PEGASYS dosing and administration

PEGASYS is indicated for the treatment of chronic HCV. It can be used alone or in combination with ribavirin, depending on disease state and individual factors. 1

PEGASYS is available in the following administration options1:

Patients should be instructed regarding the different forms of administration. Please see PEGASYS Medication Guide for detailed instructions on each form of administration.

PEGASYS® ProClick Autoinjector
is available in two doses, 180 mcg and 135 mcg.

Not actual size.

Accurate dosing. Simplified delivery.

  • Confirmed full-dose delivery with both visual and auditory verification1
    • Fixed 135-mcg PEGASYS® ProClick Autoinjector helps patients down dose accurately from 180 mcg to 135 mcg
  • Protective shield may help prevent needle-stick injury. No exposed needle1
  • Ready to use—no reconstitution or dial adjustment required1*
    *
    Must allow the autoinjector to come to room temperature for about 20 minutes to warm up before injecting.
    • No mixing is necessary with the PEGASYS® ProClick Autoinjector. After proper inspection,* there are 3 steps to administer a dose of PEGASYS

To prescribe the PEGASYS® ProClick Autoinjector

Refer to the graphic for how to write a prescription for PEGASYS® ProClick Autoinjector.

Figure : Example prescription of Pegasys ProClick

For information on dose-reduction options between prescriptions, please contact your PEGASYS clinical specialist, or call 1-877-PEGASYS (1-877-734-2797).

The National Drug Code (NDC) numbers for the PEGASYS® ProClick Autoinjector are provided below, should you or members of your staff need them:

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)

If you have questions regarding the PEGASYS® ProClick Autoinjector, please contact your Genentech representative.

You and your patients are encouraged to report adverse events or any special situations related to Genentech products to the Genentech Drug Safety Adverse Event Reporting Telephone Line: 1-888-835-2555.

PEGASYS Prefilled Syringe (PFS)

Precise, flexible dosing

Chart: Prefilled Syringe
Not actual size.
  • Ready to use—no reconstitution or dial adjustment required1†
  • One PEGASYS PFS can accommodate 180-mcg, 135-mcg, and 90-mcg dosing regimens1
Must allow the PFS to come to room temperature for a few minutes before injecting.
Patient Convienance Pack

The National Drug Code (NDC) number for the PEGASYS Prefilled Syringe is provided below, should you or members of your staff need it:

Each PEGASYS Prefilled Syringe Monthly Convenience Pack Contains:
A box containing four 180-mcg per 0.5 mL (1/2 cc) single-use prefilled syringes with 4 needles. Each prefilled syringe is supplied with a 27-gauge, 1/2-inch needle with a needle-stick protection device. (NDC 0004-0357-30)

SELECT IMPORTANT SAFETY INFORMATION1

If severe adverse reactions or laboratory abnormalities develop during combination PEGASYS/ribavirin therapy, the dose should be modified until the adverse reactions abate. If intolerance persists after dose adjustment, PEGASYS/ribavirin therapy should be discontinued. Refer to the full prescribing information for guidelines pertaining to dose modifications and discontinuation of PEGASYS/ribavirin based on laboratory abnormalities, patient’s depression status, and cardiac status.

Single-dose vial1

The 180-µg/1.0-mL, single-use, clear-glass vial contains approximately 1.2 mL of solution to deliver 1.0 mL of drug product for subcutaneous injection.

How PEGASYS should be taken1

The prescribed dose of PEGASYS should be taken

  • Once a week
  • On the same day each week
  • At approximately the same time

Patients should be advised to alternate injection sites in lower abdomen and thighs to avoid injection site reactions.

A patient should self-inject PEGASYS only if the physician determines that it is appropriate, the patient agrees to medical follow-up as necessary, and training in proper injection technique has been provided to the patient (see illustrated PEGASYS 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 and prefilled syringes with particulate matter or discoloration should be returned to the pharmacist.

The National Drug Code (NDC) number for the PEGASYS single-use vial is provided below, should you or members of your staff need it:

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)

For self-administration instructions, please see the PEGASYS Medication Guide.

For complete dosing information, see DOSAGE AND ADMINISTRATION in the PEGASYS full Prescribing Information.

Next: PEGASYS & Chronic HCV

INDICATIONS AND USAGE

PEGASYS® (peginterferon alfa-2a), alone or in combination with COPEGUS® (ribavirin, USP), 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 >100 cells/mm3.

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

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

IMPORTANT SAFETY INFORMATION

Boxed WARNINGS

Alpha interferons, including PEGASYS, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy.

Use with ribavirin. Ribavirin, including COPEGUS, may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. [See COPEGUS Package Insert for additional information and other WARNINGS.]

