ADVISORIES
Novartis Pharmaceuticals and Health Canada inform health care professionals and the public about stronger safety recommendations regarding first-dose cardiovascular monitoring of Gilenya (fingolimod) and its use in patients with pre-existing cardiovascular conditions. There have been reports of isolated delayed-onset cardiovascular events, including transient asystole and unexplained death within 24 hours of the first dose of Gilenya. No deaths have been reported in Canada; however, 54 Canadian case reports of serious cardiovascular adverse events have been reported between March 09, 2011, and January 31, 2012, where the majority of these cases (e.g., bradycardia, hypertension, hypotension, dizziness, malaise, palpitations) have occurred within the first 6 hours of the first dose. The updated product monograph advises that an electrocardiogram be performed and blood pressure measured prior to and 6 hours after the first dose of Gilenya. Further, all patients should be monitored for signs and symptoms of bradyarrhythmia with hourly pulse and blood pressure measurement for at least 6 hours after the first dose and appropriate measures taken if heartrelated side effects occur. If serious heart-related adverse effects occur at the end of the 6-hour observation period, patients may require monitoring for a longer period. Please refer to the product monograph for further information, including a description of patient groups in which Gilenya should not be used.
Hospira Healthcare Corporation informs health care professionals of an immediate product recall of one lot of Propofol Injectable Emulsion 1%, 10 mg/mL, lot 09029DJ, with an expiry date of 2014/09/01. This recall was initiated on September 7, 2012, due to the presence of visible particles, metallic and elastomeric, identified in the propofol vial. The company requests that vials with this lot number be returned. No reports of adverse events have been received by the company; however, the company requests that physicians remain vigilant in their follow-up of postoperative patients, as inadvertent injection of particulate matter could result in local inflammation, phlebitis, allergic response and/or embolization in the body. Contact Hospira Healthcare should further information be required.
Sanofi Pasteur and Health Canada inform health care professionals and the public that a voluntary recall of several Typhim Vi (Vi polysaccharide typhoid vaccine) batches has been initiated due to potentially lower-thanexpected antigen content that may not provide the intended protection against the disease. For patients who may have received a Typhim Vi vaccination from these batches, the company does not recommend revaccination earlier than otherwise indicated. There are no tests available that can easily evaluate the level of anti-Vi serum antibodies in patients. Syringes and 20-dose vials of the following batches are impacted: G1122-1, G1557-1, G0182-2 and H0176-1. Continue to remind patients to avoid potentially contaminated food and drink, as vaccination against typhoid fever does not preclude this recommendation.
NEW PRODUCTS
Inlyta (axitinib 1 mg and 5 mg tablets by Pfizer) is an oral kinase inhibitor approved for the treatment of patients with metastatic renal cell carcinoma of clear cell histology after failure of prior systemic therapy with either a cytokine or the VEGFR-TK1, sunitinib. Inlyta should be prescribed by a qualified health care professional who is experienced in the use of antineoplastic therapy. Clinically significant adverse events associated with Inlyta are hypertension, arterial thromboembolism, hemorrhage, gastrointestinal perforation, reversible posterior leukoencephalopathy syndrome and associated deaths. Inlyta is not recommended in combination with strong inhibitors and inducers of CYP3A4. The recommended starting dose is 5 mg twice daily taken orally with or without food and swallowed whole with a glass of water. Patients who tolerate the starting dose with no adverse reactions (>Grade 2 according to Common Toxicity Adverse Event Criteria) for 2 consecutive weeks, are normotensive and are not receiving blood-pressure-lowering agents, may have their dose increased to 7 mg twice daily. The maximum dose is 10 mg twice daily. The starting dose is decreased by approximately half in patients with moderate hepatic impairment. Inlyta should not be used in patients with severe hepatic impairment, as it has not been studied in this population. Review and assess patients' current medication(s) for interactions prior to initiation of Inlyta.
