rifabutin

REMS

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

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.

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

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), STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN), rash, skin discoloration.

EENT: ocular disturbances.

GI: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), altered taste, 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, indinavir, nelfinavir, nevirapine, saquinavir (dosage adjustment may be necessary), , corticosteroids, disopyramide, quinidine, opioid analgesics, oral hypoglycemic agents, warfarin, estrogens, estrogen-containing contraceptives, phenytoin, verapamil, fluconazole, quinidine, theophylline, zidovudine, and chloramphenicol.
Efavirenz and nevirapine may ↑ levels.

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

Do not confuse rifabutin with rifapentine.
PO: May be administered without regard to meals. High-fat meals slow rate but not extent of absorption. May be mixed with foods such as applesauce. If GI upset occurs, administer with food.

Therapeutic Classification: agents for atypical mycobacterium

(Generic available)

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

(blood levels)

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

Monitor patient for signs of active tuberculosis (purified protein derivative [PPD], chest x-ray, sputum culture, blood culture, urine culture, biopsy of suspicious lymph nodes) prior to and during therapy. Rifabutin must not be administered to patients with active tuberculosis.
Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of CDAD. May begin up to several wk following cessation of therapy.
Assess patient for skin rash frequently during therapy. Discontinue rifabutin at first sign of rash; may be life-threatening. SJS, TEN, or DRESS may develop. Treat symptomatically; may recur once treatment is stopped.

Lab Test Considerations:

Monitor CBC periodically during therapy. May cause neutropenia and thrombocytopenia.

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) or uveitis (intraocular inflammation) 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.

Prevention of disseminated MAC in patients with advanced HIV infection.

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)

section name header

Pronunciation ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Implementation ⬆ ⬇

US Brand Names ⬆ ⬇

Classifications ⬆ ⬇

Availability ⬆ ⬇

Time/Action Profile ⬆ ⬇

Assessment ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

Code ⬆