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Rifabutin

Medically reviewed on September 10, 2018

Pronunciation

(rif a BYOO tin)

Index Terms

  • Ansamycin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Mycobutin: 150 mg

Generic: 150 mg

Brand Names: U.S.

  • Mycobutin

Pharmacologic Category

  • Antitubercular Agent
  • Rifamycin

Pharmacology

Inhibits DNA-dependent RNA polymerase at the beta subunit which prevents chain initiation

Absorption

Readily, 53%

Distribution

Vd: Adults: 9.3 ± 1.5 L/kg

Metabolism

To 5 metabolites; predominantly 25-O-desacetyl-rifabutin (antimicrobial activity equivalent to parent drug; contributes ≤10% of antimicrobial activity) and 31-hydroxy-rifabutin

Excretion

Urine (53% as metabolites); feces (30%)

Time to Peak

Serum: 2 to 4 hours

Half-Life Elimination

Terminal: 45 hours (range: 16 to 69 hours)

Protein Binding

85%

Special Populations: Renal Function Impairment

AUC is increased 71% in patients with CrCl <30 mL/minute.

Use: Labeled Indications

Mycobacterium avium complex (MAC), prophylaxis: Prevention of disseminated MAC disease in patients with advanced human immunodeficiency virus (HIV) infection

Off Label Uses

Mycobacterium avium complex disease (disseminated) treatment in HIV-infected patients (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, rifabutin is an effective and recommended optional adjunctive agent in the treatment of disseminated Mycobacterium avium complex (MAC) in adolescent and adult HIV-infected patients.

Tuberculosis, treatment (drug-susceptible) (excludes meningitis)

Based on the ATS, CDC, and IDSA joint guidelines on the treatment of drug-susceptible tuberculosis, rifabutin is recommended as a substitute for rifampin in patients who are currently receiving medications that have unacceptable interactions with rifampin or who have intolerance to rifampin.

Tuberculosis, treatment in HIV-infected patients (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, rifabutin as part of a multidrug regimen is an effective and recommended alternative to rifampin in the treatment of tuberculosis in adolescent and adult HIV-infected patients.

Latent tuberculosis (LTBI) in HIV-infected patients (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, rifabutin is an effective and recommended alternative to rifampin in the treatment of LTBI to prevent TB in adolescent and adult HIV-infected patients.

Contraindications

Clinically significant hypersensitivity to rifabutin, other rifamycins, or any component of the formulation

Dosing: Adult

Mycobacterium avium complex (MAC) disease (disseminated) in HIV-infected patients: Oral:

Primary prophylaxis (patients with CD4 count <50 cells/mm3): 300 mg once daily (HHS [OI adult 2017)]; alternatively, per the manufacturer, 150 mg twice daily with food may be used in patients with GI upset. May discontinue when CD4 count >100 cells/mm3 for ≥3 months in response to antiretroviral therapy (ART) (HHS [OI adult 2017]). Note: If effective ART is initiated immediately and viral suppression is achieved, some experts do not recommend routine initiation of MAC primary prophylaxis, regardless of initial CD4 count (IAS-USA [Gunthard 2016]).

Treatment (off-label use): 300 mg once daily as optional adjunct therapy with clarithromycin or azithromycin (plus ethambutol) (HHS [OI adult 2017])

Tuberculosis (off-label use): Oral:

Latent tuberculosis (LTBI) treatment (to prevent TB) in HIV-infected patients: Daily dose based on concomitant ART for 4 months (HHS [OI adult 2015]) Note: LTBI treatment is recommended in HIV-infected patients testing positive for LTBI (but have no evidence of TB disease or no prior history of treatment for active or LTBI) or in HIV-infected close contacts of anyone who has infectious TB (regardless of screening tests for LTBI). LTBI treatment is not associated with clinical benefit or recommended in HIV infected patients who are anergic and who have not had recent contact with anyone with infectious TB (HHS [OI adult 2015])

Treatment of drug-susceptible TB (excludes meningitis) (as an alternative/substitute for rifampin):

Non-HIV-infected patients: 5 mg/kg/dose (usual dose: 300 mg) once daily as part of a multidrug regimen (Nahid 2016).

