Pronunciation:

rip-RE-ti-nib

Brand Names:

• Qinlock

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Ripretinib is used to treat gastrointestinal stromal tumor (GIST) in patients who have received treatment with at least 3 other medicines (eg, imatinib). GIST is a group of cancer cells that start growing in the wall of the stomach, bowels, or rectum.

Ripretinib belongs to the group of medicines known as antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed.

Before you begin treatment with ripretinib, you should talk to your doctor about the benefits as well as the risks of using this medicine.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ripretinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ripretinib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Apalutamide
• Bosentan
• Carbamazepine
• Cenobamate
• Efavirenz
• Enzalutamide
• Etravirine
• Fedratinib
• Fexinidazole
• Fosphenytoin
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mitotane
• Modafinil
• Nafcillin
• Omaveloxolone
• Phenobarbital
• Phenytoin
• Primidone
• Rifabutin
• Rifampin
• St John's Wort

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or
• Skin problems (eg, skin cancer)—Use with caution. May make these conditions worse.

• Hypertension (high blood pressure), uncontrolled—This condition must be corrected first before using and during treatment with this medicine.

• Kidney disease, severe or
• Liver disease, moderate or severe—Use with caution. This medicine has not been studied in patients with these conditions.

• Surgery, recent—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with patient information insert. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Take this medicine at the same time each day. You may take it with or without food.

Swallow the tablet whole. Do not crush, break, or chew it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For gastrointestinal stromal tumor (GIST):
    • Adults—150 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 8 hours of your scheduled dose, take it as soon as possible and then go back to your regular dosing schedule. If you miss a dose and it is more than 8 hours of your scheduled dose, skip the missed dose and go back to your regular dosing schedule. If you vomit after taking a dose, take the next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 1 week after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 1 week after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Ripretinib may cause a serious skin problem called hand-foot syndrome or palmar-plantar erythrodysesthesia syndrome. Tell your doctor right away if you have a rash that does not go away or redness, pain, swelling, bleeding, or blisters on the palms of your hands or soles of your feet.

This medicine may increase your risk for new skin cancers (eg, cutaneous squamous cell carcinoma, melanoma). Check with your doctor right away if you have a new wart, skin sore or reddish bump that bleeds or does not heal, or change in size or color of a mole.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. If you think your blood pressure is too high, call your doctor right away.

Check with your doctor right away if you have chest pain or discomfort, dilated neck veins, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, unusual tiredness or weakness, or weight gain. These could be symptoms of a heart problem (eg, cardiac failure, acute left ventricular failure, diastolic dysfunction, ventricular hypertrophy).

This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several days before and after having surgery.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid exposure to direct sunlight, sunlamps, or other ultraviolet radiation during treatment and for at least 1 week after the last dose.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blistering, peeling, loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

chest tightness

constipation

diarrhea

difficult or labored breathing

dizziness

headache

nausea or vomiting

nervousness

pounding in the ears

rash, redness, swelling, pain, or ulceration of the skin

scaling of the skin on the hands and feet

slow or fast heartbeat

stomach pain

tingling of the hands or feet

unusual weight gain or loss

Less common

Change in size, shape, or color of existing mole

chest pain or discomfort

decreased urine output

dilated neck veins

irregular breathing

irregular heartbeat

mole that leaks fluid or bleeds

new mole

pale skin

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Rare

Increased sensitivity of the skin to sunlight

redness or other discoloration of the skin

severe sunburn

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty in moving

dry or itching skin

joint pain or swelling

lack or loss of strength

loss of appetite

loss or thinning of the hair

muscle pains or stiffness

swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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