Interferon Gamma-1b

Interferons bind to specific cell surface receptors and initiate a sequence of intracellular events that lead to the transcription of interferon-stimulated genes. The three major groups of interferons (alpha, beta, gamma) have partially overlapping biological activities that include immunoregulation such as increased resistance to microbial pathogens and inhibition of cell proliferation.

• ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO).

• ACTIMMUNE is contraindicated in patients who develop or have known hypersensitivity to interferon gamma, E. coli derived products, or any component of the product.contraindicated

For subcutaneous use only ( 2.1 ) The recommended dose is 50 mcg/m 2 for patients whose body surface area is greater than 0.5 m 2 and 1.5 mcg/kg/dose for patients whose body surface area is equal to or less than 0.5 m 2 three times weekly. ( 2.1 ) Monitor hematology, blood chemistries and urinalysis prior to the beginning of treatment and at 3-month intervals. ( 2.1 ) If severe reactions occur, reduce dose by 50 percent or discontinue therapy until the adverse reaction abates. ( 2.3 ) 2.1 Dosing Information The recommended dosage of ACTIMMUNE administered subcutaneously, for the treatment of patients with CGD and SMO is shown in Table 1 below: Table 1: Recommended Dosage for ACTIMMUNE for the Treatment of Patients with CGD and SMO Body Surface Area (m 2 ) Dose (mcg/m 2 ) Dose (International Units/m 2 ) Note that the above activity is expressed in International Units (1 million International Units/50 mcg). This is equivalent to what was previously expressed as units (1.5 million units/50 mcg).

Cardiovascular Disorders : Pre-existing cardiac conditions may be exacerbated. ( 5.1 ) Neurologic Disorders : Reduce dose or discontinue if decreased mental status, gait disturbance, dizziness occur. ( 5.2 ) Bone Marrow Toxicity : Monitor for neutropenia and thrombocytopenia particularly when administering ACTIMMUNE in combination with other potentially myelosuppressive agents. ( 5.3 ) Hepatic Toxicity : Reduce dose or discontinue to reverse severe elevations of aspartate transaminase (AST) and/or alanine transaminase (ALT); monitor liver function monthly in patients less than 1 year old. ( 5.4 ) Hypersensitivity Reactions: If serious hypersensitivity reactions occur, discontinue and institute appropriate medical therapy. ( 5.5 ) Renal Toxicity : Monitor renal function regularly when administering ACTIMMUNE to patients with severe renal insufficiency ( 5.6 ) 5.1 Cardiovascular Disorders Acute and transient "flu-like" symptoms such as fever and chills induced by ACTIMMUNE at doses of 250 mcg/m 2 /day (greater than 10 times the weekly recommended dose) or higher may exacerbate pre-existing cardiac conditions. Patients with pre-existing cardiac conditions, including ischemia, congestive heart failure or arrhythmia on ACTIMMUNE should be monitored for signs/symptoms of exacerbation. Some of the "flu-like" symptoms may be minimized by bedtime administration of ACTIMMUNE. Acetaminophen may also be used to ameliorate these effects.

The following adverse reactions are described below and elsewhere in the warnings and precautions section of the labeling: Cardiovascular Disorders [see Warnings and Precautions (5.1) ] Neurologic Disorders [see Warnings and Precautions (5.2) ] Bone Marrow Toxicity [see Warnings and Precautions (5.3) ] Hepatic Toxicity [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Renal Toxicity [see Warnings and Precautions (5.6) ] Common adverse reactions (incidence rate 2% or greater) for ACTIMMUNE include fever, headache, rash, chills, injection site erythema or tenderness, fatigue, diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc.at 1 800 77 AMGEN (1 800 772 6436)or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following data on adverse reactions are based on the subcutaneous administration of ACTIMMUNE at a dose of 50 mcg/m 2 , three times weekly, in patients with CGD during a clinical trial in the United States and Europe.

Based on animal data, may cause fetal harm. ( 8.1 ) 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. ACTIMMUNE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data ACTIMMUNE has shown an increased incidence of abortions in primates when given from gestation day 20 to 80 in doses approximately 100 times the human dose. A study in pregnant primates treated with subcutaneous doses 2 – 100 times the human dose failed to demonstrate teratogenic activity for ACTIMMUNE. Female mice treated subcutaneously with recombinant murine IFN-interferon gamma (rmuIFN-gamma) at 280 times the maximum recommended clinical dose of ACTIMMUNE from shortly after birth through puberty but not during pregnancy had offspring which exhibited decreased body weight during the lactation period. The clinical significance of this finding observed following treatment of mice with rmuIFN-gamma is uncertain. For lower doses, there is no evidence of maternal toxicity, embryotoxicity, fetotoxicity or teratogenicity in preclinical studies. 8.2 Lactation Risk Summary It is not known whether ACTIMMUNE is excreted in human milk.

