Crohn’s disease (CD) belongs to a group of diseases collectively called Inflammatory Bowel Disease (IBD) which also includes Ulcerative Colitis (UC). It is a chronic disease that can cause inflammation anywhere from the mouth to the anus anywhere along the lining of the digestive tract. It most commonly affects the small intestine and the colon. The disease can show up along different parts of the digestive tract in a continuous or patchy distribution. It typically involves both the superficial and deep layers of the intestinal wall
Symptoms of CD
Symptoms of CD depend on the severity and location of the intestinal inflammation and can range from none or mild, to severe. Symptoms may develop gradually or come on suddenly, without warning. Abdominal pain and cramping, persistent diarrhea (loose, watery, numerous bowel movements), blood in the stool and fever are hallmark symptoms of CD. Ulcers of the mouth, a lack of appetite, fatigue, nausea and vomiting and unexplained weight loss may also develop. With severe diarrhea and the digestive tracks’ inability to absorb nutrients, nutritional deficiencies may occur over time
Causes of CD
We do not yet know an exact cause of CD. Similar to other chronic inflammatory disorders (e.g. asthma, rheumatoid arthritis, psoriasis, multiple sclerosis) there is a complex interaction between an individual’s genetic make-up, their immune system and foreign substances in the environment (including dietary factors and microbes living in our gut) that are responsible for the chronic uncontrolled inflammation in CD. The impact of the various factors (genes, immune system and environment) are different for each individual accounting for the broad spectrum of how patients present with inflammation in different segments of the intestine and in various degrees of severity. Unfortunately, it appears as if once this inflammatory process is set in motion it cannot be regulated or reversed by the body itself
Who gets CD and how common is it?
Men and women appear to be affected equally. Symptoms usually start between the ages of 15-35 but can develop at any time during one’s lifetime. It used to be thought that CD predominantly affects Caucasians in North America and Western Europe, however, we now see individuals being diagnosed with CD in populations from South America, Africa and Asia where the disease was unheard of 20 years ago. CD can run in families and having a sibling or another first degree relative afflicted with the disease can increase the risk of developing the disease by ten to fifteen times as compared to the general population. However, more than 80% of patients with CD do not have a recognized genetic disposition. Given the complex genetic makeup the disease it is not inherited in the classic sense. Smoking is an important controllable risk factor in CD. People who smoke with this disease tend to have more severe forms of the disease and are at higher risk of needing surgery. People who live in industrialized countries and urban areas are also at elevated risk of having the disease. Some other factors including the use of medications such as non-steroidal anti-inflammatory drugs (aspirin-like drugs) and particular infections have been theorized to exacerbate or cause the disease although none have been shown in a consistent fashion to be the cause
How is CD diagnosed?
There is no single test to confirm the diagnosis of CD. Instead, multiple tests are usually used in combination to help arrive at the diagnosis depending on the symptoms that lead individuals to seek care. Ultimately, a colonoscopy or flexible sigmoidoscopy must be performed to directly visualize the intestine internally and to obtain small tissue samples (biopsies) for evaluation under the microscope. Other imagines studies can be used in conjunction with a colonoscopy to help in the evaluation including a barium enema, upper gastrointestinal series (UGI series) with small bowel follow through, computerized tomography scans (CT scans or ‘cat scans’), magnetic resonance imaging (MRI) or a pill camera study (capsule endoscopy) but are not mandated. Blood tests which look for antibodies and markers of inflammation along with stool specimen tests for hidden blood and infection may also be used to help confirm or exclude the diagnosis of CD
What are the complications of CD?
CD may cause symptoms outside the digestive tract including: inflammation of the eye (conjunctivitis, episcleritis, uveitis, iritis), inflammation of joints (arthritis), weakening of bones (osteoporosis), skin rashes (erythema nodosum, pyoderma gangrenosum), inflammation of the liver or bile ducts (primary sclerosing cholangitis), kidney stones, gallstones and in children, delayed growth or sexual development due to the use of steroids, malnutrition and malabsorption. Crohn’s disease may also lead to several complications over time which may be related to the disease or due to the effects of medications used to treat the disease.
