregnant while taking QINLOCK.

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

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

Females of childbearing potential must have pregnancy tests before starting treatment with QINLOCK and during treatment.

Breastfeeding

Do notbreastfeed your child during treatment with QINLOCK and for at least 1 week after the end of treatment, as this medicine may cause serious side effectsin your child. Inform your doctor if you are breastfeeding or plan to breastfeed.

Fertility

QINLOCK may affect fertility in males and females. Consult your doctor before starting treatment with QINLOCK.

Driving and using machines

QINLOCK does not directly affect your ability to drive or use machines. If you feel unwell or very tired while taking QINLOCK, do not drive or use machines until you feel safe to do so.

QINLOCK contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take QINLOCK

QINLOCK will be prescribed by a doctor with experience in the use of cancer treatments. Follow your doctor's instructions for taking this medicine exactly.

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

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

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

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

If you have kidney or severe liver problems

While being treated with QINLOCK, your doctor will closely monitor your kidney or liver function.

If you take more QINLOCK than you should

If you have accidentally taken too many tablets, seek urgent medical attention.

If you forget to take QINLOCK

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

• it has been 8 hours or less (4 hours or less for 150 mg twice-daily doses) since the scheduled time, take the missed dose as soon as you remember. Then, take the next dose at the usual time.
• it has been more than 8 hours (more than 4 hours for 150 mg twice-daily doses) since the scheduled time, skip the missed dose. Then, take the next dose at the usual time.

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

If you vomit when taking QINLOCK

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

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

4. Possible side effects

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

Serious side effects

Seek urgent medical attentionif you experience any of the following serious side effects

(see section 2):

• Skin problems(called PESS)

Palmar-plantar erythrodysesthesia syndrome (PESS) 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 interrupt treatment until your condition improves.

• High blood pressure

High blood pressure is a very common side effect when taking this medicine. If you develop:

• headache, dizziness, or feeling dizzy, which can be symptoms of high blood pressure,

your doctor may change the dose or interrupt treatment until your condition improves.

• Heart problems (heart failure)

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

• you feel very tired, short of breath, and have swollen feet or ankles, these may be symptoms of heart problems.

Tell 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 unexpected changes in your skin during treatment, such as a new wart, an open sore, or a red lump that bleeds or does not heal, or a change in the size or color of a mole. Your doctor will examine your skin when you start treatment with QINLOCK and routinely during treatment (see section 2).

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

• nausea
• constipation
• diarrhea
• vomiting
• joint pain
• headache
• shortness of breath
• blood tests showing increased levels of bilirubin, a substance produced by the liver
• blood tests showing increased levels of lipase, an enzyme involved in digestion
• blood tests showing decreased levels of phosphate
• fatigue
• hair loss
• muscle pain or muscle soreness
• weight loss
• muscle spasms
• dry skin
• back pain
• cough
• swelling of the hands and ankles
• hand or foot pain
• itching
• non-cancerous skin lesions

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

• mouth sores
• abdominal pain
• peripheral nerve damage (numbness and tingling in hands and feet, burning, stabbing, or shooting pain in the affected areas, loss of balance and coordination, and muscle weakness, especially in the feet)
• skin reactions such as peeling and inflammation of the skin, rash characterized by a flat, red area of skin covered with small bumps or acne
• abnormal liver test results (possible liver damage revealed by blood tests)
• depression
• underactive thyroid gland
• weakness
• chest pain
• rapid heart rate

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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 QINLOCK

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 on the label of the bottle, after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Store in the original package and keep the bottle tightly closed to protect from light and moisture.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering. 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

QINLOCK Composition

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

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

Product Appearance and Package Contents

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

Each bottle is child-resistant and contains 30 or 90 tablets and a desiccant. The bottles are equipped with an aluminum/polyethylene (PE) security seal. The desiccant is a moisture-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 package sizes may be marketed.

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

Strawinskylaan 3051

1077ZX, Amsterdam

Netherlands

Manufacturer

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

Strawinskylaan 3051

1077ZX, Amsterdam

Netherlands

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

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

Email: medicalinformation@deciphera.com

Date of Last Revision of this Leaflet: February 2023

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu http://www.ema.europa.eu.