26 minute read
FEATURE: HEALTHY HEART
Supporting a Healthy Heart in Pharmacy Written by Gillian Hogan, Irish Heart Foundation
The sudden collapse of Danish footballer Christian Eriksen due to a cardiac arrest during the first half of Denmark’s opening Euro 2020 match against Finland shocked viewers around the world. The quick action of Eriksen’s team mates and officials to save his life has highlighted the need for bystanders to react with speed to a cardiac arrest. When somebody suffers a cardiac arrest, without CPR or a defibrillator (AED) their chances of survival decrease by 10% every minute. Because of the quick actions by those around him, Christian Eriksen thankfully survived. Eriksen was also fortunate that the event happened in such a public place with people on hand to immediately begin CPR and use an AED. However, we know that 70% of cardiac arrests happen in the home, so it is vital that people understand what to do in that situation.
What is an AED?
An AED is an Automated External Defibrillator. It is a portable, simple to use, computerised device. When someone suffers a sudden cardiac arrest, it checks the heart’s rhythm and automatically recognises if there is a life-threatening rhythm. Once detected the AED then delivers a shock to stun the heart and help it return to its normal rhythm. As the public often run to them in times of emergencies, pharmacies are optimal locations to keep AEDs. There are a number of things to keep in mind before buying an AED including accessibility, durability, how easy it is to use, the cost, shelf life and whether or not warranty or backup is provided by the manufacturer. It is important that the AED is located in a central location, that bystanders are aware of its location, that it is accessible at all times and easy to access. AEDs should be regularly checked to ensure they work and the battery and pads are within date. After being treated on the pitch with CPR and a defibrillator, Eriksen regained consciousness and was hospitalised. He has since been fitted with an ICD.
What is an ICD?
An ICD or Implantable Cardioverter Defibrillator is a battery-powered device that is placed inside your chest cavity under your skin near your shoulder. It continuously monitors your heart rhythm. It can either act as a pacemaker detecting when the heartbeat is too slow and sends tiny electrical signals to your heart, or if your heart beat it too fast or chaotic, it emits shocks to bring the heart back into normal rhythm. People generally have ICDs implanted because their heart has been damaged by a heart attack or because they have a heart condition, often inherited, that puts them at risk of developing arrhythmias.
Prevention
Heart disease and stroke is still one of the leading causes of death in Ireland. A total of 8,744 lives were lost to heart disease and stroke last year, according to the latest figures from the Central Statistics Office. The good news is that 80 per cent of death and disability from heart disease and stroke is preventable. One of the best ways to prevent the risk of developing cardiovascular disease is to maintain a healthy lifestyle. There are a number of modifiable risk factors that can influence and increase this risk and these include high cholesterol, high blood pressure, overweight, physical activity and smoking.
Cholesterol
Cholesterol is a type of fat in our blood which is produced by the liver. Everyone has cholesterol and some of it comes from the food that we eat. Our bodies need a certain amount of cholesterol for normal cell function, to help digestion and produce certain hormones. Not all cholesterol is bad. If your total cholesterol is high, it can mean that you have a lot of LDL (bad) cholesterol in your blood. Too much LDL cholesterol can be harmful because it sticks to the inside walls of your arteries. This can lead to fatty material building up – in a process called atherosclerosis. It makes it harder for blood to flow through, which can lead to a stroke or heart attack. High cholesterol affects people of all ages. High cholesterol can be inherited but is also caused by lifestyle. People with high cholesterol often have no noticeable symptoms. The only way to know if you have high cholesterol is to go to your doctor and have a blood test. Your cholesterol can become raised for a number of reasons, including a strong family history, low physical activity, a diet high in saturated fat, smoking and having overweight or obesity. There are treatments available to patients with high cholesterol if needed. For example, medication may be prescribed to keep levels of LDL cholesterol under control. Making small changes now can make a big difference to patients’ lives now and in the future.
