Why is this medication prescribed?

Entrectinib is a medication used for the treatment of certain types of cancer, particularly solid tumors that have specific genetic mutations. It falls under the category of targeted therapy, which means it works by targeting specific molecules or genetic mutations involved in the growth and spread of cancer cells.

Entrectinib is prescribed for the following indications:

• Non-small cell lung cancer (NSCLC): It is used in adults whose cancer has a specific genetic alteration called ROS1 fusion, as detected by an FDA-approved test, and who have progressed on or are intolerant to other treatments.
• Neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumors: Entrectinib is indicated for the treatment of adults and pediatric patients 12 years of age and older with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, who have progressed following prior treatment or have no satisfactory alternative treatment options.

How should this medicine be used?

Entrectinib is typically administered orally in capsule form. The dosage and schedule may vary depending on individual factors such as the type of cancer being treated, the patient’s overall health, and other medications they may be taking. It’s crucial to follow the specific instructions provided by the prescribing healthcare provider.

It’s essential to take Entrectinib exactly as prescribed, at the same time each day, with or without food, as directed by the healthcare provider. It’s not recommended to chew, crush, or open the capsules. If a dose is missed, the patient should take it as soon as they remember, unless it is within 12 hours of the next scheduled dose, in which case they should skip the missed dose and take the next dose at the regular time. It’s important not to take extra doses to make up for a missed one.

Patients should also be aware of potential side effects and contact their healthcare provider if they experience any concerning symptoms while taking Entrectinib. Additionally, regular monitoring and follow-up appointments with the healthcare team are typically recommended to assess the treatment’s effectiveness and manage any side effects.

Other uses for this medicine

Entrectinib is primarily used for the treatment of specific types of cancer, particularly solid tumors with certain genetic alterations such as ROS1 fusion or NTRK gene fusion. However, there may be ongoing clinical trials investigating its potential use in other cancer types or settings. Patients should consult their healthcare provider or clinical trial registries for information on any other potential uses of Entrectinib.

What special precautions should I follow?

As for special precautions to be followed when using Entrectinib, it’s important for patients to discuss their medical history, current medications, and any underlying health conditions with their healthcare provider before starting treatment. Additionally, here are some key precautions to consider:

• Pregnancy and breastfeeding: Entrectinib may harm an unborn baby, so it’s essential to use effective contraception during treatment and for some time after the last dose. Breastfeeding should be avoided while taking Entrectinib and for some time after the last dose, as it may pass into breast milk and harm the nursing infant.
• Liver function: Entrectinib may cause liver problems, so regular monitoring of liver function tests may be necessary during treatment. Patients with pre-existing liver disease may require special monitoring or dose adjustments.
• Heart problems: Entrectinib may cause heart rhythm abnormalities, so patients with a history of heart problems or those taking medications that affect heart rhythm should be closely monitored during treatment.
• Interactions with other medications: Entrectinib may interact with certain medications, including strong CYP3A inhibitors and inducers, which could affect its effectiveness or increase the risk of side effects. Patients should inform their healthcare provider about all medications, supplements, and herbal products they are taking before starting Entrectinib.
• Central nervous system (CNS) effects: Entrectinib may cause dizziness, confusion, or other CNS-related side effects, which could impair the ability to drive or operate machinery. Patients should use caution when engaging in activities that require mental alertness until they know how Entrectinib affects them.
• Tumor lysis syndrome: In some cases, Entrectinib may cause tumor lysis syndrome, a serious condition that can occur when cancer cells release their contents into the bloodstream rapidly. Patients may require monitoring and treatment to prevent or manage this complication.

These are general precautions, and patients should follow the specific guidance provided by their healthcare provider. It’s essential to report any concerning symptoms or side effects experienced during treatment with Entrectinib promptly.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Entrectinib. However, it’s essential to maintain a balanced diet and stay well-hydrated during treatment. If you have any dietary concerns or restrictions due to other medical conditions, consult with your healthcare provider or a registered dietitian for personalized guidance.

What should I do if I forget a dose?

