peginterferon alfa-2a

REMS

Chronic hepatitis C (CHC) infection in adults with compensated liver disease (with other hepatitis C antiviral drugs) (should only be used as monotherapy if patients have contraindication to or do not tolerate other antiviral drugs).
CHC infection in children 5 years of age and older with compensated liver disease.
HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) infection in adults with compensated liver disease, evidence of viral replication, and elevations in serum alanine aminotransferase (ALT).
HBeAg-positive CHB in non-cirrhotic children at least 3 years of age and older with evidence of viral replication and elevations in serum ALT.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Autoimmune hepatitis;
Hepatic decompensation (Child-Pugh classes B or C) before treatment;
Since peginterferon alfa-2a is given concurrently with ribavirin, consideration must be given to all aspects of ribavirin therapy.
Pedi: Products containing benzyl alcohol should not be used in neonates.

Use Cautiously in:

Baseline neutrophil count <1500 cells/mm³ or platelet count <90,000 cells/mm³;
Hemoglobin <10 g/dL;
History of suicidal ideation or depression;
Rep: Women of reproductive potential;
OB: ↑risk of spontaneous abortion in animal studies; use only if potential maternal benefit justifies potential fetal risk; ribavirin is contraindicated in pregnancy and lactation and in men whose female partners are pregnant;
Lactation: Safety not established in breastfeeding;
Pedi: Children <3 yr (safety and effectiveness not established).

Exercise Extreme Caution in:

History of depression.

Adv. Reactions/Side Effects ⬆ ⬇

CV: chest pain, hypertension, MYOCARDIAL INFARCTION, supraventricular arrhythmias

Derm: skin reactions (including Stevens-Johnson syndrome and exfoliative dermatitis)

EENT: ↓vision, optic neuritis, papilledema, retinal hemorrhage/cotton wool spots, retinal vascular thrombosis, retinopathy

Endo: ↓growth (children), hyperglycemia, hyperthyroidism, hypoglycemia, hypothyroidism

GI: COLITIS, PANCREATITIS

Hemat: bone marrow depression

Neuro: NEUROPSYCHIATRIC REACTIONS

Resp: dyspnea, INTERSTITIAL PNEUMONITIS, pulmonary infiltrates

Misc: development/exacerbation of autoimmune disorders, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), infection

Interactions ⬆ ⬇

Drug-drug:

May ↑ serum theophylline levels (adjust dose accordingly).

Availability ⬆ ⬇

Solution for injection (prefilled syringes): 180 mcg/0.5 mL
Solution for injection (vials): 180 mcg/mL

Route/Dosage ⬆ ⬇

Chronic Hepatitis C

SC (Adults ): Genotype 1, 2, 3, or 4 or co-infection with HIV180 mcg once weekly (duration of therapy varies with concurrent antivirals used).
SC (Children ≥5 yr): Genotype 1 or 4: 180 mcg/1.73 m² X BSA once weekly (not to exceed 180 mcg) (with PO ribavirin) for 48 wk; Genotype 2 or 3: 180 mcg/1.73 m² X BSA once weekly (not to exceed 180 mcg) (with PO ribavirin) for 24 wk.

Renal Impairment

SC (Adults ): CCr 30–50 mL/min: 180 mcg once weekly; CCr <30 mL/min (including hemodialysis): 135 mcg once weekly.

Chronic Hepatitis B

SC (Adults ): 180 mcg once weekly for 48 wk.
SC (Children ≥3 yr): 180 mcg/1.73 m² X BSA once weekly (not to exceed 180 mcg) (with PO ribavirin) for 48 wk;

Renal Impairment

SC (Adults ): CCr 30–50 mL/min: 180 mcg once weekly; CCr <30 mL/min (including hemodialysis): 135 mcg once weekly.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Interferons are proteins capable of modifying the immune response.
Interferon alfa-2a is produced by recombinant DNA techniques; pegylation of interferon alfa-2a is formulated to have a longer duration of action.
Interferons also have antiviral activity.

Therapeutic effects:

Decreased progression of hepatic damage.

Classifications ⬆ ⬇

Therapeutic Classification: immune modifiers

Pharmacologic Classification: interferons

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 80 hr (range 50–140 hr).

Time/Action Profile ⬆ ⬇

(blood levels*)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	72–96 hr	approx 1 wk

*Accumulation to steady state levels occurs over 5–8 wk.

Patient/Family Teaching ⬆ ⬇

Instruct patient and family on preparation and correct technique for administration of injection and care and disposal of equipment. If a dose is missed, administer as soon as remembered if within 2 days; if >2 days, notify health care professional. Advise patient to read Medication Guidebefore starting therapy and with each Rx refill in case of changes.
Advise patient to maintain good hydration, especially during initial therapy.
Discuss possibility of flu-like reaction 3–6 hr after dose. Acetaminophen may be taken prior to injection and every 3–4 hr afterward as needed to control symptoms.
Inform patient that peginterferon alfa-2a may not reduce the risk of transmission of HCV to others or prevent cirrhosis, liver failure, or liver cancer.
Advise patient and family to notify health care professional if thoughts about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking, other unusual changes in behavior or mood occur.
Instruct patient to notify health care professional promptly if fever; chills; cough; hoarseness; sore throat; signs of infection; lower back or side pain; painful or difficult urination; bleeding gums; bruising; petechiae; blood in stools, urine, or emesis; increased fatigue; dyspnea; or orthostatic hypotension occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to avoid falls. Caution patient not to drink alcoholic beverages or take medication containing aspirin or NSAIDs; may precipitate gastric bleeding.
Instruct patient not to receive any vaccinations without advice of health care professional.
Emphasize need for periodic lab tests to monitor for side effects.
Inform patient that peginterferon alpha-2a may not reduce the risk of transmission of HCV to others or prevent cirrhosis, liver failure, or liver cancer.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and to avoid breastfeeding. If therapy is combined with ribavirin, advise females of reproductive potential and men with female partners of reproductive potential to use two forms of effective contraception during and for at least 6 mo following conclusion of therapy. Men must use a condom. May disrupt menstrual cycle.

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Indications ⬇