HELPING TO TREAT DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM AND PREVENT THEIR RECURRENCE PATIENT INFORMATION BOOKLET IF FOUND, PLEASE RETURN TO: If found, please return to: Name Address Phone number
It is important that EVERY HEALTHCARE PROFESSIONAL treating you is aware that you are taking a medicine to help treat and/or prevent blood clots. PATIENT ALERT CARD PLEASE ASK YOUR DOCTOR TO FILL IN THIS CARD AND CARRY IT WITH YOU IN YOUR WALLET OR PURSE. 2
ELIQUIS INFORMATION BOOKLET You have been given this booklet because you have been prescribed ELIQUIS (apixaban) to treat and/or prevent blood clots in some of the veins in your legs (called deep vein thrombosis) or in your lungs (called a pulmonary embolism), and to help reduce the risk of their recurrence. Sometimes you will hear both these conditions referred to as venous thromboembolism or VTE. This booklet explains how these blood clots occur, and how ELIQUIS works to help treat them and prevent them from re-occurring. You should also read the Consumer Medicine Information leaflet provided inside your pack of ELIQUIS. 3
CONTENTS ABOUT DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) 6 TAKING ELIQUIS FOR DVT/PE 18
WHAT IS DEEP VEIN THROMBOSIS (DVT)? Blood clots occur when blood pools and blood cells clump together. Your body naturally forms blood clots to stop bleeding at sites of injury. However, sometimes unwanted blood clots can form inside the big veins deep in your legs, leading to health problems. This is called deep vein thrombosis (a blood clot is known medically as a thrombosis). 6
DEEP VEIN THROMBOSIS CLOT FORMS IN LEG 7
WHAT IS A PULMONARY EMBOLISM (PE)? Pulmonary embolism (PE) is often a complication of deep vein thrombosis (DVT), whereby a clot in the veins of the thigh (or a part of it) breaks loose, travels through your blood vessels and becomes lodged in the pulmonary artery the main passage for blood flow to your lungs. If the clot is large enough to completely block the pulmonary artery, it can lead to death. PE is less common that DVT about half those with an untreated DVT develop PE within 3 months of the DVT. 1,2 PE is more serious than DVT and can be fatal if not immediately diagnosed and treated. 8
4 CLOT BLOCKS BLOOD VESSELS IN LUNGS 4 3 2 CLOT TRAVELS TO LUNGS CLOT BREAKS AWAY 3 2 1 1 CLOT FORMS IN LEGS 9
HOW DO I KNOW IF I HAVE A DVT? DVT can be difficult to diagnose as the symptoms are non-specific and can be similar to having muscle pain or soreness from cramp or a muscle strain. Symptoms may start suddenly or develop slowly over days and weeks. In some instances, there may be no symptoms at all. Possible symptoms of DVT may include: PAIN TENDERNESS SWELLING CHANGE IN SKIN COLOUR (blue/red/purple) WARMTH ON THE AFFECTED LIMB 10
HOW DO I KNOW IF I AM EXPERIENCING A PE? The symptoms of a PE depend on how badly the pulmonary artery is blocked. You may not have any symptoms and if you do, they may be non-specific and similar to conditions like pneumonia or a heart attack. If you do have symptoms they could include the following: Shortness of breath/difficulty breathing Chest pain/ discomfort A faster than normal or an irregular heartbeat, or low blood pressure Cough (with/without blood-stained mucus) Dizziness If you experience any of these symptoms, seek immediate medical assistance PE, pneumonia and heart attacks can all be fatal if not treated promptly. 11
WHAT CAUSES DVT? A DVT is generally caused by a combination of risk factors. The more risk factors you have, the higher your chances of a DVT. Below are some examples of risk factors. SLUGGISH BLOOD FLOW Long periods of physical inactivity can reduce the flow of blood through your veins, leading to increased risk of DVT. Inactivity may be a result of: > Recent major surgery (within 3 months) > Injury (within 3 months) > Long periods of sitting > Lying in bed for more than 3 days There is some evidence that long-haul travel over 8 hours duration may increase the risk of DVT if you already have risk factors for a DVT (for example, if you are pregnant or have already had a stroke). 12
HAVING BLOOD THAT CLOTS QUICKLY > Due to increased oestrogen levels caused by pregnancy (including up to 6 weeks after birth), taking the contraceptive pill or hormone replacement therapy > Due to an inherited blood clotting disorder or having stickier blood than normal OTHER MEDICAL RISK FACTORS > A chronic heart, lung or kidney disease > Certain cancers and cancer treatments PERSONAL RISK FACTORS > A personal or family history of clotting problems or DVT/PE > Smoking > Being overweight (BMI greater than 30 kg/m 2 ) > Being over 60 years of age 13
