Class: Antineoplastic Agents
VA Class: AM800
Chemical Name: Interferon αA (human leukocyte protein moiety reduced)
Molecular Formula: C860H1353N227O255S9C860H1353N229O255S9C860H1353N227O255S9
CAS Number: 76543-88-9
Brands: Intron A, Infergen, Alferon N
Systemically administered interferon alfa may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders.b c Patients should be closely monitored with periodic clinical and laboratory evaluations.b c Discontinue therapy in patients with persistently severe or worsening signs or symptoms of these conditions.b c In many, but not all cases, these disorders resolve after the drug is discontinued.b c
REMS:
FDA approved a REMS for interferon alfa to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().
Introduction
Interferon alfa is a family of homologous, species-specific proteins and, occasionally, glycoproteins with antiviral, antineoplastic, and immunomodulating activities.8 47 52 70 255 259 261 450 456 648 714 717 740 906 1211 1240 1241 1339 1426 1464
Available as interferon alfa-2b (Intron A; single interferon subtype, recombinant preparation); interferon alfacon-1 (Infergen; genetically modified interferon protein); and interferon alfa-n3 (Alferon N; a mixture of naturally occurring human interferon alfa proteins).
Uses for Interferon Alfa
Chronic Hepatitis B Virus (HBV) Infection
Interferon alfa-2b: Treatment of chronic HBV infection in adults and children ≥1 year of age with compensated liver disease.a
May be effective in HBeAg-positive patients who have elevated ALT values and in HBeAg-negative patients.a
Treatment of chronic HBV infection is complex and rapidly evolving; a specialist should be consulted to obtain the most up-to-date information regarding patient selection criteria and preferred regimens.a
Chronic Hepatitis C Virus (HCV) Infection
Interferon alfa-2b, interferon alfacon-1: Treatment of chronic HCV infection in patients with compensated liver disease.b
Interferon alfa-2b is used alone or in conjunction with oral ribavirin.b
Interferon alfa-2b in conjunction with oral ribavirin is used for the treatment of HCV infection in treatment-naive children 3–17 years of age with compensated liver disease.b
Use of interferon alfa and oral ribavirin results in higher sustained response rates than use of interferon alfa alone.
Peginterferon alfa in conjunction with oral ribavirin is considered the treatment of choice for treatment-naive patients (have not previously received interferon alfa therapy) and for previously treated patients who fail to achieve a sustained virologic response following treatment with interferon alfa alone or in conjunction with oral ribavirin.
Interferon monotherapy generally is reserved for patients in whom ribavirin is contraindicated or not tolerated.
Data are limited in HIV-infected individuals.
Treatment of chronic HCV infection is complex and rapidly evolving; a specialist should be consulted to obtain the most up-to-date information regarding patient selection criteria and preferred regimens.
Acute HCV Infection
Interferon alfa-2b: Has been used for the treatment of acute HCV infection† in an attempt to prevent progression to chronic HCV infection. Sustained virologic response achieved in many patients given interferon alfa monotherapy.
Optimum regimen (including dosage and duration of therapy) not established. Therapy usually initiated 2–4 months after onset of acute hepatitis.
Postexposure Prophylaxis of HCV
Interferon alfa, with or without oral ribavirin, is not recommended for postexposure prophylaxis of HCV† following occupational exposure to HCV.
Chronic Hepatitis D Virus Infection
Interferon alfa: Has been used with some limited success in the management of chronic hepatitis D virus infection† in adults and children coinfected with HBV.
Human Papillomavirus (HPV) Infections: External Genital and Perianal Warts
Interferon alfa-2b: Treatment of external genital and perianal exophytic warts (condylomata acuminata) caused by HPV.
