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posaconazole (Rx)Brand and Other Names:Noxafil

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral suspension

  • 40mg/mL (105mL)

tablet, delayed-release

  • 100mg

injectable solution

  • 18mg/mL (300mg/vial)
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Invasive Aspergillus & Candida Infections

Oral suspension or delayed-release tablets are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised (eg, hematopoietic stem cell transplant recipients with GVHD, hematologic malignancies with prolonged neutropenia from chemotherapy)

Oral suspension: 200 mg (5 mL) PO TID

Tablet: 300 mg PO BID on Day 1, then 300 mg PO qDay

IV: 300 mg IV BID on Day 1, then 300 mg IV qDay (see IV preparation and administration)

Duration of therapy is based on recovery from neutropenia or immunosuppression

Oropharyngeal Candidiasis

Oral suspension is indicated for oropharyngeal candidiasis

100 mg (2.5 mL) PO BID on Day 1, then 100 mg PO qDay for 13 days

Refractory to itraconazole and/or fluconazole: 400 mg (10 mL) PO BID; duration based on severity of underlying disease and clinical response

Dosage Modifications

Moderate-to-severe renal impairment (IV)

  • eGFR <50 mL/min: Avoid IV administration unless benefit/risk assessment justifies use
  • Accumulation of the IV vehicle, SBECD, is expected to occur
  • Serum creatinine levels should be closely monitored; if increases occur, consideration should be given to changing to oral posaconazole therapy

Severe renal impairment (tablets or oral suspension)

  • Variability of systemic exposure with tablets or oral suspension observed
  • Monitored closely for breakthrough fungal infections

Zygomycosis (Orphan)

Orphan indications sponsor

  • Schering-Plough Corporation; 2000 Galloping Hill Road; Kenilwortoh, NJ 07033

Dosage Forms & Strengths

oral suspension

  • 40mg/mL (105mL)

tablet, delayed-release

  • 100mg
more...

Invasive Aspergillus & Candida Infections

Indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised (eg, hematopoietic stem cell transplant recipients with GVHD, hematologic malignancies with prolonged neutropenia from chemotherapy)

<18 years (IV): Safety and efficacy not established

<13 years (tablets and oral suspension): Safety and efficacy not established

≥13 years

  • Oral suspension: 200 mg (5 mL) TID
  • Tablet: 300 mg PO BID on Day 1, then 300 mg PO qDay
  • Duration of therapy is based on recovery from neutropenia or immunosuppression

Oropharyngeal Candidiasis

Oral suspension is indicated for oropharyngeal candidiasis

<13 years: Safety and efficacy not established

≥13 years

  • Oral suspension: 100 mg (2.5 mL) PO BID on Day 1, then 100 mg PO qDay for 13 days
  • Refractory to itraconazole and/or fluconazole: 400 mg (10 mL) PO BID; duration based on severity of underlying disease and clinical response
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Interactions

Interaction Checker

posaconazole and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Fever (45%)

            Diarrhea (42%)

            Nausea (38%)

            Hypokalemia (30%)

            Headache (28%)

            Abd pain (27%)

            Anemia (25%)

            Cough (24%)

            Nausea (38%)

            Thrombocytopenia (29%)

            Constipation (21%)

            Dyspnea (20%)

            Febrile neutropenia (20%)

            Rigors (20%)

            Rash (19%)

            Bacteremia (18%)

            HTN (18%)

            Hypomagnesemia (18%)

            Fatigue (17%)

            Insomnia (17%)

            Mucositis (17%)

            Musculoskeletal pain (16%)

            Anorexia (15%)

            Herpes simplex (15%)

            Leg edema (15%)

            CMV infection (14%)

            Epistaxis (14%)

            Hypotension (14%)

            Pharyngitis (12%)

            Arthralgia (11%)

            Dizziness (11%)

            Hypoglycemia (11%)

            Petechiae (11%)

            Pruritus (11%)

            Back pain (10%)

            Dyspepsia (10%)

            Vaginal hemorrhage (10%)

            1-10%

            Anxiety (9%)

            Edema (9%)

            Hypocalcemia (9%)

            Weakness (8%)

            URI (7%)

            Postmarketing Reports

            Prolonged QT interval (up to 4% )

            Hyperbilirubinemia (2% to 3% )