If you miss a dose of Entrectinib, take it as soon as you remember, unless it’s within 12 hours of the next scheduled dose. In that case, skip the missed dose and take the next dose at the regular time. Do not take extra doses to make up for a missed one. If you’re unsure about what to do, or if you’ve missed multiple doses, contact your healthcare provider or pharmacist for advice. It’s important to maintain the prescribed dosing schedule to ensure the effectiveness of the treatment.

What side effects can this medication cause?

Entrectinib, like many medications, can cause side effects, although not everyone will experience them. Common side effects of Entrectinib may include:

• Fatigue
• Nausea and vomiting
• Constipation
• Diarrhea
• Dizziness
• Swelling (edema) in various parts of the body
• Weight gain
• Cognitive changes such as difficulty concentrating or memory problems
• Changes in taste
• Increased blood levels of liver enzymes (aspartate transaminase and alanine transaminase)
• Anemia (low red blood cell count)
• Increased blood creatinine levels (a marker of kidney function)
• Shortness of breath
• Headache
• Muscle pain or weakness
• Joint pain
• Vision changes

These side effects are not exhaustive, and there may be other potential adverse reactions associated with Entrectinib. Additionally, some side effects may be severe or require medical attention. It’s crucial for patients to report any concerning symptoms or side effects to their healthcare provider promptly.

In rare cases, Entrectinib may cause more serious side effects, including:

• Liver problems: Signs of liver problems may include yellowing of the skin or eyes (jaundice), dark urine, abdominal pain, or unusual tiredness.
• Heart rhythm abnormalities: Symptoms may include palpitations, fainting, dizziness, or shortness of breath.
• Tumor lysis syndrome: This is a rare but serious complication that can occur when cancer cells release their contents into the bloodstream rapidly. Symptoms may include nausea, vomiting, weakness, muscle cramps, seizures, or changes in kidney function.
• Central nervous system effects: In some cases, Entrectinib may cause severe dizziness, confusion, or other CNS-related symptoms.

Patients should contact their healthcare provider immediately if they experience any severe or concerning side effects while taking Entrectinib. It’s essential to discuss the risks and benefits of treatment with Entrectinib with your healthcare provider before starting therapy.

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

Storage and disposal of Entrectinib:

• Storage: Store Entrectinib capsules at room temperature between 68°F to 77°F (20°C to 25°C) in a dry place away from moisture and heat. Keep the medication in its original container, tightly closed, and out of reach of children and pets.
• Disposal: Dispose of any unused or expired Entrectinib capsules properly according to local regulations or guidelines. Do not flush them down the toilet or pour them into a drain unless instructed to do so. Consult with your healthcare provider or pharmacist for guidance on the proper disposal method.

In case of emergency/overdose

In case of an overdose or emergency situation involving Entrectinib, seek immediate medical attention or contact a poison control center right away. It’s essential to provide as much information as possible, including the amount of medication ingested, the time of ingestion, and any symptoms experienced

What other information should I know?

• Regular monitoring: Your healthcare provider may conduct regular blood tests and medical evaluations to monitor your response to Entrectinib and check for any potential side effects or complications.
• Follow-up appointments: Attend all scheduled follow-up appointments with your healthcare provider to discuss your treatment progress, any concerns or side effects you may be experiencing, and any necessary adjustments to your treatment plan.
• Avoid grapefruit: Grapefruit and grapefruit juice may interact with Entrectinib and lead to increased levels of the medication in the bloodstream, potentially increasing the risk of side effects. Avoid consuming grapefruit or grapefruit products while taking Entrectinib.
• Inform healthcare providers: Make sure to inform all healthcare providers involved in your care, including doctors, dentists, and pharmacists, that you are taking Entrectinib. This is important to prevent potential interactions with other medications or procedures.
• Patient Assistance Programs: If you’re experiencing financial difficulties in accessing Entrectinib, inquire with your healthcare provider or the pharmaceutical company about patient assistance programs or support options that may be available to you.

Always follow your healthcare provider’s instructions and recommendations regarding the use of Entrectinib, and do not hesitate to ask any questions or seek clarification about your treatment plan or medication regimen. Your safety and well-being are paramount, and your healthcare team is there to support you throughout your treatment journey.