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INTRON A SOLN
Kaposi's sarcoma
Leukemias, lymphomas, and other hematologic cancers
Melanoma and other skin cancers
Viral infections
Warts
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Drug Name:

INTRON A SOLN Rx

Generic Name and Formulations:
Interferon alfa-2b, recombinant; 10 million IU, 18 million IU, 25 million IU; per vial; for inj; contains m-cresol.

Company:
Merck & Co., Inc.

Therapeutic Use:

Indications for INTRON A SOLN:

AIDS-related Kaposi's sarcoma. Not for patients with rapidly progressive visceral disease.

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.

Contraindications:

Decompensated liver disease. Autoimmune hepatitis.

Warnings/Precautions:

May cause or exacerbate 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.

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.

See Also:

INTRON A

Pharmacological Class:

Alpha interferon.

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.

How Supplied:

Pwd (w. diluent): 10million, 18million, 50million IU/vial—1; Soln (multidose vials): 18million, 25million IU/vial—1

Indications for INTRON A SOLN:

Hairy cell leukemia. Initial treatment of clinically aggressive follicular Non-Hodgkin's lymphoma in conjunction with anthracycline-containing combination chemotherapy.

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.

Contraindications:

Decompensated liver disease. Autoimmune hepatitis.

Warnings/Precautions:

May cause or exacerbate 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.

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.

See Also:

INTRON A

Pharmacological Class:

Alpha interferon.

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.

How Supplied:

Pwd (w. diluent): 10million, 18million, 50million IU/vial—1; Soln (multidose vials): 18million, 25million IU/vial—1

Indications for INTRON A SOLN:

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.

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.

Contraindications:

Decompensated liver disease. Autoimmune hepatitis.

Warnings/Precautions:

May cause or exacerbate 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.

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.

See Also:

INTRON A

Pharmacological Class:

Alpha interferon.

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.

How Supplied:

Pwd (w. diluent): 10million, 18million, 50million IU/vial—1; Soln (multidose vials): 18million, 25million IU/vial—1

Indications for INTRON A SOLN:

Chronic hepatitis C with compensated liver disease, with or without ribavirin. Chronic hepatitis B with compensated liver disease.

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.

Contraindications:

Decompensated liver disease. Autoimmune hepatitis. When co-administered with ribavirin, its contraindication also apply to the combination regimen (eg, Pregnancy Cat.X).

Warnings/Precautions:

May cause or exacerbate 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.

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.

See Also:

INTRON A

Pharmacological Class:

Alpha interferon.

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.

How Supplied:

Pwd (w. diluent): 10million, 18million, 50million IU/vial—1; Soln (multidose vials): 18million, 25million IU/vial—1

Indications for INTRON A SOLN:

Genital warts.

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.

Contraindications:

Decompensated liver disease. Autoimmune hepatitis.

Warnings/Precautions:

May cause or exacerbate 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.

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.

See Also:

INTRON A

Pharmacological Class:

Alpha interferon.

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.

How Supplied:

Pwd (w. diluent): 10million, 18million, 50million IU/vial—1; Soln (multidose vials): 18million, 25million IU/vial—1

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