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61b19a42c4c66fd55530ca90 INLYTA 5 MG 56 TAB. https://cdn1.storehippo.com/s/6052eead9e1cf8aa024c48c8/61b199953634edd599dda3f6/webp/inlyta-5-mg-56-tab-.jpg

What is Inlyta and how is it used?

Inlyta is a prescription medicine used to treat kidney cancer that has spread or cannot be removed by surgery (advanced renal cell carcinoma or RCC):

  • in combination with avelumab or pembrolizumab as your first treatment.
  • alone when 1 prior drug treatment regimen for your RCC has not worked.

It is not known if Inlyta is safe and effective in children.

What are the possible side effects of Inlyta?

Inlyta may cause serious side effects, including:

    • High blood pressure (hypertension). High blood pressure is common with Inlyta and may sometimesbe severe. Your healthcare provider should check your blood pressure regularly during treatment with Inlyta. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with Inlyta.
    • Blood clots in your veins or arteries. Inlyta can cause blood clots which can be serious, and sometimes lead to death. Get emergency help and call your healthcare provider if you get any of the following symptoms:
      • chest pain or pressure
      • pain in your arms, back, neck or jaw
      • shortness of breath
      • numbness or weakness on one side of your body
      • trouble talking
      • headache
      • vision changes
    • Bleeding. Inlyta can cause bleeding which can be serious, and sometimes lead to death. Call your healthcare provider right away or get medical help if you develop any of the following signs or symptoms:
      • unexpected bleeding or bleeding that lasts a long time, such as:
      • unusual bleeding from the gums
      • menstrual bleeding or vaginal bleeding that is heavier than normal
      • bleeding that is severe or you cannot control
      • pink or brown urine
      • red or black stools (looks like tar)
      • bruises that happen without a known cause or get larger
      • cough up blood or blood clots
      • vomit blood or your vomit looks like “coffee grounds”
      • unexpected pain, swelling, or joint pain
      • headaches, feeling dizzy or weak
    • Heart failure. Your healthcare provider should check you for signs or symptoms of heart failure regularly during treatment with Inlyta. Heart failure can be serious and can sometimes lead to death. Tell your healthcare provider if you have any of the following symptoms during your treatment with Inlyta:
      • tiredness
      • swelling of your stomach-area (abdomen), legs or ankles
      • shortness of breath
      • protruding neck veins
    • Tear in your stomach or intestinal wall (perforation). A tear in your stomach or intestinal wall can be serious and can sometimes lead to death. Get medical help right away if you get the following symptoms:
      • severe stomach-area (abdominal) pain or stomach-area pain that does not go away
      • vomit blood
      • red or black stools
    • Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment with Inlyta. Tell your healthcare provider if you have any of the following symptoms during your treatment with Inlyta:
      • tiredness that worsens or that does not go away
      • feeling hot or cold
      • your voice deepens
      • weight gain or weight loss
      • hair loss
      • muscle cramps and aches
    • Risk of wound healing problems. Wounds may not heal properly during Inlyta treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with Inlyta.
      • You should stop taking Inlyta at least 2 days before planned surgery.
      • Your healthcare provider should tell you when you may start taking Inlyta again after surgery.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen during treatment with Inlyta. Call your healthcare provider right away if you get:
    • headache
    • seizures
    • weakness
    • confusion
    • high blood pressure
    • blindness or change in vision
    • problems thinking
  • Protein in your urine. Your healthcare provider should check your urine for protein before and during your treatment with Inlyta. If you develop protein in your urine, your healthcare provider may decrease your dose of Inlyta or stop your treatment.
  • Liver problems. Your healthcare provider will do blood tests before and during your treatment with Inlyta. Your healthcare provider may delay or stop your treatment with Inlyta if you develop severe liver problems.
  • Heart problems. When Inlyta is used with the medicine avelumab, severe heart problems can happen and can lead to death. Your healthcare provider will check you for heart problems during your treatment with Inlyta. Tell your healthcare provider right away or get medical help if you have any of the following symptoms:
    • swelling of your stomach-area, legs, hands feet or ankles
    • shortness of breath
    • nausea or vomiting
    • chest discomfort, including pain or pressure
    • weight gain
    • pain or discomfort in your arms, back, neck, or jaw
    • breaking out in a cold sweat o feeling lightheaded or dizzy

