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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.

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

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 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
  • 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.

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 healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

DESCRIPTION

Ripretinib is a kinase inhibitor. The chemical name of ripretinib is 1-(4-bromo-5-[1-ethyl-7-(methylamino)-2oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl)-3-phenylurea. The molecular formula is C24H21BrFN5O2 and the molecular weight is 510.36 g/mol. The chemical structure of ripretinib is shown below:

Ripretinib is a white to off-white crystalline solid. Ripretinib is a lipophilic, weak base, and practically insoluble in aqueous media.

Qinlock is available as a white to off-white, oval tablets for oral use containing 50 mg of ripretinib. The tablet is debossed with “DC1” on one side. Each tablet contains the following inactive ingredients: crospovidone, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and silicon dioxide.