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Lamprene
clofazimine
Adult Dosing .
Dosage forms: CAP: 50 mg
Restricted Distribution in US
- [1-800-642-2477 for more info]
leprosy (Hansen dz), multibacillary
- [standard tx]
- Dose: 300 mg PO qmo AND 50 mg PO qd x12mo; Alt: 100 mg PO qd x24mo; Info: part of multi-drug regimen; give w/ food; may continue tx beyond 12-24mo in refractory cases
- [pts who cannot take dapsone]
- Dose: 300 mg PO qmo AND 50 mg PO qd x12mo; Alt: 100 mg PO qd x36mo in dapsone-resistant cases; Info: part of multi-drug regimen; give w/ food; may continue tx beyond 12mo in refractory cases; may continue 100 mg PO qd as monotx beyond 36mo in dapsone-resistant cases
- [pts who cannot take rifampin]
- Dose: 50-100 mg PO qd x24mo; Info: part of multi-drug regimen; give w/ food; may continue tx beyond 24mo in refractory cases
leprosy (Hansen dz), paucibacillary (off-label)
- [pts who cannot take dapsone]
- Dose: 300 mg PO qmo AND 50 mg PO qd x6mo; Info: not 1st-line agent; part of multi-drug regimen; give w/ food; may continue tx beyond 6mo in refractory cases
- [pts who cannot take rifampin]
- Dose: 50 mg PO qd x24mo; Info: not 1st-line agent; part of multi-drug regimen; give w/ food; may continue tx beyond 24mo in refractory cases
leprosy reaction, type 2 (erythema nodosum leprosum), chronic
- [pts taking clofazimine in multi-drug regimen]
- Dose: incr. clofazimine to 100-200 mg PO qd until controlled, then cont. w/ 100 mg PO qd for remainder of regimen; Alt: incr. clofazimine to 300 mg PO qd x1mo, then cont. w/ 100 mg PO qd for remainder of regimen; Info: give w/ food
- [pts not taking clofazimine in multi-drug regimen]
- Dose: 100 mg PO tid for up to 12wk, then 100 mg PO bid x12wk, then 100 mg PO qd x12-24wk; Max: 12mo; Info: for severe refractory cases w/ insufficient response to corticosteroid tx; max effect not achieved until 4-6wk; give w/ food
renal dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined, caution advised
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A, B, or C: avoid use
Peds Dosing .
- Dosage forms: CAP: 50 mg
Restricted Distribution in US
- [1-800-642-2477 for more info]
leprosy (Hansen dz), multibacillary (off-label)
- [<10 yo]
- Dose: 6 mg/kg/dose PO qmo AND 1 mg/kg/day PO qod x12mo; Max: 150 mg qmo dose; 50 mg qod dose; Info: part of multi-drug regimen; give w/ food; may continue tx beyond 12mo in refractory cases
- [10-14 yo]
- Dose: 150 mg PO qmo AND 50 mg PO qod x12mo; Info: part of multi-drug regimen; give w/ food; may continue tx beyond 12mo in refractory cases
- [15 yo and older, standard tx]
- Dose: 300 mg PO qmo AND 50 mg PO qd x12mo; Alt: 100 mg PO qd x24mo; Info: part of multi-drug regimen; give w/ food; may continue tx beyond 12-24mo in refractory cases
- [15 yo and older, pts who cannot take dapsone]
- Dose: 300 mg PO qmo AND 50 mg PO qd x12mo; Alt: 100 mg PO qd x36mo in dapsone-resistant cases; Info: part of multi-drug regimen; give w/ food; may continue tx beyond 12mo in refractory cases; may continue 100 mg PO qd as monotx beyond 36mo in dapsone-resistant cases
- [15 yo and older, pts who cannot take rifampin]
- Dose: 50-100 mg PO qd x24mo; Info: part of multi-drug regimen; give w/ food; may continue tx beyond 24mo in refractory cases
leprosy (Hansen dz), paucibacillary (off-label)
- [15 yo and older, pts who cannot take dapsone]
- Dose: 300 mg PO qmo AND 50 mg PO qd x6mo; Info: not 1st-line agent; part of multi-drug regimen; give w/ food; may continue tx beyond 6mo in refractory cases
- [15 yo and older, pts who cannot take rifampin]
- Dose: 50 mg PO qd x24mo; Info: not 1st-line agent; part of multi-drug regimen; give w/ food; may continue tx beyond 24mo in refractory cases
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: pts of childbearing potential
- caution: male pts of reproductive potential
- caution: electrolyte abnormalities
- caution: long QT syndrome, congenital
- caution: QT prolongation
- caution: QT prolongation family hx
- caution: torsades de pointes hx
- caution: ventricular arrhythmia
- caution: bradycardia
- caution: MI, recent
- caution: CHF
- caution: renal impairment, severe
- caution: hepatic impairment
Drug Interactions .
