posaconazole (Rx)

Brand and Other Names:Noxafil
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral suspension

  • 40mg/mL (105mL)

tablet, delayed-release

  • 100mg

injectable solution

  • 18mg/mL (300mg/16.7mL-vial)

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

Renal impairment

  • Tablets or oral suspension
    • Severe (eGFR <20 mL/min): Due to variability, closely monitor for breakthrough fungal infections
  • Injection
    • Moderate-to-severe (eGFR <50 mL/min): Avoid unless benefit outweighs the risks
    • Accumulation of IV vehicle (betadex sulfobutyl ether sodium [SBECD]), expected to occur
    • If unavoidable, closely monitor serum creatinine; if increases occur, consider switching to oral therapy

Hepatic impairment

  • Mild-to-severe (Child-Pugh A to C): No dosage adjustment necessary; no specific study was conducted with the injection or tablets

Orphan Designations

Treatment of invasive aspergillosis

Treatment of zygomycosis

Sponsor

  • Merck, Sharp & Dohme Corp; 1 Merck Drive; Whitehouse Station, New Jersey 08889

Dosage Forms & Strengths

oral suspension

  • 40mg/mL (105mL)

oral suspension, delayed-release

  • 300mg
  • Reconstituted concentration: ~30 mg/mL

tablet, delayed-release

  • 100mg

injectable solution

  • 18mg/mL (300mg/16.7mL-vial)

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)

IV

  • <2 years: Safety and efficacy not established
  • ≥2 years
    • Loading dose: 6 mg/kg IV BID on Day 1; not to exceed 300 mg BID, then
    • Maintenance dose: 6 mg/kg IV qDay starting on the Day 2; not to exceed 300 mg qDay
    • Duration of therapy is based on recovery from neutropenia or immunosuppression

Tablets

  • <2 years: Safety and efficacy not established
  • ≥2 years and >40 kg
    • Loading dose: 300 mg PO BID on Day 1, then
    • Maintenance dose: 300 mg PO qDay starting on the Day 2
    • Duration of therapy is based on recovery from neutropenia or immunosuppression

Oral suspension

  • <13 years: Safety and efficacy not established
  • ≥13 years
    • Loading and maintenance dose: 200 mg PO TID
    • Duration of therapy is based on recovery from neutropenia or immunosuppression

Delayed-release oral suspension

  • <2 years: Safety and efficacy not established
  • ≥2 years and ≤40 kg
    • 10 to <12 kg: 90 mg PO BID on Day 1, then 90 mg PO qDay starting on Day 2
    • 12 to <17 kg: 120 mg PO BID on Day 1, then 120 mg PO qDay starting on Day 2
    • 17 to <21 kg: 150 mg PO BID on Day 1, then 150 mg PO qDay starting on Day 2
    • 21 to <26 kg: 180 mg PO BID on Day 1, then 180 mg PO qDay starting on Day 2
    • 26 to <36 kg: 210 mg PO BID on Day 1, then 210 mg PO qDay starting on Day 2
    • 36-40 kg: 240 mg PO BID on Day 1, then 240 mg PO qDay starting on Day 2
    • 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

Dosage Modifications

Renal impairment

  • Tablets or oral suspension
    • Severe (eGFR <20 mL/min): Due to variability, closely monitor for breakthrough fungal infections

Hepatic impairment

  • Mild-to-severe (Child-Pugh A to C): No dosage adjustment necessary; no specific study was conducted with the injection or tablets
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Interactions

Interaction Checker

and posaconazole

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Injection

            • Diarrhea (10-42%)
            • Pyrexia (21-31%)
            • Nausea (19-30%)
            • Hypokalemia (22-28%)
            • Rash (15-24%)
            • Headache (14-21%)
            • Vomiting (12-19%)
            • Epistaxis (14-17%)
            • Abdominal pain (13-17%)
            • Peripheral edema (12-15%)
            • Cough (9-13%)
            • Constipation (8-13%)
            • Hypomagnesemia (11-13%)
            • Decreased appetite (10-12%)
            • Hypertension (8-11%)
            • Thrombocytopenia (7-11%)
            • Upper abdominal pain (6-11%)

