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Pegasys

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Pegasys

INDICATIONS

Chronic Hepatitis C

PEGASYS, peginterferon alfa-2a, alone or in combination with COPEGUS, is indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection with compensated liver disease and have not been previously treated with interferon alpha. Efficacy has been demonstrated in subjects with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and in adult subjects with clinically stable HIV disease and CD4 count greater than 100 cells/mm³ .

  • Pegasys in combination with Copegus and an approved Hepatitis C Virus (HCV) NS3/4A protease inhibitor is indicated in adult patients (18 years of age and older) with HCV genotype 1 infection (see the Package Insert of the specific HCV NS3/4A protease inhibitor for further information).
  • Pegasys in combination with Copegus is indicated in patients with HCV genotypes other than 1, pediatric patients (5-17 years of age), or in patients with HCV genotype 1 infection where use of an HCV NS3/4A protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors.

The following points should be considered when initiating therapy with PEGASYS and COPEGUS:

  • Use of PEGASYS monotherapy is not recommended for treatment of CHC unless a patient has a contraindication to or significant intolerance to ribavirin. Combination therapy provides substantially better response rates than monotherapy [see Clinical Studies].
  • Safety and efficacy have not been demonstrated for treatment longer than 48 weeks.
  • The safety and efficacy have not been established in liver or other organ transplant recipients [see Use In Specific Populations].

Chronic Hepatitis B

PEGASYS is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation.

DOSAGE AND ADMINISTRATION

PEGASYS is administered by subcutaneous injection in the abdomen or thigh. See COPEGUS prescribing information for all instructions regarding COPEGUS dosing and administration. See the Package Insert of the specific HCV NS3/4A protease inhibitor for information regarding dosing regimen, duration and administration of the protease inhibitor in combination with Pegasys and ribavirin.

Chronic Hepatitis C

Adult Patients

PEGASYS Monotherapy

The recommended dose of PEGASYS monotherapy for chronic hepatitis C is 180 mcg (1 mL vial, 0.5 mL prefilled syringe or 0.5 mL disposable autoinjector) once weekly for 48 weeks.

PEGASYS/COPEGUS Combination Therapy

The recommended dose of PEGASYS when used in combination with ribavirin for chronic hepatitis C is 180 mcg (1 mL vial, 0.5 mL prefilled syringe or 0.5 mL disposable autoinjector) once weekly. The recommended dose of COPEGUS and duration for PEGASYS/COPEGUS therapy is based on viral genotype (see Table 1).

The daily dose of COPEGUS is 800 mg to 1200 mg administered orally in two divided doses.

COPEGUS should be taken with food.

Table 1 : PEGASYS and COPEGUS Dosing Recommendations

Hepatitis C virus Genotype PEGASYS Dose (once weekly) COPEGUS Dose (daily) Duration
Genotypes 1, 4 180 mcg < 75 kg = 1000 mg
≥ 75 kg = 1200 mg
48 weeks*
48 weeks
Genotypes 2, 3 180 mcg 800 mg 24 weeks

Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 13).
Data on genotypes 5 and 6 are insufficient for dosing recommendations.
*In patients with HCV genotype 1 infection where use of an HCV NS3/4A protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors. See the Package Insert of the specific HCV NS3/4A protease inhibitor for information regarding dosing regimen, duration and administration of the protease inhibitor in combination with Pegasys and ribavirin for treatment of genotype 1 infection.

Pediatric Patients

PEGASYS/COPEGUS Combination Therapy

PEGASYS is administered as 180 mcg/1.73 m² x BSA subcutaneously once weekly, to a maximum dose of 180 mcg, and should be given in combination with COPEGUS. The recommended treatment duration for patients with genotype 2 or 3 is 24 weeks and for other genotypes is 48 weeks.

COPEGUS is available only as a 200 mg tablet and therefore the healthcare provider should determine if this sized tablet can be swallowed by the pediatric patient. COPEGUS should be administered with food. The recommended doses for COPEGUS are provided in Table 2. Patients who initiate treatment prior to their 18th birthday should maintain pediatric dosing through the completion of therapy.