Listed below are some of the common complications:
- Anal fissure. A crack, or cleft, in or around the skin of the anus which lead to painful bowel movements, blood in the stool and sometimes drainage around the anal canal.
- Ulcers. Chronic inflammation can lead to open sores (ulcers) anywhere in the digestive tract, including the mouth, genital area (perineum) and anus.
- Fistulas. Sometimes ulcers can extend completely through the intestinal wall, creating a fistula — an abnormal tunnel between different parts of the intestine, between the intestine and skin or other organs, such as the bladder or vagina. These abnormal connections affect up to a third of patients with CD. Internal connections lead to diversion of food contents while external connections can lead to drainage and infections. When a course of medical therapy fails, surgery may be necessary to fix these abnormal connections.
- Bowel obstruction. Due to inflammation over time, parts of the bowel could form scar tissue resulting in a thickening and narrowing of the bowel, which may block the flow of digestive contents through the affected part of the intestine. Medications may be of help in decreasing the inflammation and opening up the narrowed areas but some cases require surgery to remove the disesed portion of the bowel.
- Malnutrition. Symptoms of diarrhea, pain and cramping may make it difficult to eat. In addition, inflammation of the intestine can decrease absorption of vital nutrients needed to maintain nourishment. Deficiencies of proteins, calories and vitamins may occur over a prolonged period of time. Vitamin B-12 and iron deficiency frequently lead to anemia in patients with malnutrition.
- Colon cancer. Patients with Crohn’s disease that involves the colon do have an increased risk of colon cancer depending upon the amount of the colon that is affected and the duration of disease. Less than 5% of patients develop colon cancer although this is higher than the general population. Therefore, after approximately 8 years from the start of symptoms a colonoscopy is performed every 1 to 2 years to look for precancerous changes called dysplasia. Identifying dysplasia allows the potential to remove dysplastic growths (polyps) prior to the development of cancer
What are different types of treatment for CD?
Currently, there is no cure for CD and the goal of treatment is to alleviate symptoms, prevent complications and improve quality of life. This can be achieved through suppression of the body’s immune response which is paramount to allow the intestinal tissue to heal and retain its normal function. Initially, the goal is to induce remission, which is to bring the symptoms under control. Once this step is achieved, medical therapy is used to maintain remission with the goal of decreasing the frequency of disease flares. Several groups of drugs are used to treat Crohn’s disease and are listed below:
- Aminosalicylates (5-ASA): This class of anti-inflammatory drugs is often used to treat mild to moderate symptoms in the colon and includes oral formulations of sulfasalazine and mesalamine and drugs that may be administered rectally.
- Corticosteroids: This class of medications has a general, nonspecific effect of suppressing the entire immune system and is used to treat moderate to severe forms of the disease. Prednisone, budesonide and methylprednisolone are most commonly used. These are drugs that are best utilized short-term to alleviate major flares of the disease and due to side effects, these should not be used for maintenance therapy. Owing to a significantly increased risk of osteoporosis with the use of corticosteroids, a baseline DEXA scan should be performed at the initiation of therapy. Supplementation of calcium and vitamin D, and consideration of a bisphosphonate are also warranted.
- Immune modifiers: Azathioprine, 6-MP, cyclosporine A and methotrexate alter the immune system and are also referred to as immunomodulators, used to help decrease exposure to corticosteroids, maintain disease remission and to help heal fistulas.
- Antibiotics: These are classically used to treat perianal disease, abscesses and sometimes acute flares of the disease. Metronidazole and ciprofloxacin are the most commonly used.
- Biologic therapies: This newer group of medications was first approved in 1998 for moderate to severe CD that did not respond to conventional therapy or to treat fistulae. These medications work by blocking specific chemical messages between immune cells. Biologics, like ADALIMUMAB, used in treating moderate to severe Crohn’s disease specifically target a protein called tumor necrosis factor (TNF) to help reduce the symptoms of Crohn’s.
