Also found in: Wikipedia.
Pharmacologic class: Immunomodulator
Therapeutic class: Immunologic agent
Pregnancy risk category C (monotherapy), X (when given with ribavirin)
FDA Box Warning
• Drug may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor patient closely with periodic clinical and laboratory evaluations. Withdraw drug in patients with persistently severe or worsening signs or symptoms of these conditions. In most cases, these disorders resolve once therapy ends.
• Concurrent use with ribavirin may cause birth defects or fetal death. Use extreme care to avoid pregnancy in female patients and female partners of male patients.
Binds to specific cell-surface membrane receptors, causing suppression of cell proliferation, enhanced phagocytic macrophage activity, and inhibition of viral replication
Powder for injection with diluent: 50 mcg/0.5-ml vial, 80 mcg/0.5-ml vial, 120 mcg/0.5-ml vial, 150 mcg/0.5-ml vial (Redipen)
Indications and dosages
➣ Chronic hepatitis C virus (HCV) infection in patients with compensated liver disease
Adults ages 18 and older: For monotherapy, 1 mcg/kg/week subcutaneously for 1 year given on the same day of the week. When given with ribavirin, 1.5 mcg/kg/week subcutaneously. When used in combination with ribavirin, recommended duration in interferon alfa-naïve patients is based on viral genotype. Combination treatment duration for patients who previously failed therapy is 48 weeks, regardless of HCV genotype.
Children ages 3 to 17: 60 mcg/m2/week subcutaneously in combination with ribavirin. Recommended treatment duration is based on viral genotype.
• Serious adverse reactions
• Renal impairment
• Cardiac disease
• Hematologic toxicity
• Hypersensitivity to drug or its components
• Autoimmune hepatitis
• Decompensated hepatic damage
Use cautiously in:
• renal insufficiency
• cardiovascular disease, patients with history of psychiatric disorders, patients with debilitating medical conditions, such as those with history of pulmonary disease
• human immunodeficiency virus, hepatitis B infection
• patients who have failed other interferon alfa therapy
• patients who develop neutralizing antibodies
• organ transplant recipients
• elderly patients
• pregnant or breastfeeding patients
• Reconstitute by holding dual-chamber glass cartridge upright with dose button down and pressing two halves of pen together until you hear an audible click. Then gently invert (don't shake) pen to mix solution.
• To administer, hold pen upright, attach supplied needle, and select appropriate dosage by pulling back on dosing button until dark bands are visible. Then turn button until dark band aligns with correct dose.
• Use reconstituted solution immediately.
• Know that drug may be used alone or with ribavirin.
• Don't use combination therapy in patients with creatinine clearance less than 50 ml/minute.
CNS: fatigue, headache, malaise, asthenia, dizziness, insomnia, depression, anxiety, emotional lability, irritability, poor concentration, agitation, nervousness, rigors, suicidal behavior, suicidal or homicidal ideation
CV: hypotension, tachycardia, chest pain, angina pectoris, arrhythmias, cardiomyopathy, myocardial infarction
EENT: vision decrease or loss, retinal artery or vein thrombosis, retinal hemorrhage, cotton-wool spots in visual field, rhinitis, sinusitis, pharyngitis
GI: nausea; vomiting; diarrhea; constipation; abdominal pain; dyspepsia; right upper abdominal quadrant pain; anorexia; dry mouth; ulcerative, hemorrhagic, or ischemic colitis; pancreatitis
GU: menstrual disorder
Hematologic: neutropenia, thrombocytopenia
Metabolic: aggravated hypothyroidism or hyperthyroidism
Musculoskeletal: myalgia, arthralgia, musculoskeletal pain
Respiratory: dyspnea, pneumonia, bronchiolitis obliterans, cough, sarcoidosis, pulmonary infiltrates, interstitial pneumonitis, bronchoconstriction
Skin: rash, dry skin, pruritus, sweating, flushing, alopecia
Other: exacerbation or development of autoimmune disorders, injection-site reaction, fever, viral or fungal infection, systemic lupus erythematosus, severe hypersensitivity reactions including angioedema and anaphylaxis
Drug-diagnostic tests. Bilirubin, triglycerides, uric acid: increased levels
Glucose, thyroid function tests: decreased or increased levels
Hemoglobin, neutrophils, platelets, white blood cells: decreased levels
• Before therapy begins, assess CBC (including platelet count); blood glucose level, and thyroid, kidney, and liver function tests. Continue to monitor at weeks 2, 4, 8, and 12 and then every 6 weeks during therapy (more often if abnormalities occur). Monitor thyroid function tests every 12 weeks.
☞ Assess cardiac and pulmonary status closely. Watch for signs and symptoms of infection and hypersensitivity reactions, including anaphylaxis.
☞ Monitor neurologic status. Stay alert for such behavioral changes as irritability, anxiety, depression, and homicidal or suicidal ideation.
☞ If serious adverse reaction occurs, know that drug will be discontinued or dosages adjusted accordingly.
• Monitor patient for development of diabetes mellitus, hypothyroidism, or hyperthyroidism.
• Be aware that if HCV level remains high after 6 months, drug should be discontinued.
• Tell patient to take exactly as prescribed. If he misses a dose but remembers it within 2 days, instruct him to take it as soon as possible. However, if more than 2 days have elapsed, advise him to contact prescriber.
• Teach patient or caregiver how to administer injection subcutaneously into thigh or abdomen, if appropriate, and how to properly dispose of equipment.
