Qinlock (Ripretinib): Uses, Side Effects and Dosage

What is QINLOCK?

QINLOCK is a prescription medicine used to treat adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitor medicines, including imatinib, for their GIST.

It is not known if QINLOCK is safe and effective in children.

Before taking QINLOCK, tell your healthcare provider about all of your medical conditions, including if you:

• had a type of skin problem called palmar-plantar erythrodysesthesia syndrome
• have high blood pressure
• have heart problems
• had or plan to have surgery

• are pregnant or plan to become pregnant. QINLOCK can harm your unborn baby. Tell your healthcare provider if you or your partner becomes pregnant or you think you may be pregnant during treatment with QINLOCK.

  Females who are able to become pregnant:

  • Your healthcare provider will do a pregnancy test before you start treatment with QINLOCK.
  • You should use effective birth control (contraception) during treatment with QINLOCK and for 1 week after the last dose. Talk to your healthcare provider about birth control methods that may be right for you.

  Males with female partners who are able to become pregnant:

  • You should use effective birth control during treatment with QINLOCK and for at least 1 week after your final dose.
• are breastfeeding or plan to breastfeed. It is not known if QINLOCK passes into your breast milk. Do not breastfeed during treatment with QINLOCK and for at least 1 week after your final dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

QINLOCK and certain other medicines can affect each other causing side effects or affect how QINLOCK works.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

What should I avoid while taking QINLOCK?

Your skin may be sensitive to the sun or other forms of light (photosensitivity) during treatment with QINLOCK. Avoid or limit exposure to direct sunlight, sunlamps, and other sources of ultraviolet radiation during treatment and for at least 1 week after stopping treatment with QINLOCK. Use sunscreen and wear clothes that cover your skin if you need to be out in the sun.

How should I take QINLOCK?

• Take QINLOCK exactly as your healthcare provider tells you to.
• Your healthcare provider may temporarily or permanently stop treatment or change your dose of QINLOCK if you develop side effects during treatment.
• Do not change your dose or stop taking QINLOCK unless your healthcare provider tells you to.
• Take QINLOCK 1 time each day, at the same time each day.

• Take QINLOCK with or without food.

• Swallow QINLOCK tablets whole.
• If you vomit after taking a dose of QINLOCK, do not take an extra dose. Take your next dose of QINLOCK at your scheduled time.
• If you miss a dose of QINLOCK, take it as soon as you remember if it is within 8 hours of the scheduled dose. If more than 8 hours have passed, wait until your next scheduled dose.
• If you take more than the prescribed dose of QINLOCK, call your healthcare provider.

What are the possible side effects of QINLOCK?

QINLOCK may cause serious side effects, including:

• A skin problem called palmar-plantar erythrodysesthesia syndrome. Skin problems are common and sometimes can be severe. Tell your healthcare provider right away if you develop redness, pain, blisters, bleeding, or swelling on the palms of your hands or soles of your feet, or severe rash during treatment with QINLOCK.

• New skin cancers. QINLOCK may cause skin cancers called cutaneous squamous cell carcinoma, keratoacanthoma, or melanoma.

  Talk to your healthcare provider about your risk for these cancers. Your healthcare provider should check your skin before and during treatment with QINLOCK to look for any new skin cancers.

  Check your skin and tell your healthcare provider right away about any skin changes, including a:

  • new wart
  • skin sore or reddish bump that bleeds or does not heal
  • change in size or color of a mole
• High blood pressure (Hypertension). High blood pressure is common with QINLOCK and can be severe. Your healthcare provider should check your blood pressure regularly during treatment with QINLOCK.
• Heart problems. Your healthcare provider should check you for signs or symptoms of heart failure before starting QINLOCK and regularly during treatment with QINLOCK. Heart failure can be serious and can sometimes lead to death. Tell your healthcare provider right away if you have any of the following signs or symptoms during your treatment with QINLOCK:

• tiredness
• swelling of your stomach-area (abdomen), legs or ankles

• shortness of breath
• protruding neck veins

• Risk of wound healing problems. Wounds may not heal well during treatment with QINLOCK. Tell your healthcare provider if you plan to have any surgery before or during treatment with QINLOCK.

  • Your healthcare provider should tell you when to stop taking QINLOCK before a planned surgery.
  • Your healthcare provider should tell you when you may start taking QINLOCK again after surgery.
• Risk of sensitivity to sunlight (photosensitivity). See “What should I avoid while taking QINLOCK?”

The most common side effects of QINLOCK include:

• hair thinning or hair loss
• nausea
• constipation
• diarrhea
• vomiting

• tiredness
• stomach (abdominal) pain
• muscle pain
• decreased appetite

QINLOCK may affect fertility in males which may affect the ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of QINLOCK.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store QINLOCK?

• Store QINLOCK in the original container at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
• QINLOCK comes with a desiccant packet in the bottle to protect your medicine from moisture. Do not remove the desiccant packet from the bottle.

Keep QINLOCK and all medicines out of the reach of children.

General information about the safe and effective use of QINLOCK.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use QINLOCK for a condition for which it was not prescribed. Do not give QINLOCK to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about QINLOCK that is written for health professionals.

What are the ingredients in QINLOCK?

Active ingredient: ripretinib

Inactive ingredients: crospovidone, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and silicon dioxide

Manufactured for: Deciphera Pharmaceuticals, LLC, 200 Smith Street, Waltham, MA 02451

QINLOCK is a trademark of Deciphera, LLC. All other trademarks referenced herein are the property of their respective owners.

For more information, call 1-888-724-3274 or go to www.QINLOCK.com