WHAT ARE THE COMPLICATIONS OF DVT? A serious long-term complication of DVT, aside from PE, is post-thrombotic syndrome (PTS), which has been estimated to affect between 23% and 60% of individuals who develop DVT. 3 PTS is most common within two years of a DVT episode, and occurs when the tiny valves in your leg that control the direction of blood flow are damaged by the blood clot. The damaged valves become leaky, so some blood flows the wrong way causing fluid to pool in your ankle. This leads to swelling, pain, discolouration and leg ulcers. PTS IS MORE LIKELY TO OCCUR IF: > The blood clot is above the knee > You get more than one clot in the same leg more than once > You are overweight COMPRESSION STOCKINGS MAY REDUCE THE RISK OF PTS Wearing elastic compression stockings creates a gentle pressure that improves your circulation by helping to move blood up your leg(s). Compression stockings may also be recommended or prescribed to relieve pain and swelling caused by DVT. 14
WHAT ARE THE COMPLICATIONS OF PE? PE causes the pressure inside the lungs to increase. The clot lodged in the pulmonary artery narrows the artery, raising the blood pressure in the artery. This complication of PE is called chronic thromboembolic pulmonary hypertension (CTEPH). Following PE, approximately 3 5% of people will experience CTEPH. 1,4,5 Early symptoms of CTEPH can be similar to those of PE and include the following: SHORTNESS OF BREATH RACING HEARTBEAT CHEST PAIN TIREDNESS If you experience any of these symptoms following a PE, seek immediate medical assistance CTEPH can cause other medical conditions and may be fatal. 15
IS MY DVT/PE LIKELY TO RE-OCCUR AND HOW CAN I REDUCE THE RISK OF RECURRENCE? If you have DVT/PE, the chance of having a recurrence in the first few months is high. Approximately one-third of people who have had DVT/PE will experience another one within 10 years. 6 Even in people who no longer have DVT/PE risk factors (e.g. have recovered from surgery), DVT/PE reoccurs in about 3% of people a year once anticoagulation therapy has stopped. 1 People who have DVT/PE and are not treated may be at higher risk of developing other vascular problems such as a heart attack or stroke. 7 ANTICOAGULANT MEDICATION Your doctor has given you a blood-thinning medication, called an anticoagulant, to prevent clots from forming. The main risk of taking any anticoagulant medication is bleeding either externally (e.g. nose bleed) or internally (e.g. in your stomach or brain). Your doctor has carefully weighed up your risk of having another DVT/PE against your risk of bleeding. If you have any questions concerning this, talk to your doctor. 16
LIFESTYLE Along with taking your medications as advised by your doctor, staying healthy may help to reduce your risk of DVT/PE recurrence. EATING WELL eat a healthy, high-fibre, low-fat diet and limit processed foods and alcohol EXERCISE REGULARLY and avoid sitting for long periods of time. Before starting any new form of exercise, remember to check with your doctor first to ensure it is safe to do so LOSE EXCESS BODY WEIGHT QUIT SMOKING OTHER MEDICATIONS Some medications, such as oral contraceptives and hormone replacement therapy, may increase your risk of blood clots. Be sure to let your doctor know if you are taking any other medications. RECOGNISING DVT AND PE SYMPTOMS Familiarise yourself with the common symptoms of DVT and PE, as described in this booklet. Early recognition, diagnosis and prompt treatment of DVT/PE is vital. 17
WHAT IS ELIQUIS The active substance in ELIQUIS is apixaban. It belongs to a group of medicines called antithrombotic agents. It works by inhibiting a blood clot forming substance called Factor Xa. ELIQUIS DOSING Your doctor has carefully assessed you and has decided to prescribe the anticoagulant ELIQUIS to treat your DVT or PE, or to reduce your risk of having another one. TREATMENT OF DVT/PE The recommended dose of ELIQUIS for initial treatment of DVT/PE is two 5mg tablets twice daily for the first 7 days followed by one 5mg tablet twice daily for ongoing treatment. Your doctor will likely continue you on this regimen for up to 6 months (duration of overall therapy will vary between patients). TWO 5mg TABLETS TWICE DAILY ONE 5mg TABLET TWICE DAILY MORNING NIGHT MORNING NIGHT Tablets are not actual size. 7 DAYS 6 MONTHS 18
PREVENTION OF RECURRENT DVT/PE The recommended dose of ELIQUIS to prevent recurrence of DVT/PE is one 2.5mg tablet twice daily after at least 6 months of anticoagulant treatment for DVT or PE. ONE 2.5mg TABLET TWICE DAILY MORNING NIGHT 6 MONTHS PREVENTION OF DVT/PE FOLLOWING ELECTIVE HIP OR KNEE REPLACEMENT SURGERY If you are having total hip or knee replacement surgery, you may be prescribed 2.5mg of ELIQUIS twice daily following your surgery for up to 38 days. Following total hip or knee replacement surgery, the recommended dose of ELIQUIS is one 2.5mg tablet taken twice daily. The initial dose should be taken 12 to 24 hours after surgery. In patients undergoing hip replacement surgery, the recommended duration of treatment is 32 to 38 days. In patients undergoing knee replacement surgery, the recommended duration of treatment is 10 to 14 days. 19
