Peginterferon Alfa-2A Dosage

This dosage information may not include all the information needed to use Peginterferon Alfa-2A safely and effectively. See additional information for Peginterferon Alfa-2A.

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Hepatitis C

Combination Therapy:
Peginterferon alfa-2a: 180 mcg subcutaneously once a week
Plus:
-Ribavirin tablets: 800 to 1200 mg orally per day in 2 divided doses (with food); the manufacturer's product information should be consulted for information regarding dosing and administration.
-The product information for the specific hepatitis C virus (HCV) NS3/4A protease inhibitor should be consulted for information regarding dosing regimen and administration of the protease inhibitor in combination with peginterferon alfa-2a and ribavirin for treatment of genotype 1.

Duration of therapy:
-Genotype 1 (if combination therapy includes an HCV NS3/4A protease inhibitor): The product information for the specific HCV NS3/4A protease inhibitor should be consulted for information regarding duration.
-Genotypes 1 (if combination therapy does not include an HCV NS3/4A protease inhibitor) and 4: 48 weeks
-Genotypes 2 and 3: 24 weeks
-In patients coinfected with HIV: 48 weeks, regardless of genotype

Comments:
-Data on genotypes 5 and 6 are insufficient for dosing recommendations.

Monotherapy:
180 mcg subcutaneously once a week for 48 weeks

Comments:
-Peginterferon alfa-2a should be used as part of a combination regimen (preferred); combination therapy provides substantially better response rates than monotherapy.

Approved indication: Alone or in combination with ribavirin tablets, for treatment of patients with chronic hepatitis C who have compensated liver disease and have not been previously treated with interferon alpha
-Efficacy shown in patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh A).
-Efficacy shown in patients with clinically stable HIV and CD4 count greater than 100 cells/mm3.
-Peginterferon alfa-2a in combination with ribavirin and an approved HCV NS3/4A protease inhibitor is indicated in patients with HCV genotype 1 infection.
-Peginterferon alfa-2a in combination with ribavirin is indicated in patients with genotypes other than 1 or in patients with genotype 1 infection where use of an HCV NS3/4A protease inhibitor is not warranted based on tolerability, contraindications, or other clinical factors.
-Monotherapy is not recommended unless a patient has a contraindication to or significant intolerance to ribavirin.

Usual Adult Dose for Chronic Hepatitis B

180 mcg subcutaneously once a week for 48 weeks

Approved indication: For treatment of patients with HBe antigen positive and HBe antigen negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation

Usual Pediatric Dose for Chronic Hepatitis C

5 years or older:
Peginterferon alfa-2a: 180 mcg/1.73 m2 x body surface area (BSA) subcutaneously once a week
Maximum dose: 180 mcg

Plus:
Ribavirin tablets: Approximately 15 mg/kg orally per day in 2 divided doses

Duration of therapy:
-Genotypes 2 and 3: 24 weeks
-Other genotypes: 48 weeks

Comments:
-The manufacturer's product information for ribavirin tablets should be consulted.
-Patients who reach their 18th birthday while receiving peginterferon alfa-2a plus ribavirin should remain on the pediatric dosing regimen.

Approved indication: In combination with ribavirin tablets, for treatment of patients with chronic hepatitis C who have compensated liver disease and have not been previously treated with interferon alpha
-Efficacy shown in patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh A).

Renal Dose Adjustments

Adults:
CrCl less than 30 mL/min: The dose should be reduced to 135 mcg.

Comments:
-Signs/symptoms of interferon toxicity should be closely monitored.
-If severe side effects or laboratory abnormalities develop, the dose may be reduced to 90 mcg until the side effects abate. If intolerance persists after dose adjustment, peginterferon alfa-2a/ribavirin should be discontinued.

Pediatrics: Data not available

Liver Dose Adjustments

If ALT increases are progressive despite dose reduction or accompanied by increased bilirubin or evidence of hepatic decompensation, therapy should be discontinued immediately.

Adults:
Chronic hepatitis C:
-If ALT increases are progressive, the dose should be reduced to 135 mcg and liver function should be monitored more frequently; after dose reduction or withholding, therapy can be resumed after ALT flares subside.

Chronic hepatitis B:
-If ALT elevation is greater than 5 times ULN, liver function should be monitored more frequently and either reducing the dose to 135 mcg or temporarily discontinuing therapy should be considered; after dose reduction or withholding, therapy can be resumed after ALT flares subside.
-In patients with persistent, severe (ALT levels greater than 10 times ULN) hepatitis B flares, therapy discontinuation should be considered.

Pediatrics:
-Persistent or increasing ALT elevations 5 to less than 10 times ULN: Dose should be reduced to 135 mcg/1.73 m2 x BSA; recommend monitoring weekly, further reducing dose if needed, until stable or ALT level decreases.
-Persistent ALT values 10 times ULN or greater: Therapy should be discontinued.

Dose Adjustments

ADULTS (with normal renal function):
When dose modification is required for side effects (clinical and/or laboratory), initial dose reduction to 135 mcg is recommended. Dose reduction to 90 mcg may be needed if the side effect persists or recurs. After improvement of the side effect, reescalation of the dose may be considered.

Based on Hematology:
Absolute neutrophil count (ANC) less than 750 cells/mm3: Dose should be reduced to 135 mcg.
ANC less than 500 cells/mm3: Therapy should be suspended until ANC values return to more than 1000 cells/mm3. Therapy should be reinstituted at 90 mcg and ANC should be monitored carefully.

