interferon gamma 1b (Rx)

Brand and Other Names:Actimmune
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Dosing & Uses

AdultPediatric

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

Dosage Forms & Strengths

injectable solution

  • 100mcg/0.5mL (single-dose vial)
  • 50mcg = 1 million units/m²

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

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Interactions

Interaction Checker

and interferon gamma 1b

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      Serious - Use Alternative

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            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 (7)

              • 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.

              Minor (0)

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                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

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                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

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                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.

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                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)

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                Images

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                Patient Handout

                Patient Education
                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 persist or worsen, 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: lightheadedness, fainting, mental/mood changes (e.g., 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, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), 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 (e.g., angina, irregular heartbeat, congestive heart failure), liver disease, seizure disorder, blood cell disorders (e.g., 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 (e.g., cancer chemotherapy, prednisone, cyclosporine), hydroxyurea, theophyllines (e.g., 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.Laboratory and/or medical tests (e.g., complete blood count, kidney and liver function tests) should be performed periodically to monitor your progress or check for side effects. 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 August 2021. Copyright(c) 2021 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.

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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.