The most common side effects of Inlyta with avelumab include:

  • diarrhea
  • feeling tired
  • muscle and bone pain
  • nausea
  • mouth sores
  • rash, redness, itching, or peeling of your skin on your hands and feet
  • hoarseness
  • decreased appetite
  • low levels of thyroid hormone
  • rash
  • liver problems
  • cough
  • shortness of breath
  • stomach-area (abdomen) pain
  • headache

The most common side effects of Inlyta with pembrolizumab include:

  • diarrhea
  • feeling tired or weak
  • liver problems
  • low levels of thyroid hormone
  • decreased appetite
  • rash, redness, itching or peeling of your skin on your hands and feet
  • nausea
  • mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina
  • hoarseness
  • rash
  • cough
  • constipation

The most common side effects of Inlyta when used alone include:

  • diarrhea
  • feeling tired or weak
  • decreased appetite
  • nausea
  • hoarseness
  • rash, redness, itching or peeling of your skin on your hands and feet
  • decreased weight
  • vomiting
  • constipation

Inlyta may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of Inlyta.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Inlyta (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C22H18N4OS and the molecular weight is 386.47 Daltons. The chemical structure is :

Inlyta® (axitinib)  Structural Formula Illustration

Axitinib is a white to light-yellow powder with a pKa of 4.8. The solubility of axitinib in aqueous media over the range pH 1.1 to pH 7.8 is in excess of 0.2 μg/mL. The partition coefficient (n-octanol/water) is 3.5.

Inlyta is supplied as red, film-coated tablets containing either 1 mg or 5 mg of axitinib together with microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and Opadry® II red 32K15441 as inactive ingredients. The Opadry II red 32K15441 film coating contains lactose monohydrate, HPMC 2910/Hypromellose 15cP, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide.

INDICATIONS

First-Line Advanced Renal Cell Carcinoma

INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

INLYTA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma.

Second-Line Advanced Renal Cell Carcinoma

INLYTA as a single agent is indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.

DOSAGE AND ADMINISTRATION

Recommended Dosing

First-Line Advanced RCC

The recommended dose of INLYTA is 5 mg orally taken twice daily (12 hours apart) with or without food in combination with avelumab 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. When INLYTA is used in combination with avelumab, dose escalation of INLYTA above the initial 5 mg dose may be considered at intervals of two weeks or longer. Review the Full Prescribing Information for recommended avelumab dosing information.

The recommended dose of INLYTA is 5 mg orally twice daily (12 hours apart) with or without food in combination with pembrolizumab 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. When INLYTA is used in combination with pembrolizumab, dose escalation of INLYTA above the initial 5 mg dose may be considered at intervals of six weeks or longer. Review the Full Prescribing Information for recommended pembrolizumab dosing information.

Second-Line Advanced RCC

When INLYTA is used as a single agent, the recommended starting oral dose is 5 mg twice daily. Administer INLYTA doses approximately 12 hours apart with or without food.

Important Administration Instructions

Advise patients to swallow INLYTA whole with a full glass of water. If the patient vomits or misses a dose, an additional dose should not be taken. Advise the patient to take the next prescribed dose at the usual time.

Dose Modification Guidelines

Dose increase or reduction is recommended based on individual safety and tolerability.

Over the course of treatment, patients who tolerate INLYTA for at least two consecutive weeks with no adverse reactions Grade >2 (according to the Common Toxicity Criteria for Adverse Events [CTCAE]), are normotensive, and are not receiving anti-hypertension medication, may have their dose increased. When a dose increase from 5 mg twice daily is recommended, the INLYTA dose may be increased to 7 mg twice daily, and further to 10 mg twice daily using the same criteria.

Over the course of treatment, management of some adverse drug reactions may require temporary interruption or permanent discontinuation and/or dose reduction of INLYTA therapy [see WARNINGS AND PRECAUTIONS]. If dose reduction from 5 mg twice daily is required, the recommended dose is 3 mg twice daily. If additional dose reduction is required, the recommended dose is 2 mg twice daily.

