Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Intron A Soln Generic Name & Formulations
Legal Class
Rx
General Description
Interferon alfa-2b, recombinant; 10 million IU, 18 million IU, 25 million IU; per vial; for inj; contains m-cresol.
Pharmacological Class
Alpha interferon.
See Also
How Supplied
Pwd (w. diluent): 10million, 18million, 50million IU/vial—1; Soln (multidose vials): 18million, 25million IU/vial—1
Manufacturer
Intron A Soln Indications
Indications
AIDS-related Kaposi's sarcoma. Not for patients with rapidly progressive visceral disease.
Intron A Soln Dosage and Administration
Adult
Use appropriate preparation and route: see full labeling. Use pwd form only. 30 million IU/m2 IM or SC three times weekly; continue until disease progression or maximal response achieved after 16 weeks; reduce dose by ½ or suspend therapy if severe adverse reactions occur; discontinue if persists.
Children
<18yrs: not established.
Intron A Soln Contraindications
Contraindications
Decompensated liver disease. Autoimmune hepatitis.
Intron A Soln Boxed Warnings
Boxed Warning
May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen.
Intron A Soln Warnings/Precautions
Warnings/Precautions
Risk of fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen. Cardiovascular disease (eg, MI, arrhythmias); monitor closely. Pulmonary disease (eg, COPD). Discontinue if severe psychiatric disorders (eg, suicidal behavior) or new/worsening ophthalmologic reactions develop. Severe myelosuppression; discontinue if neutrophil count <0.5 X109/L or platelets 25X109/L. Permanently discontinue if severe (Grade 3) hepatic injury or decompensation (Child-Pugh score >6 [Class B and C]) develop. Thyroid abnormalities; discontinue if uncontrolled by medication. Diabetes. Coagulation disorders. Maintain adequate hydration. Monitor CBCs, platelets, thyroid, visual and liver function before and during therapy; EKG in cardiovascular disease and cancer patients. Pwd: contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Pre-existing psoriasis or sarcoidosis. Renal impairment. Transplant recipients. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Intron A Soln Pharmacokinetics
See Literature
Intron A Soln Interactions
Interactions
Caution with myelosuppressive agents (eg, zidovudine), and drugs that can exacerbate depression. May potentiate theophylline. Increased risk of peripheral neuropathy with concomitant telbivudine. Dental/periodontal disorders, dry mouth with concomitant ribavirin.
Intron A Soln Adverse Reactions
Adverse Reactions
Flu-like symptoms (fever, headache, chills, myalgia, fatigue); abnormal LFTs, blood, cardiovascular, pulmonary, thyroid, and GU disorders, GI upset, abnormal vision, skin reactions, CNS/psychiatric reactions, colitis, hypertriglyceridemia, pancreatitis; rare: autoimmune disorders, hypersensitivity. See full labeling.
Intron A Soln Clinical Trials
See Literature
Intron A Soln Note
Not Applicable
Intron A Soln Patient Counseling
See Literature
Intron A Soln Generic Name & Formulations
Legal Class
Rx
General Description
Interferon alfa-2b, recombinant; 10 million IU, 18 million IU, 25 million IU; per vial; for inj; contains m-cresol.
Pharmacological Class
Alpha interferon.
See Also
How Supplied
Pwd (w. diluent): 10million, 18million, 50million IU/vial—1; Soln (multidose vials): 18million, 25million IU/vial—1
Manufacturer
Intron A Soln Indications
Indications
Hairy cell leukemia. Initial treatment of clinically aggressive follicular Non-Hodgkin's lymphoma in conjunction with anthracycline-containing combination chemotherapy.
Intron A Soln Dosage and Administration
Adult
Use appropriate preparation and route: see full labeling. Use SC route if platelets <50,000/mm3. Hairy cell leukemia: 2 million IU/m2 IM or SC 3 times a week for up to 6 months. Follicular lymphoma: 5 million IU SC 3 times a week for up to 18 months in conjunction with anthracycline-containing chemotherapy regimen and following completion of the chemotherapy regimen. Dose adjustments for toxicity: see full labeling.
