Bibliographic information

GuidelineWHO guidelines on leishmaniases: treatment of visceral leishmaniasis and post-kala-azar dermal leishmaniasis in eastern Africa and South-East Asia
Year of Publication2026
Issuing InstitutionWorld Health Organization

Recommendation

New

Post-kala-azar dermal leishmaniasis (PKD)L in South-East Asia. A combination of Liposomal amphotericin B (LAmB) (total dose, 20 mg/kg administered IV on days 1, 4, 8, 11 and 15) plus miltefosine (allometric dose orally BID for 21 days) or LAmB monotherapy (total dose, 20 mg/kg administered IV on days 1, 4, 8, 11 and 15) is suggested for the treatment of PKDL.

Recommended in favor

Conditional

Notes and Remarks

Serum potassium levels should be monitored for all patients on high-dose LAmB regimens

When selecting a regimen, consider the national context, such as the health system architecture, health workforce density per population, laboratory capacity, monitoring and reporting pathways, referral network, availability of pregnancy tests, contraception advice, logistics and supply chain, pharmacovigilance and antimicrobial programmes. ⸋ PKDL cases are potential reservoirs. Cases of PKDL in South-East Asia rarely self-heal; therefore, treat every patient when possible in the VL elimination programme. ⸋ Patients should be counselled about the disease, the benefits and risks of treatment and the available alternatives, which should adhere to national patient safety policies and strategies. ⸋ Miltefosine is potentially teratogenic. Its use in pregnancy is contraindicated. It should not be used in women of childbearing potential for whom pregnancy cannot be ruled out and adequate contraception cannot be assured for the duration of treatment and 2 months (for shorter miltefosine regimens, e.g. 5, 7 or 10 days) or 5 months (for≥28-day miltefosine regimen) posttreatment (67). ⸋ Children: Monitoring of ocular side effects might be particularly difficult in children; therefore, a non-miltefosine regimen or a miltefosine regimen of shorter duration can be considered. ⸋ Severely malnourished patients: A shorter regimen may be preferred for such patients. In addition, lack of food to accompany miltefosine intake might increase gastrointestinal side-effects and reduce compliance with the therapy. ⸋ Hypokalemia is a very common side-effect of LAmB, leading to tiredness, confusion, muscle weakness or cramps. This may be more prominent and dose-related in regimens of cumulative high-dose administration, e.g. 30 mg/kg of LAmB. Monitor serum potassium, other electrolytes and renal function during treatment. Proper hydration, a potassium-rich diet and potassium supplementation are important to prevent such side-effetcs. ⸋ High cumulative doses of LAmB should be administered only in centres with the capacity to monitor serum potassium, renal function, and manage electrolyte abnormalities. ⸋ If miltefosine is refused, unavailable or contraindicated, consider alternative treatment with LAmB. ⸋ Improvement of skin lesions before the end of treatment might compromise adherence, especially to the longer (paromomycin plus miltefosine) regimen. Patients should be educated.