Our regular review of pharmacotherapy FORMULARY

runny nose, itchy nose and sneezing) than those given placebo or either fluticasone n First pre-prandial GLP-1 propionate or azelastine hydrochloride receptor agonist may offer alone.2 savings In a further study, Dymista achieved EMERGENT A new once-daily parenteral symptom relief up to 6 days faster than hypoglycaemic is now available in the fluticasone propionate monotherapy and THERAPIES UK for the management of uncontrolled 5 days faster than azelastine.3 type 2 diabetes in combination with oral Dymista was well tolerated, the most hypoglycaemics and/or insulin. commonly reported adverse effects being Lyxumia (lixisenatide) is the first n Novel hay fever formulation epistaxis, headache and dysgeusia.2 prandial glucagon-like peptide-1 (GLP- shows improved symptom According to GP and allergy expert 1) receptor agonist to be developed, control Dr Dermot Ryan, effective management and with a competitive price tag, may A new nasal spray offering fast and of AR remains a challenge for both represent a cost-effective option for the powerful symptomatic control of allergic healthcare professionals and patients. NHS. rhinitis (AR) has been launched in the UK “Non-adherence to treatment remains Lixisenatide has been shown to slow by Meda Pharmaceuticals. a significant issue, with patients unsure down the process of gastric emptying, Dymista®, a novel formulation of whether current first-line treatments are and thereby lower blood sugar after a fluticasone propionate and azelastine taking effect, based on their relatively meal. hydrochloride, is licensed for the slow onset of action and limited The approval of the new agent is based symptomatic treatment of moderate to relief of symptoms. The introduction on a comprehensive trial programme, severe seasonal and perennial AR where of new treatments such as Dymista which included 11 clinical studies and monotherapy with either intranasal that can address these issues is an more than 5,000 patients. Results from antihistamine or glucocorticoid is not important development in improving Phase 3 trials showed that a combination considered sufficient. the management of such a common but of lixisenatide with basal insulin, plus oral Around one in four people in the UK difficult to manage condition,” he said. antidiabetic agents such as metformin, suffer from perennial or seasonal AR. significantly reduced levels of HbA1c, Of these, over 50% have moderate to References compared with placebo, in patients severe symptoms, and many remain 1. Pitman R, Paracha N et al. Episode pattern and with type 2 diabetes. It also reduced symptomatic in spite of receiving healthcare utilisation in patients with seasonal allergic rhinitis. Poster presented at EAACI 2012 postprandial fasting glucose compared treatment. A recent UK survey showed 2. Carr W et al. J Allergy Clin Immunol. with baseline. that most patients (70.5%) with moderate 2012;129(5):1282-89 3. Bachert C, Hampel F et al. MP29-02 and time to severe AR use multiple therapies in lyxumia AT A GLANCE§ an attempt to achieve symptom control, to response in the treatment of seasonal allergic rhinitis compared to marketed antihistamine and Active components although there is limited evidence to corticosteroid nasal sprays. Poster presented at Lixisenatide (10µg or 20µg) support this practice.1 the 30th Congress of the European Academy of solution The efficacy and safety of Dymista Allergy and Clinical Immunology (EAACI) 2011 Indication(s)* has been documented in several studies Adults with uncontrolled type 2 involving over 4000 patients, 1400 of DYMISTA AT A GLANCE§ diabetes, in combination with oral which received the new formulation. Active components hypoglycaemic agent A meta-analysis of three trials involving Azelastine hydrochloride (1mg) Dosing frequency almost 3400 patients with moderate-to- Fluticasone propionate (365µg) Starting dose: severe seasonal AR showed that those Indication(s)* 10µg o.d. for 14 days; receiving Dymista achieved significantly Moderate to severe seasonal or maintenance 20µg o.d. better reduction in total nasal symptom perennial allergic rhinitis Contraindications† score (comprising nasal congestion, Dosing frequency None† 1 spray per nostril twice daily Recommended minimum age § Please note: The information presented for Contraindications† 18 years the drugs featured is not comprehensive and None† Common adverse is taken from information provided by third Recommended minimum/ events (≥1/100)‡ party sources. For full information about any maximum age Hypoglycaemia, headache, drug featured, including special precautions, Min: 12 years Max: none gastrointestinal disturbance, please see the full summary of product characteristics using the link shown and/or Common adverse events (≥1/100) infections, dizziness, somnolence, consult the manufacturer. Epistaxis; headache, dysgeusia dyspepsia, back pain *See SmPC for full licensed indication Link for summary of product Link for summary of product †Hypersensitivity to active components and characteristics (SmPC) characteristics (SmPC) excipients is a contraindication for all drugs. www.medicines.org.uk/emc/ www.medicines.org.uk/emc/ ‡See SmPC for full details medicine/27579 medicine/27405

