Rozlytrek (Entrectinib) belongs to the class of medications called antineoplastic agents. Specifically, it is a tyrosine kinase inhibitor.

Rozlytrek (Entrectinib) is used to treat non-small cell Lung Cancer (NSCLC) that is advanced or has spread to other parts of the body, and that has a specific error in a gene called ROS1. 

Rozlytrek (Entrectinib) works by blocking the actions of specific enzymes which have an error in them. These faulty enzymes allow the cancer to grow. Blocking these enzymes may slow down or stop the cancer from growing.

NOC/c

Rozlytrek (Entrectinib) has been granted a notice of compliance with conditions (NOC/c) by Health Canada. for the treatment of solid tumours with a specific gene fault called Neurotrophic Tyrosine Receptor Kinase (NTRK) that have spread to other parts of the body and there are no other treatment options. This means that Health Canada has approved Rozlytrek (Entrectinib) to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.

Rozlytrek (Entrectinib) may be available under multiple brand names and/or in several different forms. Any specific brand name of Rozlytrek (Entrectinib) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Rozlytrek (Entrectinib) may not be used for all of the conditions discussed here.

Your doctor may have suggested Rozlytrek (Entrectinib) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Rozlytrek (Entrectinib), speak to your doctor. Do not stop taking Rozlytrek (Entrectinib) without consulting your doctor.

Do not give Rozlytrek (Entrectinib) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Rozlytrek (Entrectinib) if their doctor has not prescribed it.

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The recommended dose of Rozlytrek (Entrectinib) is 600 mg (3 x 200 mg capsules) taken by mouth, once daily. The capsules must be swallowed whole with some water. Do not crush, chew, or dissolve the medication. It may be taken with food or on an empty stomach.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Rozlytrek (Entrectinib) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. If you vomit immediately after taking a dose of Rozlytrek (Entrectinib), you may take another dose at that time. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice .

Store Rozlytrek (Entrectinib) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Rozlytrek (Entrectinib). If you are concerned about side effects, discuss the risks and benefits of Rozlytrek (Entrectinib) with your doctor.

The following side effects have been reported by at least 1% of people taking Rozlytrek (Entrectinib). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• change in sense of taste
• Constipation
• cough
• Diarrhea
• difficulty swallowing
• dizziness
• headache
• joint, muscle, or nerve pain
• loss of appetite
• muscle weakness
• nausea
• rash
• swelling
• tiredness
• trouble sleeping
• unusual sensation of touch
• vomiting
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• agitation
• anxiety
• broken bones
• confusion
• decreased attention or awareness
• disorientation
• fainting
• hallucinations (e.g., seeing or hearing things that aren't there)
• Low Blood Pressure (e.g., dizziness or fainting when rising from a lying or sitting position)
• memory problems
• problems with muscle coordination (e.g., difficulty walking, using fingers, loss of balance, slurred speech)
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of Gout (e.g., joint pain, swelling and warmth of joints)
• signs of heart failure (e.g., fast, irregular heartbeat or pulse; chest pain; sudden weight gain; difficulty breathing; leg swelling)
• signs of infection (symptoms may include Fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of lung problems (e.g., difficult or painful breathing, shortness of breath, cough, wheezing, chest pain)
• symptoms of abnormal heart rhythms (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
• vision changes (e.g., blurred vision, loss of vision, double vision, increased sensitivity to light, spots in vision)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• blood clot in lung (e.g., severe chest pain, shortness of breath, coughing up blood)
• seizures
• sepsis (infection spread into the bloodstream; e.g., fever, shaking, chills, fast heart rate, rapid, shallow breathing)
• symptoms of tumour lysis syndrome (nausea, shortness of breath, irregular heartbeat, decreased urination, muscle spasms or weakness)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Rozlytrek (Entrectinib).

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100 mg
Each yellow, opaque, hard-shelled capsule contains 100 mg of Rozlytrek (Entrectinib). Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and tartaric acid; capsule shell: hypromellose, titanium dioxide, and yellow iron oxide; printing ink: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, and strong ammonia solution.

