Understanding IBD Medications and Side Effects 187767 WF1 Form:Layout 1 11/13/09 7:27 PM Page 2 187767 WF1 CVR R1.Qxp:Layout 1 11/19/09 4:51 PM Page B

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Understanding IBD Medications and Side Effects 187767_WF1_Form:Layout 1 11/13/09 7:27 PM Page 2 187767_WF1_CVR_R1.qxp:Layout 1 11/19/09 4:51 PM Page b

Notes: Medication Log What’s Inside?

About Crohn’s Disease and Ulcerative Colitis 2 Form (i.e., pill) Purpose (why do you take it?), Name of Start Stop Dosage/ Times Taken Symptoms or and/or Method Comments, or Treatment 4 Medication Date Date Strength Daily Side Effects If you or someone you know Taken (i.e., oral) Special Instructions Over-the-Counter (OTC) Medications 5 has just been diagnosed with Prescription Medications 6 Crohn’s disease or ulcerative Off-Label 8 colitis, you may feel a bit over- Pediatric Patients 8 whelmed by the news. In fact, Pregnancy and Male Fertility 11 you may not have even heard Making the Most of Your Treatment 12 of these illnesses before. But Tips to Help Manage Your Medications 13 now that you have, you will What to Ask Your Healthcare want to learn as much as pos- Provider About Medications 14 sible about them—including Remember to Tell the Doctor 15 which medications can help Participating in Clinical Trials 16 control the diseases. That is Pregnancy Drug Safety Chart 18 the purpose of this brochure. Improving Quality of Life 20 Tools and Resources 21 IBD Medication Proﬁles 22 Glossary of Terms 32 Medication Log 35 About CCFA Inside back cover

Medication information is up to date at the time of printing. Due to rapid advances and new findings, there may be changes to this information over time. You should always check with your doctor to get the most current information.

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NSAIDs:pletely untouched.Nonsteroidal These anti-inflammatory are known as “skip” drugs suchareas. as These aspirin, differences ibuprofen, are ketoprofen, important forand decid- Medication Log About Crohn’s naproxen.ing whether inflammation of the intestinal tract disease and Off-label:is from Crohn’sUse of disease an FDA-approved or ulcerative drug colitis. for an indication other than that for which the drug wasAlthough approved you may originally. have never heard of these ulcerative colitis diseases, approximately 1.4 million American Keep track of your medication regimen on a daily basis. Fill in your medication information under each category and leave some space to record any changes, Oral:adultsBy and mouth. children suffer from Crohn’s disease such as dosage, number of times taken, symptoms, or side effects. Crohn’s disease and ulcerativetive or ulcerative colitis. Most people develop these Perianal:diseases betweenLocated around the ages the of anus, 15 and the 35. opening The colitis belong to a group of ofnumber the rectum, of newly to diagnosedthe outside people of the hasbody. exploded Form (i.e., pill) Purpose (why do you take it?), over the last 50 years. The exact reasons for this Name of Start Stop Dosage/ Times Taken Symptoms or Pouchitis: Inflammation of the lining of the in- and/or Method Comments, or conditions known as inflam-m- increase are unknown. To date, there is no known Medication Date Date Strength Daily Side Effects Taken (i.e., oral) Special Instructions matory bowel diseases, or IBD.BD. ternalcause ofpouch or cure (formed for Crohn’s from the disease small orintestine). ulcerative Rectal:colitis, andHaving that’s to dowhat with makes the rectum. the Crohn’s & Colitis Foundation of America’s (CCFA) research These disorders affect the gastrointestinal (GI) so critical. CCFA has pioneered the field of re- tract, the area of the body where digestion takes Rectum: Lowest portion of the colon. search into these difficult digestive diseases for place. As the name implies, the diseases causeause Remission:nearly a half-century.Periods in Somewhich ofsymptoms our major disappear projects inflammation of the intestine. When a part of the orhave decrease included and human good genomehealth returns. (study of genes body is inflamed, it becomes red and swollen.en. associated with IBD), microbiome (study of bac- Sores, or ulcers, may also form within the walls Smallterial species),intestine: andConnects genetic to research. the stomach and of the intestine. The ongoing inflammation leads large intestine; absorbs nutrients. to symptoms that may already be familiar too you: abdominal pain, cramping, diarrhea, rectalectal Subcutaneous: Injected under the skin. bleeding, and fatigue. For some people, symp-mp- toms are not just restricted to the GI tract. They Teratogen: An agent or substance that may may experience signs of IBD in other parts of cause defects in the developing embryo. the body, such as the eyes, joints, skin, bones,nes, Teratogenic: Capable of causing birth defects. kidney, and liver. These are referred to as ex-x- traintestinal manifestations of IBD, becausee they Toxicity: The degree to which a substance occur outside of the intestine. is harmful.

