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Halfan (Halofantrine Hydrochloride) - Summary

 
 



WARNING

HALFAN HAS BEEN SHOWN TO PROLONG QTc INTERVAL AT THE RECOMMENDED THERAPEUTIC DOSE. THERE HAVE BEEN RARE REPORTS OF SERIOUS VENTRICULAR DYSRHYTHMIAS SOMETIMES ASSOCIATED WITH DEATH, WHICH MAY BE SUDDEN. HALFAN IS THEREFORE NOT RECOMMENDED FOR USE IN COMBINATION WITH DRUGS OR CLINICAL CONDITIONS KNOWN TO PROLONG QTc INTERVAL, OR IN PATIENTS WHO HAVE PREVIOUSLY RECEIVED MEFLOQUINE, OR IN PATIENTS WITH KNOWN OR SUSPECTED VENTRICULAR DYSRHYTHMIAS, A-V CONDUCTION DISORDERS OR UNEXPLAINED SYNCOPAL ATTACKS. HALFAN SHOULD BE PRESCRIBED ONLY BY PHYSICIANS WHO HAVE SPECIAL COMPETENCE IN THE DIAGNOSIS AND TREATMENT OF MALARIA, AND WHO ARE EXPERIENCED IN THE USE OF ANTIMALARIAL DRUGS. PHYSICIANS SHOULD THOROUGHLY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING HALFAN.

 

HALFAN SUMMARY

HALFAN
(halofantrine hydrochloride)
Tablets

HALFAN (halofantrine hydrochloride) is an antimalarial drug available as tablets containing 250 mg of halofantrine hydrochloride (equivalent to 233 mg of the free base) for oral administration. The chemical name of halofantrine hydrochloride is 1,3-dichloro-α-[2-(dibutylamino) ethyl]-6-(trifluoromethyl)-9-phenanthrene-methanol hydrochloride. The drug, a white to off-white crystalline compound, is practically insoluble in water.

HALFAN tablets are indicated for the treatment of adults who can tolerate oral medication and who have mild to moderate malaria (equal to or less than 100,000 parasites/mm3) caused by Plasmodium falciparum or Plasmodium vivax.

NOTE: Patients with acute P. vivax malaria treated with HALFAN are at risk of relapse because halofantrine does not eliminate the exoerythrocytic (hepatic phase) parasites. To avoid relapse after initial treatment of the acute P. vivax infection with HALFAN, patients should subsequently be treated with an 8-aminoquinoline to eradicate the exoerythrocytic parasites.

NOTE: THE EFFICACY OF HALFAN IN THE PROPHYLAXIS OF MALARIA HAS NOT BEEN ESTABLISHED.


See all Halfan indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Halfan (Halofantrine)

GSK Seeks Approval for World's First Malaria Vaccine
Source: Medscape Infectious Diseases Headlines [2014.07.24]
GlaxoSmithKline said it is applying for regulatory approval for the world's first vaccine against malaria, designed for children in Africa.
Reuters Health Information

Global burden of HIV, malaria and TB has decreased since 'the Millennium Declaration'
Source: HIV / AIDS News From Medical News Today [2014.07.22]
The Millennium Declaration was a promise to reduce HIV, malaria and tuberculosis - adopted by governments worldwide in 2000. A new analysis examines the impact of the Declaration.

Researchers prove the effectiveness of a new drug against malaria using synchrotron light
Source: Infectious Diseases / Bacteria / Viruses News From Medical News Today [2014.07.22]
Researchers from the Universitat Politècnica de Catalunya · BarcelonaTech (UPC), the Instituto de Química Mèdica (IQM-CSIC) and the University of Glasgow have proved that the CD27 drug is a...

Trapping malaria parasite in its protective chamber inside red blood cells
Source: Blood / Hematology News From Medical News Today [2014.07.19]
Scientists may be able to entomb the malaria parasite in a prison of its own making, researchers at Washington University School of Medicine in St. Louis report in Nature.

