Alferon N (interferon alfa-n3)

Because there are differences in the potencies and differences in recommended dosages and routes of administration among the various commercially available interferon alfa preparations, the interferon alfa preparation selected for the patient should be used throughout the treatment regimen. Patients should be cautioned not to change brands or alter dosage of interferon alfa without consulting their clinician.

If severe adverse reactions or laboratory abnormalities develop during interferon alfa-2b therapy in patients with chronic HBV infection, the manufacturer states that dosage should be reduced by 50% or the drug discontinued, if appropriate, until the adverse reactions abate; if intolerance persists after dosage reduction, the drug should be discontinued.

Dosage of interferon alfa-2b should be reduced by 50% in patients with leukocyte counts less than 1500/mm3, granulocyte counts less than 750/mm3, or platelet counts less than 50,000/mm3. The drug should be permanently discontinued in patients with leukocyte counts less than 1000/mm3, granulocyte counts less than 500/mm3, or platelet counts less than 25,000/mm3. Therapy has been resumed at up to 100% of the initial dosage when leukocyte, granulocyte, and/or platelet counts returned to normal or baseline values.

If serious adverse effects or laboratory abnormalities occur in patients with chronic HCV infection receiving interferon alfa-2b and concomitant oral ribavirin, dosage of one or both drugs should be modified or therapy discontinued until the adverse effects resolve or decrease in severity. Dosage of interferon alfa-2b should be decreased by 50%. If the reduced dosage is not tolerated, the drug should be discontinued.

In patients receiving interferon alfa-2b monotherapy who do not tolerate the usual dosage of the drug, dosage should be reduced by 50% or the drug temporarily withheld until adverse effects resolve. If the reduced dosage is not tolerated, the drug should be discontinued.

In patients receiving concomitant oral ribavirin, dosage of interferon alfa-2b should be reduced by 50% if leukocyte count is 1000 to less than 1500/mm3, neutrophil count is 500 to less than 750/mm3, or platelet count is 25,000 to less than 50,000/mm3 (50,000 to less than 70,000/mm3 in children). Both interferon alfa-2b and ribavirin should be permanently discontinued if leukocyte count is less than 1000/mm3, neutrophil count is less than 500/mm3, platelet count is less than 25,000/mm3 (less than 50,000/mm3 in children), hemoglobin concentration is less than 8.5 g/dL, or serum creatinine is greater than 2 mg/dL (in children).

In adults who have a history of stable cardiac disease, dosage of interferon alfa-2b should be decreased by 50% and ribavirin dosage decreased by 200 mg daily if hemoglobin concentrations decrease by 2 g/dL or more during any 4-week period. Both drugs should be permanently discontinued if hemoglobin concentrations are less than 8.5 g/dL (or less than 12 g/dL after 4 weeks of reduced dosage).

Therapy with interferon alfa-2b and oral ribavirin should be discontinued in patients with severe depression and/or suicidal ideation, and appropriate psychiatric care should be initiated.

No dosing information is available for this tab.

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No dosing information is available for this tab.

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There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Interferon alfa-2b (Intron(R) A) is contraindicated in patients with known hypersensitivity (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa or any ingredient in the formulation.

Interferon alfa-n3 (Alferon(R) N) is contraindicated in patients with known hypersensitivity to human interferon alfa proteins or any component in the formulation. Interferon alfa-n3 also is contraindicated in patients with a history of anaphylactic reactions to murine (mouse) immunoglobulin G (IgG), egg protein, or neomycin (see Sensitivity Reactions under Cautions: Warnings/Precautions); a history of allergy to chickens or feathers is not a contraindication.

Interferon alfa-2b is contraindicated in patients with autoimmune hepatitis or hepatic decompensation (Child-Pugh score exceeding 6, class B and C). (See Hepatic Effects under Warnings/Precautions: Other Warnings/Precautions, in Cautions.)

Concomitant use of oral ribavirin is contraindicated in women who are or may become pregnant, men whose female partners are pregnant, patients with known hypersensitivity to ribavirin or any ingredient in the formulation, patients with hemoglobinopathies (e.g., thalassemia major, sickle cell anemia), and patients with creatinine clearances less than 50 mL/minute. (See Concomitant Oral Ribavirin under Warnings/Precautions: Warnings, in Cautions.)

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects observed in 20% or more of patients with chronic HBV infection receiving interferon alfa in clinical studies include alopecia, anorexia, fatigue, fever, headache, myalgia, nausea, and rigors.

