Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 100mcg/0.5mL (single-dose vial)
- 50mcg = 1 million units/m²
Chronic Granulomatous Disease
Indicated to reduce frequency and severity of infections associated with chronic granulomatous disease
BSA >0.5 m²: 50 mcg/m² SC 3 times/week
BSA ≤0.5 m²: 1.5 mcg/kg SC 3 times/week
Malignant Osteopetrosis
Indicated to delay time to progression for severe malignant osteopetrosis
BSA >0.5 m²: 50 mcg/m² SC 3 times/week
BSA ≤0.5 m²: 1.5 mcg/kg SC 3 times/week
Orphan Designations
Friedriech's ataxia
Renal cell carcinoma
Sponsor
- Horizon Pharma Ireland Limited; Adelaide Chambers; Dublin 8; IRELAND
Administration
Optimum sites are right and left deltoid, anterior thigh
If severe reactions occur, reduce dose by 50 percent or discontinue therapy until the adverse reaction abates
Monitor
CBC, blood chemistries, urinalysis: q3month
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (2)
- deferiprone
deferiprone, interferon gamma 1b. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, interferon gamma 1b. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
Monitor Closely (8)
- acalabrutinib
acalabrutinib, interferon gamma 1b. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- dichlorphenamide
dichlorphenamide and interferon gamma 1b both decrease serum potassium. Use Caution/Monitor.
- hydroxyurea
interferon gamma 1b, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Cutaneous vasculitic toxicities (eg, vasculitic ulcerations and gangrene) were reported during therapy with hydroxyurea in patients with a history of, or currently receiving, interferon therapy.
- lomustine
lomustine, interferon gamma 1b. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- ponesimod
ponesimod and interferon gamma 1b both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- siponimod
siponimod and interferon gamma 1b both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- theophylline
interferon gamma 1b increases levels of theophylline by decreasing metabolism. Use Caution/Monitor. Greater risk of interaction in smokers.
- ublituximab
ublituximab and interferon gamma 1b both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
Adverse Effects
>10%
Fever (52%)
Headache (33%)
Rash (17%)
Chills (14%)
Diarrhea (14%)
Injection site erythema/tenderness (14%)
Vomiting (13%)
Nausea (10%)
1-10%
Arthralgia
Myalgia
Warnings
Contraindications
Hypersensitivity to interferon gamma or E. coli-derived products
Cautions
Immunocompromised patients
Potential for hepatotoxicity
If severe reactions occur, decrease dose 50% or withhold until side effects subside
Caution in cardiovascular disease; pre-existing cardiac conditions may be exacerbated
Reduce dose or discontinue if decreased mental status, gait disturbance, dizziness occur
Monitor for neutropenia and thrombocytopenia particularly when administering in combination with other potentially myelosuppressive agents
Reduce dose or discontinue to reverse severe elevations of aspartate transaminase (AST) and/or alanine transaminase (ALT); monitor liver function monthly in patients <1 year old
If serious hypersensitivity reactions occur, discontinue and institute appropriate medical therapy
Monitor renal function regularly when administering therapy to patients with severe renal insufficiency
Refrigerate vials-do not freeze or shake
The stopper of the glass vial contains natural rubber (a derivative of latex) which may cause allergic reactions
May cause flu-like symptoms
No preservatives-discard unused portions
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Not known whether excreted in breast milk, discontinue drug or do not nurse
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Recombinant human interferon gamma-1b, cytokine that confers greater resistance to microbial pathogens and regulates immune processes
Pharmacokinetics
Absorption: 89% (SC, IM)
Half-life: 38 min (IV); 3 hr (IM); 5.9 hr (SC)
Peak plasma time: 4 hr (IM); 7 hr (SC)
Images
Patient Handout
interferon gamma-1b subcutaneous
INTERFERON GAMMA 1B - INJECTION
(IN-ter-FEER-on GAM-ma wun-bee)
COMMON BRAND NAME(S): Actimmune
USES: This medication is used to reduce the frequency and severity of serious infections due to chronic granulomatous disease, a disorder that runs in families. This drug is often used along with antibiotics to help prevent these serious infections.This medication is also used to slow the worsening of malignant osteopetrosis, another disorder that runs in families, that affects bones, nerves, and blood.This medication is the same as a protein that your body naturally produces (interferon). In the body, it is thought to work by affecting cell function/growth and the body's natural defenses (immune system) in many ways. Adding more interferon may help your body fight off serious infections.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection under the skin as directed by your doctor, usually 3 times weekly (for example, Monday, Wednesday, and Friday). This medication is best used in the evening before bedtime to reduce side effects.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake the solution. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.It is important to change the location of the injection site with each dose to avoid problem areas under the skin. Choose a different injection site with each dose. The thighs and upper arms are recommended sites for the injection. Do not inject into skin that is irritated, sore, or infected.The dosage is based on your body size, medical condition, and response to treatment. Do not change the dose or how often you use this medication without your doctor's approval. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each evening that you have a scheduled dose.
SIDE EFFECTS: Injection site reactions (pain/swelling/redness), diarrhea, upset stomach, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches may occur, especially when you first start this medication. These symptoms usually last about 1 day after the injection and improve or go away after a few months of continued use. You can reduce these side effects by injecting this medicine at bedtime and using a fever reducer/pain reliever such as acetaminophen before or after each dose. Consult your doctor or pharmacist for more information.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, lightheadedness, fainting, mental/mood changes (such as confusion, depression), shaking (tremors), trouble walking, slow/fast/irregular heartbeat, shortness of breath, swelling of the ankles/feet, increasing tiredness, joint pain, butterfly-shaped rash on the face, easy bleeding/bruising, signs of infection (such as sore throat that doesn't go away, fever), stomach/abdominal pain, black/tarry stools, dark urine, signs of kidney problems (such as change in the amount of urine), yellowing eyes/skin.Get medical help right away if any of these rare but very serious side effects occur: chest/jaw/left arm pain, weakness on one side of the body, trouble speaking, sudden vision changes, seizures, pain/redness/swelling of the arms/legs, calf pain/swelling that is warm to the touch, coughing up blood.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using interferon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex found in the packaging), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as angina, irregular heartbeat, congestive heart failure), liver disease, seizure disorder, blood cell disorders (such as anemia, neutropenia, thrombocytopenia).This drug may make you tired or cause mental changes. Alcohol or marijuana (cannabis) can make you more tired or cause mental changes. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Do not have immunizations/vaccinations without the consent of your doctor.Children, especially those younger than 1 year, may be at greater risk for effects on the liver while using this drug. The manufacturer recommends regular laboratory tests (liver function tests), especially in children younger than 1 year.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: drugs that may affect your immune system (such as cancer chemotherapy, prednisone, cyclosporine), hydroxyurea, theophyllines (such as aminophylline, theophylline).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, kidney/liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Store in the refrigerator. Do not freeze. This medication should not be left at room temperature for more than 12 hours before use. If this occurs, do not use the medication and do not put it back into the refrigerator. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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