Why is this medication prescribed?

Rozlytrek (entrectinib) is a prescription medication used for the treatment of certain types of cancer. It is an oral tyrosine kinase inhibitor that targets specific proteins involved in the growth and survival of cancer cells. Rozlytrek is primarily indicated for:

• Non-Small Cell Lung Cancer (NSCLC): Rozlytrek is prescribed for the treatment of adult patients with metastatic NSCLC whose tumors are ROS1-positive.
• Neurotrophic Tyrosine Receptor Kinase (NTRK) Fusion-Positive Solid Tumors: It is also indicated for the treatment of adult and pediatric patients (12 years of age and older) with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

How should this medicine be used?

Rozlytrek (entrectinib) is a prescription medication used to treat certain types of cancer, and its use should be directed by a healthcare professional. The following is a general guideline for the use of Rozlytrek, but individual circumstances may vary:

• Dosage: The recommended dosage can vary depending on the specific type of cancer being treated and individual patient factors. The healthcare provider will determine the appropriate dose.
• Administration: Rozlytrek is typically taken orally in the form of capsules. The capsules should be swallowed whole with water and can be taken with or without food. It’s important not to open or crush the capsules.
• Genetic Testing: Before starting Rozlytrek, genetic testing may be performed to identify specific genetic abnormalities, such as ROS1 rearrangements or NTRK gene fusions, which make the patient eligible for treatment with Rozlytrek.
• Regular Monitoring: Healthcare providers may conduct regular monitoring, including liver function tests, during treatment to assess the patient’s response and manage any potential side effects.
• Contraception: Effective contraception is advised during treatment with Rozlytrek, as the medication may cause harm to a developing fetus.

Always follow your healthcare provider’s instructions regarding the use of Rozlytrek, and consult with them if you have any concerns or questions about the medication. It’s crucial to maintain open communication with your healthcare team to ensure the most effective and safe management of your cholesterol levels.

Other uses for this medicine

Rozlytrek is primarily approved for the treatment of ROS1-positive metastatic non-small cell lung cancer (NSCLC) and NTRK gene fusion-positive solid tumors. Ongoing research may explore additional uses for Rozlytrek, but patients should consult with their healthcare provider for the latest information on approved indications.

What special precautions should I follow?

Regarding special precautions for Rozlytrek, here are some key considerations:

• Genetic Testing: Before prescribing Rozlytrek, healthcare providers may perform genetic testing to determine if a patient’s cancer has specific genetic abnormalities, such as ROS1 rearrangements or NTRK gene fusions.
• Liver Function: Rozlytrek can affect liver function. Regular monitoring of liver function tests may be necessary during treatment. If a patient develops signs of liver problems, such as jaundice (yellowing of the skin or eyes), dark urine, or persistent nausea, they should contact their healthcare provider.
• Interactions with Other Medications: Patients should inform their healthcare provider about all medications, including prescription and over-the-counter drugs, as well as any supplements they are taking. Some medications may interact with Rozlytrek and affect its effectiveness or increase the risk of side effects.
• Pregnancy and Breastfeeding: Rozlytrek can cause harm to a developing fetus. Therefore, it is important for patients to use effective contraception during treatment and for some time after the last dose. Breastfeeding should be avoided while taking Rozlytrek.
• Central Nervous System (CNS) Effects: Rozlytrek may cause central nervous system side effects, such as dizziness, changes in mood or behavior, and cognitive impairment. Patients should exercise caution when operating machinery or driving until they know how Rozlytrek affects them.
• Gastrointestinal Effects: Rozlytrek may cause gastrointestinal side effects, including nausea, diarrhea, vomiting, and constipation. Patients should inform their healthcare provider if these symptoms are severe or persistent.

It’s important for individuals to communicate openly with their healthcare team, report any side effects or concerns promptly, and attend regular follow-up appointments to monitor their response to treatment.

As information can change, it’s advisable to consult with a healthcare professional or refer to the most recent prescribing information for Rozlytrek for the latest guidance and precautions.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Rozlytrek. However, it’s important to follow general guidelines for maintaining a healthy diet during cancer treatment. Patients should stay hydrated, consume a balanced diet rich in nutrients, and discuss any dietary concerns or restrictions with their healthcare team.

What should I do if I forget a dose?

