peginterferon alfa 2a (Rx)

Brand and Other Names:Pegasys, Pegasys ProClick
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

vial for single use

  • 180mcg/mL

prefilled syringe for single use

  • 180mcg/0.5mL

autoinjector for single use

  • 135mcg/0.5mL
  • 180mcg/0.5mL

Chronic Hepatitis C

Indicated as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is indicated for the treatment of adults with chronic hepatitis C (CHC) with compensated liver disease

180 mcg SC once weekly

Treatment duration (CHC)

  • If used in combination with other antiviral drugs for CHC, refer to the prescribing information of the other HCV antiviral drugs for the recommended dosage of the other HCV antiviral drugs and duration of the entire treatment regimen
  • Genotypes 1, 4: 48 weeks if PEG-INF-alfa-2a and ribavirin are used without other HCV antiviral drugs
  • Genotypes 2, 3: 24 weeks if PEG-INF-alfa-2a and ribavirin are used without other HCV antiviral drugs
  • Genotypes 5, 6: Insufficient data to recommend use
  • PEG-INF-alfa-2a monotherapy: 48 weeks
  • HIV coinfection: 48 weeks if PEG-INF-alfa-2a and ribavirin are used without other HCV antiviral drugs (regardless of HCV genotype)

Dosing Considerations (CHC)

  • PEG-INF-alfa-2a monotherapy is only indicated for the treatment of patients with CHC with compensated liver disease if there are contraindications or significant intolerance to other HCV antiviral drugs
  • PEG-INF-alfa-2a alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa
  • Not recommended for treatment of patients with CHC who have had solid organ transplantation

Chronic Hepatitis B

Indicated for the treatment of adults with HBeAg-positive and HBeAg-negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation

180 mcg SC once weekly for 48 weeks

Dosage Modifications

Neutropenia

  • ANC <750 cells/mm³: Reduce dose to 135 mcg SC once weekly
  • ANC <500 cells/mm³: Discontinue treatment until ANC values return to >1000 cells/mm³ and then reinstitute at 90 mcg SC once weekly; monitor ANC

Thrombocytopenia

  • Platelet <50,000 cells/mm³: Reduce dose to 90 mcg SC once weekly
  • Platelets <25,000 cells/mm³: Discontinue

Increased ALT

  • If ALT increases are progressive despite dose reduction or accompanied by increased bilirubin or evidence of hepatic decompensation, therapy should be immediately discontinued
  • Chronic hepatitis C: If ALT increases above baseline values, reduce dose to 135 mcg/week and perform more frequent monitoring of liver function; after dosage reduction or withholding, therapy can be resumed after ALT flares subside
  • Chronic hepatitis B (ALT >5 xULN): Monitor LFTs more frequently; consider reducing the dosage to 135 mcg/week or temporarily discontinuing treatment; after dosage reduction or withholding, therapy can be resumed after ALT flares subside
  • Consider discontinuing in adults with persistent, severe hepatitis B flares (ALT >10 xULN)

Renal impairment

  • CrCl 30-50 mL/min: 180 mcg once weekly
  • CrCl <30 mL/min (including patients on hemodialysis): 135 mcg once weekly
  • If severe adverse reactions or laboratory abnormalities develop, dose can be reduced to 90 mcg once weekly until adverse reactions abate
  • If intolerance persists after dosage adjustment, discontinued

Depression

  • Mild: No dosage change; if severity increases after 8 wk, discontinue or decrease dose and consider psychiatric consult
  • Moderate: Decrease dose; if severity increases after 8 wk, discontinue permanently and obtain immediate psychiatric consult
  • Severe: Discontinue permanently and obtain immediate psychiatric consult

Administration

Administer by SC injection once weekly in abdomen or thigh

Chronic Myelogenous Leukemia (Orphan)

Orphan indication sponsor

  • Hoffman-La Roche Inc; 340 Kingsland St; Nutley, NJ 07110-1199

Renal Cell Carcinoma (Orphan)

