A-Z Drug Facts > Interferon Alfacon-1

Interferon Alfacon-1

Pronouncation: (IN-ter-FEER-ahn AL-fuh-con-1)
Class: Immunomodulator

Trade Names:
Infergen
- Injection 9 mcg
- Injection 15 mcg

Pharmacology

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These small protein molecules bind to specific cell-surface receptors and initiate complex sequences of intracellular events, including production of enzymes and other products with antiviral, antiproliferative, and immunomodulatory effects.

Pharmacokinetics

Absorption

The T _max is 24 to 36 h (products).

Indications and Usage

Treatment of chronic hepatitis C virus (HVC) infection in patients older than 18 yr of age with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA.

Contraindications

Allergy to alpha-interferons, Escherichia coli -derived products, or any component of the product.

Dosage and Administration

Initial Therapy
Adults

Subcutaneous 9 mcg 3 times/wk for 24 wk.

Nonresponders/Relapse
Adults

Subcutaneous 15 mcg 3 times/wk for up to 48 wk.

Dose Reduction
Adults

Subcutaneous Withhold dosage temporarily for patients who experience a severe adverse reaction. If reaction does not become tolerable, discontinue therapy. Dose reduction to 7.5 mcg may be necessary following an intolerable adverse reaction.

General Advice

• For subcutaneous administration only. Not for intradermal, IM, IV, or intra-arterial administration.
• Administer at bedtime to reduce incidence and severity of flu-like symptoms.
• Do not administer if particulate matter, cloudiness, or discoloration noted.
• Rotate injection sites (eg, buttocks, thighs, abdomen, back of arms). Use a different area for each injection. Do not inject into areas where the skin is tender, bruised, red, or hard.
• Vials contain no preservative. Use only 1 dose per vial and do not re-enter the vial. Discard any unused portion. Do not save or combine unused portions for later use.

Storage/Stability

Store vials in refrigerator (36° to 46°F). Do not freeze. Avoid exposure to sunlight and vigorous shaking. May allow solution to come to room temperature just prior to injection.

Drug Interactions

Agents metabolized by CYP pathway, myelosuppressive agents

Use interferon alfacon-1 with caution.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension, palpitation (5%).

CNS

Headache (82%); insomnia (39%); nervousness (31%); depression (26%); dizziness (25%); abnormal thinking (20%); anxiety (19%); paresthesia (13%); emotional lability (12%); hypoesthesia, amnesia (10%); hypertonia, somnolence (7%); agitation (6%); confusion, hyperesthesia, decreased libido, apathy (5%).

Dermatologic

Alopecia, pruritus (14%); rash, increased sweating (13%); erythema (9%); dry skin (6%); wound (4%).

EENT

Pharyngitis (34%); rhinitis (13%); conjunctivitis (8%); tinnitus (6%); earache, eye pain, abnormal vision (5%); otitis (3%).

Endocrine

Abnormal thyroid test (9%).

GI

Abdominal pain (41%); nausea (40%); diarrhea (29%); anorexia (24%); dyspepsia (21%); vomiting (13%); constipation (9%); flatulence (8%); toothache (7%); decreased salivation, hemorrhoids, ulcerative stomatitis (6%); gingivitis, taste perversion (5%).

Genitourinary

Dysmenorrhea (9%); vaginitis (8%); menstrual disorder (6%); menorrhagia, breast mass (5%); genital moniliasis, breast pain (2%).

Hematologic-Lymphatic

Granulocytopenia (42%); leukopenia (28%); thrombocytopenia (19%); lymphocytosis (11%); lymphadenopathy, ecchymosis, anemia (6%); increased PT (3%).

Hepatic

Tender liver (6%); hepatomegaly (5%).

Lab Tests

Decreased hemoglobin, hematocrit, WBC, and platelets; increased triglycerides.

Local

Injection-site erythema (23%); injection-site pain (11%); injection-site ecchymosis (6%).

Metabolic-Nutritional

Hypertriglyceridemia (6%); weight decrease (5%).