Interferon alfa-n3: Treatment of refractory or recurring external warts (condylomata acuminata) caused by HPV.d
Interferon alfa not considered a first-line agent for the treatment of external HPV warts because of the inconvenient route of administration, need for frequent clinician visits, and high frequency of systemic adverse effects.g CDC recommends that external HPV warts be treated with a self-administered topical therapy (podofilox, imiquimod), a topical therapy administered by a health-care provider (podophyllum resin, trichloroacetic acid [TCA], bichloroacetic acid [BCA]), or a surgical technique (cryotherapy, electrosurgery, surgical excision).g Intralesional interferon alfa or laser surgery are alternatives.g
Primary goal is destruction or clearance of visible warts.g No regimen has been shown to eradicate HPV infection; effect on transmission of HPV unknown.g
West Nile Virus Infection
Interferon alfa-2b: Under investigation for the treatment of symptomatic West Nile virus infection†.
Treatment of HIV Infection
Low-dose oral interferon alfa was investigated in patients with HIV infection†; low-dose oral interferon alfa is not effective for the treatment of HIV infection.
Hairy Cell Leukemia
Interferon alfa-2b: Treatment of hairy cell leukemia2 4 135 153 219 1620 1621 1623 1627 1629 1635 (leukemic reticuloendotheliosis).171 1636
Complete response achieved in 10% of patients and overall response achieved in approximately 80% of patients.2 4 119 121 122 123 124 125 126 127 128 129 130 131 132 134 135 136 138 141 142 143 170 175 178 181 182 184 185 188 193 194 195 199 200 202 219 220 248 249 250 252 253 260 1620 1624 1630 1635 1636 h
Used as an alternative agent for hairy cell leukemia; cladribine or pentostatin are first-line agents (achieve higher complete response rates than interferon alfa).1619 1620 1621 1622 1623 1624 1625 1627 1630 1632 1637 h
AIDS-related Kaposi’s Sarcoma
Interferon alfa-2b: Palliative treatment of AIDS-related (epidemic) Kaposi’s sarcoma in selected adults2 152 153 204 206 210 377 378 1647 1648 1649 (designated an orphan drug by FDA for this indication).1546
Should not be used in patients with rapidly progressive or life-threatening disease;2 153 1549 1692 response generally is slow91 156 1549 1692 and poor.2 145 153 154 155 156 196 203 204 378 381 383 384 385 386 387 388 389 1549
Chronic Myelogenous Leukemia
Interferon alfa-2b: Has been used for the treatment of adult-type (Philadelphia chromosome-positive) chronic myelogenous (myelocytic, myeloid) leukemia (CML)†259 260 261 299 300 301 302 303 305 306 307 308 309 310 311 312 1029 1420 1479 1533 1594 1638 1639 1640 1641 1642 1643 1644 1645 (designated an orphan drug by FDA for this indication).1546
Non-Hodgkin’s and Cutaneous T-cell Lymphomas
Interferon alfa-2b: Although labeled for use in conjunction with an anthracycline for the initial treatment of clinically aggressive follicular non-Hodgkin's lymphoma in adultsb , other agents are preferred.i
Efficacy in patients with low-grade, low-tumor-burden follicular non-Hodgkin's lymphoma not demonstrated.b
Interferon alfa: Has been used for the treatment of cutaneous T-cell lymphomas†.88 92 172 254 257 299 302 342 348 1109 1110 1111 1117 1118 1382 1385
Renal Cell Carcinoma
Interferon alfa: Has been used in the treatment of metastatic renal cell carcinoma† in selected patients.715 1625 1693 1694 1697
Bladder Cancer
Interferon alfa: Has been used for prophylaxis351 or treatment356 1065 1552 of superficial bladder cancer†.
