IMPORTANT SAFETY INFORMATION

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 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 if you have any of the following symptoms during your treatment with QINLOCK:

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

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 and when you may start taking QINLOCK again after surgery.

The most common side effects of QINLOCK include:

  • hair thinning or hair loss
  • tiredness
  • nausea
  • abdominal pain
  • constipation
  • muscle pain
  • diarrhea
  • decreased appetite
  • vomiting

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 the FDA at 1-800-FDA-1088

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 heart problems
  • have high blood pressure
  • had or plan to have surgery

For females, tell your healthcare provider if you:

  • are pregnant or plan to become pregnant. QINLOCK may harm your unborn baby. erythrodysesthesia syndrome
  • can become pregnant as your healthcare provider will do a pregnancy test before you start treatment with QINLOCK.
  • become pregnant or think you may be pregnant during treatment with QINLOCK.
  • can become pregnant. Use effective birth control (contraception) during treatment with QINLOCK and for at least 1 week after the final dose. Talk to your healthcare provider about birth control methods that may be right for you.
  • 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.

For males with female partners who are able to become pregnant:

  • use effective birth control during treatment with QINLOCK and for at least 1 week after the final dose.
  • if your female partner becomes pregnant during your treatment with QINLOCK, tell your healthcare provider right away.

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.

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.

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.

INDICATION

What is QINLOCK?

QINLOCK is a prescription medicine used to treat adults with advanced gastrointestinal stromal tumor (GIST) who have received 3 or more prior treatments for their GIST.

Please see complete Prescribing Information, including Patient Information.

© 2021 Deciphera Pharmaceuticals. The QINLOCK® word mark and logo are registered trademarks of Deciphera Pharmaceuticals, LLC. The Deciphera logo is a trademark of Deciphera Pharmaceuticals, LLC. All rights reserved. DCPH-P00371 02/21