PDferon® contains Interferon alfa-2b which is a biological response modifier.
PDferon® is supplied as 3MIU and 5MIU ampules.
PDferon® is used for treatment of both chronic hepatitis B and C.
PDferon® contains Alfa interferon which is a water-soluble protein with a molecular weight of 19,271 daltons produced by recombinant DNA techniques. It is obtained from the bacterial fermentation of a strain of Escherichia coli bearing a genetically engineered plasmid containing an interferon alfa-2b gene from human leukocytes.
Clinical pharmacology:
PDferon® contains Interferons which are a family of naturally occurring small proteins and glycoproteins with molecular weights of approximately 15,000 to 27,600 daltons produced and secreted by cells in response to viral infections and to synthetic or biological inducers.
Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface and initiate a complex sequence of intracellular events which inhibit virus replication in virus-infected cells.
Pharmacokinetic:
PDferon® maximum serum concentration: 3-12 hours after administration
PDferon® elimination half-life: approximately 2-3 hours
Indications:
PDferon® is used for treatment of:
- Chronic hepatitis B
- Chronic hepatitis C
- AIDS-related Kaposi sarcoma
- Follucular lymphoma
- Hairy cell leukemia
- Malignant melanoma
- Condyloma acuminate (certain types of genital warts)
Side effects:
The most frequently reported side effects are “Flu-like” symptoms, particularly fever, headache, chills, myalgia and fatigue.
Other common reported side effects: chest pain, dizziness, alopecia, rash, xerostomia, leukopenia, anemia, thrombocytopenia, injection site reaction, weakness, skeletal pain, cough, GI disorders.
Contraindications:
- Hypersensitivity to interferon alpha or any component of the product
- Autoimmune hepatitis
- Decompensated liver disease
PDferon® and ribavirin combination therapy is additionally contraindicated in:
- Patients with hypersensitivity to ribavirin or any other component of the product
- Women who are pregnant
- Men whose female partners are pregnant
- Patients with hemoglobinopathies (e.g., thalassemia major, sickle cell anemia)
- Patients with creatinine clearance less than 50 mL/min.
Drug interactions:
- Potentially myelosuppressive agents such as Zidovudine
- Theophylline
Monitoring parameters:
Following laboratory tests are recommended for all patients on PDferon® therapy, prior to beginning treatment and then periodically thereafter:
- Standard hematologic tests: including hemoglobin, complete and differential white blood cell counts, and platelet count.
- Blood chemistries electrolytes L
- Liver function tests
- TSH