May be useful as second-line agent.351
Ovarian Cancer
Interferon alfa: Has been used intraperitoneally for the treatment of minimal residual epithelial ovarian cancer† in a limited number of patients.358 359 360
Skin Cancers
Interferon alfa: Has been used intralesionally for the treatment of basal cell carcinoma†272 1466 1467 1468 1469 1470 and squamous cell carcinoma†.158
Melanoma
Interferon alfa-2b: Used as an adjunct to surgery1609 (within 56 days of surgery) in adults with melanoma who are disease free but at high risk for systemic recurrence.b e
Palliative treatment of metastatic melanoma† in selected patients, alone and in combination with other agents.1342 1343 1344 1345 1346 1347 1443 1444 1445 1446 1530 1531 1532 1646
Interferon Alfa Dosage and Administration
General
Available in several interferon alfa subtypes and dosage forms (powder for injection, solution for injection, multiple-dose pens);b c d preparation to be used and appropriate concentration depend on the intended use.b Ensure that the correct preparation is used.b c d
Administration
Interferon alfa-2b (Intron A): Administer by IM, sub-Q, or intralesional injection or IV infusion.b
Interferon alfacon-1 (Infergen): Administer by sub-Q injection.c
Interferon alfa-n3 (Alferon N) : Administer by intralesional injection.d
Interferon alfa-2b (Intron A) and alfacon-1 (Infergen) may be self-administered if the clinician determines that the patient and/or their caregiver are competent to prepare and safely administer the drug after appropriate training and with medical follow-up as necessary.2
When feasible, administer in the evening or at bedtime to prevent or ameliorate adverse effects. Consider concomitant use of acetaminophen to reduce adverse effects.
IV Administration
Interferon alfa-2b (Intron A)
Reconstitute vial of interferon alfa-2b powder for injection containing 10, 18, or 50 million units of the drug by adding 1 mL of sterile water for injection.b Swirl gently.b Withdraw appropriate dose and add to 100 mL of 0.9% sodium chloride injection.b Do not dilute to a final concentration <100,000 units/mL.b Prepare solutions immediately before use.b
Interferon alfa-2b powder for injection containing 10, 18, or 50 million units intended for use in the induction phase of treatment for malignant melanoma.b
Infuse over 20 minutes.b
Do not administer interferon alfa-2b solution for injection by IV injection.b
IM Injection
Interferon alfa-2b (Intron A)
Reconstitute vial of interferon alfa-2b powder for injection containing 10, 18, or 50 million units of drug by adding 1 mL of sterile water for injection.b Swirl gently.b
Interferon alfa-2b solution for injection is administered undiluted.b
Administer interferon alfa-2b into anterolateral thigh, upper arm, or outer area of the buttocks.b
Vial size to be used and appropriate concentration depend on the intended use.b
Vials of interferon alfa-2b powder for injection containing 10 million units and the solution for injection containing 10 million units/mL are intended for use in the treatment of HBV infection.b
Vials of interferon alfa-2b powder for injection containing 18 million units are intended for use in the treatment of HCV infection.b
Vials of interferon alfa-2b powder for injection containing 10 million units and the solution for injection containing 6 or 10 million units/mL are intended for use in the treatment of hairy cell leukemia.b
Vials of interferon alfa-2b powder for injection containing 50 million units are intended for use in the treatment of AIDS-related Kaposi’s sarcoma.b
Interferon alfa-2b solution for injection in multiple-dose pens should not be used for IM injection.
Do not use vials of interferon alfa-2b powder for injection containing 50 million units to prepare solutions for treatment of HBV or HCV infection; volume of drug required would be small and subject to possible inaccurate measurement.f
Sub-Q Injection
Interferon alfa-2b (Intron A)
Reconstitute vial of interferon alfa-2b powder for injection containing 10, 18, or 50 million units of drug by adding 1 mL of sterile water for injection.b Swirl gently.b
Interferon alfa-2b solution for injection is administered undiluted.b Available in vials. Also available in multiple-dose pens designed to deliver 3–12 doses of the drug. Use the needles provided with the pens; use a new needle for each dose.