Latuda (lurasidone 40 mg, 80 mg and 120 mg film-coated tablets by Sunovion) is an antipsychotic approved for the acute treatment of patients with schizophrenia who are ≥18 years. It is not indicated in elderly patients with dementia. Latuda is administered with food, as this helps increase absorption 2–3 fold. The recommended starting dose is 40 mg once daily. Doses of above 80 mg may be considered for certain patients based on individual clinical judgement, as higher doses may be associated with increased side effects. Doses may need adjustment in patients with renal impairment. Common adverse events observed in placebo-controlled trials were nausea, somnolence, akathisia and parkinsonism. Latuda is contraindicated in combination with strong inhibitors or inducers of the CYP3A4 enzyme. For patients on diltiazem, the dose of Latuda should not exceed 40 mg once daily. Advise patients to avoid grapefruit juice while taking Latuda. Review and assess patients' current medication(s) for interactions prior to initiation of Latuda.
NEW INDICATIONS
Cervarix (human papillomavirus vaccine types 16 and 18, recombinant, AS04 adjuvanted by GlaxoSmithKline Inc.) is now indicated in females from 9 to 25 years of age (as opposed to 10 to 25 years of age).
Exjade (deferasirox dispersible tablets for oral suspension by Novartis Pharmaceuticals Canada Inc.) is now indicated for the treatment of chronic iron overload in patients aged 10 years and older with non-transfusion-dependent thalassemia syndromes.
Inspra (eplerenone by Pfizer Canada Inc.) is now indicated as an adjunct to standard therapy to reduce the risk of cardiovascular mortality and hospitalization for heart failure in patients with NYHA class II systolic chronic heart failure and left ventricular systolic dysfunction. In patients 75 years and older a reduction in cardiovascular mortality was not observed with Inspra.
Januvia (sitagliptin by Merck Canada Inc.) is now indicated as add-on combination therapy with premixed or long-/intermediate-acting insulin (with or without metformin) in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control.
Janumet (metformin/sitagliptin by Merck Canada Inc.) is now indicated in combination with premixed or long-/intermediate-acting insulin as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus inadequately controlled on metformin, and premixed or long-/intermediate-acting insulin.
NEW STRENGTHS
Januvia (sitagliptin by Merck Canada Inc.) is now available as 25 mg and 50 mg tablets. The 50 mg tablet is used in patients with moderate renal insufficiency and the 25 mg tablet is used in patients with severe renal insufficiency, including those with end-stage renal disease on dialysis. Januvia was previously only available as 100 mg tablets.
Sublinox (zolpidem by Meda AB) is now available in 5 mg orally disintegrating tablets for use in the elderly and in patients with hepatic impairment.
Zyclara (imiquimod topical cream by Medicis Pharmaceutical Corporation) is now available as 2.5% topical cream. Zyclara was previously only available as a 3.75% topical cream.
NEW DOSING REGIMEN
Zestril (lisinopril tablets by AstraZeneca Inc.) has dosing recommendations for hypertensive pediatric patients. The recommended initial dose is 2.5 mg in patients 20 to 50 kg and 5 mg in patients ≥50 kg.
Zofran (ondansetron 2 mg/mL injection by GlaxoSmithKline Inc.) has a new dosing regimen for the prevention of chemotherapy-induced nausea and vomiting based on results of a QT-prolongating study. The maximum recommended IV dose is 16 mg over 15 minutes. A single dose greater than the 16 mg should not be given.
NEW DOSING FORM
Cambia (diclofenac potassium powder for oral solution) 50 mg sachets are now available from Tribute Pharmaceuticals Canada Ltd. Diclofenac is also available in other dosage forms, including tablets.
Divigel (estradiol 0.1% gel by Ferring Pharmaceuticals) is now available. It is supplied in single-dose foil packets of 0.25, 0.5 and 1.0 g, corresponding to 0.25, 0.5 and 1.0 mg estradiol, respectively.
Ondansetron hydrochloride dihydrate injection (Sandoz Canada Inc.) 4 mg/2 mL and 8 mg/4 mL are now available as a box of 5 x 2 mL and 5 x 4 mL ampoules. It is presently not available as vials.
NEW GENERICS
Candesartan/hydrochlorothiazide 16/12.5 mg is now available from Cobalt Pharmaceuticals Company and Sandoz Canada Inc. This is a new alternative to Atacand Plus.
Irbesartan 75 mg, 150 mg and 300 mg tablets are now available from Apotex Advancing Generics. This is a new alternative to Avapro.
Valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg tablets are now available from Apotex Inc. This is a new alternative to Diovan HCT.