Advisories
Health Canada informs consumers and health professionals of changes to the product monographs of methotrexate and proton pump inhibitors (PPIs) to include safety information regarding a potential interaction with concomitant use. High-dose methotrexate (usually seen in the treatment of cancer) and PPIs taken at the same time may increase blood methotrexate levels, which may produce kidney failure, inflammation of the digestive tract, irregular heartbeat, muscle pain, infections and diarrhea. Although there have been a number of studies suggesting this possible interaction between PPIs and methotrexate, a definite association between use of PPIs and an increase in methotrexate levels has not been confirmed. Assess PPI use in patients, especially those on high-dose methotrexate, to see if the medication is needed and, if so, whether a reduced dose would be as effective in outcome.
Amgen Canada, Inc. and Health Canada inform health professionals and the public about the risk of atypical femoral fractures associated with Prolia (denosumab), with cases confirmed in an ongoing open-label extension study of a phase III fracture trial in postmenopausal osteoporosis (FREEDOM). These events occur rarely, in less than 1 in 10,000 patients treated with Prolia, based on 31,266 subject years of exposure to Prolia in bone loss studies. The warning and precautions section of the product monograph has been updated to reflect this information. Advise patients to report any dull, unusual aching pain in the thigh, hip or groin area to their health professional(s).
Merck Canada, Inc. and Health Canada inform health professionals and the public about the new safety recommendation on the dose of Zocor (simvastatin, generics available) and the associated increased risk of myopathy or rhabdomyolysis. An increased risk of myopathy or rhabdomyolysis is seen with the regular use of simvastatin 80 mg, especially during the first year of treatment. The recommended dose range for simvastatin is 5 to 40 mg daily. Recommend switching to an alternative low-density lipoprotein (LDL)–lowering medication if your patients are unable to achieve their LDL-cholesterol goals. Restrict the use of simvastatin 80 mg to patients who have been taking this dose chronically with no evidence of muscle toxicity or to patients at high risk of cardiovascular complications who do not tolerate other statins and in whom there is a net benefit. The product monograph provides recommendation on simvastatin doses when taken with some interacting drugs and foods. Advise patients to report any unexplained muscle problems to their health professional(s).
GlaxoSmithKline, Inc. and Health Canada notify health professionals and the public of the risk of electrocardiographic QT interval prolongation associated with Zofran (ondansetron), which can lead to torsade de pointes (TdP). A dose-dependent prolongation of the corrected QT interval (QTc) was identified among healthy subjects treated with ondansetron. The maximum recommended single intravenous (IV) dose of Zofran is 16 mg infused over 15 minutes. No longer recommended are the 32 mg IV dose of Zofran and the 8 mg IV dose followed by a 1 mg/hour continuous infusion of Zofran. Identify and, if possible, correct any risk factors, such as electrolyte abnormalities, congenital long QT syndrome or concomitant use of other medications, which may predispose patients to prolongation of the QT interval prior to Zofran administration. Please refer to the product monograph for further information on risk factors for TdP. There are no changes recommended to the oral dosing for Zofran in adults and to the oral or IV dosing in children. Advise patients to report any signs or symptoms of an abnormal heart rate while taking Zofran, such as dizziness, palpitations or syncope.
New Products
Edarbi (azilsartan medoxomil 40 mg and 80 mg tablets by Takeda Canada, Inc.) is an angiotensin II receptor blocker approved for the treatment of mild to moderate essential hypertension. It can be used as monotherapy, concomitantly with thiazide diuretics or calcium channel blockers. The recommended starting dose in adults is 40 mg once daily with or without food. The dose may be increased to a maximum of 80 mg once daily when additional blood pressure reduction is required. Although an initial dose adjustment may not be necessary in elderly patients, use with caution in patients aged ≥75 years who may be at risk of hypotension. No dose adjustment is required in mild or moderate renal impairment. Most of the antihypertensive effect occurs within the first 2 weeks of dosing in trials. Use with caution in patients with severe renal impairment or end-stage renal disease and in those with severe hepatic impairment.
New Indications
Byetta (exenatide injection 250 mcg/mL by Eli Lilly Canada, Inc.) is now indicated in combination with insulin glargine (with or without metformin) to improve glycemic control in patients with type 2 diabetes mellitus, when insulin glargine (with or without metformin), in addition to diet and exercise, does not provide adequate glycemic control.
Eliquis (apixaban 5 mg tablets by Pfizer Canada, Inc.) is now indicated for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
Herceptin (trastuzumab 440 mg/vial for infusion by Hoffmann-La Roche Limited) is now indicated for the treatment of patients with early stage breast cancer with ECOG 0-1 status, whose tumours overexpress HER2, and fitting the following criteria: following surgery and after chemotherapy; following adjuvant chemotherapy consisting of doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel; or in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
Humira (adalimumab 40 mg/0.8 mL sterile solution subcutaneous injection by AbbVie Corporation) is now indicated in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 to 17 years of age who have had an inadequate response to one or more disease-modifying antirheumatic drugs. Humira can be used as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is not appropriate.
Intelence (etravirine tablets by Janssen, Inc.) is now indicated in combination with other antiretroviral agents, for the treatment of HIV-1 infection in antiretroviral treatment‒experienced pediatric patients 6 years to less than 18 years of age, including those with nonnucleoside reverse transcriptase inhibitor resistance.
Prolia (denosumab 60 mg/mL solution for injection by Amgen Canada, Inc.) is now indicated for the treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
New Strengths
Eliquis (apixaban by Pfizer Canada, Inc.) is now available as 5 mg tablets. Eliquis was previously only available as 2.5 mg tablets for a different indication, specifically prevention of venous thromboembolism following elective hip or knee replacement surgery.
Intelence (etravirine tablets by Janssen, Inc.) is now available as 25 mg tablets. Intelence was previously only available as 100 mg and 200 mg tablets. Please see dosing regimen below.
New Dosing Regimen
Intelence (etravirine tablets by Janssen, Inc.) has dosing recommendations for pediatrics. The recommended dose for pediatric patients (6 years to less than 18 years of age and weighing at least 16 kg) is based on body weight. Please see product monograph for details.
New Generics
Tramadol/acetaminophen 37.5/325 mg is now available from Odan Laboratories Ltd. This is a new alternative to Tramacet.
Discontinued Products
Benzac AC 10 by Galderma Canada, Inc. has been discontinued. Benzac W Wash 10 continues to be available.
Changes In Appearance
Atorvastatin 10 mg, 20 mg, 40 mg and 80 mg tablets by Cobalt Pharmaceuticals Company may have a change in appearance. Cobalt Pharmaceuticals Company will be transitioning to new tablet markings and new round bottles.
New Dosage Form
Cipralex Meltz (escitalopram 10 mg and 20 mg orodispersible tablets by Lundbeck Canada, Inc.) is a new orally dissolving tablet formulation. Cipralex 10 mg and 20 mg regular tablets continue to be available.
Name Change
The brand name for dabigatran etexilate by Boehringer Ingelheim Ltd. is now Pradaxa. It was previously Pradax.
Biography
Alka Bhalla is a pharmacist consultant with the NIHB in Ottawa and the West Carleton Family Health Team in Carp, Ontario.