What is the clinical course and prognosis in CD?
Most people with CD with the proper medical care tend to live healthy, productive lives with a normal life span. Maintenance of remission and surveillance for complications are the major goals which lead to maintaining quality of life in patients with CD. Regular visits with a gastroenterologist and developing a longstanding relationship are vital to managing this disease
What is Ulcerative Colitis?
Ulcerative colitis (UC) is a disease marked by inflammation of the lining of the colon and rectum, together known as the large intestine. This inflammation causes irritation in the lining of the large intestine which leads to the symptoms of UC. Though UC always affects the lowest part of the large intestine (the rectum), in some patients it can be present throughout the entire colon. UC belongs to a group of diseases called inflammatory bowel diseases which also includes Crohn’s disease (CD). Though it was once thought that UC and CD were two different diseases, as many as 10% of patients may have features of both diseases and this is called indeterminate colitis. It is important to note that inflammatory bowel disease (IBD) is different from irritable bowel syndrome (IBS).
Symptoms of UC
The symptoms of ulcerative colitis depend on the severity of inflammation and the amount of the colon that is affected by the disease. In patients with mild to moderate inflammation, symptoms can include rectal bleeding, diarrhea, mild abdominal cramping, stool urgency, and tenesmus (discomfort and the feeling that you have not completely emptied your rectum after a bowel movement). When more severe inflammation is present, patients often develop fever, dehydration, severe abdominal pain, weight loss, loss of appetite or growth retardation (in children and adolescents with UC). Individuals with moderate or severe inflammation may also have to wake up at night to have bowel movements and may lose control of bowel movements. Some of the symptoms of UC may be non-specific and could be caused by other diseases such as Crohn’s disease, irritable bowel syndrome, or infection. Your doctor can help determine the cause of your symptoms and should be consulted should you experience a significant change in your symptoms.
Causes of UC
The way in which patients get ulcerative colitis is still poorly understood. There seems to be an interaction between the unique genetic makeup of an individual, environmental factors, and a patient’s specific immune system that triggers the disease. UC is not an infection that can be passed from person to person. Men and women are equally affected by UC. UC is more common in first degree relatives (siblings, parents, and children) of patients affected by UC and up to 20% of patients will have an affected family member. Despite the influence of genetics, the majority of patients with UC do not pass the disease to their children. There is no way to predict those at higher risk. Cases of ulcerative colitis have been identified throughout the world though certain populations, including those living in Northern climates and those of Jewish descent, are at higher risk of developing UC. Individuals having their appendix removed prior to the age of 20 appear to be at lower risk of developing UC. No specific infectious agent has been linked to UC and diet, breast feeding, and various medications have also been examined but none have been found to cause UC. It has been observed that smokers have lower rates of UC than non-smokers. Furthermore, those who smoke and have UC tend to have a milder course of UC than those who do not smoke (note that this is the exact opposite effect that smoking has on Crohn’s disease). Despite the protective role smoking appears to have on the development and natural history of UC, it is not recommended that patients start smoking to prevent UC due to the fact that there are so many other illnesses and cancers in which smoking is a definite risk factor. UC is an immune-mediated disease in which there is loss of control of the normal bowel immune activity and the ongoing activity results in damage to the bowel wall
How is UC diagnosed?
Your doctor will usually suspect the diagnosis of ulcerative colitis based on your symptoms, but confirmation of the diagnosis requires testing. Blood work is often checked to look for markers of inflammation or anemia (low blood counts), though these tests can be normal in patients with mild disease. Tests of your stool to look for evidence of an intestinal infection are often obtained. Radiologic images including x-rays and CT scans are usually not recommended but may be performed. All patients with symptoms consistent with UC should have a colonoscopy or flexible sigmoidoscopy to confirm the diagnosis assuming that they are healthy enough to undergo the procedure. During this procedure, your gastroenterologist will be able to directly examine the lining of your colon and rectum to look for evidence of inflammation and take small biopsies to be examined under a microscope to look for the cause of the inflammation.
