Aentrek 200 (Entrectinib)

Aentrek(entrectinib) is used to treat a certain type of non-small cell lung cancer (NSCLC) in adults that has spread to other parts of the body. It is also used to treat certain types of solid tumors in adults and children 12 years of age and older that cannot be treated by surgery or that has spread to other parts of the body and that worsened after treatment with other chemotherapy medications. Aentrek(entrectinib) is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

Usage

Aentrek(entrectinib) comes as a capsule to take by mouth. It is usually taken with or without food once daily. Take Aentrek(entrectinib)at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Take Aentrek(entrectinib) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open, chew, or crush them.

If you vomit immediately after you take Aentrek(entrectinib), take another dose as soon as possible.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions should follow

Before taking Aentrek(entrectinib)

• tell your doctor and pharmacist if you are allergic to Aentrek(entrectinib), any other medications, or any of the ingredients in Aentrek(entrectinib) capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the following: aprepitant (Emend), certain antifungal medications such as fluconazole (Diflucan), itraconazole (Omel, Sporanox), or ketoconazole; certain medications for arrhythmias such as amiodarone (Nexterone, Pacerone), procainamide, quinidine (in Nuedexta), and sotalol (Betapace, Sorine, Sotylize); azithromycin (Zithromax); clarithromycin (Biaxin, in Prevpac); diltiazem (Cardizem, Tiazac, others); erythromycin (E.E.S., Erythrocin, others); enzalutamide (Xtandi); certain HIV medications such as efavirenz (Sustiva, in Atripla), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra, others), or saquinavir (Invirase); lithium (Lithobid); modafinil (Provigil); nefazodone; oxcarbazepine (Trileptal); phenobarbital; phenytoin (Dilantin, Phenytek); pioglitazone (Actos, in Actoplus, Duetact, Oseni); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifater); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); and verapamil (Calan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with Aentrek(entrectinib), so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor what herbal products you are taking.
• tell your doctor if you have or have ever had a nervous system condition, a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), a slow or irregular heartbeat, a heart attack, heart failure, or heart or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for at least 5 weeks after your final dose. If you are a male, you and your partner should use birth control during your treatment with Aentrek(entrectinib) and for 3 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking Aentrek(entrectinib), call your doctor immediately. Entrectinib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking Aentrek(entrectinib) and for 7 days after the final dose.
• you should know that Aentrek(entrectinib)may make cause dizziness or confusion. Do not drive a car or operate machinery until you know how this medication affects you.

Special dietary instructions should I follow

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Missed or forget a dose

If you miss a dose by less than 12 hours, take the missed dose as soon as you remember it and then take the next dose at the scheduled time. However, if you miss a dose by more than 12 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects can this medication cause?

Aentrek(entrectinib) may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• constipation
• diarrhea
• taste changes
• headache
• cough, fever, or other signs of infection
• muscle or joint pain
• back pain
• weight changes
• rash
• difficulty falling or staying asleep

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• difficulty with learning, memory, attention, or problem solving
• mood changes such as anxiety, depression, confusion, or agitation
• bone pain or difficulty moving
• vision problems or changes in vision
• joint pain, stiffness, redness, or swelling
• pain in upper right part of the stomach, yellowing of skin or eyes, loss of appetite, or bleeding or bruising easily
• shortness of breath; difficulty breathing when lying down; or swelling of the arms, legs, hands, or feet

Aentrek(entrectinib) may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.