Orphan indication sponsor

  • Hoffman-La Roche Inc; 340 Kingsland St; Nutley, NJ 07110-1199

Dosage Forms & Strengths

vial for single use

  • 180mcg/mL

prefilled syringe for single use

  • 180mcg/0.5mL

autoinjector for single use

  • 135mcg/0.5mL
  • 180mcg/0.5mL

Chronic Hepatitis C

Indicated in combination with ribavirin for treatment of chronic hepatitis C of children aged ≥5 yr with CHC and compensated liver disease

<5 years: Safety and efficacy not established

≥5 years: 180 mcg/1.73 m² SC qWeek with daily ribavirin  

Treatment duration

  • Genotypes 2, 3: 24 weeks
  • Genotypes 1, 4: 48 weeks
  • Patients who initiate treatment prior to their 18th birthday should maintain the recommended pediatric dosage (not the adult dosage) through the completion of therapy
  • Refer to ribavirin prescribing information for dose and duration

Dosage Modifications

Neutropenia

  • ANC 750-999 cells/mm³: Immediately decrease dose to 135 mcg/1.73 m² x BSA (weeks 1-2); no modification if this occurs during weeks 3-48
  • ANC 500-749 cells/mm³: Delay or hold treatment until >750 cells/mm³ then resume dose at 135 mcg/1.73 m² x BSA (weeks 1-2) or immediately decrease dose to 135 mcg/1.73 m² x BSA (weeks 3-48)
  • ANC 250-499 cells/mm³: Delay or hold treatment until >750 cells/mm³ then resume dose at 90 mcg/1.73 m² x BSA (weeks 1-2) or 135 mcg/1.73 m² x BSA (weeks 3-48)
  • ANC <250 cells/mm³ (or febrile neutropenia): Discontinue

Thrombocytopenia

  • Platelets <50,000 cells/mm³: Decrease dose to 90 mcg/1.73 m² x BSA SC once weekly

Increased ALT

  • ALT ≥5 to <10 xULN: Decrease dose to 135 mcg/1.73 m² x BSA SC once weekly; monitor weekly, reduce dosage further if necessary until stable or ALT level decreases
  • Persistent ALT ≥10 x ULN: Discontinue

Depression

  • Mild: No dosage change; if severity increases after 8 wk, discontinue or decrease dose and consider psychiatric consult
  • Moderate: Decrease dose; if severity increases after 8 wk, discontinue permanently and obtain immediate psychiatric consult
  • Severe: Discontinue permanently and obtain immediate psychiatric consult

Administration

Administer by SC injection once weekly in abdomen or thigh

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Interactions

Interaction Checker

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            Adverse Effects

            >10%

            Fatigue (24% to 67% )

            Headache (27% to 54% )

            Fever (24% to 54% )

            Myalgia (26% to 51% )

            Influenza-like illness (25% to 47% )

            Rigor (25% to 47% )

            Neutropenia (21% to 40% )

            Anxiety (19% to 33% )

            Feeling nervous (19% to 33% )

            Irritability (19% to 33% )

            Diarrhea (11% to 31% )

            Injection site inflammation (10% to 31% )

            Insomnia (19% to 30% )

            Arthralgia (22% to 28% )

            Alopecia (18% to 28% )

            Abdominal pain (8% to 26% )

            Nausea and vomiting (5% to 25% )

            Loss of appetite (16% to 24% )

            Injection site reaction (22% to 23% )

            Dizziness (13% to 23% )

            Depression (18% to 20% )

            Pruritus (12% to 19% )

            Dermatitis (8% to 16% )

            Weight decreased (4% to 16% )

            Lymphocytopenia (Severe) (5% to 14% )

            Anemia (2% to 14%)

            Lymphocyte count abnormal (3% to 14% )

            Dyspnea (4% to 13% )

            1-10%

            Reduced concentration (8% to 10% )

            Cough (4% to 10% )

            Dry skin (4% to 10% )