Table 2 : COPEGUS Dosing Recommendations for Pediatric Patients

Body Weight in kilograms (kg) COPEGUS Daily Dose* COPEGUS Number of Tablets
23 – 33 400 mg/day 1 x 200 mg tablet A.M.
1 x 200 mg tablet P.M.
34 – 46 600 mg/day 1 x 200 mg tablet A.M.
2 x 200 mg tablets P.M.
47 – 59 800 mg/day 2 x 200 mg tablets A.M.
2 x 200 mg tablets P.M.
60 – 74 1000 mg/day 2 x 200 mg tablets A.M.
3 x 200 mg tablets P.M.
≥ 75 1200 mg/day 3 x 200 mg tablets A.M.
3 x 200 mg tablets P.M.
*approximately 15 mg/kg/day

Chronic Hepatitis C with HIV Coinfection

Adult Patients

PEGASYS Monotherapy

The recommended dose of PEGASYS monotherapy for chronic hepatitis C in patients coinfected with HIV is 180 mcg (1 mL vial, 0.5 mL prefilled syringe or 0.5 mL disposable autoinjector) once weekly for 48 weeks.

PEGASYS/COPEGUS Combination Therapy

The recommended dose when used in combination with ribavirin is PEGASYS 180 mcg once weekly and COPEGUS 800 mg orally daily given in two divided doses for a total of 48 weeks, regardless of genotype.

Since COPEGUS absorption increases when administered with a meal, patients are advised to take COPEGUS with food.

Chronic Hepatitis B

Adult Patients

PEGASYS Monotherapy

The recommended dose of PEGASYS monotherapy for hepatitis B is 180 mcg (1 mL vial, 0.5 mL prefilled syringe or 0.5 mL disposable autoinjector) once weekly for 48 weeks.

Dose Modifications

If severe adverse reactions or laboratory abnormalities develop during combination PEGASYS/COPEGUS therapy, the dose should be modified until the adverse reactions abate. If intolerance persists after dose adjustment, PEGASYS/COPEGUS therapy should be discontinued. Table 3, Table 4, Table 5, and Table 6 provide guidelines for dose modifications and discontinuation of PEGASYS/COPEGUS based on laboratory abnormalities, patient's depression status, and cardiac status.

Adult Patients

When dose modification of PEGASYS is required for adverse reactions (clinical and/or laboratory), initial dose reduction to 135 mcg (which is 0.75 mL for the vials or adjustment to the corresponding graduation mark for the prefilled syringes) is recommended. Dose modification to 135 mcg per week can also be achieved by using a 135 mcg/0.5 mL strength disposable autoinjector. Dose reduction to 90 mcg (which is 0.5 mL for the vials or adjustment to the corresponding graduation mark for the prefilled syringes) may be needed if the adverse reaction persists or recurs. Following improvement of the adverse reaction, re-escalation of the dose may be considered [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Table 3 : PEGASYS Hematological Dose Modification Guidelines

Laboratory Values Recommended Dose
ANC < 750 cells/mm³
ANC < 500 cells/mm³
Reduce to 135 mcg
Discontinue treatment until ANC values return to more than 1000 cells/mm³ . Reinstitute at 90 mcg and monitor ANC.
Platelet < 50,000 cells/mm³
Platelet < 25,000 cells/mm³
Reduce to 90 mcg
Discontinue treatment

Table 4 : Guidelines for Modification or Discontinuation of PEGASYS and for Scheduling Visits for Adult Patients with Depression

Depression Severity Initial Management (4-8 weeks) Depression Status
Dose modification Visit schedule Remains stable Improves Worsens
Mild No change Evaluate once weekly by visit and/or phone Continue weekly visit schedule Resume normal visit schedule (See moderate or severe depression)
Moderate Decrease PEGASYS dose to 135 mcg (in some cases dose reduction to 90 mcg may be needed) Evaluate once weekly (office visit at least every other week) Consider psychiatric consultation. Continue reduced dosing If symptoms improve and are stable for 4 weeks, may resume normal visit schedule. Continue reduced dosing or return to normal dose (See severe depression)
Severe Discontinue PEGASYS permanently Obtain immediate psychiatric consultation Psychiatric therapy necessary

Pediatric Patients

If toxicities occur which may be related to PEGASYS or COPEGUS administration, the dose of one or both drugs can be modified. Additionally, COPEGUS or PEGASYS plus COPEGUS combination therapy can be discontinued. COPEGUS should never be given as monotherapy. Recommendations for dose modifications in pediatric patients for toxicities associated with PEGASYS administration are presented in Table 5.

When dose modification is required for moderate to severe adverse reactions (clinical or laboratory), modification to 135 mcg/1.73 m² x BSA is generally adequate. However, in some cases, dose modification to 90 mcg/1.73 m² x BSA or 45 mcg/1.73 m² x BSA may be needed. 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 outlined in Table 4.

