Dosing & Uses
Dosage Forms & Strengths
vial
- 180mcg/mL (single-dose)
prefilled syringe
- 180mcg/0.5mL (single-dose)
Chronic Hepatitis C
Indicated as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs for treatment of adults with chronic hepatitis C (CHC) with compensated liver disease
180 mcg SC once weekly
Treatment duration (CHC)
- Refer to 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
- Genotype 1 in combination with ribavirin or alone: Discontinue treatment if at least a 210 reduction from baseline in HCV RNA has not been demonstrated by 12 weeks or if undetectable HCV RNA has not been achieved after 24 weeks
- 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)
Chronic Hepatitis
Indicated for 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 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 to 90 mcg SC once weekly
- Platelets <25,000 cells/mm3: Discontinue treatment
Increased ALT
- If ALT increases are progressive despite dose reduction or accompanied by increased bilirubin or evidence of hepatic decompensation, discontinue treatment immediately
- Chronic hepatitis C: If ALT increases above baseline values, reduce to 135 mcg/week and perform more frequent monitoring of liver function; after dosage reduction or withholding, resume therapy after ALT flares subside
- Chronic hepatitis B (ALT >5x ULN): Monitor LFTs more frequently; consider reducing the dosage to 135 mcg/week or temporarily discontinuing treatment; after dosage reduction or withholding, resume therapy after ALT flares subside
- Consider discontinuing in adults with persistent, severe hepatitis B flares (ALT >10x ULN)
Depression
-
Mild
- No dosage change; evaluate once weekly by visit and/or phone
- Depression severity remains stable after 8 weeks: Continue weekly visit schedule
- Depression severity improves after 8 weeks: Resume normal visit schedule
- Depression severity improves after 8 weeks: Discontinue or reduce dosage to 135 mcg or 90 mcg once weekly and consider psychiatric consult
-
Moderate
- Reduce dosage to 135 mcg or 90 mcg once weekly; evaluate once weekly (office visit at least every other week)
- Depression severity remains stable after 8 weeks: Continue reduce dosing; consider psychiatric consultation
- If symptoms improve and are stable for 4 weeks, may resume normal visit schedule; continue reduced dosage or return to normal dosage
- Depression severity improves after 8 weeks: Discontinue permanently and obtain immediate psychiatric consult
-
Severe
- Discontinue permanently; obtain immediate psychiatric consult
- Depression management after 8 weeks: Psychiatric therapy necessary
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, reduce dose to 90 mcg once weekly until adverse reactions abate
- If intolerance persists after dosage adjustment, discontinued treatment
Hepatic impairment
- CHC patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons,
- During treatment, closely monitor patients’ clinical status and hepatic and discontinue treatment immediately if decompensation (Child-Pugh score ≥6) is observed
Dosing Considerations
Preform pregnancy screening for females of childbearing potential
CHC
- 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 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
- 180mcg/mL (single-dose)
prefilled syringe
- 180mcg/0.5mL (single-dose)
Chronic Hepatitis C
Indicated in combination with ribavirin for treatment of chronic hepatitis C (CHC) in children aged ≥5 yr with CHC and compensated liver disease
<5 years: Safety and efficacy not established
≥5 years H4
- 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
Chronic Hepatitis B
Indicated for treatment of HBeAg-positive CHB in non-cirrhotic children aged ≥3 years with evidence of viral replication and elevations in ALT
180 mcg/1.73 m2 x BSA (maximum dose: 180 mcg) SC qWeek for 48 weeks
Dosage Modifications
Neutropenia (CHC)
-
ANC 750-999 cells/mm^3
- Week 1-2: Immediately decrease dose to 135 mcg/1.73 m2 x BSA
- Week 3-48: No modification
-
ANC 500-749 cells/mm^3
- Week 1-2: Delay or hold treatment until >750 cells/mm3 then resume dose at 135 mcg/1.73 m2 x BSA; assess 3x/week to verify ANC >750 cells/mm3
- Week 3-48: Immediately decrease dose to 135 mcg/1.73 m2 x BSA
-
ANC 250-499 cells/mm^3
- Week 1-2: Delay or hold treatment until >750 cells/mm3 then resume dose at 90 mcg/1.73 m2 x BSA