HIV-infected patients (and not receiving protease inhibitors, efavirenz, rilpivirine or elvitegravir/cobicistat/emtricitabine/tenofovir): 5 mg/kg/day (usual dose: 300 mg) once daily or intermittently 3 times weekly as part of a multidrug regimen (HHS [OI adult 2015]).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Mycobacterium avium complex disease in HIV-exposed/-infected patients (off-label use): Oral:

Prophylaxis for recurrence of Mycobacterium avium complex (MAC): Infants and Children: 5 mg/kg (maximum dose: 300 mg) once daily as an optional add-on to primary therapy of clarithromycin and ethambutol (CDC 2009).

Prophylaxis for first episode of MAC: Children ≥6 years: 300 mg once daily (CDC 2009).

Treatment of severe MAC:

Infants and Children: 10 to 20 mg/kg (maximum dose: 300 mg) once daily, in addition to primary therapy of clarithromycin and ethambutol (CDC 2009).

Adolescents (disseminated disease): Refer to adult dosing.

Tuberculosis, treatment of drug-susceptible disease (as an alternative/substitute for rifampin) (excludes meningitis) (off-label use): Oral:

Non-HIV-infected patients: Children and Adolescents: Appropriate dosing is unknown; estimated at 5 mg/kg/dose once daily (Nahid 2016)

HIV-exposed/-infected patients:

Infants and Children: 10 to 20 mg/kg (maximum dose: 300 mg) once daily or intermittently 2 to 3 times weekly (CDC 2009).

Adolescents (and not receiving protease inhibitors, efavirenz, rilpivirine or elvitegravir/cobicistat/emtricitabine/tenofovir): Refer to adult dosing.

Tuberculosis, LTBI treatment (to prevent TB) in HIV-infected patients (alternative to preferred therapy) (off-label use): Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Reduce dose by 50%

Dosing: Hepatic Impairment

Mild impairment: No dosage adjustment necessary.

Moderate to severe impairment: There are no dosage adjustments provided in manufacturer's labeling (has not been studied).

Extemporaneously Prepared

A 20 mg/mL rifabutin oral suspension may be made with capsules and a 1:1 mixture of Ora-Sweet® and Ora-Plus®. Empty the the powder from eight 150 mg rifabutin capsules into a glass mortar; add 20 mL of vehicle and mix to a uniform paste. Mix while adding vehicle in incremental proportions to almost 60 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 60 mL. Label "shake well". Stable for 12 weeks at 4°C, 25°C, 30°C, and 40°C.

Haslam JL, Egodage KL, Chen Y, et al, "Stability of Rifabutin in Two Extemporaneously Compounded Oral Liquids," Am J Health Syst Pharm, 1999, 56(4):333-6.10690216

Administration

May be administered with meals to minimize nausea or vomiting.

Dietary Considerations

May be taken with meals.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

Alfentanil: Rifamycin Derivatives may decrease the serum concentration of Alfentanil. Management: Monitor closely for decreased alfentanil effectiveness. Increased alfentanil doses will likely be needed. Alternatively, changing from alfentanil to a different opioid anesthetic (e.g., sufentanil) may also be considered. Consider therapy modification

Antifungal Agents (Azole Derivatives, Systemic): May increase the serum concentration of Rifamycin Derivatives. Only rifabutin appears to be affected. Rifamycin Derivatives may decrease the serum concentration of Antifungal Agents (Azole Derivatives, Systemic). Management: Avoid these combinations when possible. Voriconazole and isavuconazonium are considered contraindicated. Consider therapy modification

Atazanavir: May increase serum concentrations of the active metabolite(s) of Rifabutin. Atazanavir may increase the serum concentration of Rifabutin. Management: Reduce rifabutin doses. Atazanavir US labeling recommends a decrease of at least 75%, to 150 mg every other day or 3 times per week for adults. Clinical guidelines recommend 150 mg/day or 300 mg 3 times per week with atazanavir/ritonavir. Consider therapy modification

Atovaquone: Rifamycin Derivatives may decrease the serum concentration of Atovaquone. Avoid combination

Barbiturates: Rifamycin Derivatives may increase the metabolism of Barbiturates. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Bedaquiline: Rifabutin may enhance the adverse/toxic effect of Bedaquiline. Rifabutin may decrease the serum concentration of Bedaquiline. Avoid combination

Bictegravir: Rifabutin may decrease the serum concentration of Bictegravir. Avoid combination

Boceprevir: Rifabutin may decrease the serum concentration of Boceprevir. Boceprevir may increase the serum concentration of Rifabutin. Avoid combination

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Calcium Channel Blockers: Rifamycin Derivatives may decrease the serum concentration of Calcium Channel Blockers. This primarily affects oral forms of calcium channel blockers. Management: The labeling for some US and Canadian calcium channel blockers contraindicate use with rifampin, however recommendations vary. Consult appropriate labeling. Exceptions: Clevidipine. Consider therapy modification

