March 2015
Safety Related Changes
Avastin (bevacizumab) in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is now indicated for the treatment of patients with recurrent, platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior antiangiogenic therapy including bevacizumab.
Duro-K and Slow-K (potassium chloride) are now contraindicated in patients with gastric and/or intestinal ulcers.
Duro-K and Slow-K (potassium chloride) are now indicated for the treatment and specific prevention of hypokalaemia in patients who cannot tolerate oral potassium drinks or who find their taste unacceptable.
Eviplera (tenofovir disoproxil fumarate, emtricitabine and rilpivirine) is now indicated in certain virologically suppressed (HIV-1 RNA < 50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen. Patients must not have a history of resistance to any of the components of Eviplera.
Maxalon (metoclopramide hydrochloride) is now indicated in young adults and children over 1 year of age, and the use of Maxolon in patients under 20 years should be restricted to the following situations and only used as second line therapy: severe intractable vomiting of known cause; vomiting associated with radiotherapy and intolerance to cytotoxic drugs; and use as an aid to gastrointestinal intubation.
Maxolon (metoclopramide hydrochloride) is now contraindicated in children less than 1 year of age.
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