Interferon Gamma-1b｜Lymphoma｜HongKong DengYue Medicine

Interferon Gamma-1b Application Scope

Interferon gamma-1b (IFNγ-1b) is a recombinant cytokine with multiple therapeutic applications:

• Chronic Granulomatous Disease (CGD): Reduces frequency and severity of serious infections in patients with this rare genetic disorder affecting phagocyte function
• Severe Malignant Osteopetrosis: Delays time to disease progression in patients with this severe bone disorder
• Investigational Uses:
  • Prevention of secondary infections in ICU-acquired sustained immunosuppression (Phase 3 trial)
  • Treatment of relapsed acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) after stem cell transplantation (Phase 2 trial)
  • Adjunctive therapy for chronic pulmonary aspergillosis (Phase 2 trial)
  • Potential treatment for cutaneous T-cell lymphoma (off-label use)

Interferon Gamma-1b Characteristics

Ingredients

• Active ingredient: Recombinant human interferon gamma-1b produced in E. coli

Properties

• Molecular formula: C761H1206N214O225S
• Molecular weight: 17,145.6 g/mol
• Water-soluble dimeric cytokine (Type II interferon)

Specification

• Concentration: 2,000,000 international units (100 mcg)/0.5 mL

Packaging Specification

• Single-dose vials containing 0.5 mL solution

Storage

• Store at 2-8°C (36-46°F); do not freeze
• May be kept at room temperature for ≤12 hours before use

Expiry Date

• Typically 24 months when stored properly

Executive Standard

• Manufactured under current Good Manufacturing Practices (cGMP)

Approval Number

• Varies by country/region; original brand Actimmune approved in US (1990)

Date of Revision

• Varies by manufacturer; check specific product labeling

Manufacturer

• Originally developed by Genentech; currently marketed by Horizon Therapeutics (Actimmune)

Guidelines for Use Interferon Gamma-1b

Dosage and Administration

• Chronic Granulomatous Disease:
  • BSA >0.5 m²: 50 mcg/m² (1 million units/m²) subcutaneously 3 times weekly
  • BSA ≤0.5 m²: 1.5 mcg/kg subcutaneously 3 times weekly
• Malignant Osteopetrosis:
  • Same dosing as for CGD
• Administration:
  • Subcutaneous injection in deltoid or anterior thigh
  • Rotate injection sites
  • Do not mix with other drugs in same syringe

Adverse Reactions

Common (>10%):

• Fever (52%)
• Headache (33%)
• Chills (14%)
• Fatigue (14%)
• Rash (17%)
• Diarrhea (14%)
• Vomiting (13%)
• Injection site erythema/tenderness (14%)

Serious (require immediate medical attention):

• CNS effects (confusion, hallucinations, seizures)
• Bone marrow suppression (neutropenia, thrombocytopenia)
• Hypersensitivity reactions
• Renal insufficiency
• Hepatotoxicity

Contraindications

• Hypersensitivity to interferon gamma-1b or E. coli-derived products
• History of severe cardiac disease

Precautions

• Cardiovascular: Use caution in patients with preexisting cardiac conditions
• CNS disorders: May exacerbate preexisting conditions; use caution in seizure disorders
• Hepatic/renal impairment: Requires dose adjustment in severe cases
• Hematologic: Monitor blood counts regularly
• Pregnancy/Lactation: Use only if potential benefit justifies risk

Interferon Gamma-1b Interactions

Drug Interactions

• Zidovudine: May enhance toxicity and decrease metabolism
• Myelosuppressive agents: Increased risk of hematologic toxicity
• Centrally-acting drugs: Potential for additive CNS effects

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.