            Rash (5% to 8% )

            Thrombocytopenia (5% to 8% )

            Bacterial infectious disease (3% to 5% )

            Severe bacterial infection (1-3%)

            <1%

            Angina

            Cardiac dysrhythmia

            Aggressive behavior

            Cerebral hemorrhage

            Cerebral ischemia

            Coma

            Drug Abuse

            Peripheral neuropathy

            Psychotic disorder

            Suicide

            Diabetes mellitus

            Colitis

            Gastrointestinal hemorrhage

            Pancreatitis

            Peptic ulcer disease

            Aplastic anemia

            Thrombotic thrombocytopenic purpura

            Abnormal liver function

            Cholangitis

            Liver failure

            Steatosis of liver

            Myositis

            Corneal ulcer

            Pulmonary embolism

            Frequency Not Defined

            Myocardial infarction

            Erythroderma (rare)

            Stevens-Johnson syndrome (rare)

            Hypo/hyperthyroidism

            Hypo/hyperglycemia

            Anemia (severe)

            Cytopenia (severe)

            Autoimmune disease (rare)

            Hypersensitivity reaction (severe)

            Serous retinal detachment

            Pulmonary infiltrates

            Liver graft rejection and renal graft rejection

            Postmarketing Reports

            Pure red cell aplasia

            Hearing impairment

            Hearing loss

            Tongue pigmentation

            Dehydration

            Serious skin reactions

            Seizures

            Liver graft rejection and renal graft rejection

            Postmarketing Reports

            Limb abscess

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            Warnings

            Black Box Warnings

            Alfa interferons cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders

            Monitor closely with periodic clinical and laboratory evaluations

            Discontinue drug if persistently severe or worsening signs or symptoms of the above conditions are present; disorders typically resolve after stopping therapy

            Contraindications

            Known hypersensitivity reactions (eg, urticaria, angioedema, bronchoconstriction, anaphylaxis, Stevens-Johnson) syndrome to alpha interferons

            Autoimmune hepatitis Hepatic decompensation (Child-Pugh score >6 [class B and C]) in cirrhotic patients before treatment with or without HIV coinfection

            Neonates and infants (contains benzyl alcohol); associated with an increased incidence of neurologic and other complications which are sometimes fatal in neonates and infants

            When used in combination with other HCV antiviral drugs, the contraindications applicable to those agents are applicable to combination therapies

            Combination treatment with ribavirin is contraindicated in women who are pregnant and men whose female partners are pregnant

            Cautions

            Ribavirin may cause birth defects and/or death of the exposed fetus; patients must avoid pregnancy (female patients or female partners of male patients) while taking PEG-INF-alfa-2a and ribavirin combination therapy

            Life-threatening or fatal neuropsychiatric reactions may manifest and include suicide, suicidal ideation, homicidal ideation, depression, relapse of drug addiction, and drug overdose; these reactions may occur with and without history of previous psychiatric illness

            Hypertension, supraventricular arrhythmias, chest pain, and myocardial infarction reported; caution with pre-existing cardiovascular disease

            Suppresses bone marrow function and may result in severe cytopenias; ribavirin may potentiate the neutropenia and lymphopenia induced by alpha interferons; rare occurrences of aplastic anemia observed

            Development or exacerbation of autoimmune disorders including myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, and systemic lupus erythematosus reported

            May cause or aggravate endocrine disorders including hypothyroidism, hyperthyroidism, hyperglycemia, hypoglycemia, and diabetes mellitus

            Alpha interferons may induce or exacerbate ophthalmic disorders including decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema and serous retinal detachment

            Patients with CHC with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons

            Exacerbations of hepatitis during hepatitis B therapy are not uncommon and are characterized by transient and potentially severe increases in serum ALT

            Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension and sarcoidosis, some resulting in respiratory failure and/or patient deaths, may be induced or aggravated by alpha interferons

            Serious and severe infections (bacterial, viral, or fungal), some fatal, have been reported during treatment with alpha interferons