Children
<18yrs: not established.
Intron A Soln Contraindications
Contraindications
Decompensated liver disease. Autoimmune hepatitis.
Intron A Soln Boxed Warnings
Boxed Warning
May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen.
Intron A Soln Warnings/Precautions
Warnings/Precautions
Risk of fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen. Cardiovascular disease (eg, MI, arrhythmias); monitor closely. Pulmonary disease (eg, COPD). Discontinue if severe psychiatric disorders (eg, suicidal behavior) or new/worsening ophthalmologic reactions develop. Severe myelosuppression; discontinue if neutrophil count <0.5 X109/L or platelets 25X109/L. Permanently discontinue if severe (Grade 3) hepatic injury or decompensation (Child-Pugh score >6 [Class B and C]) develop. Thyroid abnormalities; discontinue if uncontrolled by medication. Diabetes. Coagulation disorders. Maintain adequate hydration. Monitor CBCs, platelets, thyroid, visual and liver function before and during therapy; EKG in cardiovascular disease and cancer patients. Pwd: contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Pre-existing psoriasis or sarcoidosis. Renal impairment. Transplant recipients. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Intron A Soln Pharmacokinetics
See Literature
Intron A Soln Interactions
Interactions
Caution with myelosuppressive agents (eg, zidovudine), and drugs that can exacerbate depression. May potentiate theophylline. Increased risk of peripheral neuropathy with concomitant telbivudine. Dental/periodontal disorders, dry mouth with concomitant ribavirin.
Intron A Soln Adverse Reactions
Adverse Reactions
Flu-like symptoms (fever, headache, chills, myalgia, fatigue); abnormal LFTs, blood, cardiovascular, pulmonary, thyroid, and GU disorders, GI upset, abnormal vision, skin reactions, CNS/psychiatric reactions, colitis, hypertriglyceridemia, pancreatitis; rare: autoimmune disorders, hypersensitivity. See full labeling.
Intron A Soln Clinical Trials
See Literature
Intron A Soln Note
Not Applicable
Intron A Soln Patient Counseling
See Literature
Intron A Soln Generic Name & Formulations
Legal Class
Rx
General Description
Interferon alfa-2b, recombinant; 10 million IU, 18 million IU, 25 million IU; per vial; for inj; contains m-cresol.
Pharmacological Class
Alpha interferon.
See Also
How Supplied
Pwd (w. diluent): 10million, 18million, 50million IU/vial—1; Soln (multidose vials): 18million, 25million IU/vial—1
Manufacturer
Intron A Soln Indications
Indications
Malignant melanoma, as adjuvant to surgical treatment in patients who are free of disease but at high risk for systemic recurrence, within 56 days of surgery.
Intron A Soln Dosage and Administration
Adult
Use appropriate preparation and route: see full labeling. Induction: use pwd form only. 20million IU/m2 IV over 20mins, 5 consecutive days per week, for 4wks. Maintenance: 10 million IU/m2 SC 3 times per week for 48wks. Dose adjustments for toxicity: see full labeling.
Children
<18yrs: not established.
Intron A Soln Contraindications
Contraindications
Decompensated liver disease. Autoimmune hepatitis.
Intron A Soln Boxed Warnings
Boxed Warning
May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen.
