Miltefosine｜Schistosomiasis｜HongKong DengYue Medicine

Generic Name/Brand Name: Miltefosine/Impavido (U.S.), Miltex (historical cancer use)
Indications: Leishmaniasis (visceral/cutaneous/mucosal), amoebic infections
Dosage Form: Oral capsules
Specification: 50 mg

Miltefosine Application Scope

Effective against free-living amoeba infections (Naegleria fowleri, Balamuthia mandrillaris, Acanthamoeba).
Investigated for Chagas disease, fungal infections (Candida, Aspergillus), and schistosomiasis, though not standard therapy.

Miltefosine Characteristics

Ingredients: 2-(hexadecoxy-oxido-phosphoryl)oxyethyl-trimethyl-azanium (chemical formula: C₂₁H₄₆NO₄P).
Properties:
- White to off-white crystalline solid.
- Melting point: 232–234°C (450–453°F).
- High oral bioavailability, ~98% protein-bound, slow hepatic metabolism.
Specification: 50 mg capsules.
Packaging Specification: Dispensed in original carton; exact pack size varies by manufacturer.
Storage: 20–25°C (68–77°F); protect from moisture and light.
Expiry Date: Typically 2–3 years; check manufacturer labeling.
Executive Standard: FDA-approved (2014 for leishmaniasis).
Approval Number: Varies by region (e.g., FDA NDA 204684).
Date of Revision: Updated periodically; consult latest prescribing information.
Manufacturer: Profounda Inc. (U.S. supplier).

Dosage and Administration:
- Adults/children ≥12 years:
  - 30–44 kg: 50 mg twice daily for 28 days.
  - ≥45 kg: 50 mg thrice daily for 28 days.
- Take with food to reduce GI side effects.
Adverse Reactions:
- Common: Vomiting (60%), nausea, diarrhea, dizziness, headache.
- Serious: Stevens-Johnson syndrome, thrombocytopenia, kidney/liver dysfunction.
Contraindications:
- Pregnancy (FDA Category D), Sjögren-Larsson syndrome, hypersensitivity.
Precautions:
- Verify pregnancy status pre-treatment. Use contraception during and for 5 months post-therapy.
- Monitor renal/hepatic function and platelets during treatment.

Drug Interactions:
- Moderate interactions: 6 drugs (unspecified; check databases).
- Synergy observed with sodium stibogluconate (in vitro) and amphotericin B (in vivo).
- No severe interactions reported, but caution with hepatotoxic/renal drugs.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.