What are the complications of UC?
The complications of ulcerative colitis can be divided into those affecting the colon and those occurring outside of the colon. Within the colon, UC can rarely lead to toxic megacolon or colon cancer. Toxic megacolon describes a severe disease flare with a high risk of infection and colonic perforation (holes in the colon). Patients may occasionally present with toxic megacolon as their initial presentation of UC and this complication requires hospitalization and may lead to surgery to remove the colon (colectomy). UC is known to increase the risk of colon cancer. Those patients who have had UC for a long time and those with a longer length of the colon affected are at higher risk of developing colon cancer. In general, patients begin to have an increased risk of colorectal cancer 10 years after the onset of disease symptoms and should have colonoscopy every one or two years starting at this time. Colon cancer is a rare complication and it is thought that it may be preventable based on control of inflammation of the colon and careful colonoscopy examinations that look for any pre-cancerous changes called dysplasia. Overall, the risk of colon cancer increases 0.5% yearly after 10 years of disease though patients with inflammation throughout their colon may be at higher risk. Those patients with primary sclerosing cholangitis (PSC) are at greatest risk for colon cancer and need to start screening upon diagnosis. Patients with UC are also at risk for extra-intestinal manifestations of UC (complications outside of the colon). These complications most frequently involve the liver, skin, eyes, mouth, and joints. Within the liver, patients with UC may develop primary sclerosing cholangitis. This occurs in about 3% of patients with UC. Patients with UC can develop sores in the mouth or rashes on the skin that generally only appear when UC colon symptoms are active. The most common rashes that are seen in UC are erythema nodosum (EN) and pyoderma gangrenosum (PG). EN usually presents as a red, raised, painful area most commonly on the legs and is most often seen during flares of UC. PG also presents as raised lesions on the skin (most frequently on the legs) that often develops after trauma to the skin and can lead to the formation of ulcers. Unlike in EN, the appearance of skin lesions in PG may or may not mirror the activity of bowel symptoms. The eyes can become red and painful (uveitis) and vision problems should be reported to your doctor. Arthritis is commonly associated with UC and can affect either small (such as the fingers/toes) or large joints (often the knee), though involvement of the smaller joints may have a course that is not related to activity in the colon. The joints of the spine can be affected as well, though this is less common than it is in Crohn’s disease. As in other chronic medical conditions, anxiety and depression are common in patients with UC. The unpredictability of UC and the need to take medications on a daily basis can lead to feelings of frustration or anger. Though occasional feelings of frustration can be normal, feelings of significant anxiety or depression should be brought to the attention of your physician.
What are different types of treatment for UC?
Medical treatment of ulcerative colitis generally focuses on two separate goals: the induction of remission (making a sick person well) and the maintenance of remission (keeping a well person from getting sick again). Surgery is also a treatment option for UC and will be discussed separately. Medication choices can be grouped into four general categories: aminosalicylates, steroids, immunomodulators, and biologics. Aminosalicylates are a group of anti-inflammatory medications (sulfasalazine, mesalamine, olsalazine, and balsalazide) used for both the induction and maintenance of remission in mild to moderate UC. These medications are available in both oral and rectal formulations and work on the lining of the colon to decrease inflammation. They are generally well tolerated. The most common side effects include nausea and rash. Rectal formulations of mesalamine (enemas and suppositories) are generally used for those patients with disease at the end of their colon. Steroids (prednisone) are an effective medication for the induction of remission in moderate to severe UC and are available in oral, rectal, and intravenous (IV) forms. Steroids are absorbed into the bloodstream and have a number of severe side effects that make them unsuitable for chronic use to maintain remission. These side effects include cataracts, osteoporosis, mood effects, an increased susceptibility to infection, high blood pressure, weight gain, and an underactive adrenal gland. Immunomodulators include medications such as 6-mercaptopurine and azathioprine. These are taken in pill form and absorbed into the bloodstream. They are effective for maintenance of remission in moderate to severe ulcerative colitis, but are slow to work and can take up to 2-3 months to reach their peak effect. Because of this, these medications are often combined with other medications (such as steroids) in patients who are very ill. These medications require frequent blood work as they can cause liver test abnormalities and low white blood cell counts, both of which are reversible when the medication is stopped. Adverse reactions can include nausea, rash, liver and bone marrow toxicity, pancreatitis, and rarely lymphoma. Biologic agents are medications given by injection that are used to treat moderate to severe UC. Biologic treatments are engineered to target a specific protein in the body. Biologics, like ADALIMUMAB, used in treating moderate to severe ulcerative colitis (UC) specifically target a protein called tumor necrosis factor (TNF) and can help people who’ve not responded well to immunomodulators.