Blood Pressure
Over half of all adults in Ireland over 45 years of age have high blood pressure (or hypertension). The risk factors associated with high blood pressure can be avoided if your blood pressure is controlled. However, about four in every five men and two-thirds of women with high blood pressure are not being treated. High blood pressure usually has no symptoms. The only way to find out if you have high blood pressure is to have it measured. The normal level of blood pressure is usually about 120 (systolic) over 80 (diastolic). If your blood pressure is 140 over 90 or higher (or 140 over 80 if you have diabetes) you should discuss this reading with your doctor. The only way to look after and to know if you have high blood pressure is to have it measured. It is recommended that people aged over 30 have their blood pressure checked every year. If your blood pressure is borderline high (around 140 over 90), you’ll need to get it checked more often by a doctor or nurse. Pharmacists are very well placed to detect high blood pressure and many pharmacies offer blood pressure checks with some doing 24-hour blood pressure monitoring. A 2018 study by the Irish Pharmacy Union revealed that one in four people who had their blood pressure checked at their local pharmacy as part of a new study were identified as having high blood pressure. According to the findings of the pilot study which aimed to detect people at risk of hypertension and atrial fibrillation in the community, 5.5% were found to have an irregular pulse and two per cent showed signs of both. Furthermore 26% were referred to their GP because of their check and four per cent of those were started on medication.
Physical activity and smoking cessation
Getting regular physical activity is one of the best things you can do to improve your overall health. It is recommended that adults should be active at a moderate intensity, for at least 30 minutes a day, five days a week. Smoking is a major risk factor for cardiovascular disease, including heart attack and stroke. One in every two smokers will die of a tobacco-related disease. Once you stop smoking, your mental and physical health improves immediately. After one year, your risk of having a heart attack is cut to half that of a smoker. Pharmacists around the country are also very well placed to support people to stop smoking by offer smoking cessation services and supports.
Supports and Services
At the Irish Heart Foundation, we have supported people living with cardiovascular disease for more than 50 years and we have developed a range of new services to support people living with cardiovascular disease through the Covid-19 pandemic and beyond. We run 31 support groups around the country which prior to the outbreak of Covid-19 met regularly in person. Since the pandemic, this network has transitioned to online and telephone support, making them even more accessible. The Heart Support Network, Life After Stroke and The Irish Heart Foundation’s Carers’ group are all private Facebook groups we run by to give patients access to expert information and allow them to share thoughts and concerns with similarly affected people. All groups include home-based exercise videos, advice from nurses, tips on diet and peerto-peer support which is vital at this time. New members are always welcome in all groups and are easy to join. Please email Tracy on tegan@irishheart.ie or call 01 6685001.
Heart Failure supports
Approximately 90,000 people in Ireland are living with heart failure, many of whom were cocooning during the pandemic. We established a suite of new support services for people with heart failure to help keep them well and alleviate their sense of isolation and loneliness.
The supports, which include a podcast series, nurse support line, private Facebook support page, online meetings, daily online exercise classes and peerto-peer support are all designed to help patients and their families to keep both physically and mentally well while staying at home. People can sign up to receive the supports on irishheart.ie or for queries please phone 01 668 5001 or email heartfailure@irishheart.ie.