Administer interferon alfa-2b into anterolateral thigh, upper arm, or abdomen (avoid the navel).b
Vial size to be used and appropriate concentration depend on the intended use.b
Vials of interferon alfa-2b powder for injection containing 10 million units, the solution for injection containing 10 million units/mL, and the multiple-dose pen containing 22.5, 37.5, or 75 million units are intended for use in the treatment of HBV infection.b
Vials of interferon alfa-2b powder for injection containing 18 million units and the multiple-dose pen containing 22.5 million units are intended for use in the treatment of HCV infection.b
Vials of interferon alfa-2b powder for injection containing 10 million units, the solution for injection containing 6 or 10 million units/mL, and the multiple-dose pens containing 22.5 or 37.5 million units are intended for use in the treatment of hairy cell leukemia.b
Vials of interferon alfa-2b powder for injection containing 50 million units are intended for use in the treatment of AIDS-related Kaposi’s sarcoma.b
Vials of interferon alfa-2b powder for injection containing 10 million units, the solution for injection containing 6 or 10 million units/mL, and the multiple-dose pens containing 37.5 or 75 million units are intended for use in the treatment of follicular lymphoma.b
Vials of interferon alfa-2b powder for injection containing 10 or 18 million units, the solution for injection containing 6 or 10 million units/mL, and the multiple-dose pens containing 22.5, 37.5, or 75 million units are intended for the maintenance phase in the treatment of malignant melanoma.b
Interferon alfacon-1 (Infergen)
Interferon alfacon-1 is administered undiluted.c
Vials are for single-use only; any unused portion should be discarded.c
Administer into anterolateral thigh, upper arm, or abdomen (avoid the navel and waist).c
Intralesional Administration
Interferon alfa-2b (Intron A)
Reconstitute vial of interferon alfa-2b powder for injection containing 10 million units of drug by adding 1 mL of sterile water for injection.b Swirl gently.b
Interferon alfa-2b solution for injection containing 10 million units/mL is administered undiluted.b
Use a tuberculin or similar syringe and a 25- to 30-gauge short (e.g., 0.25- to 0.5-inch) needle. Direct needle toward the center of the base of the wart, at an angle nearly parallel to the plane of the skin to deliver the drug to the core of the lesion.
Vials of the powder for injection containing 18 or 50 million units should not be used to prepare solutions for intralesional injection; solution would be hypertonic.f Multiple-dose pens should not be used for intralesional injection.
Interferon alfa-n3 (Alferon N)
Interferon alfa-n3 is administered undiluted.d
Use a 30-gauge needle.d Direct needle toward the base of the wart.d
Dosage
Because there are differences in the potencies and differences in recommended dosages and routes of administration among the various commercially available interferon alfa preparations, it is recommended that the interferon alfa preparation selected for the patient be used throughout the treatment regimen.
Pediatric Patients
Treatment of Chronic Hepatitis B Virus (HBV) Infection
Interferon Alfa-2b (Intron A)
Sub-Q
Children ≥1 year of age: 3 million units/m2 3 times weekly for the first week, then 6 million units/m2 3 times weekly (maximum of 10 million units 3 times weekly).b
Recommended duration of treatment is 16–24 weeks in HBeAg-positive patients and ≥12 months in HBeAg-negative patients.a
Dosage modification for toxicity: Reduce dosage by 50% in patients with leukocyte counts <1500/mm3, granulocyte counts <750/mm3, or platelet counts <50,000/mm3.b If leukocyte, granulocyte, and/or platelet counts return to normal or baseline values, resume at the initial dosage.b Permanently discontinue in those with leukocyte counts <1000/mm3, granulocyte counts <500/mm3, or platelet counts <25,000/mm3.b
Treatment of Chronic Hepatitis C Virus (HCV) Infection
Concomitant Therapy with Interferon Alfa-2b (Intron A) and Ribavirin
Sub-Q
Children ≥3 years of age: Interferon alfa-2b 3 million units 3 times weekly. Given in conjunction with oral ribavirin (200 mg twice daily for children weighing 25–36 kg, 200 mg every morning and 400 mg every evening for those weighing 37–49 kg, 400 mg twice daily for those weighing 50–61 kg). Children weighing >61 kg may receive the usual adult dosage of ribavirin.
Dosage modification for toxicity: If severe adverse effects develop, reduce dosage of interferon alfa-2b by 50% or temporarily interrupt therapy until adverse events resolve.b Discontinue if intolerance persists after dosage adjustment.b
Adults
Treatment of Chronic Hepatitis B Virus (HBV) Infection
Interferon Alfa-2b (Intron A)
IM or Sub-Q
30–35 million units per week given as 5 million units once daily or 10 million units 3 times weekly.
