Tibsovo Ivosidenib is a brand-name prescription drug. It’s FDA-approved to treat acute myeloid leukemia (AML) in certain situations. AML is a type of cancer that affects white blood cells. Tibsovo Ivosidenib 250 mg Price Cost in India Best at Yourmedikart. TIBSOVO ivosidenib cost is a prescription medicine used to treat: acute myeloid leukemia

Brand – Tibsovo 250 Mg

Generic name – Ivosidenib (Rx)

Classes: IDH1 Inhibitors

Tibsovo is for use in adults who either:

  • Are age 75 years or older and have been newly diagnosed with AML. Also, they can’t be able to undergo intensive chemotherapy due to other medical conditions.
  • Have relapsed or refractory AML.*

In addition, the AML must have a gene mutation (abnormal change) called IDH1. That’s short for isocitrate dehydrogenase 1.

  • Tibsovo targets a specific gene mutation called IDH1, which can affect your bone marrow. IDH1 mutation prevents young blood cells from developing into healthy adult blood cells, which can result in symptoms of acute myeloid leukemia (AML).
  • Tibsovo is for use only in adults with an IDH1 mutation. Your doctor will test you for this gene.
  • Tibsovo ivosidenib is used to treat AML after other treatments did not work or stopped working.
  • Tibsovo is used with or without azacitidine to treat newly-diagnosed AML in adults 75 years and older or who have health problems that prevent the use of certain chemotherapy treatments.
  • Tibsovo is also used to treat bile duct cancer (cholangiocarcinoma) that has progressed or has spread to other parts of the body (metastatic) after treatment with other medicine.
  • For more information about AML and how Tibsovo is used to treat it, see the “Tibsovo uses” section below.

Tibsovo Generic

Ivosidenib Tibsovo is available only as a brand-name medication. tibsovo price in india Best at Yourmedikart. TIBSOVO is a prescription medicine used to treat: acute myeloid leukemia  It’s not currently available in generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs

TIBSOVO is a Prescription Medicine used to Treat:

  • Acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation in:
    • Adults with newly diagnosed AML treated in combination with TIBSOVO and azacitidine who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments
    • Adults with newly diagnosed AML who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments
    • Adults with AML when the disease has come back or has not improved after previous treatment(s)
  • Adults with bile duct cancer (cholangiocarcinoma) that has spread:
    • Who have already received previous treatment(s) and
    • Whose tumor has a certain type of abnormal IDH1 mutation

Your healthcare provider will perform a test to make sure that TIBSOVO is right for you. It is not known if TIBSOVO is safe and effective in children.

Tibsovo Dosage

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug Forms and Strengths

Tibsovo comes as a tablet that you swallow. This medication is available in one strength: 250 milligrams (mg).

Dosage for acute Myeloid Leukemia

Tibsovo is used to treat acute myeloid leukemia (AML) in certain adults. The recommended dosage of Tibsovo for this use is 500 mg once daily. This is two 250-mg tablets.

You’ll likely follow this Tibsovo dosing schedule for at least 6 months, unless:

  • Your AML gets worse, or
  • You develop serious side effects that Tibsovo can’t manage

How to Take Tibsovo

You should take Tibsovo according to your doctor’s or healthcare provider’s instructions.

Tibsovo comes as a tablet that you swallow.

When to Take

  • You should take your dose of Tibsovo once a day. It’s best to take your dose around the same time every day. This helps keep a consistent level of the drug in your body so it can work effectively.
  • Keep in mind that Tibsovo tablets are available in one strength: 250 milligrams (mg). The usual dosage of Tibsovo is 500 mg once daily. So you’ll need to swallow two 250-mg tablets for each dose. You shouldn’t space the two tablets apart. Once per day, you should take them together or swallow one tablet right after the other.
  • To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Tibsovo with food

You can take Tibsovo tablets with or without food, but the food shouldn’t be high in fat. You also shouldn’t eat grapefruit or drink grapefruit juice with Tibsovo. For details, see “Tibsovo and foods” in the “Tibsovo interactions” section above.

Can Tibsovo be Crushed, split, or chewed?

No, you shouldn’t crush, split, or chew Tibsovo tablets. You should swallow them whole.

Ivosidenib Tibsovo and pregnancy

  • You shouldn’t take Tibsovo while pregnant. If you do, the drug may cause harm to the developing fetus.
  • Tibsovo use during pregnancy hasn’t been studied in humans. But the drug did cause harm when it was given to pregnant animals in studies. Although animal studies don’t always predict what will happen in humans, to be safe, you shouldn’t use Tibsovo if you’re pregnant.
  • If you’re pregnant or have plans to become pregnant, talk with your doctor. They can help determine whether other treatments may be right for you.

