FDA-filed SPL labeling · retrieved through openFDA

Interferon Gamma-1b Injection

Interferon gamma-1b is an immune-boosting injection used to reduce serious infections in chronic granulomatous disease and to slow disease progression in severe, malignant osteopetrosis.

Brand name Actimmune
Drug class ⓘ Interferon Gamma
Rx Form 1 Route Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMar 30, 2026
AvailabilityRx
Earliest approval/marketing year ⓘ1999
FDA-listed product records ⓘ2
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Interferon Gamma-1b Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Actimmune (interferon gamma-1b) is a specialized injection used to fight serious infections in chronic granulomatous disease and to slow progression of severe, malignant osteopetrosis. It requires careful monitoring of blood counts, liver function, and kidney function throughout treatment. Follow your prescriber's schedule closely, learn proper injection technique, and report any new or worsening symptoms promptly.

📖 Interferon Gamma-1b Injection: Patient Information Guide

A plain-language walkthrough of Interferon Gamma-1b Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Interferon gamma-1b (Actimmune) is approved for two rare inherited conditions:

  • Chronic granulomatous disease (CGD): Actimmune reduces how often and how seriously infections occur in patients with this inherited immune disorder, where certain white blood cells can't kill bacteria and fungi effectively.
  • Severe, malignant osteopetrosis (SMO): Actimmune delays how quickly the disease progresses in patients with this rare inherited bone disorder, in which bones grow abnormally dense and the immune system is impaired.
⚙️How it works▾

Interferon gamma-1b is a lab-made copy of a protein your immune system naturally produces. It binds to specific receptors on the surface of immune cells, triggering a chain of events inside those cells that turns on infection-fighting genes. This enhances the activity of macrophages (immune cells that engulf and destroy pathogens), activates natural killer (NK) cells, and boosts other parts of the immune response. In osteopetrosis, it also appears to improve osteoclast function — these are the cells responsible for breaking down old bone, which helps counteract the excessive bone buildup seen in SMO.

The exact mechanism behind its benefit in both CGD and SMO hasn't been fully worked out. Notably, measuring a patient's superoxide levels during treatment does not predict how well they're responding, so that test is not used to guide therapy.

💊How it's taken▾

Actimmune is given as a subcutaneous (under-the-skin) injection three times per week — typically on alternating days such as Monday, Wednesday, and Friday. The dose your prescriber calculates is based on your body surface area. There are no food restrictions, but taking it at bedtime may help lessen flu-like side effects. If serious side effects occur, your prescriber may reduce the dose by half or pause treatment — never adjust the dose on your own.

  • Inject into the right or left upper arm or front of the thigh
  • Rotate injection sites to reduce local skin reactions
  • Each vial is single-use only — discard leftover solution after each dose
  • Blood tests (blood counts, liver and kidney function, urinalysis) are recommended before starting and every three months during treatment
🤒Side effects — in detail▾

The most common side effects with Actimmune are flu-like symptoms that often improve as treatment continues:

  • Fever
  • Headache
  • Chills
  • Fatigue
  • Rash
  • Nausea or vomiting
  • Diarrhea
  • Redness, pain, or tenderness at the injection site
  • Muscle or joint aches

More serious reactions to watch for include signs of liver problems (yellowing skin or eyes, severe stomach pain), low blood counts (unusual bruising, bleeding, or infection), neurological changes (confusion, difficulty walking, dizziness), worsening heart symptoms, kidney problems, or a serious allergic reaction. Contact your doctor right away if any of these occur.

⚠️Warnings & precautions▾
  • Heart conditions: Flu-like symptoms caused by Actimmune can put extra stress on the heart. Patients with pre-existing ischemia, heart failure, or arrhythmia need close monitoring for worsening symptoms.
  • Nervous system effects: Confusion, gait problems, and dizziness have been reported, especially at higher doses. These are usually reversible when the dose is reduced or stopped.
  • Low blood counts: Actimmune can reduce white blood cell and platelet counts, increasing infection and bleeding risk — especially when combined with other bone marrow-suppressing drugs.
  • Liver toxicity: Liver enzyme levels can rise significantly. Infants under one year old are at higher risk and must have liver function checked monthly. Dose reduction or interruption can reverse these elevations.
  • Kidney toxicity: In patients with severe kidney disease, the drug may accumulate with repeated use. Regular kidney function monitoring is required.
  • Serious allergic reactions: Though rare, severe hypersensitivity reactions have occurred. Stop the injection and seek immediate care if this happens.
  • Latex allergy: The rubber stopper on the Actimmune vial contains natural rubber (latex), which can cause reactions in latex-sensitive patients.
🔀What it interacts with▾

Actimmune can interact with several types of medications — tell your prescriber and pharmacist about everything you take:

  • Bone marrow-suppressing drugs (myelosuppressive agents): Using these together increases the risk of dangerously low blood counts; close monitoring of blood counts is required.
  • Drugs toxic to the nervous system, heart, or blood: Their harmful effects may be amplified when combined with interferon gamma-1b.
  • Vaccines and immune preparations: Taking these at the same time as Actimmune is not recommended — it may trigger an unexpected or exaggerated immune response.
  • Drugs processed by liver enzymes (cytochrome P-450 pathway): Interferon gamma can reduce activity of these liver enzymes, potentially raising blood levels of other medications broken down this way.
  • Drugs toxic to the liver or kidneys: These may affect how Actimmune is cleared from the body, potentially increasing its accumulation.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy to interferon gamma or E. coli-derived products: Actimmune must not be used — this is a contraindication.
  • Heart disease (angina, heart failure, arrhythmia): Use with caution; flu-like symptoms can stress the heart.
  • Seizure disorder or central nervous system conditions: Extra monitoring is needed; Actimmune may affect neurological function.
  • Liver disease: Actimmune can cause liver enzyme elevations and may accumulate in people with advanced liver disease. Monthly monitoring is required in infants under one year old.
  • Severe kidney disease: Actimmune may build up in the body over repeated doses; kidney function should be monitored regularly.
  • Pregnancy: Animal studies showed increased miscarriage risk at high doses. Use only if clearly needed and discussed with your doctor.
  • Breastfeeding: It isn't known whether Actimmune passes into breast milk. Discuss the risks and benefits with your doctor before breastfeeding.
  • Fertility concerns: Higher levels of interferon gamma may potentially affect fertility in both men and women; the long-term effects in younger patients are not yet known.
  • Children under 1 month: Safety and effectiveness have not been established in infants younger than one month old.
  • Older adults: Use cautiously — age-related declines in heart, liver, and kidney function may increase the risk of side effects.
  • Latex allergy: The vial stopper contains natural rubber latex — alert your healthcare team before use.
🚑If you take too much▾

Taking too much Actimmune can cause nervous system problems including confusion, dizziness, and difficulty walking, as well as low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), elevated liver enzymes, and high triglyceride levels. These effects have generally been reversible when the dose is reduced or treatment is stopped. If you think you or someone else has received too much, contact your healthcare provider or seek emergency care promptly.

📡Pharmacodynamics — effects in the body▾

Interferon gamma-1b activates the immune system in several measurable ways: it boosts the ability of macrophages to destroy microbial pathogens through oxidative metabolism, activates natural killer (NK) cells, and increases the expression of immune signaling proteins on cell surfaces. In patients with severe, malignant osteopetrosis, it has been shown to enhance osteoclast function and increase superoxide production by immune cells. However, changes in superoxide levels during treatment do not predict clinical effectiveness and should not be used to judge how well the therapy is working.

🔬Pharmacokinetics — how your body processes it▾

After subcutaneous injection, Actimmune is slowly absorbed — more than 89% of the dose reaches the bloodstream. It reaches peak blood levels roughly 7 hours after a subcutaneous dose. The half-life (time for the drug level to fall by half) is about 5.9 hours after subcutaneous injection. The drug does not appear to build up in the body with repeated daily dosing over 12 days. The liver and kidneys are both capable of clearing interferon gamma-1b from the body, and the drug is not detected in urine after administration.

📦How to store it▾

Store vials in the refrigerator at 2 to 8 °C (36 °F – 46 °F). Do Not Freeze. stored at room temperature up to 12 hours prior to use.

📄 Written from Interferon Gamma-1b Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