Stroke Support
It’s estimated that around 7,500 people are hospitalised after a stroke in Ireland each year – the equivalent of 21 strokes a day nationwide – and the majority of people will be discharged home after spending an average of around two weeks in hospital. Returning home after stroke is difficult at any time, but never more so than during the Covid-19 pandemic. So, stroke patients being discharged from hospital needed extensive extra support. To meet this need, in conjunction with the HSE National Stroke Programme, we launched a new telephone support service for stroke patients post-discharge. There are also a number of stroke patients who may need ongoing support in their recovery irrespective of whether they are newly discharged or not. Therefore, the service is open to anyone post-stroke regardless of where they are in their recovery journey. The phone service involves trained and experienced Irish Heart Foundation staff and volunteers making regular calls to stroke survivors who have been referred by acute hospital stroke teams to check on their health and wellbeing. The service provides any information or advice patients require, answers their questions about recovery from stroke, and helps ensure they have everything they need to keep safe. For more information on the stroke support service please call 01 6685001 or email support@irishheart.ie Monday to Friday 9 am to 1 pm. The Irish Heart Foundation also offers a free nurse support line with trained nurses available on phone and email support Monday to Friday 9 am to 1 pm. Anyone living with heart disease and stroke who has concerns or questions can contact the nurse support line on 01 668 5001 or support@irishheart.ie. For more information on heart health or ways to get support please see
www.irishheart.ie
BE PREPARED WHEN SEIZURES STRIKE
BUCCOLAM® is indicated for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to <18 years).1 BUCCOLAM® must only be used by parents/carers where the patient has been diagnosed to have epilepsy. For infants between 3–6 months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. 1 Please consult the Buccolam® Summary of Product Characteristics (SmPC) before prescribing. BUCCOLAM (R) is indicated for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to <18 years). BUCCOLAM (R) must only be used by parents/carers where the patient has been diagnosed to have epilepsy. For infants between 3-6 months of age, treatment should be in a hospital setting where monitoring is References: 1. Buccolam®. Summary of Product Characteristics. possible and resuscitation equipment is available. Further prescribing information is available on request from Neuraxpharm or the Summary of Product Characteristics - eMail: medinfo@neuraxpharm.com or Tel.: +353 (1) 4688 202 Marketing Authorisation Holder: Laboratories Lesvi S.L. Avinguda Joan Despi, 08970 Barcelona, Spain. Marketing Authorisation Number: EU/1/11/709/001-004 Legal Classification: POM CD. Pricing Information: POA Adverse events should be reported to: medinfo@Neuraxpharm.com - Tel: +353 (1) 4688202 or the Health Products Regulatory Authority - www.hpra.ie – e: medsafety@hpra.ie Tel +353 (1) 676 4971 Fax: +353 1 6767836
Neuraxpharm is delighted to commence operations in Ireland
Many of us will suffer mental or neurological disorders at some point in our lives. The wellbeing of those suffering from these disorders is at the heart of what we do. This is why we investigate and develop new solutions.
Our commitment has led us to become a European leader in developing medicines for Central Nervous System disorders. We strive to support our doctors, pharmacists, nurses and the families affected.
Now that we have located in Ireland, we look forward to working as part of the Irish Healthcare System, supporting patients and healthcare professionals in reducing the impact of Central Nervous System disorders in the lives of patients.
44 Hepatitis C
HCV: The Global Battle Against Viral Disease
In 2020 the year that witnessed the most significant medical and scientific collaboration on a scale unprecedented in history, three scientists who made a pivotal contribution to the global fight against bloodborne hepatitis, Harvey J. Alter, Michael Houghton, and Charles M. Rice were jointly awarded the Nobel Prize in Physiology or Medicine 2020. Their efforts along with countless others have saved millions of lives as we continue the battle against viral diseases.
This battle permeated all of our lives in 2020, in an imposing, devastating, and unpredictable manner, the fallout of which, in terms of screening and treatment across many health domains, has yet to be determined. Early indicators suggest data concerning communicable diseases, such as HIV and Syphilis, show increased prevalence. Screening for blood-borne viruses has been greatly reduced and access to drop-in facilities remains a challenge as a result of infection control procedures. In Ireland, an estimated 2030,000 people are infected with HCV and 60% of those may be undiagnosed. That's roughly the size of the population of Mullingar, many of whom are unaware they have the disease, which is a major cause of cirrhosis and liver cancer. Hepatitis C is one of the leading sources of end-stage liver disease, HCC, and liver-related deaths in the western world. It is also one of the main indications for liver transplantation worldwide.