Metabolism

Pharmacokinetic studies in patients with CGD have not been performed. The intravenous, intramuscular, and subcutaneous pharmacokinetics of ACTIMMUNE have been investigated in 24 healthy male subjects following single-dose administration of 100 mcg/m 2 (twice the recommended dose for CGD and SMO patients).

Central nervous system adverse reactions including decreased mental status, gait disturbance and dizziness have been observed, particularly in patients receiving doses greater than 100 mcg/m 2 /day by intravenous or intramuscular administration. These abnormalities were reversible within a few days upon dose reduction or discontinuation of therapy. Reversible neutropenia, elevation of hepatic enzymes and of triglycerides, and thrombocytopenia have also been observed.

• Feb 25, 1999BLABLA103836Horizon Therapeutics Ireland Dac

1. 1Pyrexia19314%
2. 2Off Label Use17012%
3. 3Pneumonia987.1%
4. 4Influenza Like Illness926.6%
5. 5Fatigue684.9%
6. 6Headache614.4%
7. 7Death604.3%
8. 8Chills554.0%
9. 9Malaise513.7%
10. 10Pain493.5%
11. 11Nausea483.5%
12. 12Dyspnoea453.2%
13. 13Vomiting402.9%
14. 14Infection392.8%
15. 15Hospitalisation372.7%

The 10 most recently updated of 251 ClinicalTrials.gov registrations naming Interferon Gamma-1b as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Assessment of Interleukin-15 and Interferon Gamma in Alopecia Areata Before and After Baricitinib.
  Completed · Interventional · 20 enrolled · Benha University
  NCT07645430updated 2026-06-12
• PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in Liberia
  Completed · Observational · 200 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT04926922updated 2026-06-12
• Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
  Active not recruiting · Observational · 224 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT00814827updated 2026-06-08
• Training Protocol on the Natural History of Tuberculosis
  Recruiting · Observational · 150 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT01212003updated 2026-06-05
• Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
  Recruiting · Phase 2 · Phase 3 · Interventional · 2,530 enrolled · Johns Hopkins University
  NCT06568484updated 2026-06-03
• Viral Specific T-Lymphocytes to Treat Adenovirus, CMV and EBV
  Terminated · Phase 1 · Phase 2 · Interventional · 8 enrolled · Jessie L. Alexander, MD
  NCT04364178updated 2026-05-27
• Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists
  Recruiting · Phase 1 · Phase 2 · Interventional · 50 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT05463133updated 2026-05-14
• Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant
  Recruiting · Phase 1 · Interventional · 15 enrolled · City of Hope Medical Center
  NCT06996119updated 2026-05-11
• Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS
  Not yet recruiting · Phase 2 · Interventional · 60 enrolled · NYU Langone Health
  NCT07567014updated 2026-05-06
• Immune Response During the Conservative and Minimal Invasive Treatment of Pain Caused by Lumbar Disc Herniation
  Completed · Interventional · 128 enrolled · Josip Juraj Strossmayer University of Osijek
  NCT06545812updated 2026-05-04

Frequently asked questions

How does Interferon Gamma-1b work?

Interferons bind to specific cell surface receptors and initiate a sequence of intracellular events that lead to the transcription of interferon-stimulated genes. The three major groups of interferons (alpha, beta, gamma) have partially overlapping biological activities that include immunoregulation such as increased resistance to microbial pathogens and inhibition of cell proliferation.

What is Interferon Gamma-1b used for?

According to FDA labeling, Interferon Gamma-1b carries indications including: ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Interferon Gamma-1b?

Interferon Gamma-1b is classified as Interferon gamma, Biological Response Modifiers, Transcription Factor Activity, Cellular Growth Phase Arrest, Increased Cytokine Activity.

What are the brand names for Interferon Gamma-1b?

Interferon Gamma-1b is marketed under brand names including Actimmune.

What are the contraindications for Interferon Gamma-1b?

Interferon Gamma-1b labeling lists contraindications including: ACTIMMUNE is contraindicated in patients who develop or have known hypersensitivity to interferon gamma, E. coli derived products, or any component of the product.. Always consult the full prescribing information and a clinician.