            Ulcerative and hemorrhagic/ischemic colitis, sometimes fatal, have been observed within 12 weeks of starting alpha interferon treatment

            Pancreatitis, sometimes fatal, has occurred during alpha interferon and ribavirin treatment

            Severe acute hypersensitivity reactions (eg, urticaria, angioedema, bronchoconstriction, and anaphylaxis) observed

            Pediatric patients treated with PEG-INF-alfa-2a plus ribavirin showed a delay in weight and height increases; growth inhibition observed in chronic hepatitis C pediatric subjects 5 -17 years of age receiving peginterferon alfa-2a plus ribavirin thearpy combination for up to 48 weeks; at end of 2 years follow-up after treatment, most subjects had returned to baseline normative curve percentiles for weight and height; 16% of subjects were more than 15 percentiles below their baseline weight curve and 11% were more than 15 percentiles below their baseline height curve

            Growth inhibition was also observed in chronic hepatitis B pediatric subjects 3-17 years of age during therapy lasting up to 48 weeks; at week 48, 11% of subjects 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 end of treatment, 12% of subjects were more than 15 percentiles below their baseline weight curve and 12% were more than 15 percentiles below their baseline height curve; no data are available on longer term follow-up post-treatment in these patients

            Peripheral neuropathy has been reported when alpha interferons were given in combination with telbivudine

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            Pregnancy & Lactation

            Pregnancy

            A registry has been established to monitor maternal and fetal outcomes of pregnancies of female patients and female partners of male patients exposed to ribavirin during pregnancy or who become pregnant within 6 months following cessation of treatment with ribavirin; healthcare providers and patients are encouraged to report such cases by calling 1-800-593-2214

            There are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk; based on animal reproduction studies, therapy can cause fetal harm and should be assumed to have abortifacient potential; non-pegylated interferon alfa-2a treatment caused abortion when given to pregnant rhesus monkeys

            Combination treatment with ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant; significant teratogenic and/or embryocidal effects demonstrated in all animal species exposed to ribavirin

            Pregnancy testing

            • Females of reproductive potential must undergo pregnancy testing before initiation of treatment as monotherapy or in combination with ribavirin or with other HCV drugs; females of reproductive potential receiving therapy in combination with ribavirin must have a routine pregnancy test performed monthly during treatment and for at least 6 months following treatment; female partners of male patients receiving treatment in combination with ribavirin must have a routine pregnancy test performed monthly during treatment and for at least 6 months posttherapy

            Contraception

            • Because of abortifacient potential of therapy, females of reproductive potential should be advised to use effective contraception during therapy; however, when receiving treatment in combination with ribavirin, women of reproductive potential and their partners must use effective contraception during treatment and for at least 6 months after the last dose

            Infertility

            • Based on mechanism of action and studies in female monkeys, treatment can cause disruption of menstrual cycle; no female fertility study has been performed

            Lactation

            There is no information regarding presence of peginterferon alfa-2a in human milk, effects on breastfed infant, or on milk production; because of potential for adverse reactions from drugs in nursing infants, a decision must be made whether to discontinue nursing or discontinue treatment; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from treatment or from underlying maternal condition

            The Centers for Disease Control and Prevention recommends that HIV-infected mothers not breastfeed their infants to avoid potential transmission of HIV; therefore, CHC- and CHB-infected mothers coinfected with HIV should not breastfeed their infants

            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

            Recombinant alfa-2a interferon w/ polyethylene glycol (PEG) side chain

            Immunomodulatory cytokine that enhances phagocytic activity of macrophages and cytotoxic activity of lymphocytes for target cells

            Pharmacokinetics

            Half-Life: 80 hr

            Peak Plasma Time: 72-96 hr

            Total Body Clearance: 94 mL/hr

            Metabolism: Conjugation w/ polyethylene glycol slows metabolism

            Enzymes Inhibited: CYP1A2

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            Formulary

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