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination

CloZAPine: CYP3A4 Inducers (Weak) may decrease the serum concentration of CloZAPine. Monitor therapy

CycloSPORINE (Systemic): Rifamycin Derivatives may increase the metabolism of CycloSPORINE (Systemic). Consider therapy modification

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dapsone (Systemic): Rifabutin may decrease the serum concentration of Dapsone (Systemic). Monitor therapy

Darunavir: May increase serum concentrations of the active metabolite(s) of Rifabutin. Rifabutin may increase the serum concentration of Darunavir. Darunavir may increase the serum concentration of Rifabutin. Management: Reduce rifabutin doses. Darunavir US labeling recommends a decrease of at least 75%, to 150 mg every other day or 3 times per week for adults. Clinical guidelines recommend 150 mg/day or 300 mg 3 times per week when used with darunavir/ritonavir. Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Delavirdine: Rifamycin Derivatives may increase the metabolism of Delavirdine. Delavirdine may increase the serum concentration of Rifamycin Derivatives. Specifically, Rifabutin serum concentration may be increased. Avoid combination

Efavirenz: May decrease the serum concentration of Rifabutin. Rifabutin may decrease the serum concentration of Efavirenz. Management: If efavirenz is to be used with daily rifabutin, increase the planned rifabutin adult dose by 50%. If used with regimens where rifabutin is administered 2-3 times per week, consider doubling the rifabutin dose. Consider therapy modification

Elvitegravir: May increase serum concentrations of the active metabolite(s) of Rifabutin. Rifabutin may decrease the serum concentration of Elvitegravir. Management: For single-agent elvitegravir, a rifabutin dose reduction of at least 75% is required (ie, reduction to adult dose of 150 mg every other day or three times/week). Use of elvitegravir combination products with rifabutin is not recommended. Avoid combination

Erlotinib: Rifabutin may decrease the serum concentration of Erlotinib. Management: Avoid combination if possible. If combination must be used, increase erlotinib dose by 50 mg increments every 2 weeks as tolerated, to a maximum of 450 mg/day. Consider therapy modification

Estrogen Derivatives (Contraceptive): Rifamycin Derivatives may decrease the serum concentration of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification

Etravirine: Rifabutin may decrease the serum concentration of Etravirine. Management: Avoid concomitant use with rifabutin if a protease inhibitor/ritonavir combination is also used. Monitor therapy

Fosamprenavir: May increase serum concentrations of the active metabolite(s) of Rifabutin. Rifabutin may increase the serum concentration of Fosamprenavir. Fosamprenavir may increase the serum concentration of Rifabutin. Management: Reduce rifabutin doses. See full monograph for specific recommendations. Consider therapy modification

HMG-CoA Reductase Inhibitors (Statins): Rifamycin Derivatives may decrease the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Consider use of noninteracting antilipemic agents (note: pitavastatin concentrations may increase with rifamycin treatment). Monitor for altered HMG-CoA reductase inhibitor effects. Rifabutin and fluvastatin, or possibly pravastatin, may pose lower risk. Exceptions: Pitavastatin; Rosuvastatin. Consider therapy modification

Imatinib: Rifamycin Derivatives may decrease the serum concentration of Imatinib. Management: Avoid concurrent use of imatinib with the rifamycin derivatives when possible. If such a combination must be used, increase imatinib dose by at least 50% and monitor the patient's clinical response closely. Consider therapy modification

Indinavir: May increase serum concentrations of the active metabolite(s) of Rifabutin. Rifabutin may decrease the serum concentration of Indinavir. Indinavir may increase the serum concentration of Rifabutin. Management: Reduce rifabutin dose by 50% and increase adult indinavir dose to 1 g every 8 hours, per US labeling. Consistent with this, clinical guidelines recommend a rifabutin dose of 150 mg/day or 300 mg 3 times per week when used with indinavir/ritonavir. Consider therapy modification

Isoniazid: Rifamycin Derivatives may enhance the hepatotoxic effect of Isoniazid. Even so, this is a frequently employed combination regimen. Monitor therapy

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Ledipasvir: Rifabutin may decrease the serum concentration of Ledipasvir. Avoid combination