20 HOW TO TAKE ELIQUIS
You should swallow the ELIQUIS tablet whole with a glass of water. If you have difficulty swallowing tablets, talk to your doctor. ELIQUIS can be taken with or without food. If necessary, ELIQUIS tablets may be removed from the blister pack for use in dose-administration aids. To help you remember, try to fit taking your tablets with a normal routine that happens twice a day (e.g. cleaning your teeth). You should also read the Consumer Medicine Information leaflet that came with your pack of ELIQUIS. 21
HOW LONG DO I NEED TO TAKE ELIQUIS FOR? The length of treatment with ELIQUIS for DVT/PE will vary from person to person. Your doctor will carefully assess the benefits and risks of treatment before determining an appropriate treatment duration. You should always follow your doctor s instructions and continue to take your medication for as long as your doctor has told you to do so. Do not stop taking your medicine or lower the dose without first checking with your doctor. If you stop taking ELIQUIS suddenly, you may increase your risk of developing a blood clot. 22
WHAT SHOULD I DO IF I MISS A DOSE? If you miss a dose of ELIQUIS, take the medicine as soon as you remember and then take the next tablet of ELIQUIS at the usual time, then continue as normal. Do not take a double dose to make up for the forgotten tablet. If you are not sure what to do, ask your doctor or pharmacist. Do not run out of ELIQUIS refill your prescription before you run out. 23
WHAT SHOULD I DO IF I TAKE TOO MUCH ELIQUIS? Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 for advice, or go to the Accident and Emergency Department at the nearest hospital. Do this even if there are no signs of discomfort or poisoning. Take the medicine pack with you, even if there are no tablets left. You may need urgent medical attention. Symptoms of an overdose may include bleeding that does not stop. There is currently no antidote for ELIQUIS. 24
THINGS TO BE AWARE OF WHEN TAKING ELIQUIS INFORM YOUR DOCTOR AND/OR DENTIST: If you are having any surgical or dental procedures; your doctor or dentist may need to reduce your dose or temporarily stop you taking ELIQUIS. About all medicines you are taking, including herbal remedies (e.g. St John s Wort) and medicines you bought yourself at the pharmacy (e.g. aspirin). This is because certain medicines and supplements can interfere with the blood-thinning effects of ELIQUIS, increasing the risk of bleeding or making it less effective. Some of these medicines are listed in the Consumer Medicine Information leaflet that comes in your ELIQUIS pack. If you are pregnant or breastfeeding, have liver disease or a bleeding disorder as you should not be prescribed ELIQUIS. 25
POSSIBLE SIDE EFFECTS Like all medicines, ELIQUIS can cause side effects, although not everybody gets them. Like other anticoagulants, ELIQUIS may cause bleeding that may potentially be life-threatening and require immediate medical attention. Tell your doctor or pharmacist about any side effects that you experience, even if they are not listed in the Consumer Medicine Information leaflet or in this booklet. 26
OTHER COMMON SIDE EFFECTS INCLUDE: BRUISING BLOOD IN THE URINE (that stains the urine pink or red) NAUSEA (feeling sick) A list of some possible side effects can be found in the Consumer Medicine Information leaflet inside your pack of ELIQUIS. 27
28 NOTES
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30 NOTES
eliquis.com.au For further information on ELIQUIS, download the Pfizer Meds app available on the App Store References: 1. Kearon C. Circulation 2003; 107 (Suppl 1): I22 I30. 2. Ho WK. Aust Fam Physician 2010; 39(7): 468 474. 3. Ashrani AA, Hiet JA. J Thromb Thrombolysis 2009; 28: 465 476. 4. McNeil K, Dunning J. Heart 2007; 93: 1152 1158. 5. Pengo V et al. N Engl J Med 2004; 350: 2257 2264. 6. Centers for Disease Control and Prevention. Venous thromboembolism (blood clots): Data and statistics. www.cdc.gov/ncbddd/dvt/data.html (updated June 22 2015; accessed 3 January 2017). 7. Goldhaber SZ, Bounameaux H. Lancet 2012; 379: 1835 1846. 31
Bristol-Myers Squibb Australia Pty Ltd. ABN 33 004 333 322. Level 2, 4 Nexus Court, Mulgrave VIC 3170 Australia. Pfizer Australia Pty Ltd. 38 42 Wharf Road, West Ryde NSW 2114 Australia. Registered trademark. McCann Health 10683177. PP-ELI-AUS-0424. 432AU1700026-01. February 2017.