200 mg
Each orange, opaque, hard-shelled capsule contains 200 mg of Rozlytrek (Entrectinib). Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and tartaric acid; capsule shell: hypromellose, titanium dioxide, and FD&C Yellow No. 6; printing ink: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, and strong ammonia solution.

Do not take Rozlytrek (Entrectinib) if you are allergic to Rozlytrek (Entrectinib) or any ingredients of the medication.

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There may be an interaction between Rozlytrek (Entrectinib) and any of the following:

• antiarrythmics (e.g., Amiodarone, Disopyramide, Dronedarone, procainamide, Propafenone, quinidine, quinine, Sotalol)
• antipsychotics (e.g., Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone, Ziprasidone)
• Apalutamide
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Bosentan
• Citalopram
• Cobicistat
• conivaptan
• Deferasirox
• Diltiazem
• Domperidone
• efavirenz
• Enzalutamide
• Escitalopram
• grapefruit juice
• Hepatitis C antivirals (e.g., dasabuvir, ombitasvir, paritaprevir)
• HIV protease inhibitors (e.g., atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir)
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• mifepristone
• Modafinil
• Ondansetron
• protein kinase inhibitors (e.g., Crizotinib, Dabrafenib, imatinib, Lenvatinib, Palbociclib, Vandetanib)
• quinolone antibiotics (e.g., levofloxacin, moxifloxacin)
• rifabutin
• rifampin
• St. John's wort
• Sarilumab
• seizure medications (e.g., Carbamazepine, Eslicarbazepine, Phenobarbital, Phenytoin, primidone)
• Stiripentol
• Tocilizumab
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Rozlytrek (Entrectinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Rozlytrek (Entrectinib).

Birth control: Rozlytrek (Entrectinib) may cause harm to the developing baby if it is taken by either parent while the mother is pregnant. Women who may become pregnant should use effective birth control while taking Rozlytrek (Entrectinib) and for 5 weeks after taking the last dose. Men taking Rozlytrek (Entrectinib), whose partners may become pregnant, should use effective birth control during treatment and for 3 months after the last dose.

Bone health: Rozlytrek (Entrectinib) has been associated with an increased risk in fractures, which may occur within several months of starting to take Rozlytrek (Entrectinib). While some fractures are reported after falls or other injuries, some fractures have been reported with no memorable cause. Most fractures occur in the legs or hips. Report any unusual pain to your doctor immediately.

Driving/operating machinery: Rozlytrek (Entrectinib) may cause dizziness, blurred vision, or decreased mental alertness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how Rozlytrek (Entrectinib) affects you.

Heart failure: Rozlytrek (Entrectinib) may cause or worsen symptoms of Congestive Heart Failure. If you have heart disease such as Angina, congestive heart failure, or arrhythmia, discuss with your doctor how Rozlytrek (Entrectinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Rozlytrek (Entrectinib), and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart failure, such as shortness of breath, rapid heartbeat, or swollen legs, feet, or hands.

Heart rhythm: Rozlytrek (Entrectinib) can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how Rozlytrek (Entrectinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Rozlytrek (Entrectinib), and whether any special monitoring is needed.

Your doctor will monitor your heart rhythm regularly while you are taking Rozlytrek (Entrectinib) with a test called an electrocardiogram (ECG). You should not take Rozlytrek (Entrectinib) if your ECG already shows that you have QT prolongation or if you are taking a medication that can cause QT prolongation.

Liver function: Liver disease or reduced liver function may cause Rozlytrek (Entrectinib) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Rozlytrek (Entrectinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Rozlytrek (Entrectinib), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Rozlytrek (Entrectinib).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Tumour lysis syndrome: Rozlytrek (Entrectinib), like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea and shortness of breath, and notice cloudy urine or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Pregnancy: Rozlytrek (Entrectinib) should not be used during pregnancy, as it may cause harm to the developing baby. If you become pregnant while taking Rozlytrek (Entrectinib), contact your doctor immediately.

Breast-feeding: It is not known if Rozlytrek (Entrectinib) passes into breast milk. If you are a breast-feeding mother and are taking Rozlytrek (Entrectinib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Rozlytrek (Entrectinib) have not been established for children.

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