Rozlytrek (Entrectinib)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Rozlytrek Used For?
Rozlytrek is a targeted cancer medicine that works by blocking specific altered enzymes that help cancer cells grow and spread.
Primary Uses
Rozlytrek treats adults with ROS1-positive non-small cell lung cancer that is advanced or has spread to other parts of the body. It also treats children 12 years and older, adolescents, and adults with NTRK fusion-positive cancers that are advanced or metastatic when other treatments haven’t worked or aren’t suitable.
How It Works
Rozlytrek blocks the action of altered enzymes caused by changes in NTRK or ROS1 genes. These altered enzymes encourage cancer cells to grow. By blocking them, Rozlytrek may slow down or stop cancer growth and may help shrink tumors.
Provisional Approval: This medicine has provisional approval in Australia based on preliminary studies. More evidence is being collected to fully confirm its benefits and safety.
How to Take Rozlytrek
Take Rozlytrek exactly as prescribed by your doctor. The capsules should be swallowed whole with water and never opened or chewed.
Dosage Instructions
Adults: Take 600 mg (3 x 200 mg capsules) once daily at about the same time each day. Children and adolescents: Your doctor will calculate the dose based on weight and height. Take with or without food. If you vomit immediately after taking a dose, take another dose.
What If You Miss a Dose?
If more than 12 hours until your next dose: Take the missed dose as soon as you remember. If less than 12 hours until your next dose: Skip the missed dose and take your next dose at the usual time.
Important: Never take a double dose to make up for a missed dose. Always swallow capsules whole – do not open, dissolve, or chew them.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Diarrhea and/or constipation
- Nausea and/or vomiting
- Stomach pain
- Loss of muscle coordination, unsteady walking
- Muscle weakness and/or pain
- Feeling tired
- Fever
- Difficulty swallowing
- Changes in taste
- Numbness or weakness in arms and legs
- Symptoms of anemia (tiredness, shortness of breath, dizziness, pale appearance)
- Weight gain
- Loss of appetite
- Dehydration
- Blurred vision
- Rash
- Swelling or puffiness of skin
- Sleep disturbances
- Headache
- Joint pain or bone discomfort
Seek immediate medical attention if you experience:
- Persistent coughing or wheezing, shortness of breath, swelling in legs or arms (fluid retention)
- Feeling dizzy or light-headed (may indicate abnormal heart rhythm or low blood pressure)
- Loss of consciousness or fainting
- Feeling confused, mood changes, memory problems, hallucinations
- Tumor lysis syndrome symptoms: nausea, vomiting, muscle cramps, decreased urination, irritability, seizures
Important Warnings
Before taking Rozlytrek, tell your doctor about all your medical conditions and medications to ensure it’s safe for you.
Who Should Not Take Rozlytrek
Do not take Rozlytrek if you are allergic to entrectinib or any ingredients in the capsules. Signs of allergic reaction include shortness of breath, wheezing, difficulty breathing, swelling of face/lips/tongue, rash, itching, or hives.
Medical Conditions to Discuss
Tell your doctor if you have heart problems (prolonged QT interval, congestive heart failure), inherited sugar intolerance problems (galactose intolerance, lactase deficiency, glucose-galactose malabsorption), liver problems, or kidney problems.
Pregnancy and Breastfeeding
Rozlytrek may harm an unborn baby. Do not take if pregnant. Women must use effective contraception during treatment and for 5 weeks after the last dose. Men must use effective contraception during treatment and for 3 months after the last dose. Do not breastfeed while taking Rozlytrek.
Pregnancy Warning: This medication can cause serious harm to an unborn baby. Both men and women must use effective birth control during treatment and for weeks/months after stopping.
Drug Interactions
Several medications can interfere with Rozlytrek and affect how it works. Always tell your doctor about all medicines you’re taking.
Grapefruit interaction: Do not drink grapefruit juice or eat grapefruit during treatment. It may increase the medicine in your blood to harmful levels.
- Cancer medicines: nilotinib, topotecan, lapatinib, mitoxantrone
- Immunosuppressants: everolimus, sirolimus
- St. John’s Wort (herbal antidepressant)
- HIV medicines: ritonavir, saquinavir
- Antifungal medicines: ketoconazole, itraconazole, voriconazole, posaconazole
- Anti-seizure medicines: phenytoin, carbamazepine, phenobarbital
- Antibiotics: rifampicin, rifabutin
Alcohol & Driving
Rozlytrek can affect your ability to drive safely and operate machinery. Be cautious until you know how this medication affects you.
Alcohol
The source does not specifically mention alcohol interactions, but discuss alcohol use with your doctor as it may interact with your treatment.
Driving and Operating Machinery
Be careful driving or using machines until you know how Rozlytrek affects you. This medication may cause confusion, hallucinations, fainting, blurred vision, or dizziness. If you experience these symptoms, do not drive or operate machinery. Children should be careful when riding bicycles or climbing trees.
Storage
Store Rozlytrek in the original bottle, tightly closed, at room temperature below 30°C (86°F). Keep in a cool, dry place away from moisture, heat, and sunlight. Do not store in the bathroom, near a sink, in the car, or on window sills. Keep out of reach of children. Take expired or unwanted medicine to any pharmacy for safe disposal.
Overdose Information
If you think you have taken too much Rozlytrek, seek urgent medical attention immediately. Call the Poisons Information Centre at 13 11 26, contact your doctor, or go to the nearest hospital Emergency Department, even if you feel fine or have no symptoms of poisoning.
Frequently Asked Questions
The source doesn’t specify how long Rozlytrek takes to work. Your doctor will monitor your progress with regular blood tests and check-ups to see how well the medication is working for your specific cancer.
Yes, Rozlytrek capsules can be taken with or without food. Take them with a full glass of water and swallow them whole – never open, dissolve, or chew the capsules.
If it’s more than 12 hours until your next dose, take the missed dose as soon as you remember. If it’s less than 12 hours until your next dose, skip the missed dose and take your next dose at the usual time. Never take a double dose.
No, do not drink grapefruit juice or eat grapefruit during your treatment with Rozlytrek. Grapefruit may increase the amount of medicine in your blood to harmful levels.
Do not stop taking Rozlytrek suddenly, even if you feel well. Always talk to your doctor before stopping or changing the amount you take. Your doctor may need to gradually adjust your treatment.
Yes, both men and women must use highly effective contraception during treatment. Women should continue contraception for at least 5 weeks after the last dose, and men for at least 3 months after the last dose.
If you vomit immediately after taking a dose of Rozlytrek, take another dose. However, if vomiting continues to be a problem, contact your doctor as they may need to adjust your treatment.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.