            Oral suspension

            • Fever (6-45%)
            • Nausea (9-38%)
            • Hypokalemia (30%)
            • Thrombocytopenia (29%)
            • Vomiting (7-29%)
            • Headache (8-28%)
            • Abdominal pain (5-27%)
            • Coughing (3-25%)
            • Anemia (2-25%)
            • Neutropenia (4-23%)
            • Constipation (21%)
            • Dyspnea (1-20%)
            • Rigors (<20%)
            • Anorexia (2-19%)
            • Rash (3-19%)
            • Hypomagnesemia (18%)
            • Hypertension (18%)
            • ALT increased, Grade 3 or 4 (6-17%)
            • AST >3x ULN (6-17%)
            • Fatigue (2-17%)
            • Insomnia (1-17%)
            • Musculoskeletal pain (16%)
            • Edema legs (15%)
            • Epistaxis (14%)
            • Hypotension (14%)
            • Decrease weight (1-14%)
            • Tachycardia (12%)
            • Pharyngitis (12%)
            • Oral candidiasis (<12%)
            • Hyperglycemia (11%)
            • Pruritus (11%)
            • Petechiae (11%)
            • Dizziness (11%)
            • Arthralgia (11%)
            • Herpes simplex (3-11%)
            • ALT >3x ULN (3-11%)
            • Pain (1-11%)
            • Dehydration (1-11%)

            Tablets

            • Diarrhea (29%)
            • Pyrexia (28%)
            • Nausea (27%)
            • Hypokalemia (22%)
            • Cough (17%)
            • Rash (16%)
            • Peripheral edema (16%)
            • Epistaxis (14%)
            • Headache (14%)
            • Mucosal inflammation (14%)
            • Thrombocytopenia (14%)
            • Vomiting (13%)
            • Alkaline phosphatase >3x ULN (3-13%)
            • Abdominal pain (11%)
            • Hypertension 23 (11%)

            1-10%

            Injection

            • Petechiae (8-10%)
            • Anemia (7-10%)
            • Dyspnea (7-10%)

            Tablets

            • Anemia (10%)
            • Constipation (10%)
            • Asthenia (10%)
            • Chills (10%)
            • Hypomagnesemia (10%)

            Oral suspension

            • Back pain (10%)
            • Bilirubinemia (10%)
            • Vaginal hemorrhage (10%)
            • Dyspepsia (10%)
            • Pneumonia (3-10%)
            • Sweating increased (2-10%)
            • Edema (9%)
            • Hypocalcemia (9%)
            • Bilirubin increased, Grade 3 or 4 (7-9%)
            • Weakness (8%)
            • Hemolytic uremic syndrome (<5%)
            • Thrombotic thrombocytopenic purpura (<5%)
            • Neutropenia aggravated (<5%)
            • Adrenal insufficiency (<5%)
            • Paresthesia (<5%)
            • Allergic reaction (<5%)
            • Torsades de pointes (<5%)
            • Pulmonary embolism (<5%)
            • Pancreatitis (<5%)
            • Bilirubinemia (<5%)
            • Hepatic enzymes increased (<5%)
            • Hepatic function abnormal (<5%)
            • Hepatitis (<5%)
            • Hepatomegaly (<5%)
            • Jaundice (<5%)
            • AST/ALT increased (<5%)
            • Hypokalemia (<5%)
            • Thrombocytopenia (<5%)
            • Renal failure acute (<5%)
            • Total bilirubin > 1.5x ULN (3-5%)
            • AST, Grade 3 or 4 (3-4%)
            • Alkaline phosphatase, Grade 3 or 4 (1-3%)

            Postmarketing Reports

            Pseudoaldosteronism

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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)

            Coadministration with the HMG-CoA reductase inhibitors (statins) that are primarily metabolized through CYP3A4 (eg, atorvastatin, lovastatin, simvastatin)

            Concurrent use with ergot alkaloids

            Delayed-release oral suspension only

            • Patients with known or suspected hereditary fructose intolerance (HFI)

            Cautions

            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; consider discontinuing therapy in patients who develop abnormal LFTs or monitor LFTs during treatment

            Closely monitor patients with severe renal impairment for breakthrough fungal infections due to the variability in exposure of the delayed-release tablets and oral suspension; avoid use of injection in patients with moderate or severe renal impairment (eGFR <50 mL/min); unless benefit outweighs risks

            Electrolyte disturbances, especially those involving potassium, magnesium or calcium levels, should be monitored and corrected as necessary before and during posaconazole therapy

            Closely monitor patients who have severe diarrhea or vomiting for breakthrough fungal infections when receiving delayed-release tablets, oral suspension, or delayed-release oral suspension

            Use of delayed-release oral suspension in patients with HFI

            • Delayed-release oral suspension contains sorbitol, an inactive ingredient, and may precipitate a metabolic crisis that may include, but is not limited to life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure in patients with HFI
            • Review patient history of HFI symptoms (nausea, vomiting, abdominal pain) with sorbitol/fructose/sucrose exposure before using the delayed-release oral suspension
            • Diagnosis of HFI may not yet be established in pediatric patients

