Overview
Indications
IMPAVIDO (miltefosine) capsules are indicated in adults and adolescents ≥12 years of age weighing ≥ 30 kg for the treatment of: Limitations of Use: 14.1 Leishmania donovani [see Clinical Trials ()] Visceral leishmaniasis caused by. Leishmania braziliensis Leishmania guyanensis 14.2 Leishmania panamensis [see Clinical Trials ()] Cutaneous leishmaniasis caused by,, and. 14.3 Leishmania braziliensis [see Clinical Trials ()] Mucosal leishmaniasis caused by. Leishmania 14.1 14.2 [see Clinical Trials
Boxed Warning
FDA Black Box Warning
4.1 5.1 8.1 8.8 13.1 [see Contraindications (), Warnings and Precautions (), Use in Specific Populations (,) and Nonclinical Toxicology ()] IMPAVIDO may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose. Do no
Indications & Related Conditions
Conditions associated via SNOMED clinical relationships
Administration & Protocol
Dosing, route, and treatment protocol
Detailed dosage and administration information is available in the full FDA drug label.
View full prescribing information on DailyMedMonitoring & Follow-Up
Biomarkers relevant to this intervention via related conditions
No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.
Clinical Trials
3 trials linked to this intervention
Recent Trials
Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis
Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children
Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh
Research Evidence
Published studies and systematic reviews
Research data from MEDLINE/PubMed
Benefits & Expected Outcomes
Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.
Risks & Side Effects
Adverse reaction and safety data for this drug is sourced from the FDA-approved label.
View adverse reactions & drug interactions on DailyMedRelated Symptoms
Symptoms associated with conditions this intervention addresses
No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.
Alternatives & Comparisons
Alternative treatments, comparison data, and clinical decision support are pending physician authorship.
This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.
Do not start, stop, or change any treatment without consulting your healthcare provider.
Quick Facts
- Type
- Substance / Medication
- Fully Specified Name
- Miltefosine (substance)
- SNOMED CT
- 713642004
- UMLS CUI
- C0068006
- RxNorm CUI
- 1494066
- Labeler
- Profounda, Inc.
Clinical Data
This intervention maps to 3 entities in the Healos knowledge graph.
Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.