Overview
clofazimine
antimycobacterial
- CYP2C8 inhibitor, weak
- CYP2D6 inhibitor, weak
- CYP3A4 inhibitor, moderate
- alters GI flora
- impairs immunomodulatory bacterial infective agent
- prolongs QT interval (known)
Contraindicated
- cisapride
- domperidone
- dronedarone
- flibanserin
- levoketoconazole
- lomitapide
- pimozide
- thioridazine
Avoid/Use Alternative
- adagrasib
- alfentanil
- alprazolam
- amiodarone
- anagrelide
- apomorphine
- aprepitant
- arsenic trioxide
- artemether/lumefantrine
- asenapine
- avapritinib
- azithromycin
- BCG live intravesical
- bedaquiline
- bosentan
- bosutinib
- brigatinib
- buspirone
- cabozantinib
- cholera vaccine, live
- citalopram
- clarithromycin
- cobimetinib
- codeine
- colchicine
- conivaptan
- crizotinib
- defactinib
- degarelix
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- dihydrocodeine
- dihydroergotamine
- disopyramide
- dofetilide
- doxorubicin
- droperidol
- efavirenz
- elacestrant
- eliglustat
- encorafenib
- ensartinib
- entrectinib
- ephedra
- ergotamine
- eribulin
- erythromycin
- etrasimod
- fentanyl
- fexinidazole
- flecainide
- fluoxetine
- fosaprepitant
- foscarnet
- gepotidacin
- givinostat
- glasdegib
- goserelin
- grapefruit
- histrelin
- hydrocodone
- hydroxychloroquine
- ibutilide
- iloperidone
- inotuzumab ozogamicin
- isoflurane
- ivabradine
- ivacaftor
- ivosidenib
- ixabepilone
- lefamulin
- lemborexant
- leuprolide
- levofloxacin
- lonafarnib
- loperamide
- lopinavir/ritonavir
- lovastatin
- lurbinectedin
- macimorelin
- macitentan
- meperidine
- methadone
- methylergonovine
- midazolam
- mifepristone
- mobocertinib
- moxifloxacin
- naloxegol
- neratinib
- nilotinib
- nirogacestat
- nisoldipine
- olaparib
- oliceridine
- omaveloxolone
- osimertinib
- oxaliplatin
- oxycodone
- ozanimod
- pacritinib
- paliperidone
- palovarotene
- panobinostat
- pazopanib
- pemigatinib
- pentamidine
- pexidartinib
- phenobarbital
- pimavanserin
- pitolisant
- ponesimod
- pralsetinib
- procainamide
- propafenone
- quetiapine
- quinidine (antiarrhythmic)
- quinine
- quizartinib
- repotrectinib
- revumenib
- ribociclib
- rilpivirine
- rivaroxaban
- rucaparib
- selpercatinib
- selumetinib
- sertraline
- sevoflurane
- simvastatin
- siponimod
- solifenacin
- sonidegib
- sorafenib
- sotalol
- sufentanil
- tazemetostat
- tetrabenazine
- tolvaptan
- toremifene
- tramadol
- trazodone
- triptorelin
- typhoid vaccine, live
- vandetanib
- vardenafil
- vemurafenib
- venetoclax
- ziprasidone
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- albuterol
- albuterol inhaled
- alfuzosin
- amisulpride
- amitriptyline
- apalutamide
- apixaban
- arformoterol inhaled
- aripiprazole oral
- asciminib
- atorvastatin
- avanafil
- avatrombopag
- axitinib
- berotralstat
- brexpiprazole
- bromocriptine
- budesonide
- buprenorphine
- butorphanol
- capivasertib
- carbamazepine
- cariprazine
- ceritinib
- chloroquine
- chlorpromazine
- cilostazol
- ciprofloxacin
- clomipramine
- clonazepam
- clozapine
- copanlisib
- cyclosporine
- daridorexant
- dasatinib
- deflazacort
- deutetrabenazine
- docetaxel
- donepezil
- elexacaftor/tezacaftor/ivacaftor
- epirubicin
- eplerenone
- erdafitinib
- escitalopram
- estazolam
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- everolimus
- fedratinib
- felodipine
- finerenone
- fingolimod
- fluconazole
- fluorouracil
- formoterol inhaled
- fostemsavir
- futibatinib
- gemtuzumab ozogamicin