Although Crohn’s disease and ulcerative colitisolitis Ulcer: A sore on the skin or in the lining of the share a lot of symptoms, they do have somee GI tract. marked differences. While inflammation relatedlated to Crohn’s disease may involve any part of the Ulceration: The process or fact of being eroded GI tract from the mouth to the anus (includingg the away, as by an ulcer. esophagus, stomach, small intestine, and largearge Ulcerative colitis: A relatively common disease intestine), ulcerative colitis is limited to justt the that causes inflammation of the large intestine large intestine (including the colon and rectum).tum). (the colon). Another distinguishing feature of ulcerative colitis is that it starts in the rectum and extendsends from there in a continuous line of inflammation.tion. In contrast, Crohn’s disease may appear in “patches,” affecting some areas of the GI tractract while leaving other sections in between com-m-

Physician Name: Physician Phone Number: Pharmacy Phone Number: 2 335 187767_WF1_TXT.qxp:Layout 1 11/13/09 7:45 PM Page 4 187767_WF1_TXT.qxp:Layout 1 11/13/09 7:45 PM Page 5

appapproach. Doctors will customize treatment to tthe individual’s needs based on the type Treatment and severity of symptoms. It may be given in ddifferent dosages, formulations, and for To date, there is no known diffdifferent lengths of time.

cause of or cure for IBD, butt MeMedications can be given in oral form (by fortunately there are many momouth), intravenously (through a vein), or subsubcutaneous (by injection under the skin). effective treatments to helpp TopTopical therapies are administered rectally, as control these diseases. supsuppositories, enemas, creams, and ointments. It is important to keep in mind that a person’s The three main goals of treatments for IBD are: thetherapeutic needs may change over time. What worworks at one point during the illness may not Achieving remission (defined as the absenceence be eeffective during another stage. It is important of symptoms). for the patient and doctor to discuss thoroughly Maintaining remission (defined as preventingnting whiwhich course of therapy is best—bearing in flare-ups of disease). minmind that a combination of therapies may be the optimal treatment plan. Improving quality of life (defined personally).ally). OverOver-the-Counter (OTC) Medications These goals may be achieved either with a com- PrescrPrescription medications reduce intestinal inflam- bination of over-the-counter and prescriptionon matiomation and form the core of IBD treatment. Even medications, or surgery depending on eachh so, thethese important prescription medications may individual case. (For more on surgery, visit not eleliminate all of your symptoms. Naturally, www.ccfa.org). When considering medicationon you maym want to take over-the-counter medica- options, you should remember the followingg tions in an effort to feel better. Before doing so, key points: speak with your doctor, or other healthcare pro- fessiofessional, as sometimes these symptoms may Symptoms of these long-term diseases may indicaindicate a worsening of the inflammation that range from mild to severe and may include,e, but may requirere either hospitalization or a change are not limited to, diarrhea, abdominal cramp-ramp- in youyour prescription IBD medication. ing, nausea, pain, rectal bleeding, and fever.ever. Other times these symptoms do not reflect a People will go through periods in which the worseworsening of the condition and can be treated illness is active and is causing symptoms. Such with over-the-countero medications. Your doctor periods are known as flares. These episodesdes may recommendre loperamide (Imodium®) to re- are usually followed by times of remissionon. lieve ddiarrhea, or anti-gas products for bloating. Remission occurs when symptoms eitherr To redreduce joint pain and fever, your doctor may disappear completely or lessen considerablyably recomrecommend acetaminophen (Tylenol®) or non- and good health returns. These disease-freefree steroisteroidal anti-inflammatory drugs (NSAID)— periods can last months or even years. such aas aspirin, ibuprofen (Advil®, Motrin®), or napronaproxen (Aleve®). NSAIDs will work to alleviate Because each person with IBD is different,t, the joint ssymptoms but can irritate the small intes- treatment used to control his or her illnessss is tine oor colon, thus promoting inflammation, so unique, as well. There is no “one-size-fits-all”-all”

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these should be used with great care. Makee sure Immunomodulators:Imm These include azathio- that you follow instructions with all OTC products,ducts, prine,prin 6-mercaptopurine (6-MP), methotrexate, but again, speak with your healthcare professionalsional and cyclosporine. This class of medications first before you take any of these medicationsons. modifiesmo the body’s immune system so that it cannotcan cause ongoing inflammation. Usually Prescription Medications givengive orally (methotrexate is injectable), im- munomodulatorsmu are typically used in people Some medications used to treat Crohn’s diseasesease for whom aminosalicylates and corticosteroids and ulcerative colitis have been around for haven’thav been effective, or have been only par- years. Others are more recent breakthroughs.hs. tiallytial effective. They may be useful in reducing The most commonly prescribed medicationss fall or eliminatinge reliance on corticosteroids. into five basic categories: TheyThe also may be effective in maintaining remissionrem in people who haven’t responded Aminosalicylates: These include aspirin-likelike to oother medications given for this purpose. compounds that contain 5-aminosalicylicc acid ImmunomodulatorsImm may take up to three (5-ASA), such as sulfasalazine, balsalazide,e, monthsmo to begin working. mesalamine, and olsalazine. These drugs, which can be given either orally or rectally, do not BiologicBio therapies: These therapies are genet- suppress the immune system but decreasese icallyical engineered to target very specific mole- inflammation at the wall of the intestine itself, culescule involved in the inflammatory process. and help heal both in the short- and long-term.term. The newest class of therapy to be used in IBD, They are effective in treating mild-to-moderateerate thesethe include adalimumab, certolizumab episodes of IBD. They also are useful in pre- pegol,peg infliximab, and natalizumab. These are venting relapses (return of symptoms). not drugs, but proteins (antibodies) that target the action of certain other proteins that cause Corticosteroids: These medications, whichch inflammation.infl include prednisone, prednisolone, and budesonide, affect the body’s ability to begin TheseThe medications are indicated for people and maintain an inflammatory process. Inn ad- with moderately to severely active disease dition, they work to keep the immune systemstem who haven’t responded well to conventional in check. Prednisone and prednisolone are therapy.the They also are effective for reducing used for people with moderate-to-severee fistulasfistu . (Fistulas, which may occur with Crohn’s Crohn’s disease and ulcerative colitis. Budes-udes- disease,dise are small tunnels connecting one loop onide is used for people with mild to moderatederate of intestinei to another or two organs in the ileal Crohn’s disease, and right-sided colonlon bodybod that are usually not connected.) Biologics Crohn’s disease. They can be administereded may be an effective strategy for reducing steroid orally, rectally, or intravenously. Effectivee for use,use as well as for maintaining remission. short-term control of acute episodes (flaresres), they are not recommended for long-term or Antibiotics:Ant Metronidazole, ciprofloxacin, and maintenance use because of their side effects.fects. otheroth antibiotics may be used when infections— If you cannot discontinue steroids withoutut suchsuc as an abscess—occur. They treat Crohn’s, suffering a relapse of symptoms, your doctoroctor colitiscoli and perianal Crohn’s disease. They are may add some other medications to helpp also used for post-surgical problems such manage your disease. It is important not to as ppouchitis. suddenly stop taking this medication.

