Betaferon

interferon beta-1b

Betaferon (UK), Betaseron, Extavia

Pharmacologic class: Biological response modifier

Therapeutic class: Antiviral, immunoregulator

Pregnancy risk category C

Action

Binds and competes with specific receptors on cell surface, inducing various interferon-induced gene products. Also inhibits proliferation of T cells.

Availability

Lyophilized powder for injection (beta-1a): 22 mcg (6 million international units; Rebif), 33 mcg (6.6 million international units; Avonex), 44 mcg (12 million international units; Rebif)

Lyophilized powder for injection (beta-1b): 0.3 mg in glass, single-use, 3-ml vial

Powder for injection (beta-1b): 0.3 mg (9.6 million international units; Betaseron)

Prefilled syringes (beta-1a): 30 mcg/0.5 ml (Avonex)

Indications and dosages

To reduce frequency of exacerbations in relapsing-remitting multiple sclerosis

Adults ages 18 and older: 8.8 mcg Rebif subcutaneously three times weekly, increased over a 4-week period to 44 mcg three times weekly. Or 30 mcg Avonex I.M. once a week. Or 8 million international units (0.25 mg) Betaseron subcutaneously every other day. Or initially, 0.0625 mg (0.25 ml) (Extavia) subcutaneously every other day, increased over 6 weeks to 0.25 mg (1 ml) every other day.

Contraindications

• Hypersensitivity to drug, its components, or albumin

Precautions

Use cautiously in:
• cardiac disease, seizure disorders, mental disorders, depression, suicidal tendencies
• women of childbearing age
• pregnant or breastfeeding patients
• children ages 18 and younger.

Administration

• Reconstitute Avonex (I.M. injection) and Rebif (subcutaneous injection) using diluent provided, according to instructions provided.
• Reconstitute Betaseron (subcutaneous injection) using 1.2 ml of diluent supplied by manufacturer, to yield a concentration of 0.25 mg/ml. Swirl gently to mix; don't shake. Use reconstituted drug within 3 hours; discard unused portion.
• Reconstitute Extavia (subcutaneous injection) by attaching prefilled, single-use syringe containing 1.2 ml of diluent supplied by manufacturer to vial using vial adapter. Slowly inject 1.2 ml of diluent into vial to yield a concentration of 0.25 mg/ml. Swirl gently to mix; don't shake. Use reconstituted drug within 3 hours; discard unused portion.

Adverse reactions

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

CV: chest pain, hypertension, palpitations, arrhythmias

EENT: visual disturbances, stye, hearing disorders, nasal congestion, sinusitis, rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, eructation, stomatitis, dry mouth, intestinal obstruction

GU: gynecomastia, breast pain, early or delayed menses, menstrual bleeding or spotting, shortened duration of menstrual flow, menorrhagia

Hematologic: anemia, neutropenia, leukopenia, thrombocytopenia

Metabolic: hypocalcemia

Musculoskeletal: joint pain, back pain, myalgia, myasthenia

Respiratory: cough, dyspnea

Skin: rash, dry skin, pruritus, flushing, alopecia, dermatitis, diaphoresis

Other: gingivitis, flulike symptoms, weight loss, edema, candidiasis, lymphadenopathy, inflammation, pain

Interactions

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, glucose, lactate dehydrogenase, neutralizing antibodies, phosphorus, uric acid: increased values

Hemoglobin, neutrophils, white blood cells: decreased values

Patient monitoring

Before therapy 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.
• Watch for GI upset. Provide small, frequent meals to minimize nausea and vomiting.

Monitor for mental status changes, depression, and suicidal ideation.
• Evaluate for bleeding and bruising.
• Institute infection-control measures. Monitor for infection symptoms.

Patient teaching

• Teach patient or caregiver how to administer drug subcutaneously or I.M., rotate injection sites, and track dosing schedule and injection sites on calendar.
• Advise patient to avoid sources of potential infection, such as crowds and people with known infections.
• Tell 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, alertness, and vision.

Tell patient to contact prescriber immediately if depression or suicidal ideation occurs.
• Inform female patient that drug is linked to fetal abnormalities. Advise her not to get pregnant during therapy, and to use barrier contraception. Tell her to consult prescriber before breastfeeding.

Instruct patient to immediately report signs or symptoms of infection (such as fever, chills, sore throat, achiness), unusual bleeding or bruising, mental status changes, dizziness, palpitations, or chest pain.
• 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 tests mentioned above.

Betaferon

A brand name for INTERFERON BETA-1b.
References in periodicals archive ?
With funding from Bayer, Reder and other researchers tracked down all but six of the 372 patients who participated in a betaferon trial in 1988, before the drug was approved in the U.
The aim of the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) trial, funded by Bayer HealthCare Pharmaceuticals, was to compare the efficacy, safety, and tolerability of 250 micro/g or 500 micro/g interferon beta-1b with Glatiramer acetate for treating relapsing-remitting multiple sclerosis.
The study was sponsored by Bayer Schering Pharma, which markets interferon beta- lb (Betaseron in the United States and Canada; Betaferon elsewhere).
27), suggesting that Merck must raise its offer of 77 euros per share or face a competing bid for the maker of multiple-sclerosis treatment Betaferon and the oral contraceptive Yasmin.
Jonathan Godding, 37, spends pounds 8,000 a year on Betaferon which is only available to one in 10 MS sufferers in Britain.
50] for Betaferon, Aileron, and Multileron, the three compounds that showed greatest potency for inhibition of CPE.
The 28-year-old, who suffers from multiple sclerosis, relies on Betaferon jabs to reduce the severity and frequency of the debilitating attacks.
People who have used Copaxone by injection can't participate--and people who have used the interferons, either Avonex or Betaseron (or Rebif or Betaferon outside the U.
TreatmentTrends: Multiple Sclerosis (EU) 2012 report also finds that the greatest percent of neurologists continue to voice a first-line preference for Biogen Idec's Avonex or a high dose/high frequency interferon (Merck Serono's Rebif for RRMS and Bayer's Betaferon for progressive MS).
Physicians prefer Avonex, Betaferon, Copaxone, Rebif -- or ABCRs -- as first line therapy because of the 10 years of clinical data establishing their efficacy and safety," said Frost & Sullivan Healthcare Industry Analyst Aish Vivekanandan .
While cutaneous side-effects have been reported in all the GA and IFNB Phase III studies, only the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) study has compared the two treatments.
When I had to give myself a Betaferon injection for the first time, the nurse gave me the encouragement I needed, and afterwards she gave me an enormous hug.