- Week 3-48: 135 mcg/1.73 m2 x BSA
-
ANC <250 cells/mm^3 (or febrile neutropenia)
- Discontinue treatment
Neutropenia (CHB)
- ANC 750-999 cells/mm3: No dosage modification
- ANC 500-749 cells/mm3: Immediately decrease dose to 135 mcg/1.73 m2 x BSA
- ANC 250-499 cells/mm3: Interrupt dosing until ANC ≥1000 cells/mm3, then resume dose with 90 mcg/1.73 m2 x BSA and monitor
- ANC <250 cells/mm3 (or febrile neutropenia): Discontinue treatment
Thrombocytopenia
- Platelets 25,000 to <50,000 cells/mm3: Decrease dose to 90 mcg/1.73 m2 x BSA SC once weekly
- Platelets ≤25,000 cells/mm3: Discontinue treatment
Increased ALT
-
Persistent or increasing elevations ALT ≥5 to <10x ULN
- CHC: Decrease dose to 135 mcg/1.73 m2 x BSA; monitor weekly, reduce dosage further if necessary until stable or ALT level decreases
- CHB: Decrease dose to 135 mcg/1.73 m2 x BSA; monitor weekly to ensure ALT is stable or decreasing
- Persistent ALT ≥10x ULN: Discontinue treatment
Depression
-
Mild
- No dosage change; evaluate once weekly by visit and/or phone
- Depression severity remains stable after 8 weeks: Continue weekly visit schedule
- Depression severity improves after 8 weeks: Resume normal visit schedule
- Depression severity improves after 8 weeks: Discontinue or reduce dosage to 135 or 90 mcg/1.73 m2 once weekly and consider psychiatric consult
-
Moderate
- Reduce dosage to 135 or 90 mcg/1.73 m2 once weekly; evaluate once weekly (office visit at least every other week)
- Depression severity remains stable after 8 weeks: Continue reduce dosing; consider psychiatric consultation
- If symptoms improve and are stable for 4 weeks, may resume normal visit schedule; continue reduced dosage or return to normal dosage
- Depression severity improves after 8 weeks: Discontinue permanently and obtain immediate psychiatric consult
-
Severe
- Discontinue permanently; obtain immediate psychiatric consult
- Depression management after 8 weeks: Psychiatric therapy necessary
Renal impairment
- Dosage recommendations for pediatric patients with renal impairment are not available
Hepatic impairment
- CHC patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons,
- During treatment, closely monitor patients’ clinical status and hepatic and discontinue treatment immediately if decompensation (Child-Pugh score ≥6) is observed
Dosing Considerations
Preform pregnancy screening for females of childbearing potential
CHC
- 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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- fezolinetant
peginterferon alfa 2a will increase the level or effect of fezolinetant by affecting hepatic enzyme CYP1A2 metabolism. Contraindicated. Fezolinetant AUC and peak plasma concentration are increased if coadministered with drugs that are weak, moderate, or strong CYP1A2 inhibitors
Serious - Use Alternative (7)
- alosetron
peginterferon alfa 2a will increase the level or effect of alosetron by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.
- deferiprone
deferiprone, peginterferon alfa 2a. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- duloxetine
peginterferon alfa 2a will increase the level or effect of duloxetine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.
- pexidartinib
peginterferon alfa 2a and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.
- pretomanid
peginterferon alfa 2a, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, peginterferon alfa 2a. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- tizanidine
peginterferon alfa 2a will increase the level or effect of tizanidine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.
Monitor Closely (18)
- acalabrutinib
acalabrutinib, peginterferon alfa 2a. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- clomipramine
peginterferon alfa 2a will increase the level or effect of clomipramine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- clozapine
peginterferon alfa 2a will increase the level or effect of clozapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- eltrombopag
peginterferon alfa 2a will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- hydroxyurea
peginterferon alfa 2a, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Cutaneous vasculitic toxicities (eg, vasculitic ulcerations and gangrene) were reported during therapy with hydroxyurea in patients with a history of, or currently receiving, interferon therapy.