☞ Advise patient to stop drug and promptly report infection symptoms, such as high fever, easy bruising or bleeding, decreased vision, chest pain, shortness of breath, severe stomach or lower back pain, depression, or suicidal or homicidal thoughts.
• Urge patient to have periodic eye exams.
• Instruct female patient of childbearing age to avoid pregnancy and to use two birth control methods before, during, and up to 6 months after therapy. Instruct male patient to use condoms.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.
peginterferon alfa-2B(peg-in-ter-feer-on al-fa 2b) ,
ClassificationTherapeutic: immune modifiers
|Subcut||unknown||6 mo or more||unknown|
Adverse Reactions/Side Effects
Central nervous system
- suicidal ideation (life-threatening)
- anxiety (most frequent)
- depression (most frequent)
- dizziness (most frequent)
- fatigue (most frequent)
- headache (most frequent)
- insomnia (most frequent)
- aggressive behavior
- homicidal ideation
Ear, Eye, Nose, Throat
- cotton wool spots
- retinal artery/vein obstruction
- retinal hemorrhage
- myocardial infarction (life-threatening)
- heart block
- pulmonary infiltrates/pNEumonitis (life-threatening)
- pharyngitis (most frequent)
- colitis (life-threatening)
- pancreatitis (life-threatening)
- abdominal pain (most frequent)
- anorexia (most frequent)
- diarrhea (most frequent)
- ↑ liver enzymes (most frequent)
- nausea (most frequent)
- alopecia (most frequent)
- dry skin
- ↑ sweating
- thyroid abnormalities
- neutropenia (life-threatening)
- thromboCytopenia (life-threatening)
- injection site pain/reactions (most frequent)
- weight loss
- musculoskeletal pain (most frequent)
- allergic reactions including anaphylaxis
- fever (most frequent)
- flu-like syndrome (most frequent)
- development of antibodies
- development/exacerbation of autoimmune disorders
Drug-Drug interactionNone currently known.
Route/DosageDose modifications are recommended for depression, renal dysfunction, or hematologic toxicity
- Assess patient for development of flu-like syndrome (fever, chills, myalgia, headache). Symptoms tend to decrease, even with continued therapy. Acetaminophen or administration at bedtime may be used to control these symptoms.
- Assess mental status throughout therapy. May cause depression and suicidal ideation. May require discontinuation of medication and continued treatment.
- Monitor cardiac status, especially in patients with underlying cardiac disease. Monitor ECG prior to and periodically during therapy.
- Assess patient for signs and symptoms of ulcerative colitis (abdominal pain, bloody diarrhea, fever). Discontinue peginterferon alpha 2b immediately if these symptoms occur; may be fatal. Colitis usually resolves within 1-3 wks of discontinuation.
- Assess patient for signs of pancreatitis (nausea, vomiting, abdominal pain) periodically during therapy. May be fatal. Suspend therapy in patients with symptoms of pancreatitis. Discontinue therapy if pancreatitis is diagnosed.
- Observe for signs and symptoms of hypersensitivity reactions (urticaria, angioedema, bronchoconstriction, anaphylaxis). Notify health care professional and discontinue treatment immediately if these occur. Transient rashes do not necessitate discontinuation of therapy.
- Lab Test Considerations: Monitor serum HCV RNA levels after 24 wks of treatment. Discontinuation should be considered in any patient who has detectable levels after 24 wks of therapy.
- Monitor for CBC and differential prior to and periodically during therapy. May cause neutropenia and thrombocytopenia. Levels usually return to normal within 4 wks of discontinuation of therapy.
- Monitor liver function tests periodically during therapy. May cause transient elevated ALT not associated with liver dysfunction.
- May aggravate hypothyroidism or hyperthyroidism. Monitor thyroid-stimulating hormone levels.
- May cause hyperglycemia.
Potential Nursing DiagnosesRisk for injury (Side Effects)
Risk for infection (Side Effects)
- If serious adverse reactions occur, dose should be decreased by 50%. If persistent intolerance occurs following dose reduction, discontinue therapy.
- Subcutaneous: Two syringes are provided by manufacturer, one for reconstitution and one for administration. Syringes are equipped with a plastic safety shield that locks over the needle with an audible click (green stripe on safety shield fits over red stripe on needle).
- Reconstitute with 0.7 mL of supplied diluent (sterile water for injection). Do not reconstitute with other diluents. Swirl gently. Discard remaining diluent; for single use only. Do not administer solutions that are discolored or contain particulate matter. Administer immediately after reconstitution; stable for 24 hr if refrigerated. Discard unused portion.
- Administer subcut.
- Instruct patient to take medication as directed at the same time each day, same day each week. Take missed doses as soon as possible the same day or next day. Notify health care professional if dose is missed for several days. Do not double doses or take more than 1 dose/wk without consulting health care professional.
- 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.
- May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
- Review side effects with patient. Peginterferon alfa 2b may be temporarily discontinued or dose decreased by 50% if serious side effects occur.
- Instruct patient to notify health care professional promptly if abdominal pain, bloody diarrhea, or fever occur.
- Inform patient of the potential for depression and advise patient to notify health care professional immediately if depression or suicidal ideation occurs. May require discontinuation of therapy.
- Discuss with patient the possibility of hair loss. Explore coping strategies.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Advise patient to inform health care professional if pregnancy is planned or suspected, or if breast feeding.
- Emphasize need for periodic lab tests to monitor for side effects.
- Home Care Issues: Instruct patient and family on preparation and correct technique for administration of injection and care and disposal of equipment.
- Decrease in symptoms and improvement in liver function tests in patients with chronic hepatitis C infection.
- Improved relapse-free survival (for melanoma)