Lopinavir: May increase serum concentrations of the active metabolite(s) of Rifabutin. Rifabutin may increase the serum concentration of Lopinavir. Lopinavir may increase the serum concentration of Rifabutin. Management: Reduce rifabutin doses. Lopinavir/ritonavir US labeling recommends a decrease of at least 75%, to 150 mg every other day or 3 times per week for adults, while clinical guidelines recommend 150 mg/day or 300 mg 3 times per week. Consider therapy modification

Macrolide Antibiotics: May decrease the metabolism of Rifamycin Derivatives. Exceptions: Azithromycin (Systemic); Fidaxomicin; Roxithromycin; Spiramycin. Consider therapy modification

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Mycophenolate: Rifamycin Derivatives may decrease the serum concentration of Mycophenolate. Specifically, rifamycin derivatives may decrease the concentration of the active metabolite mycophenolic acid. Avoid combination

Nelfinavir: May increase serum concentrations of the active metabolite(s) of Rifabutin. Rifabutin may decrease the serum concentration of Nelfinavir. Nelfinavir may increase the serum concentration of Rifabutin. Management: Nelfinavir US prescribing information recommends decreasing the usual rifabutin dose by at least 50% when used with nelfinavir. Additionally, the preferred dose of nelfinavir when used in combination with rifabutin is 1250 mg twice daily. Consider therapy modification

Nevirapine: Rifabutin may decrease the serum concentration of Nevirapine. Nevirapine may decrease the serum concentration of Rifabutin. Nevirapine may increase the serum concentration of Rifabutin. Monitor therapy

Pitavastatin: Rifamycin Derivatives may increase the serum concentration of Pitavastatin. Management: Limit pitavastatin dose to a maximum of 2 mg/day with concurrent rifampin. Consider therapy modification

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Consider therapy modification

Progestins (Contraceptive): Rifamycin Derivatives may decrease the serum concentration of Progestins (Contraceptive). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification

QuiNIDine: Rifamycin Derivatives may decrease the serum concentration of QuiNIDine. Management: Consider alternatives to combination treatment with quinidine and rifampin due to large potential decreases in quinidine concentrations. Monitor for decreased quinidine concentrations/effects with initiation/dose increase of any rifamycin derivative. Consider therapy modification

Raltegravir: Rifabutin may decrease the serum concentration of Raltegravir. Specifically, minimum serum concentrations (Cmin) may be reduced. Total raltegravir exposure (i.e., AUC) may be increased. Monitor therapy

Ranolazine: Rifabutin may decrease the serum concentration of Ranolazine. Avoid combination

Rilpivirine: Rifabutin may decrease the serum concentration of Rilpivirine. Management: Increase the rilpivirine adult dose to 50 mg/day during rifabutin treatment. Decrease back to 25 mg/day following rifabutin discontinuation. Use of rifabutin with the emtricitabine/rilpivirine/tenofovir alafenamide combination product is not recommended. Consider therapy modification

Ritonavir: May increase serum concentrations of the active metabolite(s) of Rifabutin. Ritonavir may increase the serum concentration of Rifabutin. Management: Ritonavir US prescribing information recommends reducing rifabutin doses by at least 75%. Refer to drug interaction monographs addressing concomitantly administered protease inhibitors for dosing recommendations specific to ritonavir-boosted regimens. Consider therapy modification

Saquinavir: May increase serum concentrations of the active metabolite(s) of Rifabutin. Rifabutin may decrease the serum concentration of Saquinavir. Saquinavir may increase the serum concentration of Rifabutin. Management: Reduce rifabutin doses. Saquinavir US labeling recommends a decrease of at least 75%, to 150 mg every other day or 3 times per week for adults. Clinical guidelines recommend 150 mg daily or 300 mg 3 times per week when used with saquinavir/ritonavir. Consider therapy modification

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Simeprevir: Rifabutin may decrease the serum concentration of Simeprevir. Monitor therapy

Sirolimus: Rifabutin may decrease the serum concentration of Sirolimus. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Sofosbuvir: Rifabutin may decrease the serum concentration of Sofosbuvir. Avoid combination

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Tacrolimus (Systemic): Rifamycin Derivatives may decrease the serum concentration of Tacrolimus (Systemic). Management: Consider alternatives when possible. If these combination are used, monitor for reduced tacrolimus concentrations/effects following rifamycin initiation/dose increase, or increased concentrations/effects following rifamycin discontinuation/dose decrease. Consider therapy modification

Tamoxifen: Rifamycin Derivatives may increase the metabolism of Tamoxifen. Consider therapy modification