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Off-Label Sometimes doctors will prescribe medicationsons that the Food & Drug Administration (FDA) has not specifically approved for the treatment of Crohn’s or colitis. Nonetheless, these medicationsations have been shown to be very effective in reducingucing symptoms. Prescribing medications for otherr than FDA-approved conditions is known as “off-label”abel” use. Your healthcare provider may have to obtainbtain prior approval from insurance companies beforeefore prescribing a medication for off-label use. Patientstients should be aware that they or their doctor might growgrowtth and development. Here are some of the need to make a special appeal to get third-partyparty recrecomommendations for the various medication insurance payment for off-label medication.. categories:catego The use of substances found in nature, suchh as Aminosalicylates:Am These aspirin-like compounds herbs, foods, and vitamins, is considered bio-io- thattha contain 5-aminosalicylic acid (5-ASA) are logically-based practice. Unlike pharmaceuticaltical generallygen the first step in therapy for children products, natural remedies are not regulateded by with mild-to-moderate ulcerative colitis or the FDA. Crohn’sCro disease. Mesalamine and olsalazine havehav fewer side effects than sulfasalazine. The drugs can be given either orally or rectally. The number of pills may be as many as 10 to Pediatric IBD Patientsnts 16 perp day, which may be difficult with a child’s schoolsch schedule. Also, some children have Customizing treatment for the troubletrou swallowing pills. In cases where swal- lowinglow capsules is a concern, your child’s individual with IBD is critical,al, doctordoc may advise that specific capsules be but it is especially importantnt openedope and the contents mixed with food. when that patient is a child or Corticosteroids:Cor When a child has not re- spondedspo to treatment with 5-ASA, then oral teenager. corticosteroidscor may be prescribed on an outpatientout basis. For more severe cases, Most pediatric treatment choices were developedloped intravenousintr corticosteroids may be used— after initial research on adults. As a result, drug necessitatingnec a hospital stay. Once remission dosages for a child must be carefully tailoreded to is achieved,a then corticosteroid dosage is suit their age, size, and weight—in addition to taperedtap gradually. The goal is to discontinue existing symptoms, location of inflammation,on, thesethe medications as quickly as possible and and previous response to treatment. therebythe minimize side effects, which may in- cludeclud facial swelling, excessive weight gain, The same medications that are used to treatt hairhai growth, and acne. Long-term steroid use adults with IBD are also used for children. Still, in childrenc can also lead to growth problems there are some special considerations in treat-eat- and weakened bones (osteoporosis). To mini- ment because children and teenagers are goingoing mizemiz the chance of osteoporosis, adequate through a period of physical and emotional calciumcalc and vitamin D intake is essential.

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Immunomodulators: Both azathioprine and 6- mercaptopurine (6-MP) are widely prescribedribed for children with Crohn’s disease and ulcerativeerative PrePregnancy and Male colitis who do not respond to standard medications. They may minimize symptoms and FerFertility enhance growth. Treatment with 6-MP hasas been shown to work well for controlling active If youyo are considering becom- disease in children, as well as reducing or eliminating dependency on corticosteroids.ds. ing pregnant, it is recommend- They also may be effective in maintainingg ed tto try to have your IBD in remission in people who haven’t respondedded to other medications given for this purpose.ose. remremission before you do so. Methotrexate is another immunomodulatortor with similar advantages in limiting corticos-os- RecenRecent studies have shown that women do better teroid use that is increasingly being usedd in during pregnancy if their disease is not active at children and adolescents with Crohn’s disease,sease, the timtime of conception. Active disease requires with somewhat less success so far in ulcera-era- medicmedication, and most doctors prefer that their tive colitis. All patients on immunomodulatorsators patienpatients restrict medication during pregnancy. need to be monitored closely for side effects,ects, Still, mmost experts agree that the major threat which include bone marrow problems as well to the pregnancy seems to come from the active as irritation of the liver or pancreas. diseasdisease itself, rather than the medication.