Strong CYP3A4/5 Inhibitors

The concomitant use of strong CYP3A4/5 inhibitors should be avoided (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole). Selection of an alternate concomitant medication with no or minimal CYP3A4/5 inhibition potential is recommended. Although INLYTA dose adjustment has not been studied in patients receiving strong CYP3A4/5 inhibitors, if a strong CYP3A4/5 inhibitor must be co-administered, a dose decrease of INLYTA by approximately half is recommended, as this dose reduction is predicted to adjust the axitinib area under the plasma concentration vs time curve (AUC) to the range observed without inhibitors. The subsequent doses can be increased or decreased based on individual safety and tolerability. If co-administration of the strong inhibitor is discontinued, the INLYTA dose should be returned (after 3 – 5 half-lives of the inhibitor) to that used prior to initiation of the strong CYP3A4/5 inhibitor [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Hepatic Impairment

No starting dose adjustment is required when administering INLYTA to patients with mild hepatic impairment (Child-Pugh class A). Based on the pharmacokinetic data, the INLYTA starting dose should be reduced by approximately half in patients with baseline moderate hepatic impairment (Child-Pugh class B). The subsequent doses can be increased or decreased based on individual safety and tolerability. INLYTA has not been studied in patients with severe hepatic impairment (Child-Pugh class C) [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].

Hepatotoxicity

In patients being treated with INLYTA in combination with avelumab:

    • If ALT or AST ≥3 times ULN but <5 times ULN or total bilirubin ≥1.5 times ULN but <3 times ULN, withhold both INLYTA and avelumab until these adverse reactions recover to Grades 0-1. If persistent (greater than 5 days), consider corticosteroid therapy [initial dose of 0.5 to 1 mg/kg/day] prednisone or equivalent followed by a taper. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. If rechallenging with INLYTA, consider dose reduction as per recommended dose modification guidelines.
  • If ALT or AST ≥5 times ULN or >3 times ULN with concurrent total bilirubin ≥2 times ULN or total bilirubin ≥3 times ULN, permanently discontinue both INLYTA and avelumab and consider corticosteroid therapy [initial dose 1 to 2 mg/kg/day prednisone or equivalent followed by a taper].

Review the Full Prescribing Information for additional dose modifications for avelumab.

In patients being treated with INLYTA in combination with pembrolizumab:

  • If ALT or AST ≥3 times ULN but <10 times ULN without concurrent total bilirubin ≥2 times ULN, withhold both INLYTA and pembrolizumab until these adverse reactions recover to Grades 0-1. Consider corticosteroid therapy. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. If rechallenging with INLYTA, consider dose reduction as per recommended dose modification guidelines.
  • If ALT or AST ≥10 times ULN or >3 times ULN with concurrent total bilirubin ≥2 times ULN, permanently discontinue both INLYTA and pembrolizumab and consider corticosteroid therapy.

Review the Full Prescribing Information for additional dose modifications for pembrolizumab.

HOW SUPPLIED

Dosage Forms And Strengths

  • 1 mg tablets of INLYTA: red, film-coated, oval tablets, debossed with “Pfizer” on one side and “1 XNB” on the other side.
  • 5 mg tablets of INLYTA: red, film-coated, triangular tablets, debossed with “Pfizer” on one side and “5 XNB” on the other side.

Storage And Handling

INLYTA tablets are supplied as follows:

1 mg tablets are red film-coated, oval tablets debossed with “Pfizer” on one side and “1 XNB” on the other; available in bottles of 180: NDC 0069-0145-01.

5 mg tablets are red film-coated, triangular tablets debossed with “Pfizer” on one side and “5 XNB” on the other; available in bottles of 60: NDC 0069-0151-11.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

SIDE EFFECTS

The following clinically significant adverse reactions are discussed elsewhere in the labeling [see WARNINGS AND PRECAUTIONS]:

  • Hypertension and hypertensive crisis [see WARNINGS AND PRECAUTIONS]
  • Arterial thromboembolic events [see WARNINGS AND PRECAUTIONS]
  • Venous thromboembolic events [see WARNINGS AND PRECAUTIONS]
  • Hemorrhage [see WARNINGS AND PRECAUTIONS]
  • Cardiac failure [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal perforation and fistula formation [see WARNINGS AND PRECAUTIONS]
  • Thyroid dysfunction [see WARNINGS AND PRECAUTIONS]
  • Reversible posterior leukoencephalopathy syndrome [see WARNINGS AND PRECAUTIONS]
  • Proteinuria [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Hepatic impairment [see WARNINGS AND PRECAUTIONS]