Guidelines for dose modification based on neutropenia, increased ALT levels, and decreased platelet counts for pediatric patients are provided in Table 5.

Table 5 : PEGASYS Dose Modification for Neutropenia, Increased ALT and Decreased Platelets in Pediatric Patients

  PEGASYS Dose Modification
Neutropenia 750-999 cells/mm³ : Week 1-2 — immediate modification to 135 mcg/1.73 m² x BSA; Week 3-48: no modification.
500-749 cells/mm³ : Week 1-2 — delay or hold dose until > 750 cells/mm³ then resume dose with a modification to 135 mcg/1.73 m² x BSA, assess weekly x 3 to verify WBC’s > 750 cells/mm³ ; Week 3-48 — immediate modification to 135 mcg/1.73 m² x BSA.
250-499 cells/mm³ : Week 1-2 — delay or hold dose until > 750 cells/mm³ then resume dose with a modification to 90 mcg/1.73 m² x BSA; Week 3-48 — delay or hold dose until > 750 cells/mm³ then resume dose with a modification to 135 mcg/1.73 m² x BSA.
< 250 cells/mm³ (or febrile neutropenia): discontinue treatment.
Increased alanine transaminase (ALT) For persistent or increasing elevations ≥ 5 but < 10 x ULN, modify
dose with a modification to 135 mcg/1.73 m² x BSA. Monitor weekly, further modifying dose if necessary, until stable or ALT level decreases. For persistent ALT values ≥ 10 x ULN discontinue treatment.
Decreased platelet count Platelet < 50,000 cells/mm³ : Modify dose to 90 mcg/1.73 m² x BSA.

COPEGUS Dose Modifications

See COPEGUS prescribing information for all instructions regarding COPEGUS dosing and administration. Adult and Pediatric Patients

Table 6 : COPEGUS Dose Modification Guidelines for Adults and Pediatric Patients

Body weight in kilograms (kg) Laboratory Values
Hemoglobin < 10 g/dL in patients with no cardiac disease, or Decrease in hemoglobin of ≥ 2 g/dL during any 4 week period in patients with history of stable cardiac disease Hemoglobin < 8.5 g/dL in patients with no cardiac disease, or Hemoglobin < 12 g/dL despite 4 weeks at reduced dose in patients with history of stable cardiac disease
Adult Patients older than 18 years of age
Any weight 1 x 200 mg tablet A.M.
2 x 200 mg tablets P.M.
Discontinue COPEGUS
Pediatric Patients 5 to 18 years of age
23 – 33 kg 1 x 200 mg tablet A.M. Discontinue COPEGUS
34 – 46 kg 1 x 200 mg tablet A.M.
1 x 200 mg tablet P.M.
47 – 59 kg 1 x 200 mg tablet A.M.
1 x 200 mg tablet P.M.
60 – 74 kg 1 x 200 mg tablet A.M.
2 x 200 mg tablets P.M.
≥75 kg 1 x 200 mg tablet A.M.
2 x 200 mg tablets P.M.

The guidelines for COPEGUS dose modifications outlined in this table also apply to laboratory abnormalities or adverse reactions other than decreases in hemoglobin values.

Adult Patients

Once COPEGUS has been withheld due to a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart COPEGUS at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that COPEGUS be increased to the original dose (1000 mg or 1200 mg).

Pediatric Patients

Upon resolution of a laboratory abnormality or clinical adverse reaction, an increase in COPEGUS dose to the original dose may be attempted depending upon the physician's judgment. If COPEGUS has been withheld due to a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart COPEGUS at one-half the full dose.

Renal Impairment

In patients with CrCL less than 30 mL/min, including patients with end-stage renal disease requiring hemodialysis, dose reduction to 135 mcg PEGASYS is recommended. Signs and symptoms of interferon toxicity should be closely monitored. If severe adverse reactions or laboratory abnormalities develop, the dose of PEGASYS may be reduced to 90 mcg until the adverse reactions abate. If intolerance persists after dose adjustment, PEGASYS/COPEGUS therapy should be discontinued.

Renal function should be evaluated in all patients on COPEGUS. The dose of COPEGUS should be reduced for patients with creatinine clearance less than or equal to 50 mL/min [see CLINICAL PHARMACOLOGY and COPEGUS prescribing information].

Table 7 : Dose Modification for Renal Impairment

Creatinine Clearance PEGASYS Dose (once weekly) COPEGUS Dose (daily)
30 to 50 mL/min 180 mcg Alternating doses, 200 mg and 400 mg every other day
< 30 mL/min 135 mcg 200 mg daily
Hemodialysis 135 mcg 200 mg daily

No data are available for pediatric subjects with renal impairment.