Biologic therapies: Infliximab was the firstrst bi- If you are pregnant and have IBD symptoms, your ologic therapy to be FDA-approved for Crohn’sohn’s doctodoctor will advise you as to which of the medica- disease in children, and is now also commonlymonly tions mentioned previously are safe to take. The used to treat ulcerative colitis. Infliximabb is FDA raranking system for drug safety during preg- usually reserved to treat more advanced or nancy categorizes all medications from “A” to aggressive disease. Other biologic therapiespies “D” (s(safest to least safe), in addition to an extra are being tested in children, and are currentlyrently categocategory, “X.” used in special situations. CatCategory A: Drugs have been tested and Antibiotics: Metronidazole is used in childrenldren foufound to be safe for use in pregnancy during and teenagers with perianal Crohn’s disease.ease. the first trimester. It may also be used as an alternative treatmenttment to 5-ASA or steroids for Crohn’s or colitis. An- CatCategory B: Used in pregnancy and does not other antibiotic option is ciprofloxacin, which appappear to cause birth defects or other problems. has been shown to be effective in adults with colitis and inflammatory changes around the CatCategory C: Drugs that have warnings and anus, including fistulas and abscesses in Crohn’srohn’s are more likely to cause a problem for mother disease. The use of ciprofloxacin and otherher or ffetus. drugs in the same class, called fluorquinolones,lones, has been associated with an increased risksk of CatCategory D: Drugs that have clear health tendonitis and joint discomfort or pain. Itss use riskrisks, but benefits may outweigh the risk. in children has been controversial in the past, although studies have not demonstrated any CatCategory X: Drugs that cause birth defects increased risk of complications in childrenen and should not be used during pregnancy. compared to adults.

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Drugs that fall into this last category have been For manyma individuals—particularly children and shown to cause birth defects and should neverver be teenagers—thisteena may seem like a major concern, taken during pregnancy. Please note: Althoughugh especiallyespec when some of those medications pro- the rating system provides valuable information,ation, duce uunwanted side effects. If you are experiencing it will no longer be used for new drug therapies,pies, unpleasantunple side effects or interactions with other under a March 2008 policy change by the FDA.DA. drugs,drugs don’t stop taking your prescribed medica- However, some healthcare professionals arere tion. SSpeak with your doctor and ask about pos- continuing to use this helpful data for existinging sible aadjustments that might reduce those effects. drug therapies. Information on all known preg-reg- nancy and nursing experience will soon appearpear Even whenw there are no side effects, or just mini- in the prescribing insert of any medication. mal ones,on it may still seem like a nuisance to be [See page 18 for recommendations.] on a steadys regimen of medication. Seek support from yyour healthcare provider. Remember, though, Because pregnancy is such a personal matterer and that takingta maintenance medication can signifi- there are so many factors that go into how a preg- cantly reduce the risk of flares in both Crohn’s nancy may turn out, the choice of what medicinesicines diseasediseas and ulcerative colitis. In between flares, to take before and during pregnancy shouldd be most peoplep feel quite well and free of symptoms. discussed with the healthcare provider treatingating your disease, as well as your obstetrician. Tips to Help You Manage Your MedMedications: While most of the recommendations regardinging medication use and pregnancy focus on women,omen, TakTaking medication correctly means more than there are some for men as well. For three monthsonths just taking the right amount at the right time. before conception, men should avoid takingtaking Talk to your doctor or pharmacist and learn as the drug methotrexate. Because the medicationation mumuch as possible about the medications you sulfasalazine decreases sperm count and there-here- taktake and how they may affect you. fore may cause infertility, a man taking this drug should switch to another 5-ASA compound (with TakTake medications as directed. Remember, his doctor’s approval). Discuss all medicationsons momore is not necessarily better. with your doctor. SomSome medications require close monitoring for side effects. Don’t forget to complete bloblood work and follow-up visits as requested Making the most off by yyour provider. ReaRead drug labels carefully. If the print on the your treatment concontainer is difficult to read, ask your pharmacist if it can be made larger. Crohn’s disease and ulcerativetive Use the same pharmacy every time you get colitis are long-term diseases.ses. youyour prescription filled. Pharmacies can help you keep track of what you are taking. This means that people with these conditionsns may need to take medication indefinitely. While DonDon’t take any medications that have expired. not every person with IBD will be on medicationation all of the time, most people will require therapyrapy DonDon’t take anyone else’s medications or share most of the time. youyours with others.

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WhWhy is this medication necessary?

How long will I need to take this medication?

How does this medication work?

Can I take vitamins, minerals, herbs, or other supsupplements while using the medication?

Can I take over-the-counter (OTC) medications for joint pain, diarrhea, or abdominal pain?

WhWhat kind of side effects might I experience? WhWhich are cause for alarm, and what should I do if these occur?

