rifabutin (Rx)

Brand and Other Names:Mycobutin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 150mg

oral solution

  • 10mg/mL
  • 20mg/mL

Mycobacterium avium Complex Prophylaxis

Indicated for prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection

300 mg PO qDay

Dosage Modifications

Nausea, vomiting, or GI upset: 150 mg PO BID with food

Renal impairment

  • Mild or moderate: No dose adjustment required
  • Severe (CrCl <30mL/min): Reduce dose by 50%

Hepatic impairment

  • Mild: No dose adjustment required
  • Moderate-to-severe: Not studied

Active Tuberculosis (off-label)

5 mg/kg PO qDay or 2-3x/week + other antitubercular agents, not to exceed 300 mg/dose

Mycobacterium avium Complex Treatment (Orphan)

Orphan designation for treatment of disseminated Mycobacterium avium complex disease

Sponsor

  • Pfizer, Inc; 235 East 42nd Street; New York, NY 10017

Dosage Forms & Strengths

capsule

  • 150mg

oral solution

  • 10mg/mL
  • 20mg/mL

Mycobacterium Avium Complex (Off-Label)

Treatment: 5-10 mg/kg PO qDay; not to exceed 300 mg/day

Prophylaxis: 1st episode in HIV/recurrence: 5 mg/kg PO qDay; not to exceed 300 mg/day

Active Tuberculosis with HIV (Off-label)

10-20 mg/kg PO qDay OR 2x/week + other antitubercular agents; not to exceed 300 mg/dose

Crohn Disease (Orphan)

Orphan designation for pediatric Crohn disease in combination with clarithromycin, rifabutin, and clofazimine

Sponsor

  • RedHill Biopharma Ltd; 42 Givati St; Israel
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Interactions

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            Adverse Effects

            >10%

            Discoloration of urine (30%)

            Neutropenia (25%)

            Leukopenia (17%)

            Rash (11%)

            1-10%

            Incr AST/ALT (7-9%)

            Thrombocytopenia (5%)

            Abdominal pain (4%)

            Diarrhea (3%)

            Eructation (3%)

            Headache (3%)

            Nausea/vomiting (3%)

            Anorexia (2%)

            Flatulence (2%)

            Anemia

            Myalgia

            Postmarketing reports

            Blood and lymphatic system disorders: Agranulocytosis, lymphopenia, granulocytopenia, white blood cell count decreased, neutrophil count decreased), platelet count decreased

            Immune system disorders: Hypersensitivity, bronchospasm

            Gastrointestinal disorders: Clostridium difficile colitis/ Clostridium difficile associated diarrhea

            Pyrexia, rash and other hypersensitivity reactions such as eosinophilia, bronchospasm and shock might occur, as has been seen with other antibacterials; a limited number of skin discoloration have been reported

            Drug reaction with eosinophilia and systemic symptoms (DRESS); other severe cutaneous adverse reactions such as SJS, TEN, and acute generalized exanthematous pustulosis

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            Warnings

            Contraindications

            Hypersensitivity to rifamycins

            Concomitant live bacterial vaccines

            Cautions

            Monitor hematologic status

            Eye pain, redness, loss of vision may indicate inflammatory ocular condition

            Joint stiffness, swelling, tenderness or paresthesia may indicate arthralgias or myositis

            May have brown-orange color of urine, feces, saliva, sputum, perspiration, tears, and skin

            Severe Cutaneous Adverse Reactions

            • Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) reported
            • Closely monitor patients that develop a skin rash; discontinue therapy if lesions progress
            • Specifically, for DRESS, a multi-system potential life-threatening SCAR, time to onset of first symptoms may be prolonged; DRESS is a clinical diagnosis, and its clinical presentation remains the basis for decision making; an early withdrawal of therapy is essential because of the syndrome’s mortality and visceral involvement (eg, liver, bone marrow or kidney)
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            Pregnancy & Lactation

            Pregnancy

            Rifabutin crosses the placenta

            Animal studies

            • In rats and rabbit, doses up to 40 times the recommended human daily dose (RHDD) were not teratogenic
            • In rats, but fetal viability was decreased at the highest doses and at 8 times RHDD, fetal skeletal variation was observed
            • In rabbits, a dose of 16 times RHDD showed maternal toxicity

            Lactation

            No studies have examined if excreted in breast milk; however, women with HIV infection should not breastfeed

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits DNA-dependent RNA polymerase

            Absorption

            Readily absorbed: 53%

            Bioavailability, absolute (HIV infected individual): 20%

            Peak plasma time: 2-4 hr

            Distribution

            Distributed in body tissues including the lungs, liver, spleen, eyes, & kidneys

            Vd: 9.32 L/kg

            Protein bound: 85%

            Metabolism

            Metabolized by hepatic CYP3A4 to active and inactive metabolites

            Elimination

            Half-life: 45 hr (range: 16-69 hr)

            Excretion

            • Urine: 10% as unchanged drug, 53% as metabolites
            • Feces: 10% as unchanged drug, 30% as metabolites
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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            rifabutin oral
            -
            150 mg capsule
            rifabutin oral
            -
            150 mg capsule
            Mycobutin oral
            -
            150 mg capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            rifabutin oral

            RIFABUTIN - ORAL

            (rye-fuh-BYOU-tin)

            COMMON BRAND NAME(S): Mycobutin

            USES: This medication is used alone or with another medication to help prevent a certain serious infection (Mycobacterium avium complex-MAC). Rifabutin is known as a rifamycin antibiotic. It works by stopping the growth of bacteria.This antibiotic treats and prevents only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

            HOW TO USE: Take this medication by mouth with or without food, usually once or twice daily or as directed by your doctor. Take this medication with food if stomach upset occurs. For the treatment of tuberculosis, this drug is sometimes taken twice weekly.Dosage is based on your medical condition, weight, interacting drugs, and response to treatment.For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day.Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early or skipping doses may allow the bacteria to continue to grow, which may result in a return of the infection and cause the infection to be more difficult to treat (resistant).Tell your doctor if your condition lasts or gets worse.

            SIDE EFFECTS: Diarrhea, stomach upset, changes in taste, or nausea/vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.This medication may cause urine, sweat, saliva, or tears to turn brown-orange. This effect is harmless and will disappear when the medication is stopped. However, dentures and contact lenses may be permanently stained.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, easy bleeding/bruising, muscle weakness/pain, joint pain/swelling, eye pain/redness, vision problems, chest pain/pressure, unusual weakness/tiredness, dark urine, yellowing eyes/skin.This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever that doesn't go away, new or worsening lymph node swelling, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking rifabutin, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (such as rifampin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, a certain blood disorder (porphyria).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Rifabutin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using rifabutin before having any immunizations/vaccinations.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding. If you have HIV disease, do not breast-feed because breast milk can transmit HIV.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: azole antifungals (such as fluconazole, itraconazole, voriconazole), ciprofloxacin, macrolide antibiotics (such as clarithromycin).Rifabutin can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include aprepitant/fosaprepitant, lurasidone, phenytoin, ranolazine, suvorexant, tacrolimus, tasimelteon, "blood thinners" (such as warfarin), calcium channel blockers (such as diltiazem, verapamil), certain combination products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir), among others.This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as liver function, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised December 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            • View the formulary and any restrictions for each plan.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.