Pazopanib hydrochloride: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{KS}}
|authorTag={{KS}}
|aOrAn=a
|genericName=pazopanib hydrochloride
|aOrAn=an
|drugClass=antineoplastic agent
|indicationType=treatment
|indication=advanced [[renal cell carcinoma]], advanced soft tissue sarcoma,
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=[[hypertension]], hair color change, [[lymphocytopenia]], musculoskeletal pain,[[headache]], [[dyspnea]]
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=HEPATOTOXICITY
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended.
|fdaLIADAdult===Indications==
* VOTRIENT® is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).


* Content
* VOTRIENT is indicated for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.


<!--Adult Indications and Dosage-->
Limitation of Use: The efficacy of VOTRIENT for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.


<!--FDA-Labeled Indications and Dosage (Adult)-->
==Dosage==
|fdaLIADAdult======Condition1=====
* The recommended starting dose of VOTRIENT is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). The dose of VOTRIENT should not exceed 800 mg.


* Dosing Information
* Do not crush tablets due to the potential for increased rate of absorption which may affect systemic exposure.


:* Dosage
* If a dose is missed, it should not be taken if it is less than 12 hours until the next dose.


=====Condition2=====
==Dose Modification Guidelines==


* Dosing Information
* In RCC, the initial dose reduction should be 400 mg, and additional dose decrease or increase should be in 200 mg steps based on individual tolerability.


:* Dosage
* In STS, a decrease or increase should be in 200 mg steps based on individual tolerability.


=====Condition3=====
* Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. In patients with moderate hepatic impairment, alternatives to VOTRIENT should be considered. If VOTRIENT is used in patients with moderate hepatic impairment, the dose should be reduced to 200 mg per day. VOTRIENT is not recommended in patients with severe hepatic impairment.


* Dosing Information
* Concomitant Strong CYP3A4 Inhibitors: The concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) increases pazopanib concentrations and should be avoided. Consider an alternate concomitant medication with no or minimal potential to inhibit CYP3A4. If coadministration of a strong CYP3A4 inhibitor is warranted, reduce the dose of VOTRIENT to 400 mg. Further dose reductions may be needed if adverse effects occur during therapy.


:* Dosage
Concomitant Strong CYP3A4 Inducer: The concomitant use of strong CYP3A4 inducers (e.g., rifampin) may decrease pazopanib concentrations and should be avoided. Consider an alternate concomitant medication with no or minimal enzyme induction potential. VOTRIENT should not be used in patients who cannot avoid chronic use of strong CYP3A4 inducers.


=====Condition4=====
== DOSAGE FORMS AND STRENGTHS==
* 200 mg tablets of VOTRIENT — modified capsule-shaped, gray, film-coated with GS JT debossed on one side. Each tablet contains 216.7 mg of pazopanib hydrochloride equivalent to 200 mg of pazopanib.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Dosing Information


:* Dosage
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Off-Label Use and Dosage (Adult)-->


<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport======Condition1=====


Revision as of 19:43, 26 January 2015

Pazopanib hydrochloride
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

HEPATOTOXICITY
See full prescribing information for complete Boxed Warning.
Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended.

Overview

Pazopanib hydrochloride is an antineoplastic agent that is FDA approved for the treatment of advanced renal cell carcinoma, advanced soft tissue sarcoma,. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypertension, hair color change, lymphocytopenia, musculoskeletal pain,headache, dyspnea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • VOTRIENT® is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
  • VOTRIENT is indicated for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.

Limitation of Use: The efficacy of VOTRIENT for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.

Dosage

  • The recommended starting dose of VOTRIENT is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). The dose of VOTRIENT should not exceed 800 mg.
  • Do not crush tablets due to the potential for increased rate of absorption which may affect systemic exposure.
  • If a dose is missed, it should not be taken if it is less than 12 hours until the next dose.

Dose Modification Guidelines

  • In RCC, the initial dose reduction should be 400 mg, and additional dose decrease or increase should be in 200 mg steps based on individual tolerability.
  • In STS, a decrease or increase should be in 200 mg steps based on individual tolerability.
  • Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. In patients with moderate hepatic impairment, alternatives to VOTRIENT should be considered. If VOTRIENT is used in patients with moderate hepatic impairment, the dose should be reduced to 200 mg per day. VOTRIENT is not recommended in patients with severe hepatic impairment.
  • Concomitant Strong CYP3A4 Inhibitors: The concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) increases pazopanib concentrations and should be avoided. Consider an alternate concomitant medication with no or minimal potential to inhibit CYP3A4. If coadministration of a strong CYP3A4 inhibitor is warranted, reduce the dose of VOTRIENT to 400 mg. Further dose reductions may be needed if adverse effects occur during therapy.

Concomitant Strong CYP3A4 Inducer: The concomitant use of strong CYP3A4 inducers (e.g., rifampin) may decrease pazopanib concentrations and should be avoided. Consider an alternate concomitant medication with no or minimal enzyme induction potential. VOTRIENT should not be used in patients who cannot avoid chronic use of strong CYP3A4 inducers.

DOSAGE FORMS AND STRENGTHS

  • 200 mg tablets of VOTRIENT — modified capsule-shaped, gray, film-coated with GS JT debossed on one side. Each tablet contains 216.7 mg of pazopanib hydrochloride equivalent to 200 mg of pazopanib.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pazopanib hydrochloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pazopanib hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Pazopanib hydrochloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Pazopanib hydrochloride in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pazopanib hydrochloride in pediatric patients.

Contraindications

  • Condition1

Warnings

HEPATOTOXICITY
See full prescribing information for complete Boxed Warning.
Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Pazopanib hydrochloride in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Pazopanib hydrochloride in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pazopanib hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Pazopanib hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pazopanib hydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Pazopanib hydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Pazopanib hydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Pazopanib hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pazopanib hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pazopanib hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pazopanib hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pazopanib hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pazopanib hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Pazopanib hydrochloride in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Pazopanib hydrochloride in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Pazopanib hydrochloride in the drug label.

Pharmacology

There is limited information regarding Pazopanib hydrochloride Pharmacology in the drug label.

Mechanism of Action

Structure

File:Pazopanib hydrochloride01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Pazopanib hydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Pazopanib hydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Pazopanib hydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Pazopanib hydrochloride in the drug label.

How Supplied

Storage

There is limited information regarding Pazopanib hydrochloride Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Pazopanib hydrochloride |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Pazopanib hydrochloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Pazopanib hydrochloride in the drug label.

Precautions with Alcohol

  • Alcohol-Pazopanib hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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