Aentrek ENTRECTINIB 100MG 30'S Approval No. 02 L 0844/21 Expiry Date 21-8-2027

[Indications]

ROS1-positive non-small cell lung cancer. For adults whose cancer has metastasized (spread to other parts of the body).

Solid tumors with NTRK gene fusions but without certain TRK protein resistance mutations. For adults and children over 12 years old whose cancer has metastasized or cannot be removed by surgery, has progressed after other treatments, or cannot be treated with other therapies.

[Usage and Dosage]

Entrectinib comes as a capsule that you take by mouth. It is usually taken once daily with or without food.

Swallow the capsule whole without opening, chewing or crushing.

If you vomit right after taking entrectinib, take another dose as soon as possible.

Missed doses

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

How to take entrectinib

Entrectinib comes as a capsule that you take by mouth. It is usually taken once daily with or without food. Take entrectinib at about the same time each day. Follow the instructions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you don't understand. Take entrectinib exactly as directed. Do not take more or less of it, or more often than your doctor prescribed.

Swallow the capsule whole without opening, chewing or crushing.

If you vomit right after taking entrectinib, take another dose as soon as possible.

[Precautions for taking entrectinib]

1. If you are allergic to entrectinib, any other medicines, or any of the ingredients in entrectinib capsules, tell your doctor and pharmacist. Ask your pharmacist for a list of ingredients.

Tell your doctor and pharmacist about other prescription and over-the-counter medicines, vitamins, nutritional supplements, and herbal products you take or plan to take. Be sure to mention the following: aprepitant (Emend), certain antifungal medicines such as fluconazole (Diflucan), itraconazole (Omel, Sporanox), or ketoconazole. Certain medicines for abnormal heart rhythms, 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 (Ees. Erythrocin, others); enzalutamide (Xtandi); certain HIV medicines, such as efavirenz (Sustiva, in Atripla), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra, others), or saquinavir (Invirase); lithium (Lithobid); modafinil (Provigil); and 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 dose of your medication or monitor you carefully for side effects. Many other drugs can also interact with entrectinib, so be sure to tell your doctor about all the medicines you are taking, even those that do not appear on this list.

2. Tell your doctor what herbal products you are taking, especially St. John's wort.

3. Tell your doctor if you have or have ever had a nervous system disease, QT prolongation (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.

4. Tell your doctor if you are pregnant, planning to become pregnant, or planning to have children. If you are a woman, you need to take a pregnancy test before starting treatment and use contraception to prevent pregnancy during treatment and for at least 5 weeks after the last dose. 5. If you are a man, you and your partner should use contraception during your treatment with entrectinib and for 3 months after the last dose. Talk to your doctor about contraception methods you can use during treatment. If you or your partner becomes pregnant while taking entrectinib, call your doctor immediately. Entrectinib may harm the fetus.

6. Tell your doctor if you are breast-feeding. You should not breast-feed while you are taking entrectinib and after 7 days of your last dose.

7. You should know that entrectinib may cause dizziness or confusion. Do not drive a car or operate machinery until you understand how this medicine affects you.

[Dietary taboos when taking entrectinib]

Do not eat grapefruit or drink grapefruit juice while you are taking this medicine.

What should I do if I forget to take my medicine?

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

[What are the side effects of entrectinib]

Common side effects of entretinoinib include fatigue, constipation, dyspepsia, edema, dizziness, diarrhea, nausea, paresthesia, dyspnea, myalgia, cognitive impairment, weight gain, cough, vomiting, fever, arthralgia, and visual impairment.

The most serious side effects are congestive heart failure, central nervous system effects, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation, and visual disturbances.

Entrectinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away.

Tiredness; constipation; diarrhea; change in taste; headache; cough, fever, or other symptoms of infection.

Muscle or joint pain; back pain; weight changes; rash; trouble sleeping. Some side effects may be serious.

If you experience any of these symptoms, call your doctor or get emergency treatment right away.

Difficulty learning, remembering, or concentrating; mood changes, such as anxiety, depression, confusion, or irritability.

Bone pain or difficulty moving; vision problems or vision changes; joint pain, stiffness, redness, or swelling.

Pain in the upper right side of your stomach, yellowing of your skin or eyes, loss of appetite, or easy bleeding or bruising.

shortness of breath; trouble breathing when lying down; or swelling in your arms, legs, hands, or feet.

Entrectinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.

Entrectinib dosage instructions:

Entrectinib capsules can be taken orally. Usually taken once a day, with or without food.

Swallow the capsule whole without opening, chewing or crushing.

If you vomit right after taking entrectinib, take another dose as soon as possible.

Entrectinib dosage:

Specifications: 100mg*30 tablets, 200mg*90 tablets

Adults with metastatic ROS1-positive non-small cell lung cancer:

Oral, 600 mg once a day until disease progression or unacceptable toxicity

NTRK gene fusion-positive solid tumors:

aldult:

Oral, 600 mg once a day until disease progression or unacceptable toxicity

Children 12 years and older:

Body surface area > 1.50 m2: Oral, 600 mg once a day

Body surface area 1.11-1.50 m2: Oral, 500 mg, once a day

Body surface area 0.91-1.10 m2: Oral, 400 mg once a day

Missed doses

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