Liver Function

Adult Patients

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

In chronic hepatitis C patients with progressive ALT increases above baseline values, the dose of PEGASYS should be reduced to 135 mcg and more frequent monitoring of liver function should be performed. After PEGASYS dose reduction or withholding, therapy can be resumed after ALT flares subside.

In chronic hepatitis B patients with elevations in ALT (greater than 5 x ULN), more frequent monitoring of liver function should be performed and consideration should be given to either reducing the dose of PEGASYS to 135 mcg or temporarily discontinuing treatment. After PEGASYS dose reduction or withholding, therapy can be resumed after ALT flares subside.

In adult patients with persistent, severe (ALT greater than 10 times above the upper limit of normal) hepatitis B flares, consideration should be given to discontinuation of treatment.

Discontinuation of Dosing

Discontinuation of therapy 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 undetectable HCV RNA after 24 weeks of therapy [see Clinical Studies].

During treatment, patients' clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation is observed [see CONTRAINDICATIONS].

Patients should be monitored for serious adverse reactions, some of which may become life threatening. Patients with persistently severe or worsening signs or symptoms should have their therapy withdrawn [see BOXED WARNING].

See the Package Insert of the specific HCV NS3/4A protease inhibitor for information regarding discontinuation of dosing of the protease inhibitor in combination with Pegasys and ribavirin.

Preparation and Administration

A patient should self-inject PEGASYS only if the physician determines that it is appropriate and the patient agrees to medical follow-up as necessary and has been trained in proper injection technique [see illustrated FDA Approved Medication Guide for directions on injection site preparation and injection instructions].

PEGASYS should be inspected visually for particulate matter and discoloration before administration, and not used if particulate matter is visible or product is discolored. Vials, prefilled syringes, and disposable autoinjectors with particulate matter or discoloration should be returned to the pharmacist.

Discard the unused portion of PEGASYS in single-use vials or prefilled syringes in excess of the labeled volume. Use only one vial or prefilled syringe or disposable autoinjector per dose.

HOW SUPPLIED

Dosage Forms And Strengths

  • Vial for single use: 180 mcg/mL
  • Prefilled Syringe for single use: 180 mcg/0.5 mL
  • Autoinjector for single use: 180 mcg/0.5 mL
  • Autoinjector for single use: 135 mcg/0.5 mL

Each PEGASYS Single Use Vial Package Contains:

A box containing 180 mcg per 1 mL solution in a single use vial. (NDC 0004-0350-09)

Each PEGASYS Prefilled Syringe Monthly Convenience Pack Contains:

A box containing four 180 mcg per 0.5 mL (½ cc) single use prefilled syringes with 4 needles with or without 4 alcohol swabs. Each prefilled syringe is supplied with a 27-gauge, ½-inch needle with a needle-stick protection device. (NDC 0004-0352-39) with alcohol swabs (NDC 0004-0357-30) without alcohol swabs

Each PEGASYS ProClick™ Autoinjector Package Contains:

A box containing one 180 mcg per 0.5 mL PEGASYS ProClick™single use autoinjector. (NDC 0004-0365-09)

A box containing one 135 mcg per 0.5 mL PEGASYS ProClick™single use autoinjector. (NDC 0004-0360-09)

Each PEGASYS ProClick™ Autoinjector Monthly Convenience Pack Contains:

A box containing four 180 mcg per 0.5 mL PEGASYS ProClick™single use autoinjectors. (NDC 0004-0365-30)

A box containing four 135 mcg per 0.5 mL PEGASYS ProClick™single use autoinjectors. (NDC 0004-0360-30)

Storage and Handling

Store in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not leave PEGASYS out of the refrigerator for more than 24 hours. Do not freeze or shake. Protect from light. Vials, prefilled syringes and autoinjectors are for single use only. Discard any unused portion remaining in the vial, prefilled syringe.

Disposal Instructions

If home use is prescribed, a puncture-resistant container for the disposal of used needles, syringes and autoinjectors should be supplied to the patients. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of any needles, syringes and autoinjectors. The full container should be disposed of according to the directions provided by the physician [see FDA-Approved Medication Guide].

Distributed by: Genentech USA, Inc. A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Issued: 05 2013

Last reviewed on RxList: 7/12/2013
This monograph has been modified to include the generic and brand name in many instances.

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