Drop-In HCV Treatments
The Number of people completing treatment for Hep C in Ireland fell to 110 in the first quarter of 2021, a sizable decline from the 354 in the same period in 2019 and the 193 in 2020 (*). Just 532 people commenced treatment in 2020 compared to 1,196 in 2019. According to Professor Jack Lambert, Consultant in Infectious Diseases and Genitourinary Medicine at Dublin’s Mater Hospital and UCD, “At the moment, we have probably had as many, if not more, new infections in the past five years as we have successfully treated,”. The untreated spread of HCV poses a significant challenge, particularly given the impact this virus has on socio-economically disadvantaged persons including PWIDs, prisoners, migrants, and the homeless. Taking into account that the model of care in Ireland is still centralised towards hospital clinics or specialist addiction services, linkages to care for those on the periphery including some of these marginalised groups is greatly reduced.
Scale Up Screening
Wider screening for at-risk groups particularly amongst certain age cohorts namely the baby boomer generation (those born between 1946 to 1964) as recommended by the CDC recommendation report in 2012, may provide an opportunity to identify hidden infections. According to the WHO, countries that are delivering successful elimination strategies are screening widely amongst at-risk groups. “Everyone should have a Hep C test once in their lifetime, probably during their forties, as is the case in the US, we must target other cohorts for screening,” said Professor Jack Lambert. In 2019 The National Hepatitis C Treatment Programme (NHCTP) led by Professor Aiden McCormick, published Community Treatment Guidelines which outlined details of the programme for trained level 1 and level 2 GP’s and community pharmacists. All participating GPs must be registered to prescribe methadone, and training is coordinated by the ICGP, PCRS, and hospital pharmacists. In 2020 11 patients started treatment in a pharmacy dispensing site (National Hepatitis C Treatment Registry Monthly Report). However, burgeoning evidence about micro elimination in at-risk groups has led to discussions between the NHCTP and various pharmacists in Ireland about initiating a pilot pharmacy-led programme. Growing evidence from Scotland, Australia, and the US suggest that pharmacists are in a unique position to increase access to care and improve health outcomes for patients with an HCV diagnosis.
Capacity building through shared care
We see this working successfully for many disease areas where this sharing of strengths, skills, and resources increases equality of access to care and reduces the heavy burden on primary care services. Pharmacists have a multitude of touchpoints to support national public health agendas in an age of growing demand for healthcare. The
Written by Kristy Hayes, Head of Advocacy, The Hepatitis C Partnership
fallout of COVID-19 will demand greater collaboration amongst healthcare professionals and with an estimated 85M visits a year, who are better placed than Irish Pharmacists to meet these demands. The hugely successful COVID-19 vaccine programme is a testament to the potential success of this approach.
Decentralised Models of Care
Initiation of this multidisciplinary approach must embrace a decentralized model of care as outlined by the WHO and The American Association for the Study of Liver Diseases (AASLAD), in terms of tackling the burden of HCV in our communities. Creating the necessary infrastructure for elimination requires crossdisciplinary approaches to increase screening, testing, and diagnosis. Recent evidence seems to suggest a more central role of pharmacists who benefit from existing relationships with patients. Andrew Radley, consultant in public health pharmacy at NHS Tayside in Scotland, and his team, have examined the efficacy of this pathway across 55 pharmacies involving 2718 patients who attended for OST. Staff from all sites received training on Good Clinical Practice, testing for BBVs as well as Information on Hepatitis C and its treatment. Pharmacists completed a pretreatment checklist of medical comorbidities, medical history, and concomitant medication to look for drug-drug interactions (DDIs), phlebotomy in the pharmacy determining suitability for treatment. Simplifying and expanding access enhanced HCV testing and increased treatment uptake in this pathway and treatment success mirrored that of the conventional pathway. Treatment success more than doubled across the board and significant capacity was added to secondary care settings which were also estimated to be more cost-effective.