Tibsovo and Fertility

  • Tibsovo may cause fertility problems in females and males. (“Fertility” is the ability to become pregnant or cause someone to become pregnant.) This means that Tibsovo treatment may affect your ability to have a biological child.
  • If you’re concerned about fertility problems with Tibsovo treatment, talk with your doctor.

What If I Miss a Dose?

  • If you miss a dose of Tibsovo, take the dose as soon as possible but at least 12 hours before your next scheduled dose. Then take your next dose at your usual time the following day. You shouldn’t take more than one dose within 12 hours.
  • For example, if you usually take Tibsovo at 7 a.m. and miss your dose, you can take the missed dose no later than 7 p.m. The next day, you can take your regularly scheduled dose of Tibsovo at 7 a.m. If it was after 7 p.m. that you remember you missed a dose, you should skip the dose and take your next regular dose at 7 a.m. the next day. If you have questions about missed doses, talk with your doctor.
  • To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I Need to Use this Drug long Term?

Tibsovo is meant to be used as a long-term treatment. If you and your doctor determine that Tibsovo is safe for you, and your AML doesn’t get worse, then you’ll take this drug for at least 6 months.

SAFETY INFORMATION

TIBSOVO may cause serious side effects, including:

  • Differentiation Syndrome in AML Patients. Differentiation syndrome is a common condition, which can be serious, that affects your blood cells and may be life-threatening or lead to death. Differentiation syndrome in adults with acute myeloid leukemia (AML) has happened as early as 1 day and up to 3 months after starting TIBSOVO. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome during treatment with TIBSOVO:
  • Fever
  • Cough
  • Trouble breathing
  • Rash
  • Decreased urination
  • Dizziness or lightheadedness
  • Rapid weight gain
  • Swelling of your arms and legs

If you develop signs and symptoms of differentiation syndrome, your healthcare provider may treat you with a corticosteroid medicine or a medicine called hydroxyurea and may monitor you in the hospital.

  • Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint.
  • Guillain-Barré Syndrome. Guillain-Barré syndrome has happened in people treated with TIBSOVO. Your healthcare provider will monitor you for nervous system problems and will permanently stop your treatment with TIBSOVO if you develop Guillain-Barré syndrome. Tell your healthcare provider right away if you develop any signs or symptoms of Guillain-Barré syndrome, including:
  • Weakness or tingling feeling in your legs, arms, or upper body
  • Numbness and pain on one side or both sides of your body
  • Any changes in your ability to see, touch, hear, or taste
  • Burning or prickling sensation
  • Difficulty breathing

The most common side effects of TIBSOVO when used in combination with azacitidine or alone in adults with AML include:

  • Changes in certain blood cell counts
  • Diarrhea
  • Increased blood sugar
  • Fatigue
  • Changes in certain liver function tests
  • Swelling of arms or legs
  • Decreased levels of electrolytes in the blood
  • Nausea
  • Vomiting
  • Decreased appetite
  • Joint pain
  • Shortness of breath
  • Uric acid increased
  • Stomach (abdominal) pain
  • Changes in certain kidney function tests
  • Pain or sores in your mouth or throat
  • Rash
  • Irregular heart rhythm or heartbeat (QTc prolongation)
  • Differentiation syndrome
  • Muscle pain

The most common side effects of TIBSOVO in adults with Cholangiocarcinoma include:

  • Fatigue
  • Nausea
  • Abdominal pain
  • Diarrhea
  • Cough
  • Decreased appetite
  • Fluid and swelling in your stomach area
  • Vomiting
  • Hemoglobin decreased (anemia)
  • Rash
  • Changes in liver function tests

Your healthcare provider will do blood tests before you start and during treatment with TIBSOVO. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with TIBSOVO if you develop certain side effects.

TIBSOVO may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of TIBSOVO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or

Before taking TIBSOVO, tell your healthcare provider about all of your medical conditions, including if you:

  • Have any heart problems, including a condition called long QT syndrome
  • Have problems with abnormal electrolytes, such as sodium, potassium, calcium, or magnesium levels
  • So have nervous system problems
  • Have problems with your kidneys or are on dialysis
  • Have any liver disorders, including cirrhosis
  • Are pregnant or plan to become pregnant. TIBSOVO can cause harm to your unborn baby. You should avoid becoming pregnant during treatment with TIBSOVO. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with TIBSOVO
  • Are breastfeeding or plan to breastfeed. It is not known if TIBSOVO passes into your breast milk. Do not breastfeed during your treatment with TIBSOVO and for 1 month after your last dose of TIBSOVO

Tibsovo Side Effects

  • Tibsovo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Tibsovo. These lists do not include all possible side effects.
  • For more information about the possible side effects of Tibsovo, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be concerning or bothersome.
  • Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Tibsovo, you can do so through MedWatch.