57

Supplements & herbs that interact with Interferon Gamma-1b Injection

57 supplements and herbal products have documented interactions with Interferon Gamma-1b Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 53
  • Minor · 1
Every supplement checked against Interferon Gamma-1b Injection — ranked by severity The full interaction hub: 3 major · 53 moderate · 1 minor · every one linked to its full report. Check Interferon Gamma-1b Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Interferon Gamma-1b Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Actimmune being used to treat — I've never heard of these conditions before. ▾
Actimmune is used for two rare inherited diseases. The first is chronic granulomatous disease (CGD), where certain immune cells can't destroy bacteria and fungi the way they should — so patients get serious, hard-to-treat infections. Actimmune helps reduce how often those infections happen and how severe they are. The second is severe, malignant osteopetrosis (SMO), a condition where bones grow too dense because the cells that normally break down old bone don't work properly. Actimmune helps slow how quickly that disease progresses.
How do I take Actimmune, and do I have to go to a clinic for every injection? ▾
No, you don't have to go to a clinic every time. Actimmune is given as a subcutaneous injection — that means under the skin — three times a week, usually on alternating days like Monday, Wednesday, and Friday. Once you or a family member have been trained properly by your healthcare team, you can do the injections at home. Good spots are the upper arm or front thigh. Taking it at bedtime can help reduce flu-like symptoms like fever and chills.
What side effects should I expect, and which ones mean I need to call my doctor? ▾
The most common side effects are flu-like: fever, headache, chills, and fatigue. You might also notice redness or tenderness at the injection site, nausea, or diarrhea. These often get better as your body adjusts. Call your doctor right away if you notice confusion, trouble walking, dizziness, yellowing of the skin or eyes, unusual bruising or bleeding, chest pain, or signs of a serious allergic reaction like hives or trouble breathing. These could be signs of a more serious problem that needs attention quickly.
Are there any medications or vaccines I need to avoid while taking Actimmune? ▾
Yes, a few things to be aware of. Don't receive vaccines or other immune-type preparations at the same time as Actimmune — it can cause an unpredictable immune reaction. If you're taking any medications that lower your blood counts or that could affect your liver, kidneys, heart, or nervous system, let your prescriber know, because combining them with Actimmune may increase the risk of side effects. It's always worth telling every member of your healthcare team — including dentists and pharmacists — that you're on Actimmune.
I'm worried about using this while pregnant. Is it safe? ▾
This is an important question. There are no solid human studies on Actimmune use during pregnancy. Animal studies at high doses showed an increased risk of miscarriage, which is a real concern. Actimmune should only be used during pregnancy if your doctor decides the benefit clearly outweighs the potential risk to the baby. If you're pregnant, thinking about becoming pregnant, or breastfeeding, have an honest conversation with your prescriber before continuing treatment.
What kind of monitoring or blood tests will I need while on Actimmune? ▾
Your doctor will want to keep a close eye on your body's response to Actimmune. Before you start and then every three months during treatment, you'll have blood tests to check your blood cell counts, liver function, kidney function, and urine. If you're an infant under one year old, liver function needs to be checked monthly because younger patients are at higher risk for liver enzyme elevations. Regular monitoring isn't something to skip — it helps catch any problems early so the dose can be adjusted if needed.
Is Interferon Gamma-1b Injection available over the counter? ▾
Interferon Gamma-1b Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Interferon Gamma-1b Injection first available? ▾
Interferon Gamma-1b Injection has been available in the United States since at least 1999, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Interferon Gamma-1b Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Interferon Gamma-1b Injection comes

Interferon Gamma-1b Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Under the skin
Brands Actimmune
How this form is used
What it may be used for
  • Actimmune is used to reduce the frequency and severity of serious infections in patients with chronic granulomatous disease (CGD)
  • Actimmune is used to delay disease progression in patients with severe, malignant osteopetrosis (SMO)
Important instructions
  • Actimmune is given as a subcutaneous (under-the-skin) injection three times per week, typically on alternating days
  • Actimmune should be injected into the right or left deltoid (upper arm) or the front of the thigh
  • Actimmune is a single-dose vial — discard any unused portion after each injection; do not mix with other drugs in the same syringe
  • Actimmune should be inspected before each use — it should be clear and colorless; do not use if it appears cloudy or contains particles
Available strengths 1 strength
2 FDA-listed product records ⓘ

📊 Interferon Gamma-1b Injection across the U.S. market

How Interferon Gamma-1b Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
1
Manufacturers
1
Brand names
2
FDA-listed product records ⓘ
1999
First marketed ⓘ

📈 How widely Interferon Gamma-1b Injection is used

A general measure of how commonly Interferon Gamma-1b Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Interferon Gamma-1b Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

438
Medicaid prescriptions filled (Q1–Q4 2025)
$29M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Interferon Gamma-1b Injection prescribed? Of the 1,597 medications we measure, Interferon Gamma-1b Injection ranks #1,374 by Medicaid prescriptions — more than 14% of them.

Where Interferon Gamma-1b Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Interferon Gamma-1b Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

0.5 ML interferon gamma-1b 0.2 MG/ML Injection

438 Medicaid prescriptions (Q1–Q4 2025) 100% of Interferon Gamma-1b Injection prescriptions shown $29M gross reimbursement (before rebates) ≈ $66,129 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 240448

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Interferon Gamma-1b Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Interferon Gamma-1b Injection NDCs with Medicaid activity.

🔍 Compare Interferon Gamma-1b Injection products

A representative set of FDA-listed product records for Interferon Gamma-1b Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
100 mcg/0.5 mL Subcutaneous Horizon Therapeutics USA, Inc. × 2 listings BLA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Interferon Gamma-1b Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Interferon Gamma-1b Injection RxCUI 5882 1 dose form · 1 strength

Look up RxCUI 5882 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Actimmune

🏭 Manufacturers & labelers

Horizon Therapeutics USA, Inc. 2

RxNorm drug class

Interferon Gamma-1b Injection belongs to the Interferon gamma class.

Pharmacologic class Interferon gamma

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 30, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Interferon Gamma-1b Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Interferon Gamma-1b Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
2
Distinct labelers/manufacturers represented
1
Linked representative label ⓘ
Horizon Therapeutics USA, Inc.
Linked label effective
Mar 30, 2026
Composite sections available
21
Linked SPL Set ID
5d0b1256-1981-4519-94f4-a4a2f98bd8a3
Linked SPL Document ID
8d803fd6-c715-4d8b-818b-bd5d537c3d60
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Horizon Therapeutics USA, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.