Pronunciation:

kloe-FAZ-i-meen

Brand Names:

• Lamprene

Uses of This Medicine:

Clofazimine is used together with other medicines to treat a form of leprosy (also known as Hansen's disease), called lepromatous leprosy, including dapsone-resistant lepromatous leprosy, and lepromatous leprosy complicated by erythema nodosum leprosum. Lepromatous leprosy is a more severe and contagious form of the disease, has widespread skin bumps and rashes (multibacillary leprosy), numbness, and muscle weakness, and may also affect body organs (eg, nose, kidneys, male reproductive organs).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of clofazimine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clofazimine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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

• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Bosutinib
• Buprenorphine
• Buserelin
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clothiapine
• Clozapine
• Colchicine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Elexacaftor
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Fosaprepitant
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lumefantrine
• Lurbinectedin
• Macimorelin
• Mavacamten
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Palovarotene
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Posaconazole
• Pralsetinib
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tezacaftor
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zolpidem
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Hydroxide
• Magnesium Hydroxide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Orange Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression or
• Heart rhythm problems (eg, QT prolongation) or
• Stomach or bowel problems—Use with caution. May make these conditions worse.

• Kidney disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

• Liver disease—Avoid use in patients with this condition, unless the benefits outweigh the risks.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take this medicine with meals.

To help clear up your leprosy completely, it is very important that you keep using clofazimine for the full time of treatment, even if you begin to feel better after a few months. You may have to take it every day for as long as 2 to 3 years. If you stop using this medicine too soon, your symptoms may return, worsen, or infect other people.

This medicine is taken together with other medicines (eg, other antileprosy medicines, steroids). Follow your doctor's orders on the right times to take these medicines.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take each dose at the same time every day. If you need help in planning the best time to take your medicines, check with your doctor or pharmacist.

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 form (capsules):
  • For lepromatous leprosy (dapsone-sensitive):
    • Adults—100 milligrams (mg) in combination with two other antileprosy drugs for at least 2 years. Your doctor may give you an appropriate antileprosy drug after.
    • Children—Use and dose must be determined by your doctor.
  • For lepromatous leprosy (dapsone-resistant):
    • Adults—100 milligrams (mg) in combination with one or more other antileprosy drugs for 3 years. Your doctor may then give you 100 mg of clofazimine once a day.
    • Children—Use and dose must be determined by your doctor.
  • For lepromatous leprosy complicated by erythema nodosum leprosum:
    • Adults—100 to 200 milligrams (mg) once a day for up to 3 months, in combination with other antileprosy drugs and steroids. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Your doctor will give you a pregnancy test before starting treatment with this medicine to make sure you are not pregnant.

If your symptoms do not improve within 1 to 3 months, or if they become worse, check with your doctor.

This medicine may be stored in the different organs of the body (eg, lymph nodes, bowels, spleen, liver) as crystals. When stored in the bowels, this may lead to bowel blockage or stomach or bowel bleeding. This medicine may also cause splenic infarction, where the spleen does not get enough oxygen. Check with your doctor right away if you have nausea, vomiting, diarrhea, black or bloody stools, stomach pain, or pain spreading to the left shoulder.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.

Clofazimine may cause orange-pink to brownish-black discoloration of the skin within a few weeks after you start using it. Because of the skin discoloration, some patients may become depressed. It may also cause your sweat, tears, spit, urine, stools, and the whites of your eyes to turn red or brownish-black in color. The discoloration will go away when you stop using this medicine. However, it may take several months or years for the skin to clear up completely. If skin discoloration causes you to feel very depressed or to have thoughts of suicide, check with your doctor right away.

Clofazimine may cause dry, rough, itchy, or scaly skin. You may use a skin cream, lotion, or oil may help treat this problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Constipation

diarrhea

heartburn

indigestion

loss of appetite

nausea

pain or discomfort in the chest, upper stomach, or throat

stomach pain

vomiting

Less common

Blurry vision

dry mouth

dryness, burning, itching, or irritation of the eye

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

sweating

troubled breathing

unexplained weight loss

unusual tiredness or weakness

Rare

Bloody or black, tarry stools

bloody or cloudy urine

bone pain

chest pain

chills

constipation

cough

dark urine

decreased urine

decreased vision

depression and thoughts of suicide secondary to skin discoloration

difficult, burning, or painful urination

fever

frequent urge to urinate

general tiredness and weakness

irregular heartbeat

light-colored stools

mood changes

muscle pain or cramps

nerve pain

numbness or tingling in the hands, feet, or lips

pain in the chest, groin, or legs, especially the calves

pain spreading to the left shoulder

pale skin

seizures

severe stomach pain

severe, sudden headache

slurred speech

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach cramping

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

swelling

swollen, painful, or tender lymph glands in the neck, armpit, or groin

troubled breathing with exertion

unusual bleeding or bruising

upper right abdominal pain and fullness

vision changes

vomiting of blood or material that looks like coffee grounds

yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Dry, rough, or scaly skin

pink to brownish black skin discoloration

Less common

Discoloration of the eye, urine, stool, spit, sweat

itching, skin rash

Rare

Bad unusual or unpleasant (after)taste

change in taste

dizziness

drowsiness

giddiness

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 may report side effects to the FDA at 1-800-FDA-1088.