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standards of non-Merck sources.
Pronunciation
(in ter FEER on AL fa en three)
Generic Available (U.S.)
No
Medication Guide
An FDA-approved patient medication guide, which is available with the product information and at http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088613.pdf, must be dispensed with this medication.
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Use: Labeled Indications
Patients ≥18 years of age: Intralesional treatment of refractory or recurring genital or venereal warts (condylomata acuminata)
Pregnancy Risk Factor
C
Pregnancy Considerations
Safety and efficacy for use during pregnancy have not been established. Interferon alpha has been shown to decrease serum estradiol and progesterone levels in humans. Menstrual irregularities and abortion have been reported in animals. Effective contraception is recommended during treatment.
Lactation
Excretion in breast milk unknown/not recommended
Contraindications
Hypersensitivity to alpha interferon or any component of the formulation; anaphylactic sensitivity to mouse immunoglobulin, egg protein, or neomycin
Warnings/Precautions
Special handling:
• Hazardous agent: Use appropriate precautions for handling and disposal.
Concerns related to adverse effects:
• Flu-like symptoms: Flu-like symptoms are common; may aggravate debilitating conditions.
Disease-related concerns:
• Bone marrow suppression: Use with caution in patients with severe myelosuppression.
• Cardiovascular disease: Use with caution in patients with pre-existing cardiac disease, including unstable angina, uncontrolled HF, or arrhythmias.
• Coagulation disorders: Use with caution in patients with coagulation disorders (such as thrombophlebitis, pulmonary embolism, hemophilia).
• Diabetes: Use with caution in patients with diabetes with ketoacidosis.
• Pulmonary disease: Use with caution in patients with severe pulmonary disease.
• Seizure disorder: Use with caution in patients with a history of seizure disorder.
Special populations:
• Pediatrics: Safety and efficacy have not been not established in children.
Dosage form specific issues:
• Albumin: Contains albumin, which may carry a remote risk of transmitting Creutzfeldt-Jakob or other viral diseases.
• Product variability: Due to differences in dosage, patients should not change brands of interferons.
Adverse Reactions
Note: Adverse reaction incidence noted below is specific to intralesional administration in patients with condylomata acuminata. Flu-like reactions, consisting of headache, fever, and/or myalgia, were reported in 30% of patients, and abated with repeated dosing.
>10%:
Central nervous system: Fever (40%), headache (31%), chills (14%), fatigue (14%)
Hematologic: Decreased WBC (11%)
Neuromuscular & skeletal: Myalgia (45%)
Miscellaneous: Flu-like syndrome (30%)
1% to 10%:
Central nervous system: Malaise (9%), dizziness (9%), depression (2%), insomnia (2%), thirst (1%)
Dermatologic: Pruritus (2%)
Gastrointestinal: Nausea (45), vomiting (3%), dyspepsia (3%), diarrhea (2%), tongue hyperesthesia (1%), taste disturbance (1%)
Genitourinary: Groin lymph node swelling (1%)
Neuromuscular & skeletal: Arthralgia (5%), back pain (4%), cramps (1%), paresthesia (1%)
Ocular: Visual disturbance (1%)
Respiratory: Rhinitis (2%), pharyngitis (1%), nosebleed (1%)
Miscellaneous: Diaphoresis increased (2%), vasovagal reaction (2%)
<1%: Dysuria, hot flashes, impaired concentration, nervousness, photosensitivity. Rare adverse reactions reported with other alfa-interferons include depression, suicide, autoimmune disorders, ophthalmic disorders.
Metabolism/Transport Effects
None known.
Drug Interactions
Aldesleukin: Interferons (Alfa) may enhance the adverse/toxic effect of Aldesleukin. In particular, risks of myocardial and renal toxicity may be increased by this combination. Risk D: Consider therapy modification
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for agranulocytosis may be increased. Risk X: Avoid combination
Methadone: Interferons (Alfa) may increase the serum concentration of Methadone. Risk C: Monitor therapy
Ribavirin: Interferons (Alfa) may enhance the adverse/toxic effect of Ribavirin. Hemolytic anemia has been observed. Risk C: Monitor therapy
Theophylline Derivatives: Interferons may decrease the metabolism of Theophylline Derivatives. Exceptions: Dyphylline. Risk C: Monitor therapy
Zidovudine: Interferons may enhance the adverse/toxic effect of Zidovudine. Interferons may decrease the metabolism of Zidovudine. Risk C: Monitor therapy
Storage
Store solution at 2°C to 8°C (36°F to 46°F); do not freeze or shake solution.
Mechanism of Action
Interferons interact with cells through high affinity cell surface receptors. Following activation, multiple effects can be detected including induction of gene transcription. Inhibits cellular growth, alters the state of cellular differentiation, interferes with oncogene expression, alters cell surface antigen expression, increases phagocytic activity of macrophages, and augments cytotoxicity of lymphocytes for target cells
Dosage
Adults: Inject 250,000 units (0.05 mL) in each wart twice weekly for a maximum of 8 weeks; therapy should not be repeated for at least 3 months after the initial 8-week course of therapy
Anesthesia and Critical Care Concerns/Other Considerations
Indications and dosage regimens are specific for a particular brand of interferon; other brands have different indications and dosage guidelines.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation), metallic taste, tongue hyperesthesia, abnormal taste, thirst, rhinitis, pharyngitis, nosebleed, increased diaphoresis, taste disturbance, and gingivitis.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
Dizziness and drowsiness are common; may cause delirium or neurotoxicity. Severe psychiatric disorders, including depression and suicidal behavior, have been associated with some interferons. Careful neuropsychiatric monitoring is recommended.
Mental Health: Effects on Psychiatric Treatment
May cause leukopenia; use caution with clozapine and carbamazepine; concurrent use with psychotropics may produce additive sedation and dry mouth
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution:
Alferon® N: 5 million int. units (1 mL) [contains albumin (human), chicken egg protein, mouse protein]
References
Vial T and Descotes J, “Clinical Toxicity of the Interferons,” Drug Saf, 1994, 10(2):115-50.
International Brand Names
Lexi-Comp.com
Last full review/revision November 2011
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