Platelet count less than 50,000 cells/mm3: Dose should be reduced to 90 mcg.
Platelet count less than 25,000 cells/mm3: Therapy should be discontinued.

Based on Depression:
-Mild: No adjustment recommended.
-Moderate: Initial management (4 to 8 weeks) includes reducing dose to 135 mcg; dose reduction to 90 mcg may be required in some cases. Patient should be evaluated once weekly (office visit at least every other week). If symptoms improve and are stable for 4 weeks, recommendations are to continue reduced dosing or return to normal dose.
-Severe: Peginterferon alfa-2a should be permanently discontinued. Psychiatric therapy may be necessary.

PEDIATRICS (with normal renal function):
If toxicities occur which may be related to peginterferon alfa-2a or ribavirin tablets, the dose of one or both drugs can be modified. Also, ribavirin or peginterferon alfa-2a/ribavirin can be discontinued. Ribavirin should never be given alone.

When dose modification is required for moderate to severe side effects (clinical or laboratory), reduction to 135 mcg/1.73 m2 x BSA is usually adequate. Dose reduction to 90 mcg/1.73 m2 x BSA or 45 mcg/1.73 m2 x BSA may be needed in some cases. Up to 3 dose modifications for toxicity can be made before discontinuation is considered. These modifications apply to pediatric patients with depression, who can be managed similar to the algorithm for adult patients with depression.

Neutropenia:
750 to 999 cells/mm3:
-Week 1 to 2: Dose should be reduced to 135 mcg/1.73 m2 x BSA at once.
-Week 3 to 48: No modification.

500 to 749 cells/mm3:
-Week 1 to 2: Dose should be delayed or held until greater than 750 cells/mm3, then dose should be resumed at 135 mcg/1.73 m2 x BSA. Weekly assessment is recommended for 3 weeks to verify white blood cells greater than 750 cells/mm3.
-Week 3 to 48: Dose should be reduced to 135 mcg/1.73 m2 x BSA at once.

250 to 499 cells/mm3:
-Week 1 to 2: Dose should be delayed or held until greater than 750 cells/mm3, then dose should be resumed at 90 mcg/1.73 m2 x BSA.
-Week 3 to 48: Dose should be delayed or held until greater than 750 cells/mm3, then dose should be resumed at 135 mcg/1.73 m2 x BSA.

Less than 250 cells/mm3 (or febrile neutropenia): Therapy should be discontinued.

Decreased Platelet Count:
Platelets less than 50,000 cells/mm3: Dose should be reduced to 90 mcg/1.73 m2 x BSA.

COMMENTS:
-If severe side effects or laboratory abnormalities develop during combination therapy, the dose should be modified until the side effects abate. If intolerance persists after dose adjustment, peginterferon alfa-2a/ribavirin should be discontinued.
-The manufacturer's product information for ribavirin tablets should be consulted for additional information.

DISCONTINUATION OF THERAPY:
-Therapy discontinuation should be considered if the patient has failed to demonstrate at least a 2 log10 reduction from baseline in HCV RNA titer by 12 weeks of therapy, or if HCV RNA levels remain detectable after 24 weeks of therapy.
-Therapy should be discontinued at once if hepatic decompensation occurs.
-Therapy should be discontinued in patients with severe or worsening signs/symptoms of serious side effects (some may become life-threatening).
-The product information for the specific HCV NS3/4A protease inhibitor should be consulted for information regarding discontinuation of therapy.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Adults:
CrCl less than 30 mL/min, including end-stage renal disease requiring hemodialysis: The dose should be reduced to 135 mcg.

Comments:
-Signs/symptoms of interferon toxicity should be closely monitored.
-If severe side effects or laboratory abnormalities develop, the dose may be reduced to 90 mcg until the side effects abate. If intolerance persists after dose adjustment, peginterferon alfa-2a/ribavirin should be discontinued.

Pediatrics: Data not available

Other Comments

Administration advice:
-The patient may self-inject peginterferon alfa-2a only if the physician determines that it is appropriate, training in proper technique has been provided, and the patient agrees to medical follow-up as necessary.
-Administer dose on the same day of each week and at the same time.
-Administer the subcutaneous injection in the abdomen or thigh.

Storage requirements:
-Store in refrigerator at 2C to 8C (36F to 46F); do not freeze or shake.
-Do not leave out of the refrigerator for more than 24 hours.
-Protect from light.

Preparation techniques: The manufacturer's product information should be consulted.

General:
-For combination therapy: The manufacturer's product information for ribavirin and for the specific HCV NS3/4A protease inhibitor should be consulted.
-Safety and efficacy have not been established for treatment beyond 48 weeks.

Monitoring:
-Cardiovascular: ECG for patients with preexisting cardiac disease (before combination therapy)
-General: Standard biochemical laboratory tests (before therapy, at 4 weeks, and periodically during therapy); HCV RNA (periodically during therapy); signs/symptoms of interferon toxicity or other serious side effects
-Hematologic: Standard laboratory tests (before therapy and at 2 weeks and 4 weeks); CBC (before and routinely during therapy)
-Hepatic: Clinical status and hepatic function (during therapy; more often if ALT flares)
-Ocular: Eye examination in all patients (at baseline); ophthalmologic exams in patients with preexisting ophthalmologic disorders (periodically during therapy)
-Psychiatric: Signs/symptoms of depression and other psychiatric symptoms
-Renal: Renal function by estimating CrCl (before therapy); CrCl in patients with renal dysfunction

Patient advice:
-Patients should be well hydrated, especially during initial stages of therapy.

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