What is Exemptia?
EXEMPTIA is a prescription medicine used to reduce signs and symptoms, and to achieve and maintain clinical remission in adults with moderate to severe Crohn’s disease or Ulcerative colitis who have not responded well to conventional treatments. EXEMPTIA is also used to reduce signs and symptoms and achieve clinical remission in these adults who have also lost response to or are unable to tolerate infliximab.
How Exemptia works?
EXEMPTIA is a medicine called a tumor necrosis factor (TNF) blocker. EXEMPTIA targets and helps block TNF-alpha. TNF plays a role in the process that causes inflammation.
Results with Exemptia
Clinical Trial of EXEMPTIA in Indian Patients:
Globally Adalimumab is available as HUMIRA. A clinical study was conducted in India to assess if efficacy and safety of EXEMPTIA is similar to HUMIRA A total 162 subjects were screened at 11 investigational sites in India, of which, 120 subjects were enrolled in the study, 60 subjects in each group viz. EXEMPTIA and Innovator’s Adalimumab. This trial was conducted for a period of 12 weeks.
How well did EXEMPTIA work in this trial?
After treatment with EXEMPTIA, at Visit 5 (on day 84), 82% patients had 20% improvement in rheumatoid arthritis (RA) symptoms, 46% patients had 50% improvement in RA symptoms and 14% patients had 70% improvement in RA symptoms. These results were similar to those with Innovator’s Adalimumab.
How safe was EXEMPTIA in this trial?
Overall, EXEMPTIA was safe and well tolerated in this study. The safety profile of both EXEMPTIA and HUMIRA was similar.
What were the commonly observed side- effects with EXEMPTIA in this trial?
Dyspnoea (difficulty in breathing), Fungal infection, Gastritis, Headache, Injection site reaction, Oligomenorrhoea(menstrual periods occur at intervals of greater than 35 days, with only four to nine periods in a year),Pollakiuria(an excessive frequent urination),Polymenorrhoea (occurrence of menstrual cycles at frequency that is higher than normal),Pulmonary tuberculosis, Fever, Rash, Urinary tract infection, Vomiting, Abdominal discomfort, Abdominal pain, Accelerated hypertension (rapid and sudden increase in blood pressure ), Asthenia (abnormal physical weakness), Chest pain, Cough, Diarrhoea and Dyspepsia (indigestion) Majority of adverse events were mild in intensity and not related to the study drug. There were no persistent changes from baseline in laboratory parameters in both treatment groups.
Do not try to inject EXEMPTIA yourself until you have been shown the right way to give the injections and have read and understood this Instructions for Use. If your doctor decides that you or a caregiver may be able to give your injections of EXEMPTIA at home, you should receive training on the right way to prepare and inject EXEMPTIA. It is important that you read, understand, and follow these instructions so that you inject EXEMPTIA the right way. It is also important to talk to your doctor to be sure that you understand your EXEMPTIA dosing instructions. To help you remember when to inject EXEMPTIA, you can mark your calendar ahead of time. Call your healthcare provider if you or your caregiver has any questions about the right way to inject EXEMPTIA.
