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(in-ter-FEER-ahn BAY-tah 1b)
Betaseron
Powder for injection, lyophilized: 0.3 mg
Class: Interferon
Immunomodulator

 Action Unknown; however, the biologic response-modifying properties are mediated through the interactions of interferon beta-1b with specific cell receptors found on the surface of human cells. Binding to these receptors induces the expression of a number of interferon-induced gene products that are believed to be mediators of the biological action of the drug.

 Indications To reduce the frequency of clinical exacerbations of relapsing-remitting multiple sclerosis in ambulatory patients.

 Contraindications History of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of formulation.

 Route/Dosage

Adults: SC 0.25 mg every other day.

 Interactions

Zidovudine: Plasma levels of zidovudine may be elevated, increasing the pharmacologic and adverse effects.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Generalized edema; migraine; palpitation; hypertension; tachycardia; peripheral vascular disorder; hemorrhage; angina pectoris; arrhythmia; atrial fibrillation; cardiomegaly; cardiac arrest; cerebral hemorrhage; cerebral ischemia; endocarditis; heart failure; hypotension; MI; pericardial effusion; postural hypotension; pulmonary embolus; spider angioma; subarachnoid hemorrhage; syncope; thrombophlebitis; thrombosis; varicose vein; vasospasm; increased venous pressure; ventricular extrasystoles; ventricular fibrillation. CNS: Depression; anxiety; emotional lability; depersonalization; suicide attempts; confusion; headache; dizziness; hypertonia; anxiety; nervousness; somnolence; speech disorder; convulsion; hyperkinesias; amnesia; abnormal gait; acute brain syndrome; agitation; apathy; aphasia; ataxia; brain edema; chronic brain syndrome; coma; delirium; delusions; dementia; dystonia; encephalopathy; euphoria; facial paralysis; foot drop; hallucination; decreased libido; manic reaction; meningitis; neuralgia; neuropathy; neurosis; paralysis; paranoid reaction; psychosis; decreased reflexes; stupor; subdural hematoma; torticollis; tremor. DERMATOLOGIC: Petechia; contact dermatitis; erythema nodosum; exfoliative dermatitis; furunculosis; hirsutism; leukoderma; lichenoid dermatitis; maculopapular rash; skin necrosis; skin ulcer; urticaria; vesiculobullous rash. EENT: Laryngitis; conjunctivitis; abnormal vision; esophagitis; glossitis; diplopia; nystagmus; oculogyric crisis; ophthalmoplegia; papilledema; blepharitis; blindness; deafness; dry eyes; ear pain; iritis; keratoconjunctivitis; mydriasis; otitis externa; otitis media; parosmia; photophobia; retinitis; taste loss; taste perversion; visual field defect. GI: Abdominal pain; diarrhea; constipation; vomiting; GI disorder; aphthous stomatitis; cardiospasm; cheilitis; cholecystitis; cholelithiasis; duodenal ulcer; dry mouth; enteritis; fecal impaction; fecal incontinence; flatulence; gastritis; GI hemorrhage; gingivitis; hematemesis; ileus; increased salivation; intestinal obstruction; melena; nausea; oral leukoplakia; oral moniliasis; pancreatitis; periodontal abscess; proctitis; rectal hemorrhage; salivary gland enlargement; stomach ulcer; tenesmus. GU: Intermenstrual bleeding and spotting; urinary retention; early or delayed menses; decreased days of menstrual flow; spotting and clotting during menstruation; dysmenorrhea; metrorrhagia; cystitis; breast pain; menorrhagia; urinary urgency; fibrocystic breast; breast neoplasm; anuria; balanitis; breast engorgement; cervicitis; epididymitis; gynecomastia; hematuria; impotence; kidney calculus; kidney failure; kidney tubular disorder; leukorrhea; nephritis; nocturia; oliguria; polyuria; salpingitis; urethritis; urinary incontinence; enlarged uterine fibroids; uterine neoplasm; vaginal hemorrhage. HEMATOLOGIC: Lymphadenopathy; decreased lymphocytes, absolute neutrophil count, and WBC; chronic lymphocytic leukemia; decreased hemoglobin; decreased platelets. HEPATIC: Abnormal liver enzymes; hepatitis; hepatomegaly. METABOLIC: Decreased glucose; increased total bilirubin; increased urine protein; weight gain and loss; Cushing syndrome; diabetes insipidus; diabetes mellitus; hypothyroidism; inappropriate ADH; increased alkaline phosphatase; elevated BUN; increased calcium; cyanosis; glycosuria; hypoglycemia; hypoxia; ketosis. RESPIRATORY: Sinusitis; dyspnea; apnea; asthma; atelectasis; lung carcinoma; hemoptysis; hiccup; hyperventilation; hypoventilation; interstitial pneumonia; lung edema; pleural effusion; pneumonia; pneumothorax. OTHER: Injection site necrosis; necrosis; inflammation; pain; hypersensitivity; flu-like symptoms (eg, myalgia, fever, chills, malaise); pain; asthenia; pelvic pain; cyst; goiter; myasthenia; abscess; adenoma; anaphylactic reaction; ascites, cellulitis; hernia; hydrocephalus; hypothermia; infection; peritonitis; splenomegaly; photosensitivity; sarcoma; sepsis; shock; thirst; arthritis; arthrosis; bursitis; leg cramps; muscle atrophy; myopathy; myositis; ptosis; tenosynovitis.

