Qinlock^® (ripretinib)
safety

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:
  • tiredness
  • shortness of breath
  • swelling of your stomach-area (abdomen), legs, or ankles
  • 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 and when you may start taking Qinlock again after surgery.
• Risk of sensitivity to sunlight (photosensitivity). Your skin may be sensitive to the sun or other forms of light 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.

The most common side effects of Qinlock include:

• Hair thinning or hair loss
• Tiredness
• Nausea
• Stomach (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

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

Tell your healthcare provider if you:

• are pregnant or plan to become pregnant. Qinlock can harm your unborn baby.
• or your partner becomes pregnant, or you think you may be pregnant during treatment with Qinlock.
• 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 1 week after your last dose.

Females who can 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.

For males with female partners who can become pregnant:

• You should use effective birth control during treatment with Qinlock and for 1 week after your last dose.

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.