In discussions with Andrew Radley earlier in the year, he stressed the importance of linking pharmacists with the care network and ensuring the buy-in of all pharmacy staff as key factors in achieving micro elimination. Approaches such as these provide a great
The Team of The Hepatitis C Partnership
Parnell Street
opportunity to deliver clinical services in line with public health, with Remuneration increasingly being based on clinic services as opposed to dispensing alone. Web-based applications will see prescriptions dispensed online and a paradigm shift for pharmacists as key providers in the primary care network look set to prevail in the landscape. In Tayside, community pharmacists are set to join OST teams later in the year to help integrate this model of care. The key take-home message here is related to the significance of relationships. The acknowledgment of the trusted relationship between pharmacists and their patients but also within their wider peer group. Pharmacists taking this leap of faith were supported, mentored and teams worked with them to establish this pathway. This relational empathy was applied to health promotion and harm reduction discussions during screening and treatment.
Relationships make a difference
It’s widely said that the quality of a patient's experience dictates concordance with healthcare advice. Peers, many of whom have lived experience of HCV are a key component of any successful community programme. Many of those with an HCV diagnosis are screened by peers and the trust ensuing from positive and often trauma-informed engagement leads to greater treatment success. “ I only found it I had Hep C in 2020 when I attend a Hep C session, I had a swab and I went to the hospital to give blood and they said yeah you have Hepatitis C, I reckon I had it for 30 years without knowing", said Michelle, HCV Peer with the Hepatitis C Partnership. Michelle, like many others, was engaged in a recovery programme and had never been tested for HCV until a peer worker from the Mater Hospital delivered an HCV awareness session. Linking peers into any future HCV pharmacyled initiative across various engagement points would seem essential for success.
Making HCV a rare disease
Models of care and indeed the success of our neighbours in Scotland should be considered in light of their elimination achievements. In 2020, the Tayside region encompassing about 416,090 people, became one of the first regions in the world to eliminate HCV. With a comparable population and great enthusiasm for knowledge sharing this model could see many of our barriers to engagement reduced if not eliminated. The recently published WHO Interim Guidance for Country Validation of Viral Hepatitis Elimination, provides a global framework for the validation of elimination and overall proposes the use of absolute impact targets to validate elimination at the national level for each country. The NHCTP is set to publish a revised and updated National Hepatitis C strategy, which is currently being reviewed by the department of health. The Hep C partnership, a national collaborative network of stakeholders working towards ensuring the elimination of Hepatitis C in Ireland, hopes to support these efforts through an initiative set to launch in November this year, called Roadmap to Zero. The purpose of the project is to identify the current operational Cascade of Care for Hepatitis C and to identify and progress following lines of inquiry towards the development of a Roadmap to Cure. We aim to align our objectives with those of the National Treatment Program to focus on filling gaps and ensuring the implementation of the national treatment guidelines. In doing so we will deliver a document that communicates this process as well as highlighting best practice initiatives for elimination. It is our responsibility to ensure that people who experience being marginalised are not excluded from the process and have access to information, support, and services that meet their needs. Our vision is to see a world free from liver-related diseases associated with Hepatitis C infection. We have received some fantastic feedback already from this initiative and we look forward to continued support from the pharmaceutical community. For more information please contact kristy@hepcpartnership.ie or visit www.hepcpartnership.ie.
