INTRON A is indicated for the initial treatment of clinically aggressive Follicular Non-Hodgkin’s Lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 years of age or older.

Subtype:

Follicular Lymphoma (FL)

License:

FDA

Class:

Interferons

Newly Diagnosed

PIhttp://www.merck.com/product/usa/pi_circulars/i/intron_a/intron_a_5ml_pi.pdf 

1. Approved Labelling

INTRON A is indicated for the initial treatment of clinically aggressive Follicular Non-Hodgkin’s Lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 years of age or older.

Efficacy of INTRON A therapy in patients with low-grade, low- tumor burden Follicular Non-Hodgkin’s Lymphoma has not been demonstrated.

2. Treatment Regimen

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.

Dose Adjustment:

Doses of myelosuppressive drugs were reduced by 25% from a full-dose CHOP regimen, and cycle length increased by 33% (e.g., from 21 to 28 days) when alpha interferon was added to the regimen.

Delay chemotherapy cycle if neutrophil count was less than 1500/mm3 or platelet count was less than 75,000/mm3.

INTRON A should be permanently discontinued if SGOT exceeds greater than 5x the upper limit of normal or serum creatinine greater than 2.0 mg/dL.

Administration of INTRON A therapy should be withheld for a neutrophil count less than 1000/mm3, or a platelet count less than 50,000/mm3.

INTRON A dose should be reduced by 50% (2.5 MIU TIW) for a neutrophil count greater than 1000/mm3, but less than 1500/mm3. The INTRON A dose may be re- escalated to the starting dose (5 million IU TIW) after resolution of hematologic toxicity (ANC greater than 1500/mm3).

3. AE/Warnings

Please see PI

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