Mild Side Effects

Mild side effects of Tibsovo can include:

  • Fatigue (lack of energy)
  • Joint pain
  • Diarrhea
  • Edema (swelling caused by fluid collection, usually in the lower legs)
  • Nausea
  • Shortness of breath
  • Mouth sores
  • Rash
  • Cough
  • Decreased appetite
  • Muscle pain
  • Constipation
  • Fever
  • Mild changes in lab tests, including:
    • Increased levels of white blood cells
    • Decreased levels of hemoglobin (a protein in red blood cells that carry oxygen)
    • Decreased levels of electrolytes
    • Changes in liver or kidney function tests

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side Effects

Serious side effects from Tibsovo aren’t common, but they can occur. tibsovo price in india best Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Severe changes in lab tests, including:*
    • Increased levels of white blood cells
    • Decreased levels of hemoglobin (a protein in red blood cells that carry oxygen)
    • Decreased levels of electrolytes
    • Changes in liver or kidney function tests
  • Guillain-Barré syndrome (a disease that affects your nervous system). Symptoms can include:
    • Weakness or a prickling or burning sensation in your legs, arms, or upper body
    • Pain and numbness on one or both sides of your body
    • Changes in your sense of taste, touch, vision, or hearing
    • Trouble breathing
  • Changes in heart rhythm.†
  • Differentiation syndrome (a serious condition that affects your blood cells).†‡
  • Allergic reaction.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Changes in heart rhythm

Tibsovo may cause a serious change in heart rhythm called QT prolongation in some people. QT prolongation is a type of abnormal heart rhythm. This side effect was seen in clinical studies of the drug.

Your risk for developing QT prolongation may be higher if you either:

  • Already have a heart condition such as congestive heart failure
  • Are taking certain medications that interact with Tibsovo

Symptoms of QT prolongation can include dizziness, lightheadedness, and fainting. If you experience these symptoms while using Tibsovo, talk with your doctor right away. They may want to perform tests to check your heart rhythm. If your results show heart rhythm changes, your doctor may have you stop taking Tibsovo.

If you have questions or concerns about this side effect, talk with your doctor.

Fatigue

  • In a clinical study, fatigue (lack of energy) was one of the most common side effects that occurred in people taking Tibsovo.
  • In some people, fatigue may occur even if they get adequate sleep. But this side effect may ease or go away after a few weeks of taking Tibsovo. To find out more about how often this side effect occurred in clinical trials, see the drug’s prescribing information.

Fatigue is commonly described as feeling physically or mentally exhausted. If you feel this way after starting Tibsovo treatment, the following tips may help:

  • Be sure to get adequate sleep. Aim for 7 to 8 hours each night.
  • Try to exercise regularly, such as going for a daily walk.
  • Listen to your body and rest or nap when needed.
  • Make sure to drink plenty of water.
  • Don’t overload your schedule or set unrealistic expectations for your day.

If you develop fatigue that’s concerning to you, talk with your doctor. They may be able to suggest treatments to help.

Differentiation Syndrome

Treatment with Tibsovo can increase your risk for differentiation syndrome (DS). This is a serious condition that affects your blood cells. In fact, Tibsovo has a boxed warning Trusted Source for DS. Boxed warnings are the most serious type of FDA warnings. They alert doctors and patients about drug effects that may be dangerous.

DS is a common* side effect that can occur within 1 day or up to 3 months after starting Tibsovo treatment. If DS isn’t treated, it can lead to organ failure or, in some cases, death. It’s important to get immediate medical care if you develop symptoms such as:

  • Fever
  • Trouble breathing or cough
  • Rash
  • Unexplained weight gain that occurs quickly, such as over a few days or a week
  • Swelling in your arms, hands, legs, or feet
  • Feeling lightheaded

If you develop DS, you may receive medications such as hydroxyurea (Hydrea, Droxia) or a corticosteroid, such as dexamethasone (Decadron). Depending on your condition, your doctor may have you stay in the hospital for monitoring until your symptoms improve. They may also have you stop taking Tibsovo.

