after reconstitution and withdrawal of a single dose.
Dose Adjustment
NOTE: Regular laboratory testing should be performed to monitor laboratory abnormalities for the purpose of dose modifications (see PRECAUTIONS, Laboratory Tests section).
INTRON A should be withheld for severe adverse reactions, including granulocyte counts >250/mm3 but <500/mm3 or SGPT/SGOT >5–10× upper limit of normal, until adverse reactions abate. INTRON A treatment should be restarted at 50% of the previous dose.
INTRON A should be permanently discontinued for:
Toxicity that does not abate after withholding INTRON A
Severe adverse reactions which recur in patients receiving reduced doses of INTRON A
Granulocyte count <250/mm3 or SGPT/SGOT of >10× upper limit of normal
Follicular Lymphoma
(see DOSAGE and ADMINISTRATION, General section)
Dose
The recommended dose of INTRON A for the treatment of follicular lymphoma is 5 million IU subcutaneously three times per week for up to 18 months in conjunction with anthracycline-containing chemotherapy regimen and following completion of the chemotherapy regimen.
Dosage Forms for this Indication Dosage Form Concentration Route Fixed Doses
Powder 10 MIU (single-dose) 10 MIU/mL SC N/A
Solution 18 MIU multidose 6 MIU/mL SC N/A
Solution 25 MIU multidose 10 MIU/mL SC N/A
Pen 5 MIU/dose multidose 25 MIU/mL SC 2.5, 5.0
Pen 10 MIU/dose multidose 50 MIU/mL SC 5.0
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.
Dose Adjustment
Doses of myelosuppressive drugs were reduced by 25% from a full-dose CHOP regimen, and cycle length increased by 33% (eg, from 21 to 28 days) when alpha interferon was added to the regimen.
Delay chemotherapy cycle if neutrophil count was <1500/mm3 or platelet count was <75,000/mm3.
INTRON A should be permanently discontinued if SGOT exceeds >5× the upper limit of normal or serum creatinine >2.0 mg/dL (see WARNINGS).
Administration of INTRON A therapy should be withheld for a neutrophil count <1000/mm3, or a platelet count <50,000/mm3.
INTRON A dose should be reduced by 50% (2.5 MIU TIW) for a neutrophil count >1000/mm3, but <1500/mm3. The INTRON A dose may be re-escalated to the starting dose (5 million IU TIW) after resolution of hematologic toxicity (ANC >1500/mm3).
Condylomata Acuminata
(see DOSAGE and ADMINISTRATION, General section)
Dose
The recommended dose is 1.0 million IU per lesion in a maximum of 5 lesions in a single course. The lesions should be injected three times weekly on alternate days for 3 weeks. An additional course may be administered at 12 to16 weeks.
Dosage Forms for This Indication Dosage Form Concentration Route
Powder 10 MIU (single-dose) 10 MIU/mL IL
Solution 25 MIU multidose 10 MIU/mL IL
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.
NOTE: Do not use the following formulations for this indication:
the 18 million or 50 million IU Powder for Injection
the 18 million IU multidose INTRON A Solution for Injection
the Multidose Pens
Dose Adjustment
None
Technique for Injection
The injection should be administered intralesionally using a Tuberculin or similar syringe and a 2
