Pegasys (peginterferon alfa-2a)

Dosage of peginterferon alfa-2a should be adjusted in patients who develop adverse neuropsychiatric (i.e., depression) or hematologic effects, or other serious adverse effects or laboratory abnormalities.

Peginterferon alfa-2a (Pegasys(R)) is administered by subcutaneous injection once weekly.

Subcutaneous injections of peginterferon alfa-2a should be made into the abdomen or thigh. Areas of the navel and waistline should be avoided. Injection sites should be rotated.

Peginterferon alfa-2a may beself-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug after appropriate training and with medical follow-up as necessary. Patients and/or their caregivers who administer peginterferon alfa-2a in a home setting should be carefully instructed in the proper administration of the drug, including aseptic technique. They should be cautioned against reuse of syringes and needles and should be supplied with a puncture-resistant container for the proper, safe disposal of such equipment after use. In addition, they should be provided with instructions on the proper disposal of full disposal containers.

Vials and prefilled syringes containing peginterferon alfa-2a should be stored in a refrigerator at 2-8degreesC, protected from light, and should not be frozen or shaken. Vials and prefilled syringes should be allowed to reach room temperature and for condensation on the outside of the prefilled syringe to disappear before administration, but should not be kept out of a refrigerator for more than 24 hours.

Vials and prefilled syringes containing peginterferon alfa-2a should be inspected visually for particulate matter and discoloration prior to administration. The solution should be clear and colorless to light yellow, and should not be used if discolored or cloudy or if particulates are present. Vials and prefilled syringes are for single-use only and any unused portions should be discarded.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis, Stevens-Johnson syndrome) to interferon alfas, including peginterferon alf-2a, or any ingredient in the formulation.

*Autoimmune hepatitis.

*Hepatic decompensation (Child-Pugh score >6, class B and C) in cirrhotic patients prior to treatment.

*Hepatic decompensation (Child-Pugh score >=6) in cirrhotic patients with chronic HCV infection who are coinfected with HIV prior to treatment.

*Use in neonates and infants (this preparation contains benzyl alcohol).

*When used in combination with other HCV antivirals, the contraindications applicable to those agents are applicable to combination therapy.

*Concomitant use of ribavirin and peginterferon alfa-2a is contraindicated in women who are pregnant and men whose female partners are pregnant.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse reactions (incidence >40%) reported in adult patients receiving peginterferon alfa-2a are fatigue/asthenia, pyrexia, myalgia, and headache. The common adverse reactions observed in pediatric patients are similar to those reported in adults.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Efficacy and safety of peginterferon alfa-2a have been established for the treatment of chronic HCV infection in pediatric patients 5 to 17 years of age and for the treatment of chronic HBV infection in pediatric patients 3 to 17 years of age. Efficacy and safety of peginterferon alfa-2a in pediatric patients with chronic HCV infection younger than 5 years of age have not been established. Peginterferon alfa-2a has not been studied to date in pediatric patients with chronic HBV infection and liver cirrhosis and the efficacy and safety of the drug in pediatric patients younger than 3 years of age have not been established.

Delays in weight and height increases compared with baseline have been reported in pediatric patients receiving peginterferon alfa-2a and oral ribavirin therapy for chronic HCV infection. Decreased weight and height for age z-scores as well as percentiles of the normative population have been reported. Data from pediatric patients receiving peginterferon alfa-2a and oral ribavirin indicate that at the end of treatment, 43% of patients experienced a weight percentile decrease of more than 15 percentiles and 25% experienced a height percentile decrease of more than 15 percentiles on their baseline height curves. At the end of 2-years follow-up after completion of treatment, most children had returned to baseline normative growth curve percentiles for weight and height but 16% of the patients were more than 15 percentiles below their baseline weight curve and 11% were more than 15 percentiles below their baseline height curve at 2 years posttreatment. The available longer-term data on patients who were followed up for 6 years post-treatment are too limited to determine the risk of reduced height in some patients.

Delays in weight and height increases were also observed in chronic HBV pediatric patients during therapy with peginterferon alfa-2a lasting up to 48 weeks. After 48 weeks of treatment, 13% of pediatric patients were more than 15 percentiles below their baseline weight curve and 6% were more than 15 percentiles below their baseline height curve. At 24 weeks after the end of treatment, 11% of patients were more than 15 percentiles below their baseline weight curve and 12% were more than 15 percentiles below their baseline height curve. At 5 years post-treatment, the percentage of patients with decreases of more than 15 percentiles from their baseline curves was 29% for weight and 18% for height.

The manufacturer states that peginterferon alfa-2a (Pegasys(R)) is contraindicated in neonates and infants; each vial contains 10 mg and each prefilled syringe contains 5 mg of benzyl alcohol as a preservative. Although a causal relationship has not been established, administration of injections preserved with benzyl alcohol has been associated with toxicity (e.g., neurologic) in neonates and infants, which is sometimes fatal. Toxicity appears to have resulted from administration of large amounts (i.e., 100-400 mg/kg daily) of benzyl alcohol in these neonates. Although use of drugs preserved with benzyl alcohol should be avoided in neonates whenever possible, the American Academy of Pediatrics (AAP) states that the presence of small amounts of the preservative in a commercially available injection should not proscribe its use when indicated in neonates.

There are no adequate and well-controlled studies of peginterferon alfa-2a in pregnant women to inform a drug-associated risk. Based on animal reproduction studies, peginterferon alfa-2a can cause fetal harm and should be assumed to have abortifacient potential.

Peginterferon alfa-2a combination treatment with ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant as significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.

It is not known whether peginterferon alfa-2a is distributed into human milk. The effects of peginterferon alfa-2a on the breastfed infant and the drug's effects on milk production also are not known. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for peginterferon alfa-2a and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Because geriatric patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.

The manufacturer states that younger patients generally have higher virologic response rates to peginterferon alfa-2a than older patients. Clinical studies of peginterferon alfa-2a did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently than younger adults.

Peginterferon alfa-2a should be used with caution in geriatric patients. Adverse reactions related to alfa interferons, such as CNS, cardiac, and systemic (e.g., flu-like) effects, may be more severe in geriatric patients than in younger adults. Because geriatric patients are more likely to have decreased renal function and because patients with renal impairment may be at increased risk of drug-induced toxicity, dosage should be selected carefully and it may be useful to monitor renal function during therapy. The drug should be used with caution in geriatric patients with creatinine clearance <=50 mL/minute, and the dosage should be reduced in patients with creatinine clearance <30 mL/minute.