fidaxomicin (Rx)

Brand and Other Names:Dificid
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg
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Clostridium Difficile Colitis

Macrolide antibiotic indicated for Clostridium difficile-associated diarrhea in adults

200 mg PO q12hr for 10 days

May take with or without food

Renal Impairment

Dose adjustment not necessary

Hepatic Impairment

Not studied; dose adjustment not necessary since minimally absorbed

<18 years: Safety and efficacy not established

Clostridium difficile Infection (Orphan)

Indicated for Clostridium difficile infection in pediatric patients 16 yr or younger

Orphan indication sponsor

  • Optimer Pharmaceuticals, Inc; 10110 Sorrento Valley Road; San Diego, CA 92121
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Adverse Effects

>10%

Nausea (11%)

1-10%

Vomiting (7%)

Abdominal pain (6%)

Gastrointestinal hemorrhage (4%)

Anemia (2%)

Neutropenia (2%)

<1%

Increased alkaline phosphatase

Decreased blood bicarbonate

Drug eruption

Increased hepatic enzymes

Megacolon

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Warnings

Contraindications

Hypersensitivity

Cautions

Not indicated for systemic infections

Only use for infection proven or strongly suspected to be caused by C difficile to avoid development of drug resistant bacteria

Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face reported; discontinue and treat appropriately if reaction occurs therapy should be instituted

Some patients with hypersensitivity reactions also reported a history of allergy to other macrolides

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown whether distributed in breast milk; caution advised

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

Macrolide antibiotic; bactericidal against C difficile in vitro, inhibiting RNA synthesis by RNA polymerases

Absorption

Bioavailability: Minimal systemic absorption

Peak Plasma Time: 2 hr (range 1-5 hr)

Peak Plasma Concentration: 5.2 ng/mL (+/- 2.81)

AUC: 14 ng•hr/mL

P-gp substrate, but not significantly affected by P-gp inhibitors

Distribution

Fecal Concentrations: 639-2710 mcg/g; OP-1118 213-1210 mcg/g

Metabolism

Metabolized by hydrolysis at the isobutyryl ester to form OP-1118

Metabolites: OP-1118 (active metabolite)

Enzyme substrate, inhibitor, or inducer: Not dependent on CYP450 enzymes

Elimination

Half-life: 9 hr

Excretion: Feces (92%)

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
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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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