            Increased liver enzymes (1% to 3% )

            Liver damage (1% )

            Adrenal insufficiency

            Cholestasis

            Liver failure (rare )

            Seizure

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            Warnings

            Contraindications

            Hypersensitivity to posaconazole or other azoles

            Coadministration with sirolimus; increases sirolimus blood concentrations by ~9-fold

            CYP3A4 substrates that prolong the QT interval (eg, pimozide, quinidine); posaconazole inhibits CYP3A4 isoenzyme

            Coadministration with the HMG-CoA reductase inhibitors (statins) that are primarily metabolized through CYP3A4 (eg, atorvastatin, lovastatin, simvastatin); increased statin plasma concentration can lead to rhabdomyolysis

            May increase plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism

            Cautions

            Coadministration with calcineurin inhibitors (eg, cyclosporine, tacrolimus); increases whole concentrations of calcineurin inhibitors

            Coadministration with midazolam increases midazolam plasma concentrations by ~5-fold; increased risk of prolonged hypnotic and sedative effects

            May prolong QT interval; cases of torsades de pointes reported

            Hepatic reactions reported including mild-to-moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin, and clinical hepatitis

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: unknown; weigh risk/benefit

            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.

            more...
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            Pharmacology

            Mechanism of Action

            Inhibits fungal cell membrane sterol biosynthesis

            Absorption

            Increased by food

            Peak plasma time: 3-5 hr (oral susp); 3-4 hr (tablet); 1.5 hr (IV)

            Peak plasma concentration: 1590 ng/mL (IV)

            Distribution

            Protein bound: >98%

            Vd: 287 L (oral); 261 L (IV)

            Metabolism

            Metabolized primarily by glucuronide conjugates

            Strong CYP3A4 inhibitor

            Elimination

            Half-life: 35 hr (oral susp); 26-31 hr (tablet); 24.6 hr (IV)

            Total body clearance: 51.2 L/hr (oral susp); 9.39 L/hr (tablet); 7.3 L/hr (IV)

            Excretion: 71% feces; 13% urine

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            Administration

            IV Compatibility

            IV solutions

            • Dextrose 5% in water
            • 0.9% NaCl

            Y-site administration

            • Amikacin
            • Caspofungin, ciprofloxacine
            • Daptomycin, dobutamine
            • Famotidine
            • Gentamicin
            • Hydromorphone
            • Levofloxacin, lorazepam
            • Meropenem, micafungin, morphine
            • Norepinephrine
            • Potassium chloride
            • Vancomycin

            IV Preparation

            Equilibrate the refrigerated vial to room temperature

            Aseptically transfer 16.7 mL (300 mg) of solution to an IV bag/bottle containing approximately 150 mL of 5% dextrose in water or sodium chloride 0.9%

            Should only be administered with these diluents; use of other infusion solutions may result in particulate formation

            Posaconazole injection is a single dose sterile solution without preservatives; once admixed, the product should be used immediately

            The diluted solution ranges from colorless to yellow

            IV Administration

            Must be administered through a 0.22 micron polyethersulfone (PES) or polyvinylidene difluoride (PVDF) filter

            Should be administered via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC), by slow IV infusion over ~90 minutes

            If a central venous catheter is not available, may administer through a peripheral venous catheter by slow IV infusion over 30 minutes only as a single dose in advance of central venous line placement or to bridge the period during which a central venous line is replaced or is in use for other IV treatment

            When multiple dosing is required, the infusion should be done via a central venous line

            Not for IV bolus injection

            Oral Administration

            Tablets and oral suspension are not interchangeable because of differences in dosing for each formulation

            Tablets

            • Take tablets with food
            • Tablets: Swallow whole; do not divide, crush, or chew

            Oral suspension

            • Oral suspension should be taken with a full meal or liquid nutritional supplement or an acidic carbonated beverage (eg, ginger ale) in patients unable to eat a full meal

            Storage

            Unopened vials: Store refrigerated at 2-8°C (36-46°F)

            Diluted solution

            • Posaconazole injection is a single dose sterile solution without preservatives; once admixed, the product should be used immediately
            • If not used immediately, refrigerate for up to 24 hr between 2-8°C (36-46°F)
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            Images

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            Formulary

            FormularyPatient Discounts

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

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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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