DOSE MODIFICATION

If severe adverse reactions or laboratory abnormalities develop during combination PEGASYS/ribavirin therapy, the dose should be modified until the adverse reactions abate. If intolerance persists after dose adjustment, PEGASYS/ribavirin therapy should be discontinued. Refer to the full prescribing information for guidelines pertaining to dose modifications and discontinuation of PEGASYS/ribavirin based on laboratory abnormalities, patient’s depression status, and cardiac status.

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. Renal function should be evaluated in all patients on ribavirin. Ribavirin should be reduced for patients with creatinine clearance <50 mL/min. No data are available for pediatric patients with renal impairment.

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.

During treatment, patients’ clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation is observed.

Patients should be monitored for serious adverse events, some of which may become life threatening. Patients with persistently severe or worsening signs or symptoms should have their therapy withdrawn.

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.

CONTRAINDICATIONS

PEGASYS is contraindicated in patients with:

PEGASYS is contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurologic and other complications in neonates and infants, which are sometimes fatal.

PEGASYS/ribavirin combination therapy is additionally contraindicated in:

WARNINGS AND PRECAUTIONS

Patients should be monitored for the following serious conditions, some of which may become life threatening. Patients with persistently severe or worsening signs or symptoms should have their therapy withdrawn:

Use with ribavirin:

ADVERSE REACTIONS

Adult Patients:

The most common life-threatening or fatal events induced or aggravated by PEGASYS and ribavirin include depression, suicide, relapse of drug abuse/overdose, and bacterial infections, each occurring at a frequency of <1%. Hepatic decompensation occurred in 2% (10/574) of CHC/HIV subjects.

Chronic Hepatitis C (Adult Patients)

In clinical trials, 98 to 99 percent of subjects experienced one or more adverse events. For hepatitis C subjects, the most commonly reported adverse reactions were psychiatric reactions, including depression, insomnia, irritability, anxiety, and flu-like symptoms such as fatigue, pyrexia, myalgia, headache, and rigors. Other common reactions were anorexia, nausea and vomiting, diarrhea, arthralgias, injection site reactions, alopecia, and pruritus.

The most common serious adverse event (3% in CHC and 5% in CHC/HIV) was bacterial infection (eg, sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia). Other serious adverse events occurred at a frequency of <1% and included: suicide, suicidal ideation, aggression, anxiety, drug abuse and drug overdose, angina, hepatic dysfunction, fatty liver, cholangitis, arrhythmia, diabetes mellitus, autoimmune phenomena (eg, hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis), peripheral neuropathy, aplastic anemia, peptic ulcer, gastrointestinal bleeding, pancreatitis, colitis, corneal ulcer, pulmonary embolism, coma, myositis, cerebral hemorrhage, thrombotic thrombocytopenic purpura, psychotic disorder, and hallucination.

Chronic Hepatitis C (Pediatric Patients)

In general, the safety profile observed in pediatric subjects was similar to that seen in adults. In the pediatric study, the most prevalent adverse events in subjects treated with combination therapy for up to 48 weeks with PEGASYS and ribavirin were influenza-like illness (91%), upper respiratory tract infection (60%), headache (64%), gastrointestinal disorder (56%), skin disorder (47%), and injection-site reaction (45%). Most of the adverse events reported in the study were mild or moderate in severity. Severe adverse events were reported in 2 subjects in the PEGASYS plus ribavirin combination therapy group (hyperglycemia and cholecystectomy). Pediatric subjects treated with PEGASYS plus ribavirin showed a delay in weight and height increases after 48 weeks of therapy; most had returned to baseline normative growth curve percentiles for weight and height at two years of follow-up.

Chronic Hepatitis C with HIV Coinfection (Adult Patients)

The adverse event profile of HCV/HIV coinfected subjects treated with PEGASYS/ribavirin was generally similar to that shown for monoinfected patients. Events occurring more frequently in coinfected subjects were neutropenia (40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%), and mood alteration (9%).

Chronic Hepatitis B

In clinical trials of 48-week treatment duration, the adverse event profile of PEGASYS in chronic hepatitis B was similar to that seen in chronic hepatitis C PEGASYS monotherapy use, except for exacerbations of hepatitis. Six percent of PEGASYS treated subjects in the hepatitis B studies experienced one or more serious adverse events.

The most common or important serious adverse events, all of which occurred at a frequency of less than or equal to 1%, in the hepatitis B studies were infections (sepsis, appendicitis, tuberculosis, influenza), hepatitis B flares, and thrombotic thrombocytopenic purpura.

The most commonly observed adverse reactions in patients treated with PEGASYS were pyrexia (54%), headache (27%), fatigue (24%), myalgia (26%), alopecia (18%), and anorexia (16%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see PEGASYS full Prescribing Information for Boxed WARNINGS and additional Important Safety Information.

PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-La Roche Inc. All other brands for listed products are trademarks or registered trademarks (as indicated) of their respective owners and are not trademarks of Genentech, Inc. or Hoffmann-La Roche Inc.

Reference
 
1.
PEGASYS Prescribing Information. Genentech, Inc. 2013.