New drug products in Canada
Submitted by Sailaja Byrisetty on Tue, 02/13/2007 - 11:57.
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Baraclude:
Baraclude (entecavir by Bristol-Myers Squibb Canada) is a new oral antiviral agent indicated for the treatment of chronic hepatitis B infection.
Baraclude:
Baraclude (entecavir by Bristol-Myers Squibb Canada) is a new oral antiviral agent indicated for the treatment of chronic hepatitis B infection. The recommended dose in adults and adolescents over the age of 16 is 0.5 mg once daily. In patients with a history of hepatitis B viremia during lamivudine treatment or with known mutations conferring lamivudine resistance, the dose is 1 mg once daily. Baraclude is available as 0.5 mg tablet and as a 0.05 mg /ml oral solution. Baraclude should be administered on an empty stomach (at least 2hours after a meal and at least 2 hours before the next meal).
Exjade:
Exjade (deferasirox by Novartis Pharmaceuticals Canada Inc.), an oral iron chelating agent, was issued conditional marketing approval for the management of chronic iron overload in patients with transfusion-dependent anemias aged 6 years and older and for the management of chronic iron overload in patients with transfusion-dependent anemias, aged 2 to 5 years, who cannot be adequately treated with deferoxamine. This approval is conditional, pending the results of clinical trials to confirm the drug's clinical efficacy.
The starting dose is 10, 20, or 30 mg/kg/day and is based on the patient's transfusion rate and treatment goal. Doses are adjusted based on the serum ferritin level and should not exceed 30mg/kg/day. Exjade is available as dispersible tablets for oral suspension in strengths of 125,250, and 500mg.
Menactra:
Menactra (meningococcal groups A, C, Y and W-135 polysaccharide diphtheria toxoid conjugate vaccine by Sanofi Pasteur Limited) is indicated for active immunization of individuals 2 to 55 years of age for prevention of invasive meningococcal disease caused by N.meningitidis serogroups A, C, Y and W-135. The vaccine is administered as a single intramuscular injection of 0.5 ml, with the deltoid as the prefereed site of injection. Menactra is available as both single-dose syringes and vials. Postmarketing surveillance in the United States identified 8 cases of Guillain-Barr'e syndrome within 6 weeks of receiving Menactra. This reported incidence is within the expected incidence for Guillain_barr'e syndrome. However, because of these findings, Menactra is contraindicated in people with a past history of Guillain-Barr'e syndrome.
Tysabri:
Tysabri (natalizumab by Biogen Idec Canada Inc. and Elan Corporation) is a disease-modifying, humanized monoclonal antibody indicated as monotherapy for the treatment of patients with the relapsing-remitting form of multiple sclerosis (MS). It is generally recommended for patients not responding to or tolerating other therapies for MS. The dose of natalizumab is 300 mg, given as a 1-hour intravenous infusion every 4 weeks. Tysabri is available in vials of 300 mg per 15 ml.