Ireland is not among the 11 countries worldwide on track meet to meet Hepatitis C elimination targets by 2030, warns Kristy Maclean Hayes, Head of Advocacy with the Hepatitis C Partnership. Picture: Marc O'Sullivan
Henry Place
Earl Plac e Prince’s Street North Sackville Place
O’Connell St reet Sto re St reet Foley Street Amiens Str eet Marlborough Place ey Street Aston QuayBachelor’s Walk O’Connell St reet RIVER LIFFEY Eden Quay Lower Abbey Street City Quay Fleet Street
Cathal Brugha Street James J o yce St reet Mabb ot Lan e Cathedral Street Talbot Street Custom House Quay
Talbot Street
BurghQuay
D’ Olier StreetMAVIRET® is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and not recommended in patients with moderate hepatic impairment (Child-Pugh B).1 * Refers to GT 1–6, excluding decompensated cirrhotic patients and liver or kidney transplant recipients. MAVIRET® is not indicated in decompensated cirrhosis. The recommended duration of MAVIRET® is 12 weeks in liver or kidney transplant recipients, with or without cirrhosis.1 ‡ Tablets should be swallowed whole, taken at the same time with food and not chewed, crushed, or broken.1 ITT = intent-to-treat
GPs REGISTERED TO PRESCRIBE METHADONE CAN NOW BE TRAINED TO TREAT HEPATITIS C IN THE COMMUNITY1,2 8 WEEKS: THE SHORTEST
ROUTE TO CURE† Treatment-naÏve Hepatitis C patients without cirrhosis or with compensated cirrhosis*
98%
SINGLE 8-WEEK DURATION for treatment-naïve patients1* HIGH CURE† RATES (98%) all genotypes, treatment-naïve (n=1218/1248, ITT)3 ONCE-DAILY DOSING (3 tablets) with food1‡ 0.2% discontinuation rate due to adverse reactions3 The most common adverse reactions (≥10% prevalence) were headache and fatigue3
† Cure = sustained virologic response (SVR12), defined as HCV RNA less than the lower limit of r quantification at 12 weeks after the end of treatment and was the primary endpoint in all the studies.1
Temple BarMaviret®▼ 100mg/40mg film-coated tablets PRESCRIBING INFORMATION. PRESENTATION: Each film-coated tablet contains 100 mg glecaprevir and 40 mg pibrentasvir. Please refer to the Summary of Product Characteristics (SmPC) before prescribing. INDICATION: For treatment of Chronic Hepatitis C Virus (HCV) in adults and in adolescents aged 12 to <18 years. DOSAGE AND ADMINISTRATION: Oral. Treatment to be initiated and monitored by physician experienced in the management of patients with HCV infection. See SmPC for full posology. Dosage: Adults and adolescents aged 12 to <18 years: The recommended dose of Maviret is 300 mg/120 mg (three 100 mg/40 mg tablets), taken orally, once daily at the same time with food. Treatment Duration: Patients without prior HCV therapy (GT 1, 2, 3, 4, 5, 6): No cirrhosis: 8 weeks. Cirrhosis: 8 weeks. Patients who failed prior therapy with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin: GT 1, 2, 4-6: No cirrhosis: 8 weeks. Cirrhosis: 12 weeks. GT 3: No cirrhosis: 16 G raf t on S t r e e t College Greenweeks. Cirrhosis: 16 weeks. Special Populations: HIV-1 Co-infection: Follow the dosing recommendations as above. For dosing recommendations with HIV antiviral agents, refer to SmPC for additional information. Elderly: No dose adjustment required. Renal impairment: No dose adjustment required. Hepatic impairment: No dose adjustment recommended in patients with mild hepatic impairment (Child-Pugh A). Maviret is not recommended in patients with moderate hepatic impairment (Child-Pugh B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Liver or kidney transplant patients: 12 weeks in liver or kidney transplant recipients with or without cirrhosis, with 16 week treatment duration to be considered for GT 3-infected patients who are treatment experienced Suffolk Street with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin. Paediatric Population: No dose adjustment required in adolescents aged 12 to <18 years. The safety and efficacy of Maviret in children aged less than 12 years have not yet been established. Diabetic Patients: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral treatment. Glucose levels of diabetic patients initiating direct acting antiviral therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary. CONTRAINDICATIONS: Hypersensitivity to the active substances or to any of the excipients. Patients with severe hepatic impairment (Child-Pugh C). Concomitant use with atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John’s wort (Hypericum