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interferon gamma-1b

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interferon gamma-1b,
a synthetic form of interferon-beta produced by recombinant technology that acts as a biologic response modifier and antineoplastic. It is used to reduce the frequency and severity of serious infections associated with chronic granulomatous disease; it is administered subcutaneously.

interferon [in″ter-fēr´on]
any of a family of glycoprotein biological response modifiers used as antineoplastic agents and immunoregulators; they inhibit cellular growth, alter the state of cellular differentiation, have effects on the cell cycle, interfere with oncogene expression, alter cell surface antigen expression, have effects on antibody production, and regulate cytotoxic effector cells.
interferon-α the major interferon produced by virus-induced leukocyte cultures; its primary producer cells are null cells, and its major activities are antiviral activity and activation of NK cells.
interferon alfa-2a a synthetic form of interferon-α produced by recombinant technology that acts as a biologic response modifier, used as an antineoplastic in the treatment of hairy cell leukemia and AIDS-related Kaposi's sarcoma; administered intramuscularly or subcutaneously.
interferon alfa-2b a synthetic form of interferon-α produced by recombinant technology that acts as a biologic response modifier, used in the treatment of veneral warts, hepatitis B, and chronic hepatitis C and as an antineoplastic in the treatment of hairy cell leukemia, malignant melanoma, non-Hodgkin's lymphomas, multiple myeloma, mycosis fungoides, and AIDS-related Kaposi's sarcoma; administered intramuscularly, subcutaneously, or intralesionally.
interferon alfacon-1 a synthetic interferon related to both α and β interferons, produced by recombinant DNA technology; used in the treatment of chronic hepatitis C virus infection, administered subcutaneously.
interferon alfa-n3 a highly purified mixture of natural human interferon proteins that acts as a biologic response modifier; used in the treatment of venereal warts, administered intralesionally.
interferon-β the major interferon produced by double-stranded RNA-induced fibroblast cultures; the major producer cells are fibroblasts, epithelial cells, and macrophages, and its major activity is antiviral.
interferon beta-1a a synthetic form of interferon-β produced by recombinant DNA techniques that acts as a biologic response modifier; used in the treatment of relapsing forms of multiple sclerosis; administered intramuscularly.
interferon beta-1b a synthetic modified form of interferon-β produced by recombinant DNA techniques; used as a biologic response modifier in the treatment of relapsing forms of multiple sclerosis; administered subcutaneously.
interferon-γ the major interferon produced by lymphocyte cultures that have been immunologically stimulated by mitogens or antigens; the major producer cells are T lymphocytes, and its major activity is immunoregulation.
interferon gamma-1b a synthetic form of interferon-γ produced by recombinant technology that acts as a biologic response modifier and antineoplastic. It is used to reduce the frequency and severity of serious infections associated with chronic granulomatous disease, administered subcutaneously.

interferon (in´trfir´on),
n a small class of glycoproteins capable of exerting antiviral activity in homologous cells through metabolic processes involving synthesis of RNA.
interferon alpha,
n a type formed by leukocytes in response to viral infection or by stimulation with double-stranded RNA. These protein products are used as antineoplastic agents. Specifically used as an antineoplastic agent for the treatment of Kaposi's sarcoma in AIDS patients. See also interferon alfa-2a.
interferon alfa-2a/interferon alfa-2b/interferon alfa-n1/interferon alfa-n3,
n brand names: Roferon-A, Intron-A, Alferon N;
drug class: biologic response modifier;
action: antiviral action inhibits viral replication by reprogramming virus; antitumor action suppresses cell proliferation; immunomodulating action phagacytizes target cells;
uses: hairy-cell leukemia in persons older than 18 years, metastatic melanoma, AIDS, Kaposi's sarcoma, bladder carcinoma, lymphomas, malignant myeloma, mycosis fungoides.
interferon beta,
n a type formed by fibroblasts by stimulation similar to the alpha form.
interferon gamma,
n a type formed by lymphocytes in response to mitogenic stimulation. See also interferon gamma-1b.
interferon gamma-1b,
n brand name: Actimmune;
drug class: biologic response modifier;
action: species-specific protein synthesized in response to viruses, enhances antibody-dependent cellular cytotoxicity, enhances natural killer cell activity;
uses: serious infections associated with chronic granulomatous disease.

interferon gamma-1b

Actimmune

Pharmacologic class: Biological response modifier

Therapeutic class: Antineoplastic

Pregnancy risk category C

Action

Enhances cellular toxicity and killer cell activity and promotes generation of oxygen metabolites in phagocytes, resulting in destruction of microorganisms.