- ifosfamide
ifosfamide, peginterferon alfa 2a. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Ifosfamide may enhance the toxicities of myelosuppressive agents. Monitor for increased risk of myelosuppression.
- imipramine
peginterferon alfa 2a will increase the level or effect of imipramine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- lamivudine
peginterferon alfa 2a, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of liver decompensation.
- lidocaine
peginterferon alfa 2a will increase the level or effect of lidocaine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- mexiletine
peginterferon alfa 2a will increase the level or effect of mexiletine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- olanzapine
peginterferon alfa 2a will increase the level or effect of olanzapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- pegloticase
pegloticase will decrease the level or effect of peginterferon alfa 2a by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknown
- pegvaliase
pegvaliase, peginterferon alfa 2a. Other (see comment). Use Caution/Monitor. Comment: The majority of patients treated with pegvaliase develop anti-polyethylene glycol (PEG) IgM and IgG antibodies. Risk of coadministration with different PEGylated products is unknown. There is a case report of anaphylaxis following a medroxyprogesterone acetate injectable suspension that contained PEG 3350. Carefully read all drug labels, including OTC drugs to check contents for PEG. Note: Unable to include an exhaustive product list for this interaction.
- rasagiline
peginterferon alfa 2a will increase the level or effect of rasagiline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Recommended dose of rasagiline is 0.5mg daily in combination with CYP1A2 inhibitors.
- ropinirole
peginterferon alfa 2a will increase the level or effect of ropinirole by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- theophylline
peginterferon alfa 2a will increase the level or effect of theophylline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- valoctocogene roxaparvovec
peginterferon alfa 2a and valoctocogene roxaparvovec both increase Other (see comment). Use Caution/Monitor. Medications that may cause hepatotoxicity when combined with valoctogene roxaparvovec may potentiate the risk of elevated liver enzymes. Closely monitor these medications and consider alternative medications in case of potential drug interactions.
- warfarin
peginterferon alfa 2a increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.
Minor (6)
- antipyrine
peginterferon alfa 2a will increase the level or effect of antipyrine by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
- asenapine
peginterferon alfa 2a will increase the level or effect of asenapine by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
- caffeine
peginterferon alfa 2a will increase the level or effect of caffeine by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
- frovatriptan
peginterferon alfa 2a will increase the level or effect of frovatriptan by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
- ondansetron
peginterferon alfa 2a will increase the level or effect of ondansetron by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
- riluzole
peginterferon alfa 2a will increase the level or effect of riluzole by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
Adverse Effects
>10%
CHC (adults)
- Fatigue/asthenia (56%)
- Headache (54%)
- Pyrexia (37%)
- Myalgia (37%)
- Rigors (35%)
- Arthralgia (28%)
- Nausea/vomiting (24%)
- Alopecia (23%)
- Injection site reaction (22%)
- Neutropenia (21%)
- Irritability/anxiety/nervousness (19%)
- Insomnia (19%)
- Depression (18%)
- Anorexia (17%)
- Diarrhea (16%)
- Dizziness (16%)
- Abdominal pain (15%)
- Pruritus (12%)
- Pain (11%)
CHC (pediatrics)
- Influenza like illness (91%)
- Headache (51%)
- Gastrointestinal disorder (49%)
- Injection site reaction (44%)
- Musculoskeletal pain (35%)
- Fatigue (25%)
- Irritability (24%)
- Rash (15%)
- Pruritus (11%)
- Decreased appetite (11%)
CHB
- Fatigue/asthenia (65%)
- Headache (43%)
- Pyrexia (41%)
- Myalgia (40%)
- Irritability/anxiety/nervousness (33%)
- Insomnia (30%)
- Alopecia (28%)
- Neutropenia (27%)
- Nausea/vomiting (25%)
- Rigors (25%)
- Anorexia (24%)
- Injection site reaction (23%)