Recommended duration of treatment is 16–24 weeks in HBeAg-positive patients and ≥12 months in HBeAg-negative patients.a
Dosage modification for toxicity: Reduce dosage by 50% in patients with leukocyte counts <1500/mm3, granulocyte counts <750/mm3, or platelet counts <50,000/mm3.b If leukocyte, granulocyte, and/or platelet counts return to normal or baseline values, resume at the initial dosage.b Permanently discontinue in those with leukocyte counts <1000/mm3, granulocyte counts <500/mm3, or platelet counts <25,000/mm3.b
Treatment of Chronic Hepatitis C Virus (HCV) Infection
Concomitant Therapy with Interferon Alfa-2b (Intron A) and Ribavirin
IM or Sub-Q
Interferon alfa-2b 3 million units 3 times weekly.b Given in conjunction with oral ribavirin (400 mg every morning and 600 mg every evening for those weighing ≤75 kg or 600 mg every morning and every evening for those weighing >75 kg).
Manufacturer recommends continuing the regimen for 18–24 months, depending on baseline disease characteristics, virologic response, and/or tolerability.b
Dosage modification for toxicity: If severe adverse effects develop, reduce dosage of interferon alfa-2b by 50% or temporarily interrupt therapy until adverse events resolve;b the recommended dosage of ribavirin is 200 mg every morning and 400 mg every evening. Discontinue if intolerance persists after dosage adjustment.b
Monotherapy with Interferon Alfa-2b (Intron A)
IM or Sub-Q
3 million units 3 times weekly.b
Manufacturer recommends continuing the regimen for 18–24 months, depending on baseline disease characteristics, virologic response, and/or tolerability.b
Dosage modification for toxicity: If severe adverse effects develop, reduce dosage by 50% or temporarily interrupt therapy until adverse events resolve.b Discontinue if intolerance persists after dosage adjustment.b
Monotherapy with Interferon Alfacon-1 (Infergen)
Sub-Q
9 mcg 3 times weekly.c Allow at least 48 hours to elapse between doses.c Manufacturer recommends continuing regimen for 24 weeks.c
Individuals who tolerated previous interferon therapy and did not respond to the initial regimen or relapsed after discontinuance may receive 15 mcg 3 times weekly for up to 48 weeks.c
Dosage modification for toxicity: Temporarily interrupt therapy for severe adverse reaction; discontinue if adverse reaction does not subside to a tolerable level.c Consider reducing dosage to 7.5 mcg 3 times weekly.c May need to reduce dosage to <7.5 mcg 3 times weekly; long-term administration of this dosage may compromise efficacy.c
Human Papillomavirus (HPV) Infections: External Genital and Perianal Warts
Interferon Alfa-2b (Intron A)
Intralesional Injection
1 million units into each lesion (up to 5 lesions) 3 times weekly on alternate days for 3 weeks.
Another course may be administered after 12–16 weeks.b
Interferon Alfa-n3 (Alferon N)
Intralesional Injection
250,000 units (0.05 mL) into each wart twice weekly for up to 8 weeks. Maximum dose per treatment session is 2.5 million units.d
Large warts may be injected at multiple locations around their periphery, using a total dose of 250,000 units per lesion.
Dosage modification for toxicity: Regimen may need to be modified or discontinued in patients who experience moderate to severe adverse effects.
Delay administration of a second course or other therapy until 3 months after first course unless warts enlarge or new lesions develop; many patients do not exhibit complete resolution of lesions until 3 months following cessation of therapy.
The safety and efficacy of a second course not determined.
West Nile Virus Infection†
Interferon Alfa-2b (Intron A)
IV Infusion, then Sub-Q
Loading dose of 3 million units by IV infusion over 20 minutes, 3 million units sub-Q 12 hours later, then 3 million units sub-Q every 24 hours for a total of 14 days has been used.
