Lomustine: Difference between revisions

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|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=WARNINGS
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=* Gleostine (lomustine) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.


* Content
* Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to bleeding and overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of Gleostine.


<!--Adult Indications and Dosage-->
* Since the major toxicity is delayed bone marrow suppression, blood counts should be monitored weekly for at least 6 weeks after a dose. At the recommended dosage, courses of Gleostine should not be given more frequently than every 6 weeks.


<!--FDA-Labeled Indications and Dosage (Adult)-->
* The bone marrow toxicity of Gleostine is cumulative and therefore dosage adjustment must be considered on the basis of nadir blood counts from prior dose.
|fdaLIADAdult======Condition1=====
|fdaLIADAdult======Condition1=====


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|administration=* Oral


* Intravenous
 
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|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


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|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


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<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>
|brandNames=* GLEOSTINE
 
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


Revision as of 14:29, 13 February 2015

Lomustine
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

WARNINGS
See full prescribing information for complete Boxed Warning.
* Gleostine (lomustine) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
  • Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to bleeding and overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of Gleostine.
  • Since the major toxicity is delayed bone marrow suppression, blood counts should be monitored weekly for at least 6 weeks after a dose. At the recommended dosage, courses of Gleostine should not be given more frequently than every 6 weeks.
  • The bone marrow toxicity of Gleostine is cumulative and therefore dosage adjustment must be considered on the basis of nadir blood counts from prior dose.

Overview

Lomustine is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

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 Lomustine in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

WARNINGS
See full prescribing information for complete Boxed Warning.
* Gleostine (lomustine) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
  • Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to bleeding and overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of Gleostine.
  • Since the major toxicity is delayed bone marrow suppression, blood counts should be monitored weekly for at least 6 weeks after a dose. At the recommended dosage, courses of Gleostine should not be given more frequently than every 6 weeks.
  • The bone marrow toxicity of Gleostine is cumulative and therefore dosage adjustment must be considered on the basis of nadir blood counts from prior dose.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Lomustine 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 Lomustine 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 Lomustine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Lomustine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Lomustine01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Lomustine Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

  • GLEOSTINE

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

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

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