            Drug interactions overview

            Posaconazole is a P-gp substrate and a strong CYP3A4 inhibitor; metabolized by UDP-glucuronidase

            • Rifabutin and phenytoin
              • Avoid unless benefit outweighs risks
              • Rifabutin and phenytoin may decrease posaconazole plasma concentrations by inducing UDP-glucuronidase
              • Posaconazole may also increase rifabutin and phenytoin levels by inhibiting CYP3A4
            • Antiretroviral agents
              • Efavirenz may induce UDP-glucuronidase and significantly decrease posaconazole plasma levels; avoid use
              • Ritonavir and atazanavir are CYP3A4 substrates; posaconazole may increase plasma concentrations of these drugs; closely monitor for posaconazole-related toxicities if concurrently used
              • Fosamprenavir may decrease posaconazole plasma concentration; closely monitor for breakthrough fungal infections
            • Benzodiazepines metabolized by CYP3A4
              • Closely monitor
              • Coadministration with midazolam increases midazolam plasma concentrations by ~5-fold; increased risk of prolonged hypnotic and sedative effects
            • CYP3A4 substrates that cause QT prolongation
              • Contraindicated
              • Coadministration with CYP3A4 substrates may result in increased plasma concentrations of these drugs, leading to QTc prolongation and cases of torsades de pointes
            • Immunosuppressants metabolized by CYP3A4
              • Coadministration posaconazole with calcineurin inhibitors (eg, sirolimus, tacrolimus, cyclosporine) increases blood concentrations pf calcineurin inhibitors
              • Sirolimus: Contraindicated
              • Tacrolimus: Reduce tacrolimus dose to ~1/3 of original dose when initiating posaconazole; closely monitor tacrolimus trough concentrations during and at discontinuation of posaconazole treatment and adjust tacrolimus dose accordingly
              • Cyclosporine: Reduce cyclosporine dose to ~ 3/4 of original dose when initiating cyclosporine; closely monitor tacrolimus trough concentrations during and at discontinuation of posaconazole treatment and adjust tacrolimus dose accordingly
            • HMG-CoA reductase inhibitors primarily metabolized through CYP3A4
              • Contraindicated
              • May increase plasma concentrations of simvastatin by ~10-fold
            • Ergot alkaloids
              • Contraindicated
              • May increase the plasma concentrations of ergot alkaloids which may lead to ergotism
            • Cimetidine and esomeprazole
              • Oral suspension: Cimetidine (an H2-receptor antagonist) and esomeprazole (a proton pump inhibitor) decreased posaconazole plasma concentrations; avoid use of cimetidine and esomeprazole unless the benefit outweighs the risks
            • Vinca alkaloids
              • Use with vinca alkaloids (eg, vinblastine, vincristine) may increase the plasma concentrations of vinca alkaloids and risks of neurotoxicity and other serious adverse reactions
              • Reserve azole antifungals for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options
            • Calcium channel blockers
              • May increase the plasma concentrations of calcium channel blockers metabolized by CYP3A4 (eg, verapamil, diltiazem, nifedipine, nicardipine, felodipine)
              • Closely monitor for adverse reactions and toxicity related to calcium channel blockers; consider dose reduction of calcium channel blockers
            • Digoxin
              • Increased plasma concentrations of digoxin reported in patients receiving digoxin and posaconazole; closely monitor digoxin levels
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            Pregnancy & Lactation

            Pregnancy

            Available data in pregnant women are insufficient to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; based on findings from animal data, therapy may cause fetal harm when administered to pregnant women

            Animal data

            • Skeletal malformations (cranial malformations and missing ribs) and maternal toxicity (reduced food consumption and reduced body weight gain) observed when dosed orally to pregnant rats; during organogenesis at doses greater than or equal to 1.4 times the 400 mg twice daily oral suspension regimen recommended in humans; in pregnant rabbits dosed orally during organogenesis, increased resorptions, reduced litter size, and reduced body weight gain of females were seen at doses 5 times the exposure achieved with the 400 mg twice daily oral suspension regimen; doses of ≥3 times the clinical exposure caused an increase in resorptions in these rabbits; based on animal data, advise pregnant women of potential risk to a fetus

            Lactation

            There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; drug is excreted in milk of lactating rats; when a drug is present in animal milk, it is likely that the drug will be present in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            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 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 Incompatibilities

            Lactated ringer (LR)