WhWhich OTC products would you recommend for me to take if I have pain or other symptoms? Tell your doctor or pharmacist about all WhWhat kind of interactions does this IBD medicines you take, including OTC, vitamins,mins, memedication have with other medications and herbs. I mayma be taking for other conditions? Don’t forget to take your medications withh yyouou WhWhat should I do if I miss a dose? when you travel or will be away from home.me. Before you leave, make sure you have plentyenty in WhWhat should I do if I have a negative reaction case of delays. immimmediately after taking my medication? Above all, do not stop taking your medicationsons Is it safe to drink alcoholic beverages while without your doctor’s approval even if you feel on thist medication? you cannot afford them. It is important that you take medications as prescribed, as some cannotnnot WhWhat should I do if I can’t afford my medication? be safely stopped abruptly. If the cost of treat-at- ment presents a problem for you, that is stillll not a reason to cut back or discontinue it. A numbermber RemeRemember to Tell the Doctor of patient assistance programs can help. Contactontact Before starting new medications, it is important the Crohn’s & Colitis Foundation of Americaa for yoyou to tell your doctor and other healthcare (www.ccfa.org) for more information. providproviders (including dentists or emergency room staff) abouta other medications you may be taking. What to Ask Your Healthcare Providerder Tell themth whether you: About Your Medications HavHave taken this drug before (even if there was It is only natural that you will have some concernscerns no unusual reaction). about the treatment that you (or your child) will be receiving for IBD. What should you ask yourour HavHave had an unusual or allergic reaction doctor? What do you need to know about yourour to tthis drug, or other medications. treatment or your child’s treatment? Followinging are some of the questions you may want to ask:

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Have or have had any other medical conditions.tions. Before a new drug or a new type of treatment is apapproproved, it must go through a series of clinical Take any other medication or drugs trials. Clinical trials are well-organized studies (prescription or over-the-counter). that evaluatee the treatment’s efficacy and safety. Most cclinical trials are classified into one of Take any vitamins, minerals, herbs, three phases: or other supplements. PhasePha I trials evaluate how a new drug should be giveng (by mouth, injected into the blood, or injectedi into the muscle), how often, and Participation in whatwha doses are safe to use. PhasePha II trials also test the safety of the drug, clinical trials as wwell as evaluate how well the new drug works.wor Finally, Researchers working in labo-o- PhasePha III trials test how well the new drug ratories all over the world are works.wor Trial participants are divided into groups devoted to the scientific in-- wherewhe one receives the medication and a “control”trol group receives a placebo (no chemical vestigation of Crohn’s diseasease properties).pro So, while it is possible that you’ll get the benefit of the new therapy, it is also possible and ulcerative colitis in the that you will not receive the medication. hope of finding a cure. PatientsPatien often find participation in a clinical trial That is good news when it comes to the develop-velop- a rewardingrewa experience. Anyone can participate ment of new therapies for these conditions.. as longlon as they meet the criteria for that particu- New discoveries over the past decade have led lar trial.tria Those criteria may include type of symp- to huge strides in the fields of immunology,, the toms, location or stage of disease, and age. Your study of the body’s immune defense system;m; mi- healthcarehealth provider may recommend a trial or crobiology, the study of microscopic organismssms you canca find out about them yourself from CCFA with the power to cause disease; and genetics,tics, at http://www.ccfa.org/trials/http or other sources the study of how various tendencies and traits—aits— includinginclud http://www.clinicaltrials.gov/. All clini- including diseases—are passed on from onee cal trials,tri no matter how big or small, have to be generation to another. registregistered with this clinical trials Web site.

With new information being amassed all the time, ShoulShould you participate in a clinical trial of a new there is good reason to be hopeful about futureuture drug forf Crohn’s disease or ulcerative colitis? To treatment for IBD. While we all wish for betterter make that decision, you need to be fully informed treatments today, we need to understand thathat it about that trial and the drug that is being tested. takes a long time for a promising developmentment All clinicalclin trials have both benefits and risks as- in the laboratory to become a drug ready foror sociatsociated with them. The advances in current IBD consumer use. In fact, the process of gettingg a treatmtreatment are possible only because people drug to market, from first testing to final ap-- before you offered to participate in clinical trials. proval by the Food & Drug Administration (FDA),FDA), sometimes may take as long as 10 years.

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Table I. Pregnancy Drug Safetyfety Chart

FDA pregnancyy Recommendations for Drug Recommendations for pregnancypregn category breast-feeding No human data: Adalimumab B Low risk probably compatible Alendronate C Limited human data Safety unknown

Amoxicillin/clavulanic acid B Low risk Probably compatible Limited human data: Azathioprine/ 6-mercaptopurine D Data in IBD, transplant literaliterature suggest low risk probably compatible No human data: Balsalazide B Low risk potential diarrhea Compatible with breast Budensonide C Low risk in pregnancy: limitelimited human data feeding No human data: Certolizumab pegol B Limited human data: low risrisk probably compatible Limited human data: Ciprofloxacin C Avoid: potential toxicity to cartilageca probably compatible Low risk: possible increased risk of cleft palate, ad- Corticosteroids C Compatible renal insufficiency, prematureprematur rupture of membranes Limited human data: Cyclosporine C Low risk potential toxicity Fish oil supplements --- Low risk: possibly beneficial No human data No human data: Infliximab B Low risk probably compatible Limited human data: Mesalamine B Low risk potential diarrhea Methotrexate X Contraindicated: teratogenic Contraindicated

Natalizumab C Limited human data: likely lolow risk No human data Would avoid, given limited efficacye in IBD and risk Limited human data: Metronidazole B of cleft palate potential toxicity Limited human data: Olsalazine C Low risk potential diarrhea No human data: Rifaximin C Animal teratogen: no human data probably compatible Risedronate C Limited human data Safety unknown Considered low risk; Limited human data: Sulfasalazine B give folate 2 mg daily potential diarrhea Limited human data: Tacrolimus C Use if mother’s health mandmandates potential toxicity No human data: Thalidomide X Contraindicated: teratogenic potential toxicity

