Rozlytrek specifically contains the active pharmaceutical drug entrectinib. It belongs to a group of medicines called anti-neoplastic (or anti-cancer) agents which are used for the treatment of cancer.
Rozlytrek (entrectinib) is designed to work by inhibiting the action of enzymes which have an alteration in them. This is due to the alteration in the NTRK or ROS1 genes that creates them. The altered enzymes encourage the cancerous cells to grow. This medication may resist or stop the cancer progression. It may also help in order to shrink the cancer. Rozlytrek is typically available in 100 mg and 200 mg capsules.
Therapeutic Indication(s)
Solid Tumors: The rozlytrek capsule is authorized to treat adult and pediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive locally advanced or metastatic solid tumors, who have progressed after previous therapies, or as initial therapy when there are no acceptable standard therapies.
Non-small cell lung cancer (NSCLC): Capsule of rozlytrek is also authorized to treat patients with ROS1-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
Note: Other drugs used for the treatment of Non-small cell lung cancer are as follows:
Posology and Method of Administration
Rozlytrek (entrectinib capsule) can be taken either with or without food, swallowed completely or whole and must not be opened or dissolved.
Adults: The recommended dose for adult patients is 600 mg given orally (by mouth), once daily.
Pediatric patients: The recommended dose for pediatric patients who have the ability to swallow capsules is 300 mg/m2 orally (by mouth), once daily.
The recommended dose for paediatric patients aged 12 years or older is based on body surface area (BSA); the dose for paediatric patients with a BSA of 1.11 to 1.50 m2
is 400 mg entrectinib once daily; the dose for paediatric patients with a BSA of ≥1.51 m2 is 600 mg entrectinib once daily.
Duration of Treatment: Treatment with Rozlytrek is recommended to continue until the disease is progressive or unacceptable toxicity occurs.
A validated assay is needed for the selection of patients with NTRK gene fusion +Ve solid tumours. NTRK gene fusion +Ve status must be established before initiating therapy with entrectinib. This treatment should be started by a health specialist experienced in the use of anticancer medicinal products.
Delayed or Missed Doses: In case a planned dosage is missed, patients can make up that dose unless the next scheduled dose is due within 12 hours. If vomiting occurs promptly after taking a dose of rozlytrek 600 mg, patients may repeat that dose.
Possible Adverse Reactions
Like all medicinal products, entrectinib may have certain undesired adverse reactions. Sometimes they are severe; most of the time they are minimal. Medical attention is needed in order to manage these adverse reactions. Tell your health specialist if you observe any of the following and they worry you. Your health specialist may be able to change your entrectinib dose to stop these adverse reactions happening for you.
Muscle pain: You may have muscle pain, tenderness, or weakness.
What to do:
- Report to your health specialist before you take any over-the-counter pain medication.
- Drink water throughout the day.
- Get plenty of rest.
- Avoid lifting heavy objects.
- Call your health specialist in case your muscle pain makes you unable to perform your normal daily activities.
Fluid retention: You may have swelling of your face,
lower legs or arms.
What to do:
- Call your health specialist in case you have swelling in any portion of your body.
Taste changes: You may experience taste changes while eating or drinking.
What to do:
- Talk to your health specialist in case taste changes are causing it to be hard to eat or drink.
Changes in Mental Status: You may experience changes in mental status.
What to do: Call your health specialist in case you have any of the following
- Changes in the ability to think (confusion, forgetfulness, or disturbance in attention)
- Dizziness
Diarrhea: You may have diarrhea during treatment with entrectinib.
What to do: Call your health specialist in case this happens beyond 4 times a day, or lasts for more than 1/2 days or in case you feel dizzy or lightheaded. Your health specialist may instruct you to take a medicine named Loperamide (Imodium). It is crucial to follow your health specialist’s instructions for taking this medication.
Constipation: You may have constipation during treatment with entrectinib 200 mg capsules.
What to do:
- Eat foods that are enriched with fiber; consume plenty of water.
- Call your health specialist in case you have increased straining or abdominal pain with bowel movements.
- Discuss with your health specialist about using stool softeners and laxatives in order to maintain regular bowel movements.
- Call your health specialist in case you do not have a bowel movement for a couple of days or you are not comfortable because you are not able to have a bowel movement.
This is not a full list of all probable adverse reactions. Tell your health specialist in case you have these or any other adverse reactions that you think are caused by entrectinib 100 mg capsules.
Precautions While on Rozlytrek
- Avoid eating grapefruit or drinking grapefruit juice. This can be responsible for increasing your risk of adverse reactions.
- Avoid taking St. John’s Wort.
- Avoid getting pregnant while on treatment with Rozlytrek. Talk with your health specialist about what birth control to use.
- There are special safe handling instructions for Rozlytrek 100mg/200mg. Talk to your health specialist about the precautions you require to follow when you take this medication at home.
- It is safe to handle this medication as a whole capsule.
- Store the capsules in a closed container at room temperature in a dry place such as a cabinet away from the light, heat, and moisture.
- Do not store this medicinal product in your bathroom or refrigerator.
- Keep it away from the children and do not share with anyone.
