Rozlytrek Entrectinib 200 mg tablet price in india best at Yourmedikat and uses to treat non-small cell lung Cancer.
Product – Rozlytrek 200 mg
Generic – Entrectinib
Rozlytrek is used in adults to treat non-small cell lung cancer that has spread to other parts of the body (metastatic).
- Rozlytrek 200 mg is also used in adults and children at least 12 years old who have solid tumors that have spread or cannot be safely removed with surgery, or when other treatments have failed or are not safe options.
- Rozlytrek is used only if your cancer has a specific abnormal gene. Your doctor will test you for this gene
- Rozlytrek 200 mg is a tumor-agnostic medicine that represents a new approach to treating cancer. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRKA/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer.
- Rozlytrek is approved as a once-daily oral medicine for the treatment of NTRK fusion-positive solid tumors and ROS1-positive non-small cell lung cancer in many jurisdictions including Australia, Canada, the EU, Israel, Japan, New Zealand, South Korea, Taiwan and the US, with further regulatory reviews ongoing around the world.
- Rozlytrek was granted Breakthrough Therapy designation by the US Food and Drug Administration, Sakigake designation for accelerated review by Japan’s Ministry of Health, Labour and Welfare, and Priority Medicines designation by the European Medicines Agency (EMA).
- This medication is used to treat various types of cancer. Entrectinib price belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.
What is Rozlytrek?
ROZLYTREK 200 mg is a prescription medicine used to treat:
- Adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by an abnormal ROS1 gene.
- Adults and children 12 years and older with solid tumors (cancer) that:
-
- Are caused by certain abnormal NTRK genes and
- Have spread or if surgery to remove their cancer is likely to cause severe complications, and
- There is no satisfactory alternative treatment option, or the cancer grew or spread on other treatment.
- It is not known if Rozlytrek is safe and effective for use in children less than 12 years of age.
- Rozlytrek was approved through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of Rozlytrek price for this use.
- Rozlytrek Entrectinib 200 mg tablet price in india best at Yourmedikat and uses to treat non-small cell lung cancer
How should I take Rozlytrek 200 mg ?
- Use Rozlytrek 200 mg exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
- You may take Rozlytrek with or without food.
- Swallow the capsule whole and do not crush, chew, break, or open it.
- If you vomit shortly after taking Rozlytrek, take another dose.
- Store at room temperature away from moisture and heat.
- Do not change your dose or stop taking Rozlytrek without your doctor’s advice.
Dosing Information
- Usual Adult Dose for Non-Small Cell Lung Cancer:
- 600 mg orally once a day until disease progression or unacceptable toxicity
- Use: For adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive
- Rozlytrek Entrectinib 200 mg tablet price in india best at Yourmedikat and uses to treat non-small cell lung cancer
- Usual Adult Dose for Solid Tumors:
- 600 mg orally once a day until disease progression or unacceptable toxicity
- Uses: For adult patients with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have progressed following treatment or have no satisfactory alternative therapy.
- Usual Pediatric Dose for Solid Tumors:
- 12 years and older:
-Body surface area (BSA) greater than 1.5 m2: 600 mg orally once a day
-BSA 1.11 to 1.5 m2: 500 mg orally once a day
-BSA 0.91 to 1.1 m2: 400 mg orally once a day - Use: For pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have progressed following treatment or have no satisfactory alternative therapy.
- 12 years and older:
How to use Rozlytrek 200 Mg Capsule Antineoplastic
Read the Patient Information Leaflet if available from your pharmacist before you start taking entrectinib price and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
- Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the capsules whole. Do not open, crush, chew, or dissolve the capsules.
- Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.
- The dosage is based on your medical condition, response to treatment, age, lab tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children’s dosage is also based on body size.
- Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
- If you vomit right after taking a dose, you may take another dose.
- Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.
- Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, However, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.