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Improving quality TooTools and resources of life You and your healthcare CCFA has established a rangege provprovider share one important of educational brochures, fact goagoal: to get your IBD under sheets, and programs designedned concontrol and keep it that way. to increase awareness aboutut This is also known as achieving and maintaining remissremission. One of the best ways to accomplish that these digestive diseases. is by ccarefully following the medication regimen your doctord has prescribed for you. To help you, We know living with Crohn’s or colitis can bee we hahave provided a medication log toward the difficult, but the right resources and supportrt can end of this brochure to track your treatment and make day-to-day living more comfortable. That’s care oover time. To use the log, fill in the medica- why CCFA has developed a comprehensive, free tion ininformation under each category. You may online community (www.ccfacommunity.orgg) to want tto leave blank lines under each medication provide the support individuals need in managingaging to enableena you to record any changes—such as their condition. Support groups are also avail-ail- which dosage, times taken, symptoms, or side able in many locations. Find groups in your area effecteffects—and additional comments or special di- at: www.ccfa.org/chapters, or call 1-888-694-8872.8872. rectiorections. We suggest you keep it somewhere handy so you can access it easily. The log also We recognize the importance of distributingg un- serves as a convenient reference for when you biased, accurate, and authoritative informationation speak with your healthcare providers. Also in- in order to provide education of the finest quality.uality. cluded on the next page are medication profiles. One avenue used to accomplish this is the Infor-Infor- The prprofiles include information about com- mation Resource Center (IRC). Through a toll-freell-free monly used IBD medications. number (1-888-694-8872), e-mail, or live chatat on our Web site (www.ccfa.org), Master’s degreeee These profiles do not contain all available infor- level health education professionals answerer matiomation about the risks, benefits, and additional questions and direct people to resources impor-mpor- warniwarnings for each medication listed. Please tant to their quality of life. The IRC has trulyy be- speak with your healthcare provider for more come an important lifeline for patients, families,milies, detaildetailed information. This information is not friends, healthcare professionals, and the media. intendintended to replace medical advice from your doctodoctor or other healthcare provider.

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GenericGene Name: Adalimumab

Brand Name(s): Humira®

Drug class: Biologics

FDA PPregnancy Category: B

How taken: Injection under the skin (subcutaneous)

Used For: Moderate to severe Crohn’s disease

MedicationMedi indication: Reduces signs and symptoms and inducesi and maintains clinical remission in adult patiepatients with moderately to severely active Crohn’s diseadisease who have had an inadequate response to con- ventiventional therapy. Reduces signs and symptoms and inducinduces clinical remission in patients who have lost resporesponse to or are intolerant to infliximab.

Most common side effects: Injection site reactions such as redness,re rash, swelling, itching, pain, or bruising; upperuppe respiratory infections (including sinus infections); headaches,head rash, nausea.

Other:Othe Biologics may reduce the body’s ability to fight other infections. There have been reports of serious in- fectionsfectio associated with adalimumab, including tuber- culosisculos (TB) and sepsis (a life-threatening blood infecinfection). On rare occasions certain types of cancer, incluincluding lymphoma, have been reported.

GenericGene Name: Azathioprine

Brand Name(s): Azasan®, Imuran®

Drug class: Immunomodulators

FDA PPregnancy Category: D

How taken: Oral, not given by intravenous (IV) for IBD

Used For: Ulcerative colitis and Crohn’s disease

MedicationMedi indication: Off-label use for the management of moderatemo and active inflammatory bowel disease to reducereduc signs and symptoms.

Most common side effects: Upset stomach, vomiting, diarrhea,diarr muscle aches.

Other:Othe Periodic blood work is necessary when taking ImuranImura to monitor the liver and blood counts. Infection, a smallsma risk of lymphoma, and a small risk of pancreatitis is noted.not

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Generic Name: Balsalazide Generic Name: Certolizumab pegol

Brand Name(s): Colazal® Brand Name(s): Cimzia®

Drug class: Aminosalicylates (5-ASA) Drug class: Biologics

FDA Pregnancy Category: B FDA Pregnancy Category: B

How taken: Oral How taken: Injection under the skin (subcutaneous)

Used For: Mild to moderate ulcerative colitis Used For: Moderate to severe Crohn’s disease

Medication indication: Used to treat the signs and Medication indication: Reduces signs and symptoms, symptoms of mild to moderately active ulcerative colitisolitis and maintains clinical remission in adult patients with in patients five years of age and older. Also, off-labelel moderately to severely active Crohn’s disease, who use for treatment of Crohn’s disease. have had an inadequate response to conventional therapy. Most common side effects: Headaches, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, andnd Most common side effects: Swelling, weight gain, rash, arthralgia. upper respiratory tract infection, urinary tract infection, and joint pain. Other: Avoid Colazal® if you are allergic to mediciness containing salicylates, such as aspirin, or mesalaminene Other: Biologics may reduce the body’s ability to fight (Rowasa®, Asacol®, Pentasa®, Canasa®, Lialda™, and other infections. Cases of serious infections including Apriso™). tuberculosis (TB) and sepsis (a life threatening blood infection) have been reported. Lymphoma and other cancers have been reported on rare occasions.