How Tibsovo Ivosidenib Works

  • Acute myeloid leukemia (AML) is a type of cancer that affects your blood cells. These cells are produced in your bone marrow, which is the tissue inside bones. There, blood cells normally mature into white blood cells, red blood cells, or platelets (blood cells that help your blood clot).
  • With AML, immature blood cells aren’t able to mature. Instead, they form nonfunctional myeloid cells (also known as blasts). These blasts accumulate in your bone marrow and blood. Too many blasts overcrowd your normal blood cells. This prevents them from working properly, especially your white blood cells. (White blood cells are part of your immune system and help fight off infection.)
  • Tibsovo is used to treat AML in adults with a certain gene mutation (abnormal change) known as IDH1. That’s short for isocitrate dehydrogenase 1.
  • Tibsovo is the first in a class of drugs known as IDH1 inhibitors. A drug class is a group of medications that have a similar mechanism of action (the way a drug works).
  • Tibsovo is a type of treatment called targeted therapy. These treatments seek out specific targets, such as cells with gene mutations. Tibsovo targets certain cells in your body that have the IDH1 mutation. Once this drug attaches to its target, Tibsovo inhibits (blocks) some activities of the mutated cells.
  • The end result of this targeted action is that immature blood cells can develop normally into fully functional blood cells. The goal of AML treatment is to reduce or eliminate the presence of blasts in your blood.

ivosidenib cost

How long does it take to work?

Clinical studies of Tibsovo looked at how soon after taking the drug people had blood levels that were partially or fully back to normal. This was known as a “response.” Researchers found the following:

  • In people with newly diagnosed AML who had a response to Tibsovo, the response occurred within 6 months. However, In half of the people who had a response, it occurred by 2.8 months.
  • In people with relapsed or refractory AML* who had a response to Tibsovo, the response occurred within 6 months. In half of the people who had a response, it occurred by 2 months.
    If you have questions about how soon Tibsovo may work for you, talk with your doctor.

Tibsovo Uses

The Food and Drug Administration (FDA) approves prescription drugs such as Tibsovo ivosidenib cost to treat certain conditions. Tibsovo may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Tibsovo for Acute Myeloid Leukemia

Tibsovo is FDA-approved to treat acute myeloid leukemia (AML) in adults who either:

  • Are age 75 years or older and have been newly diagnosed with AML. Also, they can’t be able to undergo intensive chemotherapy due to other medical conditions.
  • Have relapsed or refractory AML. With relapsed AML, the cancer comes back after a person has been in remission (a period of time when they don’t have any signs of cancer).

AML is refractory if the cancer continues to worsen with current treatment.

In addition, the AML must have a gene mutation (abnormal change) called IDH1. That’s short for isocitrate dehydrogenase 1. If you have AML, your doctor will have you take a blood test or provide a bone marrow sample to see if you have the IDH1 mutation.

Acute Myeloid Leukemia Explained

AML is a type of cancer of the blood cells. It occurs most often in older adults.

Inside your bones, your bone marrow makes different types of blood cells:

  • Red blood cells to carry oxygen
  • Platelets to help prevent or stop bleeding
  • White blood cells to help fight off infection
  • All blood cells start as non functioning, immature cells. As they mature, they develop into one of the three types of blood cells described above.

Myeloid cells (also known as blasts) are immature cells that normally mature into white blood cells. However, AML prevents blasts from maturing into healthy white blood cells.

Instead, too many blasts accumulate in your bone marrow and blood. This leaves little space for your healthy blood cells to function the way they normally would. When blasts overcrowd your healthy blood cells, symptoms of AML begin to appear. tibsovo price in india Ivosidenib cost Because AML symptoms often start suddenly and may include:

  • Fatigue (lack of energy)
  • Fever
  • Flu-like symptoms
  • Increased sweating
  • Frequent infections
  • Anemia (decreased red blood cell count)
  • Unexplained bleeding, such as gum or nose bleeding
  • Small red spots under the skin or other bruising
  • Loss of appetite, which can lead to weight loss
  • Abdominal (belly) pain

Diagnosis and Treatment

AML is usually diagnosed with genetic testing or by testing a sample of your bone marrow. tibsovo price Moreover, If 20% or more of your bone marrow consists of blasts or if your genetic test is positive, your doctor will diagnose you with AML.

Treatment options for AML include:

  • Chemotherapy
  • Targeted therapy, such as Tibsovo
  • Radiation therapy
  • Bone marrow transplant
  • The goal of AML treatment is to reduce the level of blasts in your bone marrow to less than 5%.

Effectiveness for Acute Myeloid Leukemia

In clinical studies, Tibsovo was effective for treating certain types of AML in adults. For details on how Tibsovo performed in this study, ivosidenib cost visit the manufacturer’s website or see the drug’s prescribing information.

