Qinlock

Package leaflet: Information for the user

QINLOCK 50 mg tablets

ripretinib
This medicinal product is under additional monitoring. This will allow rapid identification of new safety information. 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 because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What QINLOCK is and what it is used for

QINLOCK is an anticancer medicine containing the active substance ripretinib, a protein kinase inhibitor. Protein kinase inhibitors are used in the treatment of cancer because they block the activity of certain proteins involved in the growth and spread of cancer cells.
QINLOCK is indicated for the treatment of adults with gastrointestinal stromal tumour (GIST), a rare type of cancer of the digestive system, including the stomach and intestine, which:

• has spread to other parts of the body or cannot be surgically removed
• has been previously treated with at least 3 anticancer medicines, including imatinib.

If you have any questions about how QINLOCK works or why this medicine has been prescribed for you,
please consult your doctor.

2. What you need to know before taking QINLOCK

Do not take QINLOCK if you are allergic to ripretinib or to any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions
Before taking QINLOCK, talk to 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, if necessary, may prescribe medication to treat high blood pressure
• heart problems. Your doctor may perform additional tests to assess heart function before and during treatment with QINLOCK
• liver or kidney problems.

While taking QINLOCK, talk to your doctor or pharmacist if:

• you notice redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. This is a skin condition called palmar-plantar erythrodysesthesia (PPES). Your doctor may continue treatment, adjust the dose, or temporarily stop treatment until your symptoms improve (see section 4)
• you notice unexpected skin changes, such as a wart, an open sore, or a red bump that was not previously present and that bleeds or does not heal, or a change in 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 periodically during treatment. It is important to regularly check your skin
• you have surgical wounds from a recent procedure that are not healing as expected. QINLOCK may affect wound healing. Your doctor may decide to temporarily stop QINLOCK treatment several days before surgery and until the wound has healed after surgery. Your doctor will decide when to restart QINLOCK treatment. It is important that you inform your doctor if you are scheduled for any future planned surgery
• you feel tired, short of breath, notice bulging neck veins, or swelling in the abdomen, ankles, or lower legs while taking QINLOCK; these may be symptoms of heart failure (see section 4)
• your skin or eyes become more sensitive to sunlight or other forms of light. Avoid direct sunlight, sunlamps, and other sources of ultraviolet radiation while taking this medicine. Wear protective clothing and apply sunscreen with a high sun protection factor if you are exposed to strong sunlight.

Important information about contraception for men and women
QINLOCK may harm the unborn baby. Do not become pregnant while taking QINLOCK.
Use an effective method of contraception during treatment and for at least one week after
the last dose of QINLOCK if you are a woman of childbearing potential or if you are a man with a female partner of childbearing potential. If you use hormonal contraception, also use a barrier method (such as a condom). See section “Contraception, pregnancy, breastfeeding and fertility”.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as it 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 action of certain medicines. In addition, some medicines may
affect the action of QINLOCK.
In particular, tell your doctor if you are taking any of the following medicines:

• medicines used to treat fungal infections (ketoconazole, itraconazole, posaconazole, voriconazole)
• medicines used to treat bacterial infections (such as erythromycin, clarithromycin, rifampicin)
• medicines used to treat HIV (such as ritonavir, efavirenz, etravirine)
• medicines used for epilepsy or seizures (such as phenytoin, carbamazepine, phenobarbital)
• medicines used to treat irregular heartbeat (such as digoxin)
• medicines used to prevent stroke or dangerous blood clots (such as dabigatran etexilate)
• medicines used to lower high cholesterol (such as rosuvastatin)
• medicines used to reduce blood glucose or treat diabetes (such as repaglinide or metformin)
• medicines used to treat severe intestinal inflammation and rheumatic joint disorders (such as sulfasalazine)
• medicines used to treat cancer (such as paclitaxel or irinotecan)
• medicines used to prevent organ rejection (such as ciclosporin, tacrolimus)
• medicines used to treat low platelet count 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 for depression and anxiety containing St. John’s wort ( Hypericum perforatum ).

