September 11, 2015
Medication Guide: “Biologics” for IBD
This is a medication safety guide for patients deciding to take one of the “biologics” drugs for colitis or Crohns disease. This is adapted from the guide for Biologics but the information applies to all “TNF blocker” drugs in the category. These medications block the effect of one of the major immune system pathways that trigger inflammation, which in turn damages the intestine lining. Blocking this inflammation pathway allows for healing of the damage and this helps stop symptoms and prevents complications of the diseases. We are recommending the medication because we believe it offers you far more benefit than risk, but you need to understand both benefits and risks. We also need to take precautions like proper testing before treatment, vaccines before and during treatment, and monitoring for infections or complications. Please ask questions about anything you want more information about or don’t understand.
What is the most important information I should know about Biologics?
Biologics are medicines that affect your immune system. Biologics can lower the ability of the immune system to fight infections. Serious infections have happened in patients taking Biologics. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections. Biologics are medicines called a Tumor Necrosis Factor (TNF) blocker. Biologics are used in adults or children (as indicated) to treat a variety of serious forms of arthritis, but also to treat Crohn's disease and ulcerative colitis when these diseases have not responded to simpler forms of treatment. They do not cure these diseases but in many cases help stop all the symptoms and signs of the diseases, or quiet them considerably and reduce complications. They are typically used in combination with other drugs. People with these diseases have too much of a protein called tumor necrosis factor (TNF) in the affected areas of the body. BIOLOGICS can block the bad effects of TNF in those affected areas, but it can also lower the ability of the immune system to fight infections. Your doctor should test you for TB before starting Biologics(skin test or a blood test called Quantiferon). Your doctor should monitor you closely for signs and symptoms of TB during treatment with BIOLOGICS.
Before starting Biologics, tell your doctor if you:
- Think you have an infection
- Are being treated for an infection
- Have signs of an infection, such as a fever, severe cough, or flu-like symptoms
- Have any open cuts or sores on your body
- Get a lot of infections or have infections that keep coming back
- Have diabetes
- Have TB, or have been in close contact with someone with TB
- Were born in, lived in, or traveled to countries where there is more risk for getting TB, Ask your doctor if you are not sure.
- Live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infection (histoplasmosis). In California there is more of a fungal infection called coccidioidomycosis (“cocci”), particularly in the San Juaquin valley.
- Have or have had hepatitis B (our patients must get tested to find out! And some should be vaccinated if they aren’t immune)
- Are scheduled to have major surgery
After starting Biologics, call your doctor right away if you have an infection, or any sign of an infection including:
A fever, feel very tired, a new cough, flu-like symptoms Open cuts or sores on your body, warm, red, or painful skin. Biologics can make you more likely to get infections or make any infection that you may have worse.
Certain types of Cancer
There have been cases of an unusual lymphoma cancer in children and teenage patients using TNF blocking drugs, mainly if taking another immune altering drug (6MP or mercaptopurine, azathioprine). For children and adults taking TNF-blocker medicines, including Biologics, the chances of getting lymphoma or other cancers may increase but the risk of this is rare (2-6 in 10,000). Some patients receiving Biologics have developed types of cancer called non-melanoma skin cancer (basal cell cancer and squamous cell cancer of the skin), which are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that doesn't heal. Rates of this are perhaps twice the normal rate. Women who have papillomavirus on Pap tests have more risk of cervical cancer and should have annual GYN Pap exams.
How should I take Biologics?
See the sections in the separate drug guide, “How do I prepare and give an injection of Humira?” if that is the drug you use. Remicade is given by an IV (intravenous) infusion at a center that can provide these; sometimes at home. Cimzia is given by injection but it is difficult to give to yourself so typically a nurse who comes to your home once a month gives it at the office or. Simponi can be taken at home similar to Humira though as of 2015 is only approved for some cases of ulcerative colitis, not Crohn's disease. The comments about Humira apply to any of the Biologics. Humira is given by an injection under the skin. Your doctor will tell you how often to take an injection of Humira or how often you will get the other Biologic drug. This is based on your condition to be treated. Do not take Biologics more often than prescribed. • Make sure you have been shown how to inject Humira before you do it yourself. You can call your doctor or 1-800-4Biologics (448-6472) if you have any questions about giving yourself an injection of Humira. Someone you know can also help you with your injection. If you take more Humira than you were told to take, call your doctor and do not miss any doses of Biologics. If you forget to take Biologics, arrange to get a dose as soon as you can. Then, take your next dose at your regular scheduled time. This will put you back on schedule. To help you remember when to take Biologics, you can mark your calendar ahead of time. You can now travel with Humira without keeping it refrigerated/on ice packs.
What are the possible side effects of Biologics?
Biologics can cause serious side effects, in a few cases per thousand persons receiving the drug, including:
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with BIOLOGICS and during treatment with Biologics. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are takingBiologics. Patients who had a negative TB skin test before receiving Biologics have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking Biologics: a cough that does not go away, low-grade fever, weight loss or loss of body fat and muscle (wasting).
Hepatitis B virus reactivation in patients who carry the virus in their blood. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should monitor you carefully during treatment with Biologics if you carry the hepatitis B virus in your blood. Tell your doctor if you have any of the following symptoms like feeling unwell, poor appetite, tiredness (fatigue), fever, skin rash, joint pain or developing persistently dark color urine or yellow tint to eyes (jaundice).
Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.New heart failure or worsening of heart failure you already have. Symptoms include shortness of breath or swelling of your ankles or feet or sudden weight gain. Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort--pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may go away when you stop Biologics. Psoriasis. Some people using Biologics had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Biologics. Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with Biologics may be stopped.
Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.New heart failure or worsening of heart failure you already have. Symptoms include shortness of breath or swelling of your ankles or feet or 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 a rash on your cheeks or arms that gets worse in the sun. Symptoms may go away when you stop Biologics. Psoriasis. Some people using Biologics had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Biologics. Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with Biologics may be stopped.
Common side effects (a few persons per hundred receiving the drug) with Biologics include: Injection site reactions such as redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. If you have pain, redness or swelling around the injection site that doesn’t go away within a few days or gets worse, call your doctor right away.
Upper respiratory infections (including sinus infections) or inflammation without infection—nasal sprays or allergy medication (antihistamines, decongestants) commonly help but tell your doctor if these are annoying. Always call if these symptoms come with a fever. Cancer (lymphoma) has been reported in a small number of patients taking Biologics. Since this can also complicate colitis/Crohns or occur anyway, cause and effect are not clear, but there appears to be a small risk (1 in about 5,000 or 10,000 individuals getting treatment).