DRUG INTERACTIONS

CYP3A4/5 Inhibitors

Co-administration of ketoconazole, a strong inhibitor of CYP3A4/5, increased the plasma exposure of axitinib in healthy volunteers. Co-administration of INLYTA with strong CYP3A4/5 inhibitors should be avoided. Grapefruit or grapefruit juice may also increase axitinib plasma concentrations and should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 inhibition potential is recommended. If a strong CYP3A4/5 inhibitor must be co-administered, the INLYTA dose should be reduced [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

CYP3A4/5 Inducers

Co-administration of rifampin, a strong inducer of CYP3A4/5, reduced the plasma exposure of axitinib in healthy volunteers. Co-administration of INLYTA with strong CYP3A4/5 inducers (e.g., rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and St. John's wort) should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 induction potential is recommended [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Moderate CYP3A4/5 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, and nafcillin) may also reduce the plasma exposure of axitinib and should be avoided if possible.

PRECAUTIONS

Hypertension And Hypertensive Crisis

In a controlled clinical study with INLYTA for the treatment of patients with RCC, hypertension was reported in 145/359 patients (40%) receiving INLYTA and 103/355 patients (29%) receiving sorafenib. Grade 3/4 hypertension was observed in 56/359 patients (16%) receiving INLYTA and 39/355 patients (11%) receiving sorafenib. Hypertensive crisis was reported in 2/359 patients (<1%) receiving INLYTA and none of the patients receiving sorafenib. The median onset time for hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg) was within the first month of the start of INLYTA treatment and blood pressure increases have been observed as early as 4 days after starting INLYTA. Hypertension was managed with standard anti-hypertensive therapy. Discontinuation of INLYTA treatment due to hypertension occurred in 1/359 patients (<1%) receiving INLYTA and none of the patients receiving sorafenib [see ADVERSE REACTIONS].

Blood pressure should be well-controlled prior to initiating INLYTA. Patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy. In the case of persistent hypertension despite use of anti-hypertensive medications, reduce the INLYTA dose. Discontinue INLYTA if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of INLYTA, and discontinuation should be considered if there is evidence of hypertensive crisis. If INLYTA is interrupted, patients receiving anti-hypertensive medications should be monitored for hypotension [see DOSAGE AND ADMINISTRATION].

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INLYTA 5 MG 56 TAB.

INLYTA 5 MG 56 TAB.

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Description of product

What is Inlyta and how is it used?

Inlyta is a prescription medicine used to treat kidney cancer that has spread or cannot be removed by surgery (advanced renal cell carcinoma or RCC):

  • in combination with avelumab or pembrolizumab as your first treatment.
  • alone when 1 prior drug treatment regimen for your RCC has not worked.

It is not known if Inlyta is safe and effective in children.

What are the possible side effects of Inlyta?

Inlyta may cause serious side effects, including:

    • High blood pressure (hypertension). High blood pressure is common with Inlyta and may sometimesbe severe. Your healthcare provider should check your blood pressure regularly during treatment with Inlyta. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with Inlyta.
    • Blood clots in your veins or arteries. Inlyta can cause blood clots which can be serious, and sometimes lead to death. Get emergency help and call your healthcare provider if you get any of the following symptoms:
      • chest pain or pressure
      • pain in your arms, back, neck or jaw
      • shortness of breath
      • numbness or weakness on one side of your body
      • trouble talking
      • headache
      • vision changes
    • Bleeding. Inlyta can cause bleeding which can be serious, and sometimes lead to death. Call your healthcare provider right away or get medical help if you develop any of the following signs or symptoms:
      • unexpected bleeding or bleeding that lasts a long time, such as:
      • unusual bleeding from the gums
      • menstrual bleeding or vaginal bleeding that is heavier than normal
      • bleeding that is severe or you cannot control
      • pink or brown urine
      • red or black stools (looks like tar)
      • bruises that happen without a known cause or get larger
      • cough up blood or blood clots
      • vomit blood or your vomit looks like “coffee grounds”
      • unexpected pain, swelling, or joint pain
      • headaches, feeling dizzy or weak
    • Heart failure. Your healthcare provider should check you for signs or symptoms of heart failure regularly during treatment with Inlyta. Heart failure can be serious and can sometimes lead to death. Tell your healthcare provider if you have any of the following symptoms during your treatment with Inlyta:
      • tiredness
      • swelling of your stomach-area (abdomen), legs or ankles
      • shortness of breath
      • protruding neck veins
    • Tear in your stomach or intestinal wall (perforation). A tear in your stomach or intestinal wall can be serious and can sometimes lead to death. Get medical help right away if you get the following symptoms:
      • severe stomach-area (abdominal) pain or stomach-area pain that does not go away
      • vomit blood
      • red or black stools
    • Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment with Inlyta. Tell your healthcare provider if you have any of the following symptoms during your treatment with Inlyta:
      • tiredness that worsens or that does not go away
      • feeling hot or cold
      • your voice deepens
      • weight gain or weight loss
      • hair loss
      • muscle cramps and aches
    • Risk of wound healing problems. Wounds may not heal properly during Inlyta treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with Inlyta.
      • You should stop taking Inlyta at least 2 days before planned surgery.
      • Your healthcare provider should tell you when you may start taking Inlyta again after surgery.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen during treatment with Inlyta. Call your healthcare provider right away if you get:
    • headache
    • seizures
    • weakness
    • confusion
    • high blood pressure
    • blindness or change in vision
    • problems thinking
  • Protein in your urine. Your healthcare provider should check your urine for protein before and during your treatment with Inlyta. If you develop protein in your urine, your healthcare provider may decrease your dose of Inlyta or stop your treatment.
  • Liver problems. Your healthcare provider will do blood tests before and during your treatment with Inlyta. Your healthcare provider may delay or stop your treatment with Inlyta if you develop severe liver problems.
  • Heart problems. When Inlyta is used with the medicine avelumab, severe heart problems can happen and can lead to death. Your healthcare provider will check you for heart problems during your treatment with Inlyta. Tell your healthcare provider right away or get medical help if you have any of the following symptoms:
    • swelling of your stomach-area, legs, hands feet or ankles
    • shortness of breath
    • nausea or vomiting
    • chest discomfort, including pain or pressure
    • weight gain
    • pain or discomfort in your arms, back, neck, or jaw
    • breaking out in a cold sweat o feeling lightheaded or dizzy

The most common side effects of Inlyta with avelumab include:

  • diarrhea
  • feeling tired
  • muscle and bone pain
  • nausea
  • mouth sores
  • rash, redness, itching, or peeling of your skin on your hands and feet
  • hoarseness
  • decreased appetite
  • low levels of thyroid hormone
  • rash
  • liver problems
  • cough
  • shortness of breath
  • stomach-area (abdomen) pain
  • headache

The most common side effects of Inlyta with pembrolizumab include:

  • diarrhea
  • feeling tired or weak
  • liver problems
  • low levels of thyroid hormone
  • decreased appetite
  • rash, redness, itching or peeling of your skin on your hands and feet
  • nausea
  • mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina
  • hoarseness
  • rash
  • cough
  • constipation

The most common side effects of Inlyta when used alone include:

  • diarrhea
  • feeling tired or weak
  • decreased appetite
  • nausea
  • hoarseness
  • rash, redness, itching or peeling of your skin on your hands and feet
  • decreased weight
  • vomiting
  • constipation

Inlyta may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of Inlyta.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Inlyta (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C22H18N4OS and the molecular weight is 386.47 Daltons. The chemical structure is :

Inlyta® (axitinib)  Structural Formula Illustration

Axitinib is a white to light-yellow powder with a pKa of 4.8. The solubility of axitinib in aqueous media over the range pH 1.1 to pH 7.8 is in excess of 0.2 μg/mL. The partition coefficient (n-octanol/water) is 3.5.

Inlyta is supplied as red, film-coated tablets containing either 1 mg or 5 mg of axitinib together with microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and Opadry® II red 32K15441 as inactive ingredients. The Opadry II red 32K15441 film coating contains lactose monohydrate, HPMC 2910/Hypromellose 15cP, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide.

INDICATIONS

First-Line Advanced Renal Cell Carcinoma

INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

INLYTA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma.

Second-Line Advanced Renal Cell Carcinoma

INLYTA as a single agent is indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.

DOSAGE AND ADMINISTRATION

Recommended Dosing

First-Line Advanced RCC

The recommended dose of INLYTA is 5 mg orally taken twice daily (12 hours apart) with or without food in combination with avelumab 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. When INLYTA is used in combination with avelumab, dose escalation of INLYTA above the initial 5 mg dose may be considered at intervals of two weeks or longer. Review the Full Prescribing Information for recommended avelumab dosing information.

