rifabutin

REMS

Prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

Contraindicated in:

Hypersensitivity. Cross-sensitivity with other rifamycins (rifampin) may occur
Active tuberculosis
Concurrent use of ritonavir
Lactation: Lactation.

Use Cautiously in:

OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
Pedi: Safety and effectiveness not established in children.

CV: chest pain, chest pressure.

Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), rash, skin discoloration, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN).

EENT: ocular disturbances.

GI: altered taste, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), drug-induced hepatitis.

Hemat: hemolysis, neutropenia, thrombocytopenia.

MS: arthralgia, myositis.

Resp: dyspnea.

Misc: brown-orange discoloration of body fluids (urine, tears, saliva), flu-like syndrome.

Drug-Drug:

Ritonavir may significantly ↑ levels; concurrent use contraindicated.
May ↓ levels and effectiveness of efavirenz, nelfinavir, nevirapine, corticosteroids, disopyramide, quinidine, opioid analgesics, oral hypoglycemic agents, warfarin, estrogens, estrogen-containing contraceptives, phenytoin, verapamil, fluconazole, quinidine, theophylline, zidovudine, and chloramphenicol.
May ↓ levels and effectiveness of bictegravir and tenofovir alafenamide; concurrent use with bictegravir/emtricitabine/tenofovir alafenamide is not recommended.
May ↓ levels and effectiveness of doravirine; ↑ doravirine dose.
May ↓ levels and effectiveness of rilpivirine and tenofovir alafenamide; concurrent use with rilpivirine/tenofovir alafenamide/emtricitabine is not recommended.
Efavirenz and nevirapine may ↑ levels.

(Generic available)

Capsules: 150 mg;
In combination with: amoxicillin and omeprazole (Talicia). See Appendix [not included in this PDA edition].

PO (Adults): 300 mg once daily. If GI upset occurs, may give as 150 mg twice daily with food.

Appears to inhibit DNA-dependent RNA polymerase in susceptible organisms.

Therapeutic Effects:

Antimycobacterial action against susceptible organisms.

Spectrum:

Active against M. avium and most strains of M. tuberculosis.

Therapeutic Classification: agents for atypical mycobacterium

Absorption: Well absorbed following oral administration (50–85%). Absorption ↓ in patients with HIV (20%).

Distribution: Widely distributed to body tissues and fluids.

Metabolism/Excretion: Mostly metabolized by the liver; <5% excreted unchanged by the kidneys.

Half-life: 45 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	2–4 hr	24 hr

Advise patient to take medication as directed. Do not skip doses or double up on missed doses. Emphasize the importance of continuing therapy even if asymptomatic.
Advise patient to notify health care professional promptly if signs and symptoms of neutropenia (sore throat, fever, signs of infection), thrombocytopenia (unusual bleeding or bruising), or hepatitis (yellow eyes and skin, nausea, vomiting, anorexia, unusual tiredness, weakness) occur.
Caution patient to avoid the use of alcohol during this therapy, because this may increase the risk of hepatotoxicity.
Instruct patient to notify health care professional immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
Instruct patient to report symptoms of myositis (myalgia, arthralgia), uveitis (intraocular inflammation), or hypersensitivity reactions to health care professional promptly.
Inform patient that skin, saliva, sputum, sweat, tears, urine, and feces may become brown-orange and that soft contact lenses may become permanently discolored.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy.
Emphasize the importance of regular follow-up exams to monitor progress and to check for side effects.

NDC Code^*

0013- Pharmacia and Upjohn Company LLC
0013-5301- Mycobutin 0013-5301-17- 100 CAPSULE in 1 BOTTLE (0013-5301-17)

59762- Greenstone LLC
59762-1350- Rifabutin 59762-1350-1- 100 CAPSULE in 1 BOTTLE (59762-1350-1)

60687- American Health Packaging
60687-198- Rifabutin 60687-198-25- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-198-25) > 1 CAPSULE in 1 BLISTER PACK (60687-198-95)

68180- Lupin Pharmaceuticals, Inc.
68180-285- rifabutin 68180-285-01- 100 CAPSULE in 1 BOTTLE (68180-285-01)

68180- Lupin Pharmaceuticals, Inc.
68180-285- rifabutin 68180-285-07- 60 CAPSULE in 1 BOTTLE (68180-285-07)

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