- gepirone
- gilteritinib
- granisetron
- guanfacine
- haloperidol
- hydrocortisone
- hydroxyzine
- ibrutinib
- irinotecan
- itraconazole
- lapatinib
- lenvatinib
- levalbuterol inhaled
- lidocaine
- lofexidine
- lumateperone
- lurasidone
- mavacamten
- mavorixafor
- mefloquine
- metronidazole
- midostaurin
- mirtazapine
- mitapivat
- nifedipine
- nimodipine
- nortriptyline
- ofloxacin
- olodaterol inhaled
- ondansetron
- osilodrostat
- paclitaxel
- palbociclib
- palonosetron
- pasireotide
- pirtobrutinib
- ponatinib
- posaconazole
- primaquine
- promethazine
- propranolol
- quinidine (CYP2D6 inhibitor)
- ranolazine
- red yeast rice
- relugolix
- repaglinide
- rifabutin
- rimegepant
- riociguat
- romidepsin
- ruxolitinib
- ruxolitinib topical
- sacituzumab govitecan
- salmeterol inhaled
- sirolimus
- sirolimus albumin-bound
- sparsentan
- sunitinib
- suvorexant
- suzetrigine
- tacrolimus
- tadalafil
- tamsulosin
- telavancin
- temsirolimus
- terbutaline
- tezacaftor/ivacaftor
- tofacitinib
- tolterodine
- trabectedin
- triazolam
- triclabendazole
- trifluridine
- ubrogepant
- valbenazine
- vanzacaftor/tezacaftor/deutivacaftor
- venlafaxine
- vilanterol inhaled
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- voriconazole
- warfarin
- zanubrutinib
Caution Advised
- aliskiren
- avacopan
- budesonide rectal
- cyclophosphamide
- darifenacin
- dexamethasone
- duvelisib
- eletriptan
- erlotinib
- fecal microbiota, live
- grazoprevir
- ifosfamide
- isavuconazonium
- istradefylline
- larotrectinib
- lumacaftor/ivacaftor
- maraviroc
- methylprednisolone
- metoprolol
- naldemedine
- ospemifene
- perphenazine
- roflumilast
- roflumilast topical
- saxagliptin
- seladelpar
- sildenafil
- silodosin
- sirolimus topical
- ticagrelor
- tretinoin
- upadacitinib
- verapamil
- vilazodone
Adverse Reactions .
Serious Reactions
- abdominal sx, severe
- hepatitis
- jaundice
- intestinal obstruction
- GI bleeding
- splenic infarction
- thromboembolism
- QT prolongation
- torsades de pointes
Common Reactions
- skin discoloration
- nausea
- vomiting
- diarrhea
- abdominal pain
- epigastric pain
- ichthyosis
- xeroderma
- pruritus
- rash
- body fluid discoloration
- fecal discoloration
- ocular pigmentation
- ocular irritation
- hyperglycemia
- ESR elevated
- vision decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; ECG if cardiac conduction disturbance
Look/Sound-Alike Drug Names
clofazamine confused with: cloZAPine
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; risk of skin discoloration based on limited human data; risk of embryo-fetal toxicity and death based on animal data at 0.6x MRHD
Individuals of Reproductive Potential
obtain negative pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and for at least 4mo after D/C in pts of childbearing potential, and using condoms during tx and for at least 4mo after D/C in male pts
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; risk of infant skin and milk discoloration based on limited human data; no human data available to assess effects on milk production
Pharmacology .
Metabolism: unknown; CYP450: unknown
Excretion: feces primarily; Half-life: 25 days
Subclass: Leprosy (Hansen Disease)
Mechanism of Action
binds to mycobacterial DNA, inhibiting growth; exact mechanism of anti-inflammatory action unknown (riminophenazine)
Formulary .
No Formulary Selected
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