Adult Dosing

Relapsing forms of multiple sclerosis

• Initial: 0.0625 mg SC qod and then increase dose by 0.0625 mg q6wks to maximum dose of 0.25 mg qod
• Maintenance: 0.25 mg SC qod

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to albumin

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined, caution advised

See Supplemental Patient Information

• Cautiously administer in conditions common with multiple sclerosis such as depression or other mood disorders. Depression and suicide have been reported with the use of therapy
• Topical injection site necrosis occurring within the first four months of therapy has also been reported
• Therapy may cause anaphylactic reactions or allergic reactions including dyspnea, orolingual edema, skin rash and urticaria
• Prior to initiating therapy, consider theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD)

Cautions: Use cautiously in

• Hepatic impairment
• Depression
• Myelosuppression
• Thyroid disorder

Supplemental Patient Information

• Patients and caregivers should be informed of the possibility of serious adverse reactions, including depression and suicidal ideation, injection site necrosis, and anaphylaxis during the use of therapy

Pregnancy Category:C

Breastfeeding: Safety unknown. The amount of the drug excreted in milk is very low. Any interferon in breastmilk is probably destroyed in the infant's gastrointestinal tract and not absorbed, except perhaps in neonates. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 13 May 2011). Maternal medication usually compatible with breastfeeding, no observable change was seen in the nursing infant while the mother was ingesting the compound. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 13 May 2011). Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• CNS: Headache, insomnia, asthenia, malaise, myasthenia
• PSYCHIATRIC: Suicidal thoughts, depression
• RESP: Bronchospasm, dyspnea
• CV: Edema, chest pain, hypertension, capillary leak syndrome, peripheral edema
• GI: Abdominal pain, constipation, nausea, vomiting, autoimmune hepatitis, elevated LFTs, hepatotoxicity
• GU: Urinary urgency , erectile dysfunction
• DERM: Rash, skin disorder
• ENDO: Menstrual disorders, hyperthyroidism, hypothyroidism, menorrhagia, spontaneous abortion
• HEMA: Neutropenia, anemia, thrombocytopenia, lymphopenia, leukopenia, lymphadenopathy
• LOCAL: Injection-site reactions, injection-site necrosis
• MUSC: Myalgia, muscle spasm, hypertonia
• MISC: Allergic reactions including anaphylaxis, chills, fever, flu-like symptoms, pain

• Interferon; exact mechanism of action unknown. In response to viral infection and other biological inducers, it mediates antiviral, antiproliferative and immunomodulatory activities
• 50% absorbed following SC administration
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: 8 mins-4.3 hrs

US Trade Name(s)

• Betaseron
• Extavia

US Availability

Betaseron, Extavia

• PWDR for INJ: 0.3 mg/vial

Canadian Trade Name(s)

• Betaseron
• Extavia

Canadian Availability

Betaseron, Extavia

• PWDR for INJ: 0.3 mg/vial

UK Trade Name(s)

• Betaferon
• Extavia

UK Availability

Betaferon, Extavia

• PWDR for INJ: 0.3 mg/vial

Australian Trade Name(s)

• Betaferon

Australian Availability

Betaferon, Extavia

• PWDR for INJ: 0.3 mg/vial

[Outline]

Allergy & Immunology

Interferons

Neurologic

Multiple Sclerosis Agent

Immune Response Modifiers

Pricing data from www.DrugStore.com in U.S.A.

• Extavia 0.3 MG SOLR [Box] (NOVARTIS)
  1 mg = $235.98
  3 mg = $675.99
• Betaseron 0.3 MG SOLR [Box] (BAYER HEALTHCARE PHARMA)
  14 mg = $3459.9
  28 mg = $6899.59

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.