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Class: Biological therapy
Generic Name: ripretinib
Trade Name: Qinlock®

How is Qinlock used? Quinlock is approved for the treatment of patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including Qinlock.

What is the mechanism of action? Qinlock is a broad-spectrum KIT and PDGFRα inhibitor. Mutations of Kit and PDGFRα are known to drive growth of GIST.

How is Qinlock given (administered)? Qinlock is administered orally.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Qinlock. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy and be monitored for primary cutaneous malignancies, hypertension and cardiac dysfunction.

What are the common (occur in 20% or more of patients) side effects of treatment with Qinlock?

· Hair loss

· Fatigue

· Nausea

· Abdominal pain

· Constipation

· Muscle Pain

· Diarrhea

· Decrease in appetite

· Vomiting

· Hand-foot syndrome

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What are some of the less common but potentially serious side effects of Qinlock?

· Cardiac dysfunction

· Hypertension

· New primary skin malignancy

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.

• Maintain adequate rest and nutrition.

• Wear sunscreen and protective clothing and try to minimize sun exposure.

• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)

• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.

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• Wash hands often to reduce the risk of infection.

• Eat small meals frequently to help alleviate nausea.

• Avoid activities that may cause injury or bruising.

• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.

Are there any special precautions patients should be aware of before starting treatment?

· Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.

· It is important that patients inform their physician of any pre-existing conditions including hand-foot syndrome, high blood pressure or heart problems as these may worse while on treatment with Qinlock.

· Patients should inform their healthcare provider if they have had or plan on having surgery as Qinlock can impair wound healing.

· Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.

· Patients should inform their physician if taking the blood thinner, warfarin, as they may require extra monitoring and dose adjustment.

· Patients should check with their physician before starting any new drug or nutritional supplement.

· Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

· Tiredness

· Swelling of abdomen, legs or ankles

· Shortness of breath

· Protruding Neck Veins

· New wart, skin sore, or reddish bump that bleeds and does not heal

· Change in size or color of a mole

· Redness, pain, blisters, bleeding, or swelling on the palms of your hands or soles of your feet

· Severe rash

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

Updated June 19, 2020