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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.


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NEWS HIGHLIGHTS

Media Articles Related to Halfan (Halofantrine)

Also In Global Health News: HIV/AIDS In Uganda; Medical Equipment In Tanzania; Birth Control In Afghanistan; Ethiopia Malaria Fight
Source: HIV / AIDS News From Medical News Today [2009.11.17]
Changes Planned For Ugandan HIV/AIDS Campaign "The Uganda AIDS Commission (UAC) is revamping its national HIV information campaign after HIV prevention messages were less successful than hoped," PlusNews reports.

Are Sterile Mosquitoes The Answer To Malaria Elimination?
Source: Tropical Diseases News From Medical News Today [2009.11.17]
The Sterile Insect Technique (SIT), the release of sexually sterile male insects to wipe out a pest population, is one suggested solution to the problem of malaria in Africa. A new supplement, published in BioMed Central's open access Malaria Journal, reviews the history of the technique, and features details about aspects of its application in the elimination of malaria.

TIME Examines Efforts To Combat Malaria Resistance Along Thai-Cambodia Border
Source: Tropical Diseases News From Medical News Today [2009.11.16]
TIME reports on evidence along the Thai-Cambodia border that the malaria parasite is gaining resistance to artemisinin - "the only remaining effective drug in the world's arsenal against malaria's most deadly strain.

Reporting On Advances In Malaria Research
Source: Medical Devices / Diagnostics News From Medical News Today [2009.11.13]
In a novel approach at disseminating scientific research, the Johns Hopkins Malaria Research Institute (JHMRI) held a web summit to release the latest breakthroughs in malaria research, including new approaches to boosting mosquito immunity to malaria, mapping mosquito migrations, and the promise of a rapid sputum test that could revolutionize the way malaria is tracked and tested for in rural areas, which are hotbeds for the disease.

VOA News Examines Conculsion Of MIM Pan-African Malaria Conference
Source: Tropical Diseases News From Medical News Today [2009.11.10]
The 5th Multilateral Initiative on Malaria (MIM) Pan-African Conference ended Friday in Nairobi, Kenya, " with scientists expressing optimism about several developments in the works to prevent, treat, and possibly eradicate a disease that kills nearly one million people in Africa each year,"

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Published Studies Related to Halfan (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...

Intestinal lymphatic transport of halofantrine in rats assessed using a chylomicron flow blocking approach: the influence of polysorbate 60 and 80. [2008.10.02]
The aim of the study was to examine the effects of polysorbate 60 and 80 on intestinal lymphatic transport of a poorly water-soluble compound, halofantrine, using a chylomicron flow blocking approach in rats. Male Sprague-Dawley rats were pretreated intraperitoneally with 3.0 mg/kg cycloheximide or saline...

Changes in antioxidant status and biochemical indices after acute administration of artemether, artemether-lumefantrine and halofantrine in rats. [2008.04]
Artemether, artemether-lumefantrine, or coartem and halofantrine are alternative antimalarial drugs to chloroquine...

Effect of kolanut on the pharmacokinetics of the antimalarial drug halofantrine. [2008.01]
OBJECTIVE: To study the effect of the concomitant consumption of kolanut, a caffeine-containing nut, on the pharmacokinetics of halofantrine... CONCLUSIONS: Co-administration of halofantrine and kolanut caused a significant decrease in the plasma concentrations of halofantrine and the active metabolite desbutylhalofantrine probably during adsorption of the drug due to complex formation. This indicates that caution should be exerted when the drug is taken together with caffeine-containing nutrients.

Effect of kolanut on the pharmacokinetics of the antimalarial drug halofantrine. [2007.10.20]
OBJECTIVE: To study the effect of the concomitant consumption of kolanut, a caffeine-containing nut, on the pharmacokinetics of halofantrine... CONCLUSIONS: Co-administration of halofantrine and kolanut caused a significant decrease in the plasma concentrations of halofantrine and the active metabolite desbutylhalofantrine probably during adsorption of the drug due to complex formation. This indicates that caution should be exerted when the drug is taken together with caffeine-containing nutrients.

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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: 2009-11-17

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