 Precautions

Pregnancy Category C. Lactation: Undetermined. Children: Safety and efficacy not established. Necrosis: Injection site necrosis may occur within the first 4 mo of therapy at single or multiple injection sites.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Reconstitute powder using supplied diluent only. Swirl vial gently to dissolve. Do not shake vial.
  • Reconstituted solution should be clear and colorless.
  • Do not administer if particulate matter, cloudiness, or discoloration is noted.
  • Administer immediately after reconstitution, or refrigerate and use within 3 hr.
  • Withdraw prescribed dose into syringe for injection. Administer via SC route only.
  • Prescribed dose is administered every other day.
  • Rotate injection sites (eg, buttocks, thighs, abdomen, back of arms). Use a different area from where the last injection was administered. Do not inject into areas where the skin is tender, bruised, red, or hard.
  • Vials contain no preservative. Discard any unused portion. Do not combine unused portions.
  • Do not mix with other drug solutions.
  • Administer acetaminophen as prescribed for treatment of flu-like symptoms (eg, fever, myalgia).
  • Store vials in refrigerator (36° to 46°F). May store reconstituted solution in refrigerator for up to 3 hr. Do not freeze. If refrigeration is not possible, keep vials and diluent as cool as possible (< 86°F), away from heat and light, and use within 7 days.

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies.
  • Ensure that hemoglobin, CBC with differential, platelet count and blood chemistries, including LFTs, are performed before initiating therapy and periodically during therapy.
  • Ensure that women of childbearing potential is not pregnant when therapy is initiated and is using effective birth control measures.
  • Assess injection sites for evidence of reactions. Notify health care provider if broken skin, blue-black discoloration, or drainage of fluid is noted at injection site.
  • Monitor patient for signs or symptoms of depression and suicidal ideation. Implement appropriate precautions and report to health care provider if noted.
  • Assess patient for CV, CNS, GI, RESP, musculoskeletal, and general body side effects.

 Patient/Family Education

  • Explain name, dose, action, and potential side effects of drug. If patient or caregiver will be administering at home, review Betaseron Patient Information sheet with the patient or caregiver. Ensure that the patient or caregiver understands how to store, prepare, and administer the dose, and dispose of used equipment and supplies. If possible, perform the first injection under supervision of a qualified health professional.
  • Advise patient not to change the dose or stop taking unless advised by health care provider.
  • Remind patient that injection is administered every other day.
  • Advise patient that if a dose is missed to take it as soon as possible and to schedule next dose ~ 48 hr later.
  • Instruct patient to rotate injection sites as described in the Betaseron Patient Information sheet to minimize likelihood of severe injection site reactions or tissue necrosis.
  • Advise patient that “flu-like” symptoms are common and that acetaminophen can be used to relieve fever and muscle aches.
  • Advise patient to notify health care provider immediately if any of the following symptoms occurs: suicidal ideation, severely depressed mood, injection site reaction with break in skin and blue-black discoloration, swelling, drainage of fluid.
  • Advise patient to contact health care provider if experiencing bothersome side effects or any unusual problems.
  • Advise women of childbearing potential to use effective contraception during treatment.
  • Instruct women to notify health care provider if becoming pregnant, planning on becoming pregnant, or breastfeeding.
  • Instruct patient to not take any prescription or otc medications or dietary supplements unless advised by the health care provider.
  • Remind patient that office visits and laboratory tests will be required to monitor therapy and to be sure to keep appointments.

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