Dosage Forms & Strengths
Capsule
- 100mg
- 200mg
Non-small Cell Lung Cancer
- Indicated for metastatic non-small cell lung cancer (NSCLC) in adults whose tumors are ROS1-positive
- 600 mg PO Day
- Continue until disease progression or unacceptable toxicity
Neurotrophic Tyrosine Receptor Kinase Gene Fusion Solid Tumors
- Indicated for patients with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and progressed following treatment or have no satisfactory alternative therapy
- 600 mg PO Day
- Continue until disease progression or unacceptable toxicity
Dosage Modifications
Dosage modifications for adverse reactions
- First dose reduction: 400 mg day
- Second dose reduction: 200 mg day
- Permanently discontinue if toxicities persist or recur following 2 dose reductions
Congestive heart failure
- Grade 2 or 3: Withhold until recovered to Grade ≤1; resume at reduced dose
- Grade 4: Permanently discontinue
Central nervous system effects
- Intolerable Grade 2: Withhold until recovered to Grade ≤1; resume at reduced dose, as clinically appropriate
- Grade 3: Withhold until recovered to Grade ≤1; resume at reduced dose
- Grade 4: Permanently discontinue
Pregnancy & Lactation
Pregnancy
- Based on literature reports in humans with congenital mutations leading to changes in TRK signaling, findings from animal studies, and its mechanism of action, fetal harm may occur when administered to a pregnant woman
- No data available on use in pregnant women
- Verify pregnancy status of females of reproductive potential before initiating treatment
Animal data
- Administration of Entrectinib to pregnant rats during organogenesis resulted in malformations at maternal exposures ~2.7 times the human exposure at the 600-mg dose
- Advise pregnant women of the potential risk to a fetus
Contraception
- Females of Reproductive potential: Use effective contraception during treatment and for at least 5 weeks following the final dose
- Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months following the final dose
Lactation
- Firstly There are no data on the presence of Entrectinib or its metabolites in human milk or their effects on either the breastfed child or on milk production
- Owing to the potential adverse reactions in breastfed children from Entrectinib, advise a lactating woman to discontinue breastfeeding during treatment and for 7 days after the final dose
Pregnancy Categories
- A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
- B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
- C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
- D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
- X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
- NA: Information not available.
What other drugs will affect Rozlytrek 200 mg ?
- Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, Because which may increase side effects or make the medications less effective.
- Other drugs may interact with Entrectinib, including prescription and over-the-counter medicines, vitamins, and herbal products. And tell your doctor about all your current medicines and any medicine you start or stop using.
What happens if I miss a dose?
- Use the medicine as soon as you can but skip the missed dose if your next dose is due in less than 12 hours. But do not use two doses at one time.
What happens if I overdose?
- Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
- Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
- Grapefruit may interact with Entrectinib and lead to unwanted side effects. Avoid the use of grapefruit products.
Important Safety Information
What is the most important information I should know about Rozlytrek ?
Rozlytrek 200 mg may cause serious side effects, including:
-
Congestive heart failure.
-
- Rozlytrek may cause congestive heart failure or make the congestive heart failure that you already have worse. For instance, Tell your healthcare provider right away if you have any of the following signs and symptoms of congestive heart failure:
- persistent coughing or wheezing
- trouble breathing when lying down
- sudden weight gain
- increasing shortness of breath
- tiredness, weakness, or fatigue
- swelling in ankles, feet, or legs
-
Central nervous system (CNS) effects
- Rozlytrek price may cause dizziness, changes in your mood, or may affect how you think and cause confusion, hallucinations, and problems with concentration, attention, memory, and sleep. Tell your healthcare provider right away if you have any of these symptoms.
-
Bone fractures.
- Rozlytrek may increase your risk for bone fractures. Bone fractures may happen with or without a fall or other injury. Tell your healthcare provider if you have pain, changes in movement, or bone abnormalities.
-
Liver problems (hepatotoxicity).
- Your healthcare provider will do blood tests to check your liver function during treatment with Rozlytrek . Tell your healthcare provider right away if you develop symptoms of liver problems including loss of appetite, nausea or vomiting, or pain on the upper right side of your stomach area.
- Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop Rozlytrek Entrectinib 200 mg tablet price in india best at Yourmedikat and uses to treat non-small cell lung cancer if you develop liver problems with ROZLYTREK.
-
Increased uric acid level in your blood (hyperuricemia).
- Rozlytrek Entrectinib may cause an excess of uric acid in your blood. Your healthcare provider may do tests before and during your treatment with ROZLYTREK to check the uric acid level in your blood.
-
Changes in the electrical activity of your heart called QT prolongation
- QT prolongation can cause irregular heartbeats that can be life-threatening. Because Your healthcare provider will do tests before and during your treatment with Rozlytrek price to check the electrical activity of your heart and your body salts (electrolytes).
- So, tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during your treatment with ROZLYTREK. So, these may be symptoms related to QT prolongation.
-
Vision problems.