Musculoskeletal

Myalgia (58%); arthralgia (51%); back pain (42%); limb pain (26%); skeletal pain, neck pain (14%); musculoskeletal disorder (7%).

Respiratory

Upper respiratory tract infection (31%); cough (22%); sinusitis (17%); respiratory tract congestion (12%); upper respiratory tract congestion (10%); dyspnea, epistaxis (8%); bronchitis (6%).

Miscellaneous

Fatigue (71%); rigors (66%); fever (61%); body pain (54%); flu-like symptoms (15%); chest pain (13%); hot flushes (13%); malaise (11%); asthenia (10%); peripheral edema (9%); access pain (8%); allergic reaction (7%); infection (6%).

Precautions

Warnings Neuropsychiatric, autoimmune, ischemic, and infectious disorders Interferons may cause or aggravate fatal or life-threatening disorders of this nature. Persistent severe or worsening signs or symptoms may necessitate discontinuation of therapy. Closely monitor patients with periodic clinical and laboratory evaluations.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy in children younger than 18 yr of age not established.

Autoimmune disease

Do not use interferon alfacon-I in patients with autoimmune hepatitis, and use with caution in patients with other autoimmune disorders.

Bone marrow depression

Use with caution in patients with abnormally low peripheral blood cell counts or who are receiving agents known to cause myelosuppression.

Cardiac disease

Use with caution. Hypertension, supraventricular arrhythmias, chest pain, and MI have been associated with interferon therapies.

Decompensated hepatic disorder

Do not use in patients with decompensated hepatic disease. Discontinue use in patients who develop symptoms of hepatic decompensation (eg, jaundice, ascites, coagulopathy, decreased serum albumin).

Fever

May be related to flu-like symptoms associated with therapy. Rule out other possible causes if persistent fever occurs.

Ophthalmologic disorders

Decrease or loss of vision, retinopathy including macular edema, retinal hemorrhages, cotton wool spots, and retinal artery or vein thrombosis reported rarely. Optic neuritis or papilledema are induced or aggravated by treatment with alpha interferons.

Severe acute hypersensitivity

If hypersensitivity reactions occur (eg, anaphylaxis, angioedema, bronchoconstriction, urticaria), discontinue drug immediately.

Suicide/Mental disorders

Do not use in patients with history of severe psychiatric disorders. Discontinue use in patients developing severe depression, suicidal ideation, or other severe psychiatric disorders.

Thyroid disorders

Use has been associated with hypothyroidism requiring supplementation.

Overdosage

Symptoms

Anorexia, chills, fever, myalgia.

Patient Information

• Review Medication Guide if patient or caregiver will be administering at home. Ensure patient or caregiver understands how to store, prepare, and administer the dose, and how to dispose of used equipment and supplies. If possible, first injection should be performed under supervision of a qualified health care professional.
• Review dosing schedule with patient or caregiver. Advise patient or caregiver to administer prescribed dose at bedtime to minimize flu-like adverse reactions.
• Advise patient not to change the dose, stop taking, or change brand of drug unless advised by health care provider.
• Advise patient if a dose is missed to take it as soon as possible, and to schedule the next dose about 48 h later.
• Instruct patient to rotate injection sites as described in the Medication Guide to minimize likelihood of severe injection-site reactions.
• Advise patient that flu-like symptoms are common and nonnarcotic analgesics (eg, acetaminophen, ibuprofen) can be used to prevent or relieve fever, headache, and muscle and joint pain.
• Advise patient to notify health care provider immediately of any of the following: suicidal ideation, depressed mood, changes in thinking or behavior, vision changes, hives, shortness of breath or difficult breathing, persistent fever, sore throat, unusual bleeding or bruising, intolerable injection-site reaction.
• Advise patient to contact health care provider if experiencing bothersome adverse reactions or any unusual problems.
• Advise men and women of childbearing potential to use effective contraception during treatment.
• Advise patient that drug may cause drowsiness or dizziness, and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.

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