perforatum), phenobarbital, phenytoin, and primidone). SPECIAL WARNINGS AND PRECAUTIONS: Hepatitis B Virus reactivation: HBV screening should be performed in all patients before initiation of treatment. HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines. Hepatic impairment: Maviret is not recommended in patients with moderate hepatic impairment (Child-Pugh B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients who failed a prior regimen containing an NS5A- and/or an NS3/4A-inhibitor: GT 1-infected (and a very limited number of GT 4-infected) patients with prior failure on regimens that may confer resistance to glecaprevir/pibrentasvir were studied in the MAGELLAN-1 study. The risk of failure was, as expected, highest for those exposed to both classes. A resistance algorithm predictive of the risk for failure by baseline resistance has not been established. Accumulating double class resistance was a general finding for patients who failed re-treatment with glecaprevir/pibrentasvir in MAGELLAN-1. No re-treatment data is available for patients infected with GT 2, 3, 5 or 6. Maviret is not recommended for the re-treatment of patients with prior exposure to NS3/4A- and/or NS5A-inhibitors. Lactose: Maviret contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. INTERACTIONS: See SmPC for full details. Contraindicated: Dabigatran etexilate, carbamazepine, phenytoin, phenobarbital, primidone, rifampicin, ethinyloestradiolcontaining products, St. John’s wort, atazanavir, atorvastatin, simvastatin. Not Recommended: darunavir, efavirenz, lopinavir/ ritonavir, lovastatin, ciclosporin doses > 100 mg per day. Use Caution: digoxin, pravastatin, rosuvastatin, fluvastatin, pitavastatin, tacrolimus. Monitor Levels: Digoxin, Monitor INR with all vitamin K antagonists. No dose adjustment: Losartan, valsartan, sofosbuvir, raltegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, levonorgestrel, norethidrone or norgestimate as contraceptive progestogen. FERTILITY, PREGNANCY AND LACTATION: Maviret is not recommended Pearse Street in pregnancy. It is not known whether Maviret and its metabolites are excreted in breast milk. No human data on the effect of glecaprevir and/or pibrentasvir on fertility are available. SIDE EFFECTS: See SmPC for full details. Very common side effects (≥1/10): headache, fatigue. Common side effects (≥1/100 to <1/10): diarrhoea, nausea, asthenia. Frequency not known (cannot be estimated from the available data): pruritus. ▼ This medicinal product is subject to additional monitoring. This will allow
quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; website: www.hpra.ie. Suspected adverse events should also be reported to AbbVie Limited on 01-4287900.
LEGAL CATEGORY: POM(S1A) MARKETING AUTHORISATION NUMBER/ PRESENTATIONS: EU/1/17/1213/001 – blister packs containing 84 (4 x 21) filmcoated tablets. MARKETING AUTHORISATION HOLDER: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany. Further information is available from AbbVie Limited, 14 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. DATE OF REVISION: January 2020. PI/1213/008.
Life is a health journey Life is a health journey
with its ups and downs, and its challenges. These can be big or small, lifelong or temporary. Everyone, from childhood to old age, faces health challenges and needs, wherever they are. with its ups and downs, and its challenges. These can be big or small, lifelong or temporary. Everyone, from childhood to old age, faces health challenges and needs, wherever they are. We, at Sanofi, are dedicated to supporting people through their health challenges. We, at Sanofi, are dedicated to supporting people through their health challenges. As a global biopharmaceutical company, our passion is to prevent illness with vaccines, provide treatments to fight pain, and we stand by the few who suffer from rare disease as well as the millions with long-term chronic conditions. As a global biopharmaceutical company, our passion is to prevent illness with vaccines, provide treatments to fight pain, and we stand by the few who suffer from rare disease as well as the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, we transform scientific innovation into healthcare solutions around the globe. With more than 100,000 people in 100 countries, we transform scientific innovation into healthcare solutions around the globe. Our patients inspire us to pioneer. Our patients inspire us to pioneer.