Hairy Cell Leukemia
Interferon Alfa-2b (Intron A)
IM or Sub-Q
2 million units/m2 3 times weekly for up to 6 months.2 124 126 129 131 132 135 141 172 179 185 186 194 220 252 1152 1153 b
Discontinue if disease progresses or fails to respond after 6 months of therapy.b
Dosage modification for toxicity: If severe adverse effects develop, reduce dosage by 50% or temporarily interrupt therapy until adverse events resolve.b Resume with dosage of 1 million units/m2 3 times weekly.b Discontinue if severe adverse effects persist or recur after dosage adjustment.b
AIDS-Related Kaposi’s Sarcoma
Interferon Alfa-2b (Intron A)
IM or Sub-Q
FDA-labeled dosage is 30 million units/m2 3 times weekly.2 Doses of 4–18 million units/m2 have been used in patients receiving antiretroviral therapy.j
Dosage modification for toxicity: If severe adverse effects develop in patients receiving FDA-labeled dosage, reduce dosage by 50% or temporarily interrupt therapy until adverse events resolve.b May resume at reduced dosage if adverse effects subside.b Discontinue if severe adverse effects persist or recur after dosage adjustment.b
Follicular non-Hodgkin's Lymphoma
Interferon Alfa-2b (Intron A)
Sub-Q
5 million units 3 times weekly in conjunction with anthracycline-containing chemotherapy regimen; continue interferon alfa-2b after completion of the chemotherapy regimen.b Interferon alfa-2b is given for up to 18 months.b
Dosage modification of interferon alfa-2b for toxicity: Withhold for neutrophil counts <1000/mm3 or platelet counts <50,000/mm3.b Reduce by 50% for neutrophil counts of 1000–1500/mm3.b May reescalate to starting dosage after neutrophil counts increase to >1500/mm3.b Discontinue for AST >5 times the ULN or Scr >2 mg/dL.b
Doses of myelosuppressive drugs were reduced by 25% from full dose and cycle length increased by 33% (e.g., from 21 to 28 days) when interferon alfa was added to the regimen.b Delay cycle for neutrophil counts <1500/mm3 or platelet counts <75,000/mm3.b
Melanoma
Interferon Alfa-2b (Intron A)
IV
Induction therapy: 20 million units/m2 daily for 5 consecutive days per week for 4 weeks.1609 1652
Dosage modification for toxicity: Withhold for serious adverse effects including granulocyte count 250–500/mm3 or ALT and/or AST >5 to 10 times the ULN.b When adverse reaction subsides, reinitiate at 50% of the previous dosage.b Discontinue if toxicity does not subside while the drug is withheld; if serious adverse effects recur after dosage adjustment; and for granulocyte count <250/mm3 or ALT/AST >10 times the ULN.b
Sub-Q
Maintenance therapy: 10 million units/m2 3 times weekly for 48 weeks.1609 1652
Dosage modification for toxicity: Withhold for serious adverse effects including granulocyte count 250–500/mm3 or ALT and/or AST >5 to 10 times the ULN.b When adverse reaction subsides, reinitiate at 50% of the previous dosage.b Discontinue if toxicity does not subside while the drug is withheld; if serious adverse effects recur after dosage adjustment; and for granulocyte count <250/mm3 or ALT and/or AST >10 times the ULN.b
Prescribing Limits
Pediatric Patients
Chronic Hepatitis B Virus (HBV) Infection
Interferon Alfa-2b (Intron A)
Sub-Q
Maximum dosage is 10 million units 3 times weekly.b
Adults
Human Papillomavirus (HPV) Infections: External Genital and Perianal Warts
Interferon Alfa-2b (Intron A)
Intralesional Injection
Maximum number of lesions treated per course is 5.b
Interferon Alfa-n3 (Alferon N)
Intralesional Injection
The maximum recommended dose per treatment session is 2.5 million units.
Special Populations
No special population dosage recommendations at this time.e f
Cautions for Interferon Alfa
Contraindications
Use of interferon alfa-2b or interferon alfacon-1 in patients with autoimmune hepatitis.b c
Use of interferon alfa-2b or interferon alfacon-1 in patients with hepatic decompensation.b c
Hypersensitivity to interferon alfa or any ingredient in the formulations.b c d
Concomitant interferon alfa-2b and ribavirin therapy: Ribavirin is contraindicated in pregnant women; men whose female partners are pregnant; patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia); patients with Clcr <50 mL/minute.b
Warnings/Precautions
Warnings
Cardiovascular Effects
Hypotension,2 148 206 208 257 260 261 266 376 431 470 arrhythmias,2 4 260 300 374 376 461 465 469 470 475 MI,2 4 11 102 259 261 266 341 376 450 461 465 470 471 473 474 490 963 sudden death,259 261 376 471 472 474 963 and cardiomyopathy2 155 204 469 470 1340 1362 reported in patients receiving systemically administered interferon alfa.