- Rozlytrek 200 mg may cause vision problems. Your healthcare provider may stop Rozlytrek Entrectinib price and refer you to an eye specialist if you develop severe vision problems during treatment with ROZLYTREK 200 mg. For Instance, tell your healthcare provider right away if you have any loss of vision or any change in vision, including:
- Double vision
- Blurry vision
- New or increased floaters
- Seeing flashes of light
- Light hurting your eyes
- Rozlytrek 200 mg may cause vision problems. Your healthcare provider may stop Rozlytrek Entrectinib price and refer you to an eye specialist if you develop severe vision problems during treatment with ROZLYTREK 200 mg. For Instance, tell your healthcare provider right away if you have any loss of vision or any change in vision, including:
Before taking Rozlytrek, tell your healthcare provider about medical conditions
- Have any heart problems, including a condition called long QT syndrome.
- Have nervous system (neurological) problems.
- Have or have had eye or vision problems.
- are pregnant or plan to become pregnant. Rozlytrek Entrectinib price can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with ROZLYTREK price or think you may be pregnant.
- If you are able to become pregnant, your healthcare provider will do a pregnancy test before you start treatment with Rozlytrek Entrectinib.
- Females who are able to become pregnant should use effective birth control during treatment with Rozlytrek Entrectinib price and for at least 5 weeks after the final dose.
- Males who have female partners that are able to become pregnant should use effective birth control during treatment with Rozlytrek Entrectinib and for 3 months after the final dose.
- Are breastfeeding or plan to breastfeed. It is not known if Rozlytrek passes into your breast milk. Do not breastfeed during treatment with ROZLYTREK Entrectinib and for 7 days after the final dose of Rozlytrek Entrectinib 200 mg tablet price in india best at Yourmedikat and uses to treat non-small cell lung cancer. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
- Certain other medicines may affect how Rozlytrek Entrectinib price works causing side effects. Know the medicines you take. Similarly Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
What should I avoid while taking Rozlytrek Entrectinib?
- You should not drink grapefruit juice or eat grapefruit during your treatment with Rozlytrek Entrectinib 200 mg tablet price in india best at Yourmedikat and uses to treat non-small cell lung cancer. It may increase the amount of Entrectinib price in your blood to a harmful level.
- Do not drive or operate heavy machinery until you know how Rozlytrek Entrectinib 200 mg tablet price in india best at Yourmedikat and uses to treat non-small cell lung cancer affects you. Thirdly If you experience dizziness, fainting, tiredness, blurred vision, memory loss, changes in mental status, confusion, or hallucinations, do not drive or operate heavy machines until your symptoms resolve.
What are some possible side effects of Rozlytrek Entrectinib?
The most common side effects of Rozlytrek Entrectinib include:
- Tiredness
- Constipation
- Change in taste
- Swelling
- Dizziness
- Diarrhea
- Nausea
- Abnormal touch sensation
- Shortness of breath
- Muscle pain
- Confusion, mental status changes, memory problems, and hallucinations
- Weight gain
- Cough
- Vomiting
- Fever
- Joint pain
- Vision changes
These are not all the possible side effects of Rozlytrek Entrectinib price. Call your doctor for medical advice about side effects.
After that You may report side effects to the FDA at (800) FDA-1088 or . You may also report side effects to Genentech at (888) 835-2555.
Please see additional Important Safety Information in full Prescribing Information, including Patient Information.
Rozlytrek 200 mg side effects
Get emergency medical help if you have signs of an allergic reaction to Rozlytrek: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- Bone pain or problems moving.
- Secondly Fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out).
- Thirdly Nausea, vomiting, loss of appetite, right-sided upper stomach pain.
- Swelling in your lower legs, rapid weight gain.
- Cough, wheezing, shortness of breath, trouble breathing while lying down.
- Confusion, hallucinations, problems with memory or concentration.
- Dizziness, mood changes, trouble sleeping; or
- Blurred vision, double vision, increased sensitivity to light, or seeing flashes of light or “floaters” in your vision.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Warnings
- Rozlytrek price may cause new or worsened symptoms of congestive heart failure. Entrectinib price After that Call your doctor at once if you have swelling in your lower legs, rapid weight gain, cough, wheezing, shortness of breath, or trouble breathing while lying down. Rozlytrek Entrectinib 200 mg tablet price in india best at Yourmedikat and uses to treat non-small cell lung cancer that has spread to other parts of the body.