Availability

Injection: 100 mcg (2 million international units)/0.5-ml vial

Indications and dosages

Chronic granulomatous disease; severe malignant osteopetrosis

Adults with body surface area (BSA) above 0.5 m2: 50 mcg/m2 (1 million international units/m2) subcutaneously three times weekly

Adults with BSA of 0.5 m2 or less: 1.5 mcg/kg subcutaneously three times weekly in deltoid or anterior thigh

Contraindications

• Hypersensitivity to drug, its components, or Escherichia coli-derived products

Precautions

Use cautiously in:
• thyroid disorders, bone marrow depression, hepatic or cardiac disease, seizure disorders, compromised CNS function
• pregnant or breastfeeding patients
• children ages 18 and younger.

Administration

• Administer into deltoid muscle by subcutaneous route only.
• Give at bedtime if flulike symptoms occur.
• Provide antiemetics to ease nausea and vomiting, as prescribed.

RouteOnsetPeakDuration
Subcut.Unknown7 hrUnknown

Adverse reactions

CNS: dizziness, confusion, paresthesia, lethargy, depression, difficulty thinking or concentrating, insomnia, anxiety, fatigue, amnesia, nervousness, drowsiness, asthenia, malaise

CV: chest pain, hypertension, palpitations, arrhythmias

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, pancreatitis

GU: proteinuria

Hematologic: anemia, leukopenia, thrombocytopenia, neutropenia

Musculoskeletal: joint pain, back pain, myalgia

Skin: flushing, rash, dry skin, erythema

Other: flulike symptoms, weight loss, edema, hypersensitivity reaction

Interactions

Drug-drug. Bone marrow depressants: increased bone marrow depression

Zidovudine: increased zidovudine blood level

Drug-diagnostic tests. Hepatic enzymes: increased levels

Neutrophils, platelets: decreased counts

Patient monitoring

Before and monthly during therapy, assess CBC with white cell differential, glucose and electrolyte levels, and liver and kidney function tests.
• Assess fluid intake and output. Keep patient well hydrated.
• Monitor for GI upset. Provide small, frequent meals or antiemetics to ease severe nausea and vomiting.
Monitor patient for mental status changes and depression.
• Assess for flulike symptoms. If these occur, give drug at bedtime and provide supportive care, such as rest and acetaminophen for headache and fever.

Patient teaching

• Teach patient or caregiver how to administer drug subcutaneously, rotate injection sites, and track dosing schedule and injection sites on calendar.
Tell patient to contact prescriber immediately if depression occurs.
• Advise patient to eat small, frequent meals to combat nausea, vomiting, and appetite loss.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Inform female patient that drug is linked to fetal abnormalities. Advise her not to get pregnant during therapy, and to use barrier contraception.
• Tell female patient to consult prescriber before breastfeeding.
• Tell patient he'll need regular follow-up examinations and blood tests to monitor drug effects.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.



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and Boehringer Ingelheim International GmbH, Germany, have formed an international strategic partnership to develop and commercialize interferon gamma-1b under Boehringer Ingelheim's trade name, Imukin(R), in all countries outside of the United States, Canada and Japan.
The Phase II trial demonstrated that interferon gamma-1b may be effective in treating IPF, and the reanalysis confirmed those results.
Leading the hepatology portfolio is the DIRECT trial, an ongoing Phase III study of daily interferon alfacon-1 (Infergen) plus ribavirin, and an ongoing Phase II trial of daily interferon alfacon-1 plus interferon gamma-1b (Actimmune) with and without ribavirin.
 
 
 
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