Intron A Soln Warnings/Precautions
Warnings/Precautions
Risk of fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen. Cardiovascular disease (eg, MI, arrhythmias); monitor closely. Pulmonary disease (eg, COPD). Discontinue if severe psychiatric disorders (eg, suicidal behavior) or new/worsening ophthalmologic reactions develop. Severe myelosuppression; discontinue if neutrophil count <0.5 X109/L or platelets 25X109/L. Permanently discontinue if severe (Grade 3) hepatic injury or decompensation (Child-Pugh score >6 [Class B and C]) develop. Thyroid abnormalities; discontinue if uncontrolled by medication. Diabetes. Coagulation disorders. Maintain adequate hydration. Monitor CBCs, platelets, thyroid, visual and liver function before and during therapy; EKG in cardiovascular disease and cancer patients. Pwd: contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Pre-existing psoriasis or sarcoidosis. Renal impairment. Transplant recipients. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Intron A Soln Pharmacokinetics
See Literature
Intron A Soln Interactions
Interactions
Caution with myelosuppressive agents (eg, zidovudine), and drugs that can exacerbate depression. May potentiate theophylline. Increased risk of peripheral neuropathy with concomitant telbivudine. Dental/periodontal disorders, dry mouth with concomitant ribavirin.
Intron A Soln Adverse Reactions
Adverse Reactions
Flu-like symptoms (fever, headache, chills, myalgia, fatigue); abnormal LFTs, blood, cardiovascular, pulmonary, thyroid, and GU disorders, GI upset, abnormal vision, skin reactions, CNS/psychiatric reactions, colitis, hypertriglyceridemia, pancreatitis; rare: autoimmune disorders, hypersensitivity. See full labeling.
Intron A Soln Clinical Trials
See Literature
Intron A Soln Note
Not Applicable
Intron A Soln Patient Counseling
See Literature
Intron A Soln Generic Name & Formulations
Legal Class
Rx
General Description
Interferon alfa-2b, recombinant; 10 million IU, 18 million IU, 25 million IU; per vial; for inj; contains m-cresol.
Pharmacological Class
Alpha interferon.
See Also
How Supplied
Pwd (w. diluent): 10million, 18million, 50million IU/vial—1; Soln (multidose vials): 18million, 25million IU/vial—1
Manufacturer
Intron A Soln Indications
Indications
Chronic hepatitis C with compensated liver disease, with or without ribavirin. Chronic hepatitis B with compensated liver disease.
Intron A Soln Dosage and Administration
Adults and Children
Use appropriate preparation and route: see full labeling. Hepatitis C: use soln form only. ≥18yrs: 3 million IU IM or SC three times weekly for 16 weeks; if tolerated with normalization of ALT, continue to 18–24 months (72–96 weeks). With concomitant ribavirin (in previously untreated patients [≥3yrs] or those who relapsed after alpha interferon [≥18yrs]): see full labeling. Hepatitis B: <1yr: not established. 1–17yrs: 3million IU/m2 SC three times weekly for 1 week, then increase to 6million IU/m2 (max 10 million IU) three times weekly for a total of 16–24 weeks. ≥18yrs: 5 million IU daily or 10million IU IM or SC three times weekly for 16 weeks. Dose adjustments for toxicity: see full labeling. HCV/HBV co-infection: not studied.
Intron A Soln Contraindications
Contraindications
Decompensated liver disease. Autoimmune hepatitis. When co-administered with ribavirin, its contraindication also apply to the combination regimen (eg, Pregnancy Cat.X).
Intron A Soln Boxed Warnings
Boxed Warning
May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen.
Intron A Soln Warnings/Precautions
Warnings/Precautions
Risk of fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen. Cardiovascular disease (eg, MI, arrhythmias); monitor closely. Pulmonary disease (eg, COPD). Discontinue if severe psychiatric disorders (eg, suicidal behavior) or new/worsening ophthalmologic reactions develop. Severe myelosuppression; discontinue if neutrophil count <0.5 X109/L or platelets 25X109/L. Permanently discontinue if severe (Grade 3) hepatic injury or decompensation (Child-Pugh score >6 [Class B and C]) develop. Thyroid abnormalities; discontinue if uncontrolled by medication. Diabetes. Coagulation disorders. Maintain adequate hydration. Monitor CBCs, platelets, thyroid, visual and liver function before and during therapy; EKG in cardiovascular disease and cancer patients. Pwd: contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Pre-existing psoriasis or sarcoidosis. Renal impairment. Transplant recipients. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Intron A Soln Pharmacokinetics
See Literature
Intron A Soln Interactions
Interactions
Caution with myelosuppressive agents (eg, zidovudine), and drugs that can exacerbate depression. May potentiate theophylline. Increased risk of peripheral neuropathy with concomitant telbivudine. Dental/periodontal disorders, dry mouth with concomitant ribavirin.