The recommended dose of INLYTA is 5 mg orally twice daily (12 hours apart) with or without food in combination with pembrolizumab 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. When INLYTA is used in combination with pembrolizumab, dose escalation of INLYTA above the initial 5 mg dose may be considered at intervals of six weeks or longer. Review the Full Prescribing Information for recommended pembrolizumab dosing information.

Second-Line Advanced RCC

When INLYTA is used as a single agent, the recommended starting oral dose is 5 mg twice daily. Administer INLYTA doses approximately 12 hours apart with or without food.

Important Administration Instructions

Advise patients to swallow INLYTA whole with a full glass of water. If the patient vomits or misses a dose, an additional dose should not be taken. Advise the patient to take the next prescribed dose at the usual time.

Dose Modification Guidelines

Dose increase or reduction is recommended based on individual safety and tolerability.

Over the course of treatment, patients who tolerate INLYTA for at least two consecutive weeks with no adverse reactions Grade >2 (according to the Common Toxicity Criteria for Adverse Events [CTCAE]), are normotensive, and are not receiving anti-hypertension medication, may have their dose increased. When a dose increase from 5 mg twice daily is recommended, the INLYTA dose may be increased to 7 mg twice daily, and further to 10 mg twice daily using the same criteria.

Over the course of treatment, management of some adverse drug reactions may require temporary interruption or permanent discontinuation and/or dose reduction of INLYTA therapy [see WARNINGS AND PRECAUTIONS]. If dose reduction from 5 mg twice daily is required, the recommended dose is 3 mg twice daily. If additional dose reduction is required, the recommended dose is 2 mg twice daily.

Strong CYP3A4/5 Inhibitors

The concomitant use of strong CYP3A4/5 inhibitors should be avoided (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole). Selection of an alternate concomitant medication with no or minimal CYP3A4/5 inhibition potential is recommended. Although INLYTA dose adjustment has not been studied in patients receiving strong CYP3A4/5 inhibitors, if a strong CYP3A4/5 inhibitor must be co-administered, a dose decrease of INLYTA by approximately half is recommended, as this dose reduction is predicted to adjust the axitinib area under the plasma concentration vs time curve (AUC) to the range observed without inhibitors. The subsequent doses can be increased or decreased based on individual safety and tolerability. If co-administration of the strong inhibitor is discontinued, the INLYTA dose should be returned (after 3 – 5 half-lives of the inhibitor) to that used prior to initiation of the strong CYP3A4/5 inhibitor [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Hepatic Impairment

No starting dose adjustment is required when administering INLYTA to patients with mild hepatic impairment (Child-Pugh class A). Based on the pharmacokinetic data, the INLYTA starting dose should be reduced by approximately half in patients with baseline moderate hepatic impairment (Child-Pugh class B). The subsequent doses can be increased or decreased based on individual safety and tolerability. INLYTA has not been studied in patients with severe hepatic impairment (Child-Pugh class C) [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].

Hepatotoxicity

In patients being treated with INLYTA in combination with avelumab:

    • If ALT or AST ≥3 times ULN but <5 times ULN or total bilirubin ≥1.5 times ULN but <3 times ULN, withhold both INLYTA and avelumab until these adverse reactions recover to Grades 0-1. If persistent (greater than 5 days), consider corticosteroid therapy [initial dose of 0.5 to 1 mg/kg/day] prednisone or equivalent followed by a taper. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. If rechallenging with INLYTA, consider dose reduction as per recommended dose modification guidelines.
  • If ALT or AST ≥5 times ULN or >3 times ULN with concurrent total bilirubin ≥2 times ULN or total bilirubin ≥3 times ULN, permanently discontinue both INLYTA and avelumab and consider corticosteroid therapy [initial dose 1 to 2 mg/kg/day prednisone or equivalent followed by a taper].

Review the Full Prescribing Information for additional dose modifications for avelumab.