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n New option for long-term among three recommendations on pain contraception technology management drugs to emerge from the annual meeting in June this year of the The first subcutaneously delivered appraisals European Medicines Agency (EMA)’s formulation of the long-acting Pharmacovigilance Risk Assessment reversible contraceptive (LARC) Committee (PRAC). medroxyprogesterone acetate (MPA) has n Dapagliflozin (Forxiga) The recommendations regarding been launched in the UK. Sayana Press NICE has published a final appraisal codeine seek to ensure that such is injected into the thigh or abdomen determination (FAD) recommending medicines, which have been associated every 13 weeks using a prefilled device the use of the novel once-daily oral with respiratory depression, are used only (Uniject®). hypoglycaemic dapagliflozin as a in children for whom the benefits are MPA is a steroidal progestin, treatment option for adults with type 2 greater than the risks. They include: a synthetic variant of the human diabetes. Codeine-containing medicines should hormone progesterone, which prevents The guidance supports the use only be used to treat acute to moderate ovulation and provides contraception of dapagliflozin as dual therapy in pain in children above 12 years of age for 13 weeks (+/- 1 week). In the two combination with metformin, and that cannot be relieved by other simple phase 3 clinical studies of 1787 women, in combination with insulin with or analgesics. no pregnancies were reported with without other oral antidiabetic drugs. These medicines should not be used at subcutaneous MPA. In combination with metformin, all in patients aged below 18 years who Over half of the participants in the dapagliflozin is recommended for use undergo surgery for the removal of the studies experienced amenorrhea after 12 in place of a sulphonylurea (SU) for tonsils or adenoids to treat obstructive months, and over half of women did not patients in whom an SU is not tolerated sleep apnoea, as these patients are more report any significant weight changes or contraindicated, or those who are susceptible to respiratory problems. while taking subcutaneous MPA. at significant risk of hypoglycaemia The PRAC further advised that, as the In adolescents (12-18 years), use of or its consequences. The addition of risk of side effects with codeine may also Sayana Press is only indicated when other dapagliflozin to metformin may also be apply to adults, codeine should not be contraceptive methods are considered preferable to a thiazolidinedione if further used in people of any age who are known unsuitable or unacceptable. weight gain is a concern. to be ultra-rapid metabolisers, nor in Dapagliflozin is the first in a new class breastfeeding mothers. SAYANA AT A GLANCE§ of treatments known as SGLT2 inhibitors, The Committee also published Active component which work independently of insulin recommendations on two other analgesic medroxyprogesterone acetate with a mechanism of action that reduces agents prescribed commonly in primary (MPA) the amount of glucose reabsorbed in the care: Indication(s)* kidney. Long-term reversible female The efficacy and safety of dapagliflozin Diclofenac: the Committee warned that contraception has been investigated in a comprehensive the cardiovascular effects of this NSAID Dosing frequency clinical development programme when given systemically are similar to Single injection at 13 week intervals involving over 5500 patients with type 2 those of selective COX-2 inhibitors. This Main contraindications† diabetes. Data from these trials show that applies particularly when diclofenac is Pregnancy (known or suspected); it effectively lowers HbA1c and maintains used at a high dose (150mg daily) and breast or genital organ malignancy; glycaemic control in adults with type 2 for long-term treatment. vaginal bleeding; hepatic diabetes for two years. It also has the Flupirtine (oral and suppository impairment; metabolic bone disease; secondary benefit of weight loss sustained formulations) should only be used to thromboembolic/cerebrovascular for up to two years and is generally well treat acute (short-term) pain in adults disease tolerated. who cannot use other suitable pain Recommended minimum/ n See ‘What are the options after agents (such as NSAIDs and weak maximum age metformin’, Page 21 opioids) and treatment should not exceed Min: 12 years. Only rcommended 2 weeks because of the risk of damage to for females aged 12-18 years if other the liver. methods are considered unsuitable SAFETY Common adverse events (≥1/100)‡ The PRAC recommendation will need Weight increase; headache; RECOMMENDATIONS to go through a number of hoops before sexual disorders; depression; mood adoption of any EU-wide legally binding disorder decisions. Link for summary of product n European safety agency n For more details visit: characteristics (SmPC) seeks curbs on pain drugs www.ema.europa.eu/ema/index. www.medicines.org.uk/emc/ Measures to restrict the use of jsp?curl=pages/news_and_events/ medicine/27798 codeine-containing medicines for the events/2012/06/event_detail_000602. management of pain in children were jsp&mid=WC0b01ac058004d5c3

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