Adverse effects observed in 20% or more of patients with chronic HCV infection receiving interferon alfa alone or in conjunction with ribavirin in clinical studies include abdominal pain, alopecia, anemia, anorexia, arthralgia, asthenia, depression, diarrhea, dizziness, dyspnea, fatigue, fever, headache, influenza-like symptoms, musculoskeletal pain, myalgia, nausea, neutropenia, pharyngitis, rigors, somnolence, vomiting, and weight loss.

Adverse effects observed in 5% or more of patients receiving intralesional interferon alfa for treatment of external and perianal genital warts include arthralgia, back pain, chills, dizziness, fatigue, fever, headache, influenza-like syndrome, malaise, myalgia, and nausea.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy of nonconjugated interferon alfa-2b (Intron(R) A) have not been established in pediatric patients for any indications other than treatment of chronic HBV and chronic HCV infection. For treatment of chronic HBV infection, safety and efficacy of interferon alfa-2b have not been established in infants younger than 1 year of age. For treatment of chronic HCV infection, safety and efficacy of interferon alfa-2b have not been established in treatment-naive pediatric patients younger than 3 years of age or in previously treated patients younger than 18 years of age. Safety and efficacy for treatment of chronic HCV infection in treatment-native children 3-16 years of age was established based on clinical studies in this age group.

Safety and efficacy of intralesional injection of interferon alfa-2b (Intron(R) A) and alfa-n3 (Alferon(R) N) have not been established in children younger than 18 years of age. Studies have not been performed to date to evaluate use of interferon alfa-n3 in adolescents.

Safety data from clinical studies in children 3-16 years of age indicate that injection site reactions (from subcutaneous injections of interferon alfa-2b), fever, anorexia, vomiting, and emotional lability occurred more frequently in pediatric patients receiving oral ribavirin concomitantly with nonconjugated interferon alfa-2b compared with adults receiving such therapy. Conversely, pediatric patients experienced less fatigue, dyspepsia, arthralgia, insomnia, irritability, impaired concentration, dyspnea, and pruritus compared with adults. Suicidal ideation or attempts occurred more frequently among pediatric patients (principally adolescents) compared to adults during treatment and off-therapy. Like adults, other adverse psychiatric effects (depression, emotional lability, somnolence), anemia, and neutropenia were also reported in pediatric patients.

Delay in weight and height increases compared with baseline have been reported in pediatric patients receiving interferon alfa. Growth retardation was reported in some children receiving nonconjugated interferon alfa for treatment of chronic HBV infection, but growth velocity generally resumed to pretreatment rates following discontinuance of the drug. Some clinicians state that interferon alfa therapy should not be used for treatment of HBV infection in children 2 years of age or younger because of concerns that growth retardation during the first years of life may be detrimental to the overall development of the child. Although a decrease in the rate of linear growth (mean percentile assignment decrease of 7%) and a decrease in the rate of weight gain (mean percentile assignment decrease of 9%) were reported in pediatric patients with HCV infection who received a 48-week regimen of interferon alfa-2b and oral ribavirin, general reversal of these trends was noted during the 24-week posttreatment period.

Interferon alfa (alfa-2b, alfa-n3) monotherapy: Category C. (See Users Guide.)

Concomitant interferon alfa (alfa-2b) and oral ribavirin: Category X. (See Users Guide.) (See Concomitant Oral Ribavirin, under Warnings/Precautions: Warnings, in Cautions.)

Interferon alfa should be used during pregnancy only when potential benefits justify possible risks to the fetus. Women of childbearing potential should use an effective method of contraception during therapy with the drug.

Although there are no adequate and controlled studies to date in humans, interferon alfa-2b has exhibited abortifacient activity in rhesus monkeys when given in dosages of 15 and 30 million units/kg daily (estimated human equivalent of 5 and 10 million units/kg, respectively, based on body surface area adjusted for a 60-kg adult).

It is not known whether interferon alfa is distributed into milk. A decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman and potential risks to the infant.

It is not known whether interferon alfa is distributed into milk, but murine interferons distribute into milk in mice. Because of the potential for serious adverse effects to interferon alfa in nursing infants if the drug were distributed into milk, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Clinical studies of interferon alfa-2b (Intron(R) A) alone or in conjunction with oral ribavirin did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. In clinical studies of interferon alfa-2b in conjunction with oral ribavirin, anemia was reported more frequently in geriatric patients than in younger patients. Other clinical and postmarketing experience has revealed a greater incidence of adverse cardiovascular events and confusion in geriatric patients compared with younger patients.

Because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly, interferon alfa should be used with caution in this age group.