Perform baseline ECG before initiation of systemic therapy in patients with preexisting cardiac abnormalities.b Use with caution and with close monitoring in those with a history of MI and arrhythmic disorders.b
Cerebrovascular Effects
Ischemic and hemorrhagic cerebrovascular events, including hemorrhagic stroke, reported in patients receiving systemically administered interferon alfa.b c TIAs have occurred in young patients.c
Neuropsychiatric Effects
Potentially fatal neuropsychiatric events (suicide, suicidal ideation, depression, aggressive behavior) reported in patients receiving systemically administered interferon alfa.b c
Monitor patients who develop psychiatric symptoms, including depression.b c Discontinue and provide appropriate psychiatric intervention if severe depression and/or other psychiatric condition occurs.
Use of systemically administered interferon alfa is not recommended in patients with a history of psychiatric disorders.b c
Encephalopathy reported in patients (usually geriatric patients) receiving high doses of interferon alfa-2b.b
Myelosuppression
Severe cytopenias may occur in patients receiving systemically administered interferon alfa; aplastic anemia reported rarely.b c
Perform CBCs prior to and routinely during therapy.b c Adjust dosage or discontinue drug if necessary.b c
Ocular Effects
Decrease or loss of vision, retinal artery or vein thrombosis, retinal hemorrhages and cotton-wool spots reported in patients receiving systemic interferon alfa; in addition, these agents may induce or aggravate optic neuritis and papilledema.b c
Perform baseline ophthalmologic examinations prior to initiation of therapy in all patients; evaluate patients with preexisting ophthalmologic disorders (e.g. diabetic or hypertensive retinopathy) periodically during therapy.b c Any patient who develops ocular symptoms should receive a prompt and complete eye examination.b c
Discontinue therapy in patients who develop new or worsening ophthalmologic disorders.b c
Endocrine and Metabolic Effects
Thyroid dysfunction (hypothyroidism2 376 507 508 510 1361 1533 1565 or hyperthyroidism)2 376 507 509 510 1361 1362 1533 1565 1609 has occurred in patients receiving systemically administered interferon alfa. Evaluate TSH concentrations prior to initiation of interferon alfa. Any patient who develops symptoms of thyroid dysfunction should have their thyroid function evaluated and treatment initiated if needed.b
Patients with hypothyroidism or hyperthyroidism whose disease cannot be effectively treated should not receive interferon alfa.
Diabetes mellitus reported in patients receiving systemically administered interferon alfa.b c Patients with diabetes mellitus whose disease cannot be effectively treated should not receive interferon alfa.b
Hepatic Effects
Hepatotoxicity, sometimes fatal, reported in patients receiving systemically administered interferon alfa. Closely monitor patients who develop liver function abnormalities; discontinue therapy if needed.b
Patients with chronic HBV or HCV infection and decompensated liver disease, autoimmune hepatitis, or a history of autoimmune disease, and transplant recipients receiving immunosuppressive therapy may be at risk of worsening liver disease, jaundice, hepatic encephalopathy, hepatic failure, and death during interferon alfa therapy. These individuals should not receive interferon alfa.b Discontinue the drug in patients who develop signs and symptoms of hepatic failure.b
Patients with chronic HBV infection and evidence of decreasing hepatic synthetic function (e.g., decreasing serum albumin concentrations, prolonged PT) may be at risk of clinical decompensation if an increase in ALT concentration occurs during interferon alfa therapy.b Closely monitor clinical symptoms and liver function if ALT increases occur.b
Pulmonary Effects
Potentially life-threatening pulmonary infiltrates, pneumonitis, and pneumonia have been reported in patients receiving systemic interferon alfa. Obtain a chest radiograph in any patient with fever, cough, dyspnea, or other respiratory symptoms. Closely monitor, or discontinue interferon alfa, in those with pulmonary infiltrates or impairment
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