If a dose of Rozlytrek is missed, the general recommendation is to take it as soon as possible unless it is within 12 hours of the next scheduled dose. If the missed dose is within 12 hours of the next dose, it’s advisable to skip the missed dose and resume the regular dosing schedule. It’s crucial not to take a double dose to make up for a missed one. If there are concerns or questions about missed doses, it’s important to contact the healthcare provider for guidance.

What side effects can this medication cause?

Rozlytrek (entrectinib) may cause a range of side effects, and the severity can vary from person to person. It’s important for individuals to be aware of potential side effects and to promptly report any new or worsening symptoms to their healthcare provider. Some common side effects of Rozlytrek include:

• Fatigue: Feeling tired or lethargic is a common side effect.
• Nausea: Gastrointestinal symptoms such as nausea and vomiting can occur.
• Constipation or Diarrhea: Changes in bowel habits, including constipation or diarrhea, may be experienced.
• Dizziness: Rozlytrek may cause dizziness or lightheadedness.
• Increased Liver Enzymes: Elevated liver enzymes may occur, and regular monitoring of liver function may be necessary.
• Edema (Swelling): Swelling, particularly in the hands, feet, or face, may occur.
• Cognitive Effects: Some individuals may experience changes in cognitive function, such as difficulty concentrating or memory changes.
• Weight Gain: An increase in body weight may occur.
• Muscle Pain: Muscular pain or discomfort is a potential side effect.
• Increased Blood Creatinine: Elevated levels of creatinine, a marker of kidney function, may be observed.
• Anemia: A reduction in red blood cell count, leading to anemia, can occur.
• Vision Disorders: Visual disturbances, including blurred vision, may occur.
• Elevated Blood Pressure: An increase in blood pressure may be observed.

It’s important to note that not everyone will experience these side effects, and some individuals may experience side effects that are not listed here. Additionally, serious side effects can occur, and patients are advised to seek immediate medical attention if they experience severe symptoms or allergic reactions.

Patients should communicate openly with their healthcare team, attend regular follow-up appointments, and report any side effects promptly. The healthcare provider will assess the risk-benefit profile for each individual and may adjust the treatment plan based on the patient’s response and tolerance to Rozlytrek.

What should I know about storage and disposal of this medication?

Storage and Disposal of Rozlytrek:

• Storage: Rozlytrek should be stored at room temperature, between 20°C to 25°C (68°F to 77°F). It is essential to keep the medication in its original container, away from moisture, and out of reach of children.
• Do Not Share Medication: Rozlytrek is prescribed specifically for the individual patient. It should not be shared with others, even if they have similar symptoms or conditions.
• Disposal: Proper disposal of medication is important. Unused or expired Rozlytrek should be returned to a pharmacy or healthcare provider for proper disposal. Do not dispose of medication in household trash or flush it down the toilet unless instructed to do so.

In case of emergency/overdose

In the event of an overdose or emergency, it’s important to seek immediate medical attention. Symptoms of overdose may vary, and the healthcare provider or emergency services will provide appropriate treatment. It’s crucial to have the container or packaging of the medication available to provide information to healthcare professionals.

What other information should I know?

• Liver Function Monitoring: Rozlytrek can affect liver function, and regular monitoring of liver function tests may be necessary.
• Interactions with Other Medications: Inform your healthcare provider about all medications, including prescription and over-the-counter drugs, and supplements you are taking, as interactions may occur.
• Pregnancy and Contraception: Rozlytrek can be harmful to a developing fetus. Effective contraception should be used during treatment, and patients should discuss family planning with their healthcare provider.
• Central Nervous System (CNS) Effects: Rozlytrek may cause CNS-related side effects, such as dizziness or cognitive changes. Caution is advised when operating machinery or driving.
• Gastrointestinal Effects: Inform your healthcare provider if you experience severe or persistent gastrointestinal side effects, such as nausea, vomiting, or diarrhea.
• Regular Follow-Up Appointments: Attend regular follow-up appointments with your healthcare provider to monitor treatment effectiveness and address any concerns.

Individuals should always follow their healthcare provider’s specific instructions and consult with them regarding any questions or concerns about Rozlytrek. Additionally, the prescribing information for Rozlytrek should be reviewed for the most up-to-date guidance.