interferon [IFN]-beta 1B (betaseron, Extavia)
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Introduction
Tradename: Betaseron. Recombinant protein.
Indications
Contraindications
- hypersensitivity to albumin
- hypersensitivity to E. coli-derived products
- NOT recommended for patients < 18 years of age
- not recommended for patients with liver disease
Dosage
0.25 mg (8 million units) SC/IM every other day
Powder for injection: 0.3 mg (9.6 million units) single use only
Autoinjector Betaconnect available in early 2016[7]
Pharmacokinetics
- bioavailability 50%
- elimination 1/2life of 8 minutes - 4.3 hours
Monitor
- complete blood count (CBC)[1]
- liver function testings at 1, 3, & 6 month, then periodically & as clinically indicated[6];
- Canadian guidelines recommend LFTs at baseline, monthly for 6 months, then every 6 months
Adverse effects
- common (> 10%)
- flu-like symptoms decline after 4-6 weeks of therapy[1]
- fatigue[1]
- injection site inflammation
- development of antibodies with loss of clinical efficacy with chronic therapy B2) less common (1-10%)
- tachycardia, syncope, headache, lethargy, depression, emotional lability, anxiety, suicidal ideation, somnolence, agitation, confusion, hypocalcemia, spasticity, nausea/vomiting, anorexia, diarrhea, chronic weight loss, leukopenia, thrombocytopenia, anemia (mild, dose-related), weakness, retinal toxicity, visual changes, elevated liver function tests (mild & transient), renal insufficiency (elevated BUN & serum creatinine)
- uncommon (< 1%)
- other
- menstrual problems
- photosensitivity ?, sunblock recommended
- bone marrow fibrosis ?
Drug interactions
- decreased clearance/increased toxicity of zidovudine
Laboratory
Mechanism of action
- reduces frequency of relapse & new brain lesions visualized by MRI
- neutralizing antibodies IFN-beta are produced diminishing clinical effectiveness[6]
More general terms
- biological response modifier
- neurologic agent
- recombinant protein; chimer
- interferon beta
- pharmaceutical interferon
Additional terms
References
- ↑ 1.0 1.1 1.2 1.3 1.4 Medical Knowledge Self Assessment Program (MKSAP) 11, 17, 18. American College of Physicians, Philadelphia 1998, 2015, 2018
- ↑ Kaiser Permanente Northern California Regional Drug Formulary, 1998
- ↑ Drug Information & Medication Formulary, Veterans Affairs, Central California Health Care System, 1st ed., Ravnan et al eds, 1998
- ↑ Geriatric Dosage Handbook, 6th edition, Selma et al eds, Lexi-Comp, Cleveland, 2001
- ↑ Department of Veterans Affairs, VA National Formulary
- ↑ 6.0 6.1 6.2 Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260704&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 7.0 7.1 Bayer News Release. Sep 25, 2015 Bayer Receives FDA Approval for BETACONNECT - First and Only Electronic Autoinjector in Relapsing-Remitting Multiple Sclerosis (RRMS) Treatment. http://www.prnewswire.com/news-releases/bayer-receives-fda-approval-for-betaconnect---first-and-only-electronic-autoinjector-in-relapsing-remitting-multiple-sclerosis-rrms-treatment-300149438.html