Entrectinib Capsules

What is this medication?

ENTRECTINIB (en TREK ti nib) treats some types of cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ROZLYTREK

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Anxiety or panic attacks
• Bone problems
• Dementia
• Depression
• Eye disease, vision problems
• Heart disease or heart failure
• History of irregular heartbeat
• Kidney disease
• Liver disease
• Trouble sleeping
• An unusual or allergic reaction to entrectinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medication. Swallow the capsules whole. Do not take with grapefruit juice. You can take it with or without food. If it upsets your stomach, take it with food. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Pimozide
• Thioridazine

This medication may also interact with the following medications:

• Aprepitant
• Bosentan
• Certain antibiotics, such as erythromycin or clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole
• Certain medications for irregular heart beat, such as amiodarone, dofetilide, encainide, flecainide, propafenone, quinidine
• Certain medications for mental health conditions
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Cimetidine
• Ciprofloxacin
• Conivaptan
• Crizotinib
• Cyclosporine
• Digoxin
• Diltiazem
• Enzalutamide
• Grapefruit juice
• Idelalisib
• Imatinib
• Mifepristone
• Mitotane
• Modafinil
• Other medications that cause heart rhythm changes
• Rifampin
• St. John's Wort
• Verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop. You will need blood work done while you are taking this medication.

Tell your care team right away if you have any change in your eyesight.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Call your care team for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This medication decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Do not become pregnant while taking this medication or for 5 weeks after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medication and for 3 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your care team or pharmacist for more information.

Do not breast-feed while taking this medication or for 7 days after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High uric acid level—severe pain, redness, warmth, or swelling in joints, pain or trouble passing urine, pain in the lower back or sides
• Infection—fever, chills, cough, or sore throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Difficulty with paying attention, memory, or speech
• Dizziness
• Joint pain
• Nausea
• Trouble sleeping
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store below 30 degrees C (86 degrees F). Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.