- Arthralgia (22%)
- Depression (20%)
- Pruritus (19%)
- Dermatitis (16%)
- Lymphopenia (14%)
- Dizziness (14%)
- Dyspnea (13%)
- Overall resistance mechanism disorders (12%)
- Anemia (11%)
- Diarrhea (11%)
1-10%
CHC (adults)
- Overall resistance mechanism disorder (10%)
- Back pain (9%)
- Concentration impairment (8%)
- Dermatitis (8%)
- Dry mouth (6%)
- Sweating increased (6%)
- Memory impairment (6%)
- Thrombocytopenia (5%)
- Memory impairment (5%)
- Rash (5%)
- Decreased weight (4%)
- Dyspnea (4%)
- Cough (4%)
- Dry skin (4%)
- Vision blurred (4%)
- Hypothyroidism (3%)
- Lymphopenia (3%)
- Mood alteration (3%)
- Anemia (2%)
- Eczema (1%)
CHC (pediatrics)
- Insomnia (9%)
CHB
- Pain (10%)
- Concentration impairment (10%)
- Dry skin (10%)
- Cough (10%)
- Decreased weight (10%)
- Rash (8%)
- Abdominal pain (8%)
- Sweating increased (6%)
- Dyspepsia (6%)
- Vision blurred (5%)
- Eczema (5%)
- Mood alteration (5%)
- Back pain (5%)
- Thrombocytopenia (5%)
- Dyspnea exertional (4%)
- Dry mouth (4%)
- Hypothyroidism (4%)
<1%
CHC
- Dyspepsia (<1%)
- Dyspnea exertional (<1%)
Postmarketing Reports
Blood and lymphatic system disorders: Pure red cell aplasia
Ear and labyrinth disorders: Hearing impairment, hearing loss
Gastrointestinal disorders: tongue pigmentation
Immune system disorders: Liver graft rejection and renal graft rejection
Infections and infestations: Limb abscess
Metabolism and nutrition disorders: Dehydration
Skin and subcutaneous tissue disorders: Serious skin reactions
Neurological: Seizures
Warnings
Risk of Serious Disorders
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, or Stevens-Johnson syndrome)
Autoimmune hepatitis
Hepatic decompensation (Child-Pugh score >6 [class B and C]) in cirrhotic patients with or without HIV coinfection before treatment
Use in neonates and infants
Combination therapy with ribavirin is contraindicated in females who are pregnant and men whose female partners are pregnant
Cautions
Refer to prescribing information of the other HCV antiviral drugs, including ribavirin, for their warnings and precautions
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
Growth inhibition observed in children aged 5-17 years with CHC during combination therapy for up to 48 weeks with ribavirin, and also in children aged 3-17 years with CHB for up to 48 weeks during monotherapy
Laboratory tests
- Standard hematological and biochemical laboratory tests recommended for all patients
- Preform pregnancy screening for females of childbearing potential
- Administer electrocardiograms if pre-existing cardiac abnormalities exist before combination treatment with ribavirin
- After initiation, perform hematological tests at 2 and 4 weeks and biochemical tests at 4 weeks
- Perform additional testing periodically during therapy
Drug interaction overview H4
- Peginterferon alfa-2a is a weak CYP1A2 inhibitor
-
Theophylline
- Once-weekly peginterferon alfa-2a treatment for 4 weeks in healthy subjects was associated with a 25% increase in theophylline AUC
- If coadministered, monitor theophylline serum levels and consider appropriate dose adjustments
-
NRTIs
- Hepatic decompensation (including fatalities) observed when patients coinfected with CHC/HIV received NRTIs
- Closely monitor for treatment-associated toxicities when peginterferon alfa-2a/ribavirin combined with other HCV antiviral drugs and NRTIs
- Refer to prescribing information for other HCV antiviral drugs and the respective NRTIs for guidance regarding toxicity management
- Consider dose reduction or discontinuation of peginterferon alfa-2a, ribavirin, or both if worsening toxicities observed
-
Zidovudine
- Coadministration may increase risk for developing severe neutropenia and/or anemia
- Consider discontinuing zidovudine as medically appropriate
- Consider dose reduction or discontinuation of peginterferon alfa-2a, ribavirin, or both if worsening clinical toxicities observed, including hepatic decompensation (eg, Child-Pugh >6)
-
Methadone
- Coadministration increases methadone levels by 10-15% from baseline
- Clinical significance unknown; monitor for potential methadone toxicity
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women to inform of drug-associated risk
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
Animal data