Intron A Soln Adverse Reactions
Adverse Reactions
Flu-like symptoms (fever, headache, chills, myalgia, fatigue); abnormal LFTs, blood, cardiovascular, pulmonary, thyroid, and GU disorders, GI upset, abnormal vision, skin reactions, CNS/psychiatric reactions, colitis, hypertriglyceridemia, pancreatitis; rare: autoimmune disorders, hypersensitivity. See full labeling.
Intron A Soln Clinical Trials
See Literature
Intron A Soln Note
Not Applicable
Intron A Soln Patient Counseling
See Literature
Intron A Soln Generic Name & Formulations
Legal Class
Rx
General Description
Interferon alfa-2b, recombinant; 10 million IU, 18 million IU, 25 million IU; per vial; for inj; contains m-cresol.
Pharmacological Class
Alpha interferon.
See Also
How Supplied
Pwd (w. diluent): 10million, 18million, 50million IU/vial—1; Soln (multidose vials): 18million, 25million IU/vial—1
Manufacturer
Intron A Soln Indications
Indications
Genital warts.
Intron A Soln Dosage and Administration
Adult
Use appropriate preparation and route: see full labeling. Inject intralesionally 1 million IU/lesion 3 times weekly on alternate days for 3 weeks; max 5 lesions per treatment. May repeat treatment as above after 12–16 weeks.
Children
<18yrs: not established.
Intron A Soln Contraindications
Contraindications
Decompensated liver disease. Autoimmune hepatitis.
Intron A Soln Boxed Warnings
Boxed Warning
May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen.
Intron A Soln Warnings/Precautions
Warnings/Precautions
Risk of fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen. Cardiovascular disease (eg, MI, arrhythmias); monitor closely. Pulmonary disease (eg, COPD). Discontinue if severe psychiatric disorders (eg, suicidal behavior) or new/worsening ophthalmologic reactions develop. Severe myelosuppression; discontinue if neutrophil count <0.5 X109/L or platelets 25X109/L. Permanently discontinue if severe (Grade 3) hepatic injury or decompensation (Child-Pugh score >6 [Class B and C]) develop. Thyroid abnormalities; discontinue if uncontrolled by medication. Diabetes. Coagulation disorders. Maintain adequate hydration. Monitor CBCs, platelets, thyroid, visual and liver function before and during therapy; EKG in cardiovascular disease and cancer patients. Pwd: contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Pre-existing psoriasis or sarcoidosis. Renal impairment. Transplant recipients. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Intron A Soln Pharmacokinetics
See Literature
Intron A Soln Interactions
Interactions
Caution with myelosuppressive agents (eg, zidovudine), and drugs that can exacerbate depression. May potentiate theophylline. Increased risk of peripheral neuropathy with concomitant telbivudine. Dental/periodontal disorders, dry mouth with concomitant ribavirin.
Intron A Soln Adverse Reactions
Adverse Reactions
Flu-like symptoms (fever, headache, chills, myalgia, fatigue); abnormal LFTs, blood, cardiovascular, pulmonary, thyroid, and GU disorders, GI upset, abnormal vision, skin reactions, CNS/psychiatric reactions, colitis, hypertriglyceridemia, pancreatitis; rare: autoimmune disorders, hypersensitivity. See full labeling.
Intron A Soln Clinical Trials
See Literature
Intron A Soln Note
Not Applicable
Intron A Soln Patient Counseling
See Literature