            Dextrose 5% (D5W) with LR

            4.2% sodium bicarbonate

            IV Compatibility

            IV solutions

            • 0.45% NaCl
            • 0.9% NaCl
            • D5W
            • D5W 0.45% NaCl
            • D5W 0.9% NaCl
            • D5W and 20 mEq potassium chloride

            Y-site administration

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              • Vancomycin

            IV Preparation

            Equilibrate refrigerated vial to room temperature

            Aseptically transfer 16.7 mL (300 mg) of solution to an IV bag/bottle containing ~150 mL of a compatible admixture diluent; final concentration of diluted IV bag is 1-2 mg/mL

            Use of other infusion solutions may result in particulate formation

            Injection is a single dose sterile solution without preservatives; once admixed, use product immediately; if not used immediately, refrigerate for up to 24 hours at 2-8ºC (36-46ºF)

            Visually inspect product for particulate matter prior to administration; diluted solution ranges from colorless to yellow

            IV Administration

            IV infusion only; not for IV bolus injection

            Administer through a 0.22 micron polyethersulfone (PES) or polyvinylidene difluoride (PVDF) filter

            Administer 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 required, infusion should be done via central venous line

            Oral Preparation

            Oral suspension H4

            • Shake well before use
            • Administer with measured dosing spoon (marked doses of 2.5 mL and 5 mL)
            • Rinse spoon with water after each administration and before storage
            • Administer each dose during or immediately (ie, within 20 min) following a full meal to enhance absorption of the oral suspension

            Delayed-release oral suspension

            • Do not open packet in kit until ready to prepare
            • Remove 9 mL of mixing liquid using the provided BLUE syringe
            • ONLY use the mixing liquid in the kit to prepare delayed-release oral suspension
            • Using the provided mixing cup, combine 9 mL of mixing liquid and the entire contents of one packet in the kit and mix
            • Each single-use packet in the kit contains 300 mg of posaconazole to be suspended in 9 mL of mixing liquid giving a final concentration of ~30 mg/mL
            • Shake mixing cup vigorously for 45 sec to mix powder and mixing liquid from kit; check to make sure the powder is mixed; mixture should look cloudy and free of clumps
            • Reconstituted suspension must be used within 1 hr; discard unused portion of the prepared drug product

            Oral Administration

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

            Tablets

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

            Oral suspension

            • Take with a full meal or liquid nutritional supplement or an acidic carbonated beverage (eg, ginger ale) in patients unable to eat a full meal
            • If unable to eat a full meal or tolerate an oral nutritional supplement or an acidic carbonated beverage and who do not have the option of taking delayed-release tablets or injection, consider an alternative antifungal therapy or closely monitor for breakthrough fungal infections

            Delayed-release oral suspension

            • Take with food
            • Use 3-mL syringe (green) for doses ≤3 mL
            • Use 10-mL syringe (blue) for doses >3 mL
            • Administer dose orally within 1 r of mixing
            • Not all the mixture in the mixing cup will be used
            • Maximum dose that can be accurately withdrawn from mixing cup after reconstitution is 240 mg (8 mL)
            • To ensure delivery of the correct dose, ONLY provided notched tip syringes must be used for preparation and administration
            • Discard any remaining suspension; mixing cup and notched tip syringes may be hand washed and reused
            • Alternatively, mixing cup may be discarded, and a similar mixing cup with a lid may be used for subsequent doses
            • For additional supply, a separate box of notched tip syringes is provided with the kit

            Missed dose

            • >12 hr of next dose: Take as soon as possible
            • <12 hr of next dose: Skip missed dose; go back to regular schedule; do not double dose

            Storage

            Unopened vials: Refrigerate at 2-8ºC (36-46ºF)

            Tablets

            • Store at 20-25ºC (36-46ºF), excursions permitted to 15-30ºC (59-86ºF)

            Oral suspension

            • Store at 25ºC (36-46ºF), excursions permitted to 15-30ºC (59-86ºF)
            • Do not freeze

            Delayed-release oral suspension

            • Store entire kit at 20-25ºC (36-46ºF), excursions permitted to 15-30ºC (59-86ºF) in a clean, dry place
            • Do not open foil packet containing delayed-release oral suspension until ready for use
            • Once mixed, use within 1 hr; discard any unused drug

            Diluted solution

            • Vial is a single dose sterile solution without preservatives; once admixed, use immediately
            • If not used immediately, refrigerate for up to 24 hr at 2-8ºC (36-46ºF)
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            Formulary

            FormularyPatient Discounts

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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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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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.