Generic Name: Budesonide

Brand Name(s): Entocort® EC GeneGeneric Name: Ciprofloxacin

Drug class: Corticosteroids Brand Name(s): Cipro®, Proquin®

FDA Pregnancy Category: C Drug class: Antibiotics

How taken: Oral FDA PPregnancy Category: C

Used For: Mild to moderate Crohn’s disease How taken: Oral and intravenous (IV)

Medication indication: Used for the treatment of mildld to Used For: Active Crohn’s disease and pouchitis moderate active Crohn’s disease involving the ileumm and/or the ascending colon. MediMedication indication: May help control symptoms of IBD bby reducing intestinal bacteria and by directly sup- presspressing the intestine’s immune system. Effective as a Most common side effects: Headache, respiratory infec-nfec- long-long-term therapy for some patients with Crohn’s dis- tion, nausea, and symptoms of hypercorticism (too ease who have fistulas or recurrent abscesses near their much steroids in your body). These symptoms includede anusanus. Also effective for people who develop pouchitis. an increase in the size of the face and neck, acne, andnd bruising. Most common side effects: Nausea, vomiting, stomach pain, indigestion, diarrhea, headache, nervousness, Other: Entocort® EC is a nonsystemic corticosteroid, agitaagitation, anxiety, difficulty falling asleep or staying which means it is released primarily in the gastrointesti-testi- asleeasleep. nal (GI) tract, therefore causing fewer side effects. Avoid drinking grapefruit juice regularly as it can OtheOther: Contains fluoroquinolone, an ingredient associated increase the amount of Entocort® EC in your body. with an increased risk of tendonitis and tendon rupture.

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Generic Name: Cyclosporine GenericGene Name: Infliximab

Brand Name(s): Gengraf®, Neoral®, Sandimmune® Brand Name(s): Remicade®

Drug class: Immunomodulators Drug class: Biologics

FDA Pregnancy Category: C FDA PPregnancy Category: B

How taken: Oral and intravenous (IV) Infusion How taken: Intravenous (IV) Infusion

Used For: Ulcerative colitis Used For: Moderate to severe Crohn’s disease and UC

MedicationMedi indication: Indicated for reducing signs and Medication indication: Off-label use for the managementment symptoms,ing s and inducing and maintaining clinical remis- of moderate to severe ulcerative colitis. sionclinic in adult and pediatric patients with moderately to severelymode active Crohn’s disease, who have had an inade- Most common side effects: Headache; diarrhea; heart-art- quateinade response to conventional therapy. Remicade® is burn; gas; increased hair growth; acne; flushing; shakingaking indicatedis ind for reducing the number of draining enterocu- of a part of your body that you cannot control; burningng taneouscutan and rectovaginal fistulas and maintaining fis- or tingling in the hands, arms, feet, or legs; muscle or tula cclosure in adult patients with fistulizing Crohn’s joint pain; cramps. disease.disea Remicade® is indicated for reducing signs and symptoms,symp achieving clinical remission and mucosal Other: Avoid drinking grapefruit juice or eating grapefruit,fruit, healing,heali and eliminating corticosteroid use in patients as this can alter drug levels. with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Most common side effects: Infusion site reactions such as redness,redne rash, swelling, itching, or bruising; respiratory infections,infec such as sinus infections and sore throat; headache;heada coughing; stomach pain; nausea; and back pain.

Other:Othe As with all biologics, infliximab may lower the body’sbody ability to fight infection. Infections including tuber- culosisculos (TB) and sepsis (a life-threatening blood infection) have been reported. On rare occasions other cancers such as lymphomalym have been reported.

GenericGene Name: Mercaptopurine (6-MP)

Brand Name(s): Purinethol®

Drug class: Immunomodulators

FDA PPregnancy Category: D

How taken: Oral

Used For: Ulcerative colitis and Crohn’s disease

MedicationMedi indication: Off-label use for the management of moderatemo and active inflammatory bowel diseases to reducereduc signs and symptoms.

Most common side effects: Headache, weakness, or ach- iness;iness darkening of the skin; loss of appetite or weight.

Other:Othe Periodic blood work is necessary when taking mercaptopurinemerca to monitor the liver and blood counts. Infection,Infect a small risk of lymphoma, and a small risk of pancreatitispancr is noted.

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Generic Name: Mesalamine GeneGeneric Name: Metronidazole

Brand Name(s): Apriso™, Asacol®, Asacol HD®, Canasasa®, Brand Name(s): Flagyl® Lialda™, Pentasa®, Rowasa® Drug class: Antibiotics Drug class: Aminosalicylates (5-ASA) FDA PPregnancy Category: B FDA Pregnancy Category: B How taken: Oral How taken: Oral or rectal Used For: Active Crohn’s disease and pouchitis Used For: Mild to moderate ulcerative colitis MediMedication indication: Off-label use of metronidazole Medication indication: Mesalamine delayed-releasee may hhelp control symptoms of IBD by reducing intestinal tablets or capsules and extended-release capsules may bactebacteria and by directly suppressing the intestine’s im- be used to treat ulcerative colitis that affects any partrt mune system. Effective as a long-term therapy for some of the colon. Mesalamine suppositories and enemass patiepatients with Crohn’s disease who have fistulas or re- should only be used to treat inflammation of the lowerwer currecurrent abscesses near their anus. Also effective for part of the colon. It works by stopping the body fromm peoppeople who develop pouchitis. producing a certain substance that may cause pain or inflammation. Most common side effects: Nausea, vomiting, loss of ap- petitepetite, a metallic taste, diarrhea, dizziness, headaches, Most common side effects: Headache; muscle or jointnt and ddiscolored urine (dark or reddish brown). pain, aching, tightness, or stiffness; back pain; nausea;sea; vomiting; heartburn; burping; constipation; gas; dryy mouth; sore throat; cough; flu-like symptoms; stuffyy head or runny nose; ear pain; anxiety; sweating; acne;ne; GeneGeneric Name: Natalizumab slight hair loss. Brand Name(s): Tysabri®