In patients being treated with INLYTA in combination with pembrolizumab:

  • If ALT or AST ≥3 times ULN but <10 times ULN without concurrent total bilirubin ≥2 times ULN, withhold both INLYTA and pembrolizumab until these adverse reactions recover to Grades 0-1. Consider corticosteroid therapy. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. If rechallenging with INLYTA, consider dose reduction as per recommended dose modification guidelines.
  • If ALT or AST ≥10 times ULN or >3 times ULN with concurrent total bilirubin ≥2 times ULN, permanently discontinue both INLYTA and pembrolizumab and consider corticosteroid therapy.

Review the Full Prescribing Information for additional dose modifications for pembrolizumab.

HOW SUPPLIED

Dosage Forms And Strengths

  • 1 mg tablets of INLYTA: red, film-coated, oval tablets, debossed with “Pfizer” on one side and “1 XNB” on the other side.
  • 5 mg tablets of INLYTA: red, film-coated, triangular tablets, debossed with “Pfizer” on one side and “5 XNB” on the other side.

Storage And Handling

INLYTA tablets are supplied as follows:

1 mg tablets are red film-coated, oval tablets debossed with “Pfizer” on one side and “1 XNB” on the other; available in bottles of 180: NDC 0069-0145-01.

5 mg tablets are red film-coated, triangular tablets debossed with “Pfizer” on one side and “5 XNB” on the other; available in bottles of 60: NDC 0069-0151-11.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

SIDE EFFECTS

The following clinically significant adverse reactions are discussed elsewhere in the labeling [see WARNINGS AND PRECAUTIONS]:

  • Hypertension and hypertensive crisis [see WARNINGS AND PRECAUTIONS]
  • Arterial thromboembolic events [see WARNINGS AND PRECAUTIONS]
  • Venous thromboembolic events [see WARNINGS AND PRECAUTIONS]
  • Hemorrhage [see WARNINGS AND PRECAUTIONS]
  • Cardiac failure [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal perforation and fistula formation [see WARNINGS AND PRECAUTIONS]
  • Thyroid dysfunction [see WARNINGS AND PRECAUTIONS]
  • Reversible posterior leukoencephalopathy syndrome [see WARNINGS AND PRECAUTIONS]
  • Proteinuria [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Hepatic impairment [see WARNINGS AND PRECAUTIONS]

DRUG INTERACTIONS

CYP3A4/5 Inhibitors

Co-administration of ketoconazole, a strong inhibitor of CYP3A4/5, increased the plasma exposure of axitinib in healthy volunteers. Co-administration of INLYTA with strong CYP3A4/5 inhibitors should be avoided. Grapefruit or grapefruit juice may also increase axitinib plasma concentrations and should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 inhibition potential is recommended. If a strong CYP3A4/5 inhibitor must be co-administered, the INLYTA dose should be reduced [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

CYP3A4/5 Inducers

Co-administration of rifampin, a strong inducer of CYP3A4/5, reduced the plasma exposure of axitinib in healthy volunteers. Co-administration of INLYTA with strong CYP3A4/5 inducers (e.g., rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and St. John's wort) should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 induction potential is recommended [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Moderate CYP3A4/5 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, and nafcillin) may also reduce the plasma exposure of axitinib and should be avoided if possible.

PRECAUTIONS

Hypertension And Hypertensive Crisis

In a controlled clinical study with INLYTA for the treatment of patients with RCC, hypertension was reported in 145/359 patients (40%) receiving INLYTA and 103/355 patients (29%) receiving sorafenib. Grade 3/4 hypertension was observed in 56/359 patients (16%) receiving INLYTA and 39/355 patients (11%) receiving sorafenib. Hypertensive crisis was reported in 2/359 patients (<1%) receiving INLYTA and none of the patients receiving sorafenib. The median onset time for hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg) was within the first month of the start of INLYTA treatment and blood pressure increases have been observed as early as 4 days after starting INLYTA. Hypertension was managed with standard anti-hypertensive therapy. Discontinuation of INLYTA treatment due to hypertension occurred in 1/359 patients (<1%) receiving INLYTA and none of the patients receiving sorafenib [see ADVERSE REACTIONS].

Blood pressure should be well-controlled prior to initiating INLYTA. Patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy. In the case of persistent hypertension despite use of anti-hypertensive medications, reduce the INLYTA dose. Discontinue INLYTA if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of INLYTA, and discontinuation should be considered if there is evidence of hypertensive crisis. If INLYTA is interrupted, patients receiving anti-hypertensive medications should be monitored for hypotension [see DOSAGE AND ADMINISTRATION].

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