QINLOCK with food and drink
Grapefruit juice may alter the amount of QINLOCK in your body. It is recommended not to drink grapefruit juice or eat grapefruit during treatment with this medicine.
Contraception, pregnancy, breastfeeding and fertility
Contraception
Both women of childbearing potential and men must use effective contraception during treatment and
for at least one week after completion of treatment. If you use hormonal contraception, you should also
use a barrier method (such as a condom).
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to become pregnant, you should not take this
medicine unless your doctor has clearly determined that treatment with QINLOCK is necessary. Consult your doctor or pharmacist before taking this medicine.
Do not become pregnant during treatment with QINLOCK.
If you are a male patient with a pregnant partner or a female partner of childbearing potential, you must use
a barrier method (such as a condom) during sexual intercourse, during treatment and for at least one week after its completion. This medicine may harm the unborn baby.
If you are a man and your female partner becomes pregnant during treatment with QINLOCK, inform your doctor immediately.
Women of childbearing potential should undergo pregnancy testing before starting treatment with QINLOCK and during treatment.
Breastfeeding
Do not breastfeed during treatment with QINLOCK and for at least one week after completion of treatment, as this medicine may cause serious adverse effects in the breastfed infant. Inform your doctor if you are breastfeeding or plan to breastfeed.
Fertility
QINLOCK may affect fertility in both men and women. Talk to your doctor before taking QINLOCK.
Driving and using machines
QINLOCK does not directly impair the ability to drive or operate machinery. However, if you feel unwell or very tired during treatment with QINLOCK, do not drive or operate machinery until you feel able to do so safely.
QINLOCK contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take QINLOCK

QINLOCK will be prescribed by a physician experienced in the use of anticancer therapies.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended daily dose is three 50 mg tablets (150 mg) taken once daily. Take the tablets at the same time each day, with or without food. Swallow the tablets whole with a glass of water, without chewing, dividing, or crushing them. Do not take broken, cracked, or otherwise damaged tablets, as only the effects of intact tablets are known.
If you need to take certain other medicines concomitantly with QINLOCK, your doctor may increase the dose to three 50 mg tablets (150 mg) twice daily.
Treatment with QINLOCK usually continues for 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 discontinue treatment, if necessary.

If you have kidney problems or severe liver problems
During treatment with QINLOCK, your doctor will monitor your kidney or liver function more closely.

If you take more QINLOCK than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take QINLOCK
What you should do if you miss a dose depends on when you realize the omission. If you realize:

• within 8 hours (within 4 hours for doses of 150 mg twice daily) of 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 doses of 150 mg twice daily) after the scheduled time, skip the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you feel unwell while taking QINLOCK
If you feel unwell (e.g., vomit) after taking this medicine, do not take another dose, but continue your treatment as usual. Take the next dose at the regular time the following day and inform your doctor that you felt unwell.
If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Consult your doctor immediately if you experience any of the following serious side effects (see section 2):

• Skin disorders (called PPES) PPES 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 soles of your feet, your doctor may continue treatment, adjust the dose, or stop 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 vertigo, these may be symptoms of high blood pressure, and your doctor may adjust the dose or stop 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 or short of breath, or if you have swollen feet and/or ankles, these may be symptoms of heart problems.

Contact your doctor or pharmacist if you develop:

• Skin tumour Treatment with QINLOCK may cause certain types of skin tumour, such as cutaneous squamous cell carcinoma and melanoma. Inform your doctor if you notice any skin changes during treatment, such as a wart, an open sore, or a reddish bump that was not present before and that bleeds or does not heal, or any change in size or colour of a mole. Your doctor will examine your skin when you start treatment with QINLOCK and periodically during treatment (see section 2).

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

• feeling unwell (nausea)
• constipation
• diarrhoea
• malaise (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 tenderness
• weight loss
• muscle spasms
• dry skin
• back pain
• cough
• swelling in the hands and lower legs
• pain in the hands or feet
• itching sensation
• non-cancerous skin lesions

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

• mouth sores
• stomach ache (abdominal pain)
• peripheral nerve disorders (numbness and tingling in the feet or hands, burning, shooting or sharp 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, rash characterised by a flat, red area of skin covered with small bumps, or acne
• abnormal liver values (possible liver damage indicated by blood tests)
• depression
• underactive thyroid
• weakness
• chest pain
• rapid heartbeat

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store QINLOCK

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 bottle 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 and keep the bottle tightly closed to protect the medicine from light and moisture.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What QINLOCK contains

• The active substance 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 colloidal hydrated silica (E551) (see section 2 “QINLOCK contains lactose”).

Description of the appearance of QINLOCK and contents of the pack
QINLOCK tablets are oval-shaped, white or almost white, with the imprint “DC1” on one side.
Each bottle is child-resistant and contains 30 or 90 tablets and a desiccant. The bottles are sealed with an aluminum/polyethylene (PE) tamper-evident seal. The desiccant is a moisture-absorbing material contained in a sachet, included to protect the tablets from moisture. Always keep the desiccant sachet inside the bottle and do not eat it.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Deciphera Pharmaceuticals (Netherlands) B.V.
Atrium Building, 4th Floor
Strawinskylaan 3051
1077ZX, Amsterdam
The Netherlands

Manufacturer
Deciphera Pharmaceuticals (Netherlands) B.V.
Atrium Building, 4th Floor
Strawinskylaan 3051
1077ZX, Amsterdam
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Deciphera Pharmaceuticals (Netherlands) B.V.
Tél/Tel/Teл/Tlf/Τηλ/Sími/Puh: +318006333435
E-mail: [email protected]

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