Halofantrine (Oral)

Halofantrine is part of a group of medicines called antimalarials. It is used to treat malaria, an infection of red blood cells that is spread by mosquito bites.

Malaria is found in many areas, including parts of Central and South America, Hispaniola, sub-Saharan Africa, the Indian subcontinent, Southeast Asia, the Middle East, and Oceania. You can find country-specific information about malaria from the Centers for Disease Control and Prevention (CDC) or on the CDC's website at http://www.cdc.gov/travel/yellowbk.

This medicine can cause serious side effects. Because of this, it is typically used to treat severe malaria infections in places where other medicines may not be effective.

Halofantrine is available only with a prescription from your doctor.

It is important for your doctor to check your progress after treatment. This ensures that the infection is completely cleared and allows your doctor to monitor for any unwanted effects.

If your symptoms do not improve after taking this medicine for the full course of treatment, or if they get worse, consult your doctor.

Malaria is spread by the bites of certain types of infected female mosquitoes. If you are living in or traveling to an area where there is a risk of getting malaria, the following mosquito-control measures can help prevent infection:

• If possible, avoid going out between dusk and dawn because this is when mosquitoes are most active.
• Wear long-sleeved shirts and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are present.
• Apply insect repellent, preferably one containing DEET, to uncovered skin from dusk through dawn when mosquitoes are active.
• If possible, sleep in a screened or air-conditioned room or under mosquito netting treated with insecticide to avoid being bitten by malaria-carrying mosquitoes.
• Use mosquito coils or sprays to kill mosquitoes in living and sleeping areas during the evening and nighttime.

In deciding to use a medicine, you and your doctor must consider the risks and benefits of the medicine. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, like allergies to food, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There is no specific information comparing the use of halofantrine in children to its use in other age groups, but this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work the same way in older people as they do in younger adults or if they cause different side effects or problems. There is no specific information comparing the use of halofantrine in the elderly to its use in other age groups.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions might be necessary. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when using this medicine. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aurothioglucose
• Bepridil
• Cisapride
• Dronedarone
• Ketoconazole
• Levoketoconazole
• Levomethadyl
• Mesoridazine
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both medicines.

• Acecainide
• Adagrasib
• Ajmaline
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Bedaquiline
• Bretylium
• Buprenorphine
• Bupropion
• Buserelin
• Carbamazepine
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Dothiepin
• Doxepin
• Droperidol
• Efavirenz
• Encainide
• Encorafenib
• Enflurane
• Entrectinib
• Erythromycin
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Haloperidol
• Halothane
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Isoflurane
• Isradipine
• Itraconazole
• Ivabradine
• Ivosidenib
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lidoflazine
• Lofepramine
• Lofexidine
• Lopinavir
• Lorcainide
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Phenobarbital
• Pimavanserin
• Pirmenol
• Ponesimod
• Prajmaline
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Risperidone
• Selpercatinib
• Sematilide
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telavancin
• Telithromycin
• Tetrabenazine
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Zolmitriptan
• Zotepine
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as certain foods, as interactions might happen. Using alcohol or tobacco with some medicines might also cause interactions. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or provide special instructions regarding food, alcohol, or tobacco use.

• Grapefruit Juice

Using this medicine with any of the following may increase the risk of certain side effects but may be unavoidable in some situations. If used together, your doctor may change the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Cola Nut

Other Medical Problems

Other medical conditions may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Heart problems, especially abnormal heartbeat or
• Thiamine deficiency or
• Unexplained sudden fainting—These conditions increase the chance of side effects that affect the heart, including fast irregular heartbeat.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if you experience any of the following side effects:

Less common

• Coughing
• Noisy, rattling, or troubled breathing

Rare

• Abdominal pain
• Chest pain
• Confusion
• Convulsions (seizures)
• Diarrhea
• Difficulty in breathing or swallowing
• Hives
• Itching, especially of feet or hands
• Nausea
• Pounding heartbeat
• Reddish skin, especially around ears
• Swelling of eyes, face, or inside of nose
• Unusual tiredness or weakness
• Vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your healthcare professional may also have ways to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More Common

• Headache

Less common

• Aches and pain in joints
• Constipation
• Frequent urination
• Indigestion
• Loss of appetite
• Skin itching or rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Chemical Class: Phenanthrenemethanol

Halofantrine is best taken on an empty stomach to decrease the chance of side effects.

To help clear up your infection completely, take this medicine exactly as directed by your doctor for the full time of treatment. Your symptoms may come back if you stop your treatment too early. Your doctor may instruct you to take a second course of treatment after 1 week.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (oral suspension and tablets): Adults and children over 37 kilograms (81 pounds) of body weight—500 mg, taken on an empty stomach every six hours three times a day for one day. Treatment may need to be repeated after one week. Children—Dose is based on body weight and must be determined by your doctor. Treatment may need to be repeated after one week. Up to 23 kilograms (51 pounds) of body weight: Dose must be determined by your doctor. 23 to 31 kilograms (51 to 68 pounds) of body weight: 250 mg, taken on an empty stomach every six hours three times a day for one day. 32 to 37 kilograms (70 to 81 pounds) of body weight: 375 mg, taken on an empty stomach every six hours three times a day for one day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Keep the liquid form of this medicine from freezing.