In addition, Tibsovo is a recommended treatment option in the National Comprehensive Cancer Network guidelines for AML in certain adults.

Tibsovo and children

Tibsovo isn’t FDA-approved for use in children with AML.

A clinical trial is currently studying the use of  Tibsovo price in children who have cancer with an IDH1 gene mutation. Similarly The age range for eligible study participants is 12 months to 21 years.

Tibsovo and alcohol

Tibsovo doesn’t interact with alcohol.

However, alcohol may worsen certain side effects from Tibsovo, Ivosidenib cost such as nausea and diarrhea. (For more information about side effects, see the “Tibsovo side effects” section above.)

If you drink alcohol, talk with your doctor about how much is safe for you to consume while you’re taking Tibsovo.

Tibsovo Ivosidenib interactions

Tibsovo can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

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Tibsovo Ivosidenib and other Medications

Below is a list of medications that can interact with Tibsovo. But this list doesn’t contain all drugs that may interact with Tibsovo.

Before taking Tibsovo, talk with your doctor and pharmacist. tibsovo price Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Types of drugs that can interact with Tibsovo include the following.

Drugs that could be less effective than usual when taken with Tibsovo. Because Tibsovo may interact with some medications by reducing their levels and effects in your body. ivosidenib cost This can prevent the other drugs from being effective. tibsovo price Examples of medications that could be less effective than usual when taken with Tibsovo can include:

  • Firstly certain antifungals, such as itraconazole, tibsovo price fluconazole (Diflucan), and ketoconazole (Nizoral)
  • Hormonal forms of birth control, such as certain birth control pills, the patch, or the vaginal ring (NuvaRing).

Drugs that may cause QT prolongation. For instance, Tibsovo ivosidenib cost may cause a heart rhythm change called QT prolongation. Other medications can also cause this serious side effect. Taking Tibsovo with other drugs that can cause heart rhythm changes may significantly raise your risk of developing QT prolongation. ivosidenib cost Examples of these medications can include:

  • Certain anti-arrhythmic drugs, such as flecainide (Tambocor)
  • Secondly certain antifungals,* such as itraconazole, fluconazole (Diflucan), and ketoconazole (Nizoral)
  • Fluoroquinolone antibiotics, such as levofloxacin (Levaquin)
  • Certain antinausea medications, such as ondansetron (Zofran) and palonosetron (Aloxi)
  • If you have questions or concerns about drug interactions that may affect you, talk with your doctor or pharmacist.

Certain antifungals (itraconazole, ketoconazole) can also interact tibsovo price in india ivosidenib cost is best at yourmedikart with Tibsovo ivosidenib cost by significantly increasing the level of Tibsovo in your body. tibsovo price After that This further raises your risk for serious side effects. For more information about side effects, see the “Tibsovo side effects” section above.

Tibsovo ivosidenib and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Tibsovo. However, Tibsovo is known to interact with medications that are metabolized (broken down) by certain enzymes. These enzymes can also be affected by certain herbs and supplements. tibsovo price in india Great at online So, you should still check with your doctor or pharmacist before using any of these products while taking Tibsovo.

Tibsovo and foods

You can take Tibsovo price ivosidenib cost tablets with or without food. But if you choose to take Tibsovo price ivosidenib cost with food, So it shouldn’t be with high fat foods.  So This is because taking Tibsovo with high-fat foods can increase the level of the drug in your body. Too much Tibsovo in your system could raise your risk for mild or serious side effects.* It’s important that your meal or snack doesn’t contain more than 1,000 calories or 58 grams of fat.

  • You should check food labels if you aren’t sure of their fat or calorie content. For instance, Some examples of foods to limit or avoid when taking a dose of Tibsovo include bacon, butter, eggs, and whole milk.
  • You should also avoid eating grapefruit and drinking grapefruit juice while taking Tibsovo price. ivosidenib cost But The fruit and its juice can block the activity of an enzyme that helps break down Tibsovo. So if you consume grapefruit or grapefruit juice, the level of tibsovo price in your body could rise. This could increase your risk for serious side effects, such as heart rhythm changes.

Ivosidenib cost If you have any questions about eating certain foods with tibsovo price ivosidenib cost, talk with your doctor or pharmacist.

 

Tibsovo and lab tests

Whether Tibsovo can interact with lab tests isn’t known. ivosidenib cost But the drug may change certain blood levels that lab tests may check. So To learn more, see the “Tibsovo side effects” section above.

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