Adults with Crohn’s Disease or Ulcerative Colitis:
- The recommended induction dose is 160 mg at Week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), followed by 80 mg at Week 2.
- The recommended maintenance dose regimen is 40 mg every other week beginning at Week 4.
Starting on Exemptia
What should I tell my doctor BEFORE starting EXEMPTIA?
Tell your doctor about all of your health conditions, whether you:
- Have an infection, are being treated for infection, or have symptoms of an infection
- Get a lot of infections or infections that keep coming back
- Have diabetes
- Have TB or have been in close contact with someone with TB, or were born in, lived in, or travelled where there is more risk for getting TB
- Live or have lived in an area where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis
- Have or have had hepatitis B
- Are scheduled for major surgery
- Have or have had cancer
- Have numbness or tingling (lack of sensation) or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
- Have or had heart failure
- Have recently received or are scheduled to receive a vaccine. EXEMPTIA patients may receive vaccines, except for live vaccines
- Are allergic to any of the EXEMPTIA ingredients
- Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
Also tell your doctor about all the medicines you take. You should not take EXEMPTIA with abatacept, anakinra, infliximab, etanercept, certolizumab pegol, or golimumab. Tell your doctor if you have ever used rituximab, azathioprine, or mercaptopurine (6-MP).
What should I watch for AFTER starting EXEMPTIA?
EXEMPTIA can cause serious side effects, including:
- Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
- Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
- Allergic reactions. Symptoms of serious allergic reactions include hives (urticaria), trouble during breathing, and swelling of your face, eyes, lips, or mouth.
- Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
- Blood problems. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
- Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
- Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
- Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen).
- Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.Call your doctor or get medical care immediately if you develop any of the above mentioned symptoms.Common side effects of adalimumab include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headache, rash, and nausea.These are not all of the possible side effects with EXEMPTIA. Tell your doctor if you have any side effect that bothers you or that does not go away.
Remember, tell your doctor immediately if you have an infection or symptoms of an infection, including:
- Fever, sweats, or chills
- Muscle aches
- Shortness of breath
- Blood in phlegm
- Weight loss
- Warm, red, or painful skin or sores on your body
- Diarrhea or stomach pain
- Burning when you urinate
- Urinating more often than normal
- Feeling very tired
EXEMPTIA is given by injection under the skin.
How to administer?
Do not try to inject EXEMPTIA yourself until you have been shown the right way to give the injections and have read and understood this Instructions for Use. If your doctor decides that you or a caregiver may be able to give your injections of EXEMPTIA at home, you should receive training on the right way to prepare and inject EXEMPTIA . It is important that you read, understand, and follow these instructions so that you inject EXEMPTIA the right way.
Gather the material required for your injection:
You will need the following material for each injection of EXEMPTIA. Find a clean, flat surface to place the material.
- Alcohol swab
- Cotton ball or gauze pad (not included in your EXEMPTIA carton)
- EXEMPTIA prefilled syringe. See Figure A.
Choose the injection site: wash and dry your hands well. Choose an injection site on:
- The front of your thighs or
- Your lower abdomen (belly). If you choose your abdomen do not use the area 2 inches around your bellu button (navel). See Figure B
- Choose a different site each time you give yourself an injection. Each new injection should be given at least one inch from a site you used before.
- Do not inject into the skin that is:
- Sore (tender)
- scarred or where you have stretch marks
- If you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin.
- Do not inject through your clothes.
Prepare the injection site:
- Wipe the injection site with an alcohol swab using a circular motion.
- Do not touch this area again before giving the injection. Allow skin to dry before injecting. Do not fan or blow on the clean area.
Prepare the syringe and needle:
- Always hold the prefilled syringe by the body of the syringe. Hold the syringe with covered needle pointing down. See Figure C.
- Hold the syringe at eye level
- The top of the liquid may be curved
- Remove the needle cover
- Hold the syringe in one hand. With the other hand gently remove the needle cover. See Figure D.