Telaprevir: Rifabutin may decrease the serum concentration of Telaprevir. Telaprevir may increase the serum concentration of Rifabutin. Avoid combination

Temsirolimus: Rifamycin Derivatives may decrease the serum concentration of Temsirolimus. Rifamycins will likely cause an even greater decrease in the concentration of the active metabolite sirolimus. Management: Temsirolimus prescribing information recommends against coadministration with strong CYP3A4 inducers such as rifampin; however, if concurrent therapy is necessary, an increase in temsirolimus adult dose to 50 mg/week should be considered. Consider therapy modification

Tenofovir Alafenamide: Rifabutin may decrease the serum concentration of Tenofovir Alafenamide. Avoid combination

Tipranavir: May increase serum concentrations of the active metabolite(s) of Rifabutin. Tipranavir may increase the serum concentration of Rifabutin. Management: Reduce rifabutin doses. Tipranavir US labeling recommends a decrease of at least 75%, to 150 mg every other day or 3 times per week for adults. Clinical guidelines recommend 150 mg daily or 300 mg 3 times per week when used with tipranavir/ritonavir. Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Rifamycin Derivatives may increase the metabolism of Vitamin K Antagonists. Monitor therapy

Voriconazole: May increase the serum concentration of Rifamycin Derivatives. Rifamycin Derivatives may decrease the serum concentration of Voriconazole. Avoid combination

Adverse Reactions

>10%:

Dermatologic: Skin rash (11%)

Genitourinary: Discoloration of urine (30%)

Hematologic & oncologic: Neutropenia (25%), leukopenia (10% to 17%)

1% to 10%:

Gastrointestinal: Nausea (≤6%), abdominal pain (4%), dysgeusia (3%), dyspepsia (3%), eructation (3%), vomiting (≤3%), flatulence (2%)

Hematologic & oncologic: Thrombocytopenia (5%)

Neuromuscular & skeletal: Myalgia (2%)

Miscellaneous: Fever (2%)

<1%, postmarketing, and/or case reports: Abnormal T waves on ECG, agranulocytosis, aphasia, arthralgia, bronchospasm, chest pain, clostridium difficile associated diarrhea, confusion, corneal deposits, dyspnea, flu-like symptoms, granulocytopenia, hemolysis, hepatitis, hypersensitivity, jaundice, lymphocytopenia, myositis, pancytopenia, paresthesia, pseudomembranous colitis, seizure, skin discoloration, thrombotic thrombocytopenic purpura, uveitis

Warnings/Precautions

Concerns related to adverse effects:

• Hematologic toxicity: May be associated with neutropenia and/or thrombocytopenia (rarely); consider periodic monitoring of hematologic parameters and discontinue permanently if signs of thrombocytopenia (eg, petechial rash) (HHS [OI adult 2015]).

• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, hypotension, urticaria, angioedema, acute bronchospasm, conjunctivitis, thrombocytopenia, neutropenia, and flu-like syndrome, may occur with rifamycins. Discontinue use and administer supportive care if hypersensitivity occurs.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

• Uveitis: May occur; carefully monitor patients when used in combination with macrolides or azole antifungals. If uveitis is suspected, refer patient to an ophthalmologist and consider temporarily discontinuing treatment.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment; discontinue in patients with ALT ≥3 x ULN (symptomatic) or ≥5 x ULN (regardless of symptoms) (HHS [OI adult 2017]).

• Renal impairment: Use with caution in patients with renal impairment; dosage reduction recommended in severe impairment (CrCl <30 mL/minute).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Appropriate use: Must not be administered for MAC prophylaxis to patients with active tuberculosis since its use may lead to the development of TB resistant to both rifabutin and rifampin. Caution that active TB in the HIV-positive patient may present atypically (ie, negative PPD or extrapulmonary manifestations).

• Contact lenses: Remove soft contact lenses during therapy since permanent staining may occur.

• Brown/orange discoloration: Urine, feces, saliva, sweat, tears, sputum, and skin may be discolored to brown/orange.

Monitoring Parameters

Periodic liver function tests, CBC with differential, platelet count, signs/symptoms of hypersensitivity or uveitis

Pregnancy Considerations

Adverse events were seen in some animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea or change in color of body fluids to brown/orange. Have patient report immediately to prescriber angina, flu-like symptoms, bruising, bleeding, severe loss of strength and energy, shortness of breath, vision changes, eye pain, severe eye irritation, dizziness, passing out, severe nausea, severe vomiting, cough, abnormal heartbeat, signs of infection, or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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