Miltefosine: 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=WARNING: EMBRYO-FETAL TOXICITY
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=IMPAVIDO may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose. Do not administer IMPAVIDO to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing IMPAVIDO. Females of reproductive potential should be advised to use effective contraception during IMPAVIDO therapy and for 5 months after therapy.
|fdaLIADAdult===Indications==


* Content
* IMPAVIDO (miltefosine) capsules are indicated in adults and adolescents ≥12 years of age weighing ≥ 30 kg for the treatment of:


<!--Adult Indications and Dosage-->
* Visceral leishmaniasis caused by Leishmania donovani.
* Cutaneous leishmaniasis caused by Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis.
* Mucosal leishmaniasis caused by Leishmania braziliensis.


<!--FDA-Labeled Indications and Dosage (Adult)-->
'''Limitations of Use:'''
|fdaLIADAdult======Condition1=====


* Dosing Information
* Leishmania species studied in clinical trials evaluating IMPAVIDO were based on epidemiologic data.
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--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 may be geographic variation in clinical response of the same Leishmania species to IMPAVIDO.


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
* The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated.


<!--Non–Guideline-Supported Use (Adult)-->
==Dosage==
|offLabelAdultNoGuideSupport======Condition1=====


* Dosing Information
* The treatment duration is 28 consecutive days. Administer with food to ameliorate gastrointestinal adverse reactions.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


:* Dosage


=====Condition2=====
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


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=====
 
* Developed by:
 
* Class of Recommendation:


* Strength of Evidence:
* Dosing Information


:* Dosage


=====Condition2=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport======Condition1=====


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There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
 
|contraindications=* Condition1
|contraindications=* Condition1


Revision as of 14:47, 10 February 2015

Miltefosine
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

WARNING: EMBRYO-FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
IMPAVIDO may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose. Do not administer IMPAVIDO to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing IMPAVIDO. Females of reproductive potential should be advised to use effective contraception during IMPAVIDO therapy and for 5 months after therapy.

Overview

Miltefosine 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)

Indications

  • IMPAVIDO (miltefosine) capsules are indicated in adults and adolescents ≥12 years of age weighing ≥ 30 kg for the treatment of:
  • Visceral leishmaniasis caused by Leishmania donovani.
  • Cutaneous leishmaniasis caused by Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis.
  • Mucosal leishmaniasis caused by Leishmania braziliensis.

Limitations of Use:

  • Leishmania species studied in clinical trials evaluating IMPAVIDO were based on epidemiologic data.
  • There may be geographic variation in clinical response of the same Leishmania species to IMPAVIDO.
  • The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated.

Dosage

  • The treatment duration is 28 consecutive days. Administer with food to ameliorate gastrointestinal adverse reactions.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

WARNING: EMBRYO-FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
IMPAVIDO may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose. Do not administer IMPAVIDO to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing IMPAVIDO. Females of reproductive potential should be advised to use effective contraception during IMPAVIDO therapy and for 5 months after therapy.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Miltefosine01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Miltefosine 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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