- Throw away the needle cover.
- Do not touch the needle with your fingers or do not let the needle touch anything.
- Turn the syringe so that needle is facing up and hold the syringe at eye level with one hand so you can see the air in the syringe. Using your other hand, slowly push the plunger in, to push the air out throughout the needle. See Figure E.
- You may see a drop of liquid at the end of the needle. This is normal.
Position the prefilled syringe and inject EXEMPTIA:
Position the syringe:
- Hold the body of the prefilled syringe in one hand between the thumb and index finger. Hold the syringe in your hand like a pencil. See Figure F.
- Do not pull back on the plunger at any time.
- With our other hand gently squeeze the area of cleaned skin and hold it firmly. See Figure G.
- Using a quick, dart- like motion, insert the needle into the squeezed skin at an angle of about 45degrees. See Figure H.
- After the needle is in, let go of the skin. Pull back gently on the plunger.
If blood appears in the syringe:
- It means that you have entered a blood vessel.
- Do not inject EXEMPTIA.
- Pull the needle out of the skin while keeping the syringe at the same angle.
- Press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. See Figure I.
- Do not use the same syringe and needle again. Throw away the needle and syringe in your special sharps container.
- Do not rub the injection site. You may have slight bleeding. This is normal.
- Repeat all the above steps with a new prefilled syringe.
If no blood appears in the syringe:
- Slowly push the plunger all the way in, until all of the liquid is injected and syringe is empty.
- Pull the needle out of the skin while keeping the syringe at the same angle.
- Remove the syringe from the injection site keeping your thumb on the plunger rod.
- Orienting the needle away from you and others, activate “Preventis” syringe by firmly pushing the plunger rod. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation. Immediately dispose off the syringe in the nearest sharps collector.
- Press a cotton ball or gauze pad over the injection site for 10 seconds. Do not rub the injection site. You may have slight bleeding. This is normal.
Keep a record of dates and location of your injection sites. To help you remember when to take EXEMPTIA, you can mark your calendar ahead of time.
How should I store EXEMPTIA?
- Store EXEMPTIA in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original container until it is used. Protect from light.
- When travelling, EXEMPTIA should be stored in a cool carrier with an ice pack.
- Do not freeze EXEMPTIA. Do not use EXEMPTIA if frozen, even if it has been thawed.
- Refrigerated EXEMPTIA may be used until the expiration date printed on the EXEMPTIA carton and prefilled syringe.
- Do not use the prefilled syringe if the liquid is cloudy, discolored or has flakes or particles in it.
- Keep EXEMPTIA, injection supplies and all other medicines out of the reach of children.
Exemptia Care – Patient Support Programme
We would be happy to help you find the relevant tools and resources to help you in your Exemptia treatment
Are you just starting with Exemptia? Sign up for EXEMPTIA CARE programme today.
Patients and their care givers can enrol in our patient care services to avail our services or get responses to their queries:
- Email us at email@example.com
- Call us at 1800-123-CARE (1800-123-2273) from Monday to Saturday 10 AM – 6 PM IST (Indian Standard Time)
Patients and healthcare professionals will be offered the below services:
- Support for patient compliance and adherence i.e. medication reminders, status of prescription (Rx) order
- Discount coupons from renowned labs after you start on Exemptia therapy
How to set medication reminders
We know that you are very busy and remembering when to take your Exemptia medication isn’t always easy. EXEMPTIA CARE offers medication reminders the way that’s most convenient for you. Messages arrive on one day prior to the date you specify for taking the next dosage of Exemptia and a call comes one day after the date on which you have set up the medication reminder. Plus, you can change your reminder settings at any time by calling. It’s at no additional cost to you.
Set Up Medication Reminders Now
- Calling us at EXEMPTIA CARE toll free number: 1800-123-CARE (1800-123-2273)
- E-mail us at: firstname.lastname@example.org
Patient Education Guide