Anti-tank missile detector joins the fight against malaria
Source: Medical Devices / Diagnostics News From Medical News Today [2014.07.18]
State-of-the-art military hardware could soon fight malaria, one of the most deadly diseases on the planet.

more news >>

Published Studies Related to Halfan (Halofantrine)

Effect of fluconazole on the pharmacokinetics of halofantrine in healthy volunteers. [2009.12]
BACKGROUND: Halofantrine, an antimalarial drug used in endemic areas such as the tropics is mainly metabolized by CYP3A4 to the active metabolite N-desbutylhalofantrine. Fluconazole, an antifungal agent and an inhibitor of CYP3A4 is an established part of the therapy in HIV patients, who in turn are prone to malaria in the tropics. This study investigated the effect of fluconazole on the pharmacokinetics of halofantrine after concurrent administration of the two drugs... CONCLUSION: The decreased plasma concentrations of the metabolite are presumably caused by metabolic inhibition of CYP3A4 by fluconazole. Although the therapeutic consequences of this interaction are not clear caution should be exercised when co-administering both drugs to avoid accumulation and subsequent cardiotoxic effects of halofantrine.

Effects of prior administration of amodiaquine on the disposition of halofantrine in healthy volunteers. [2007.04]
The prevalence of multidrug-resistant malaria parasites brings about the switch from an antimalarial drug with poor therapeutic outcome to an effective alternative, resulting in overlap in the plasma drug levels. In this study, the influence of prior administration of amodiaquine on the pharmacokinetics and electrocardiographic effect of halofantrine (HF) was investigated in healthy volunteers...

Effect of experimental hyperlipidaemia on the electrocardiographic effects of repeated doses of halofantrine in rats. [2010.11]
BACKGROUND AND PURPOSE: Halofantrine can cause a prolongation of the cardiac QT interval, leading to serious ventricular arrhythmias...

In vitro susceptibility of Plasmodium falciparum to monodesethylamodiaquine, quinine, mefloquine and halofantrine in Abidjan (Cote d'Ivoire). [2010.06]
BACKGROUND: Malaria is the primary cause of hospitalization in Cote d'Ivoire. Early treatment is one of the strategies to control this illness. However, the spread of resistance of Plasmodium falciparum to antimalarial drugs can seriously compromise this strategy. OBJECTIVES: The aim of this study was to assess the in vitro susceptibility of P. falciparum to monodesethylamodiaquine and aminoalcohols in Abidjan (Cote d'Ivoire)... CONCLUSIONS: Our results showed that the in vitro chloroquine resistance reported in previous studies has been extended to other antimalarial drugs investigated in this study except for quinine. Therefore, it is necessary to implement a long-term monitoring system of antimalarial drug resistance.

Effects of polysorbate 80 on the in-vitro precipitation and oral bioavailability of halofantrine from polyethylene glycol 400 formulations in rats. [2010.01]
OBJECTIVES: The aim of this study was to examine the effects of formulations of polysorbate 80 (PS 80) and polyethylene glycol 400 (PEG 400) on the precipitation and oral bioavailability of the hydrophobic drug halofantrine... CONCLUSIONS: Addition of PS80 to the formulation increased the bioavailability of halofantrine and the more compound, the more PS80 was needed to prevent precipitation.

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Clinical Trials Related to Halfan (Halofantrine)

Drug Interaction Study Between Lumefantrine and Lopinavir/Ritonavir [Recruiting]
With the roll out of antiretroviral therapy (ARV) for HIV across sub-Saharan Africa an unprecedented number of people will be commencing lifelong therapy. Current estimates are that 5-6 million people in sub-Saharan Africa require ART. At the same time, the World Health Organization (WHO) Roll Back Malaria campaign is aggressively promoting the use of artemether/lumefantrine as first-line therapy for malaria in this setting. Many patients in this setting have already become resistant to first-line ARV and have moved onto lopinavir/ritonavir (Kaletra) based second-line regimens. Kaletra is a potent inhibitor of Cytochrome P450 3A4 (CYP 3A4), an enzyme responsible for the metabolism of many drugs which is found predominantly in the liver and the gut. Lumefantrine, and to a lesser extent artemether, is extensively metabolized by CYP 3A4. Therefore when given to a patient already taking Kaletra for HIV, it is likely that elevated levels of these drugs in the patient will result. There is some concern that lumefantrine may be cardiotoxic due to its structural similarity to halofantrine which is known to cause irregular heart rhythms. This has not been borne out as yet in any studies performed with lumefantrine, however it is not known what levels will be achieved in patients when it is administered with a protease inhibitor such as Kaletra. The WHO has not addressed this issue in any of its previous policy documents but has identified ARV-antimalarial drug interaction studies as a research priority. This single dose pharmacokinetic (PK) study aims to compare the levels of lumefantrine/artemether that result when it is given to a patient on Kaletra with patients not on any ARV. Data generated by this study will help address this important knowledge gap which has been identified by WHO and others as meriting urgent investigation.

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Page last updated: 2014-07-24

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