- Therapy can cause fetal harm and should be assumed to have abortifacient potential
- Nonpegylated interferon alfa-2a treatment caused abortion when given to pregnant rhesus monkeys
Pregnancy exposure registry
- Monitors 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 discontinuation of ribavirin
- Encourage healthcare providers and patients to report such cases by calling 1-800-593-2214
Pregnancy testing
-
Treatment with ribavirin or with other HCV drug
- Females of reproductive potential: Perform before initiation of treatment, monthly during treatment, and for at least 6 months following treatment
- Males with female partners of reproductive potential: Perform before initiation of treatment, monthly during treatment, and for at least 6 months following treatment
Contraception
- Females of reproductive potential: Use effective contraception during therapy; when receiving combination therapy with ribavirin, use effective contraception during treatment and for at least 6 months after last dose
Infertility
- Based on its mechanism of action and studies in female monkeys, disruption of the menstrual cycle may occur
- No female fertility study has been performed
Lactation
There is no information regarding drug presence in human milk, effects on breastfed infants, or on milk production
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.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
Absorption
Peak plasma time: 72-96 hr
Mean trough concentration at week 48: 16 ng/mL
Steady-state reached by Week 5-8
Metabolism
Inhibits CYP1A2
Elimination
Clearance: 94 mL/hr
Half-life: 160 hr (CHC)
Administration
SC Administration
SC administration only
Inject in abdomen or thigh using a different site for each injection; avoid navel and waistline
Visually inspect prefilled syringe or vial for particulate matter or discoloration before use; solution should appear clear and colorless to slightly yellowish, without particles; discard if particulates or discoloration is present
Administer correct volume for single-dose vial and prefilled syringe for the different recommended dosages
Adults: May use single-dose prefilled syringes or vials
Children and adolescents: Use single-dose vials only
Single-dose vial
- 180 mcg: Use entire 1 mL
- 135 mcg: Use 0.75 mL
- 90 mcg: Use 0.5 mL
Prefilled syringe
- Syringes marked at 90 mcg, 135 mcg, and 180 mcg
- 180 mcg: Use entire 0.5 mL
- 135 mcg: Use 0.375 mL
- 90 mcg: Use 0.25 mL
Missed dose
- Missed dose <2 days of scheduled dose: Administer as soon possible; take your next dose on next scheduled day
- Missed dose ≥≥2 days: Advise patient to reach out to healthcare provider
Storage
Vials and prefilled syringes
- Refrigerate at 36-46ºF (2-8ºC)
- Do not leave out of the refrigerator for >24 hr
- Do not freeze or shake
- Protect from light
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Pegasys subcutaneous - | 180 mcg/mL vial |  | |
| Pegasys subcutaneous - | 180 mcg/0.5 mL solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
peginterferon alfa-2a subcutaneous
PEGINTERFERON ALFA-2A - INJECTION
(peg-IN-ter-FEER-on AL-fa too-ay)
COMMON BRAND NAME(S): Pegasys
WARNING: This medication may rarely cause or worsen some serious medical conditions, including mental/mood problems (such as depression), autoimmune conditions (such as lupus, rheumatoid arthritis), blood vessel problems (such as heart disease), or infections. Careful monitoring by your doctor may decrease your risk. Tell your doctor right away if you develop any serious symptoms or side effects (see Side Effects section). Some side effects may go away or lessen after stopping treatment with this medication.
USES: Peginterferon alfa-2a is used alone or in combination with other medications to treat chronic hepatitis B and chronic hepatitis C, viral infections of the liver. It works by decreasing the amount of hepatitis virus in the body and helps your body's natural defense (immune system) fight the infection. Chronic hepatitis infection can lead to serious liver damage (cirrhosis) and liver cancer.It is not known if peginterferon can cure hepatitis B or hepatitis C infections or can prevent you from passing the virus to others. Practice "safer sex" (such as the use of latex condoms) to lower the risk of passing the virus to others.
HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using peginterferon alfa-2a and each time you get a refill. If you have any questions, ask your doctor or pharmacist.If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. To increase comfort, remove this medication from the refrigerator and let it warm to room temperature as directed in the Instructions for Use. Do not warm up this medication in any other way such as heating in the microwave or placing in hot water. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Inject this medication under the skin in your abdomen or thigh as directed by your doctor, usually once every week. Do not inject near the belly button or at the waistline. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not shake this medication. Doing so may make it work less well.The dosage is based on your medical condition, lab tests, and response to treatment. In children, the dosage is also based on height and weight. Use this medication regularly to get the most benefit from it. To help you remember, use it at about the same time on the same day each week.Drink plenty of fluids while using this medication unless your doctor directs you otherwise.
SIDE EFFECTS: See also Warning section.Most people have flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches, but these usually decrease after the first few weeks of treatment. You can lessen these side effects by injecting this medicine at bedtime and using fever reducers/pain relievers such as acetaminophen before each dose. Ask your doctor or pharmacist for more information. Nausea, vomiting, diarrhea, dry mouth, loss of appetite, dizziness, trouble sleeping, or redness/swelling at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Tooth and gum problems may sometimes occur during treatment. Having a dry mouth can worsen this side effect. Prevent dry mouth by drinking plenty of water or using a saliva substitute. Brush your teeth well at least twice a day and have regular dental exams. If you vomit, rinse your mouth afterward to lessen the chance of tooth and gum problems.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, feeling too hot or cold (more than others around you), gradual change in weight (without a change in diet or exercise), unusually slow/fast/pounding heartbeat, increased thirst/urination, black/tarry stools, signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), numbness/tingling of arms/legs.Get medical help right away if you have any very serious side effects, including: chest pain, seizures, symptoms of a stroke (such as weakness on one side of the body, trouble speaking, confusion), vision changes (such as blurred vision, partial loss of vision).This drug may cause serious mental/mood changes that may get worse during treatment or after your last dose. Tell your doctor right away if you have symptoms such as confusion, depression, thoughts of suicide or hurting others, unusual irritability, or aggressive behavior.This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before using peginterferon alfa-2a, tell your doctor or pharmacist if you are allergic to it; or to polyethylene glycol (PEG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: other liver problems (such as autoimmune hepatitis), mental/mood disorders (such as depression, psychosis, suicidal thoughts), autoimmune disorders (such as rheumatoid arthritis, lupus, psoriasis), bleeding/blood problems, diabetes, heart problems, high blood pressure, intestinal problems (such as colitis), kidney disease, lung problems (such as chronic obstructive pulmonary disease-COPD), pancreatitis, high triglyceride levels, thyroid problems, drug or alcohol use/abuse.This medication can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using peginterferon alfa-2a before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Children may be more sensitive to the side effects of this drug, especially mental/mood changes (such as severe depression, thoughts/attempts of suicide). Peginterferon may also slow down a child's growth. Normal weight gain and growth usually return after treatment is over, but the final adult height may be lower than expected. See the doctor regularly so your child's height and weight can be checked.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using peginterferon alfa-2a. Peginterferon alfa-2a may harm an unborn baby. Ask about reliable forms of birth control while using this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.Peginterferon alfa-2a, when used in combination with ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may harm an unborn baby. Reliable forms of birth control must be used whenever at least one sexual partner is using these medicines together. Female patients should continue using birth control for 9 months after stopping treatment. Male patients should continue using birth control for 6 months after stopping treatment. If you or your partner become pregnant, or if you think you or your partner may be pregnant, tell your doctor right away.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: telbivudine.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood counts, thyroid tests, virus levels, kidney/liver function, triglyceride levels, eye exams) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments.Do not change brands of interferon without asking your doctor or pharmacist. Other interferons may not have the same effects on your disease.
MISSED DOSE: If you miss a dose, use it as soon as you remember if it is within 2 days after your scheduled dose. Use your next dose on the day you usually use it. If more than 2 days have passed since your missed dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Store in the refrigerator away from light and moisture. Do not freeze. Do not leave out of the refrigerator for more than 24 hours. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised March 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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