Drug class: Biologics

Generic Name: Methotrexate FDA PPregnancy Category: C

Brand Name(s): Rheumatrex® How taken: Intravenous (IV) infusion

Drug class: Immunomodulators Used For: Moderate to severe Crohn’s disease

FDA Pregnancy Category: X MediMedication indication: Reduces signs and symptoms, and inducesi and maintains clinical remission in adult How taken: Oral or injection under the skin patiepatients with moderately to severely active Crohn’s dis- Used For: Active Crohn’s disease ease who have had an inadequate response to conven- tionational therapy, including inhibitors of TNF-alpha. Medication indication: Off-label use for the managementment of active Crohn’s disease to reduce signs and symptoms.oms. Most common side effects: Infections such as in the urinaurinary tract or upper respiratory tract, headache, tired- ness, depression, joint pain, diarrhea, and stomach Most common side effects: Nausea, hair loss, area pain. headache, dizziness, drowsiness, and mouth sores.. OtheOther: Natalizumab increases the risk of progressive Other: multimultifocal leukoencephalopathy (PML), a rare brain in- • Not recommended for individuals with pre-existing fectiofection. Natalizumab may also cause liver damage and liver disease. allergallergic reactions. • Known to cause birth defects. • It is recommended for patients to stop methotrexatee at least three months prior to planned conception. • Reduces the absorption of folic acid.

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Generic Name: Olsalazine GeneGeneric Name: Sulfasalazine

Brand Name(s): Dipentum® Brand Name(s): Azulfidine®

Drug class: Aminosalicylates (5-ASA) Drug class: Aminosalicylates (5-ASA)

FDA Pregnancy Category: C FDA PPregnancy Category: B

How taken: Oral How taken: Oral

Used For: Ulcerative colitis Used For: Ulcerative Colitis

Medication indication: For the maintenance of remissionsion MediMedication indication: For the treatment of mild to of ulcerative colitis in patients who are intolerant of modemoderate ulcerative colitis, and as adjunctive therapy sulfasalazine. in sevsevere ulcerative colitis; and for the prolongation of the remission period between acute attacks of Most common side effects: Stomach upset, bloating,g, ulcerulcerative colitis. Also, off-label use for treatment of loss of appetite, blurred vision, headache, pain in joints,oints, CrohnCrohn’s disease. and dizziness. Most common side effects: Diarrhea, headache, loss of Other: Avoid Dipentum® if you are allergic to medicineses appeappetite, upset stomach, vomiting, and stomach pain. containing salicylates, such as aspirin, or mesalamine.e. OtheOther: Low sperm count and infertility have been observed Generic Name: Prednisolone in menme treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects. Brand Name(s): Medrol®, Pediapred Oral Liquid®

Drug class: Corticosteroids

FDA Pregnancy Category: C GeneGeneric Name: Tacrolimus

How taken: Oral Brand Name(s): Prograf®

Used For: Moderate to severe Crohn’s disease and UC Drug class: Immunomodulators

Medication indication: For the management of activee FDA PPregnancy Category: C Crohn’s disease and ulcerative colitis to reduce signsns and symptoms. How taken: Oral and intravenous (IV)

Most common side effects: Upset stomach, stomachh Used For: Moderate to severe Crohn’s disease and irritation, vomiting, headache, dizziness, insomnia, ulcerulcerative colitis restlessness, depression, anxiety, and acne. MediMedication indication: Off-label use for the management of activeact Crohn’s disease and ulcerative colitis to reduce Generic Name: Prednisone signs and symptoms.

Brand Name(s): Deltasone® Most common side effects: Headache, hypertension, Drug class: Corticosteroids diarrdiarrhea, constipation, nausea, vomiting, heartburn, stomstomach pain, loss of appetite, difficulty falling asleep FDA Pregnancy Category: C or stayingsta asleep, dizziness, weakness, back or joint pain, burning, numbness, pain or tingling in the hands How taken: Oral or feet,fee rash, and itching. Used For: Moderate to severe Crohn’s disease and UC OtheOther: Avoid eating grapefruit or drinking grapefruit juice Medication indication: For the management of activee while taking tacrolimus. Crohn’s disease and ulcerative colitis to reduce signsns and symptoms.

Most common side effects: Headache, dizziness, difficulty falling asleep or staying asleep, inappropriateiate happiness, extreme changes in mood, changes in personality, bulging eyes, and acne.

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GloGlossary of terms AbsceAbscess: A collection of pus (dead neutrophils) that hhas accumulated in a cavity formed by the tissue because of an infectious process (usua(usually caused by bacteria or parasites).

AdherAdherence: Sticking to a prescribed medical regimregimen.

AminoAminosalicylates: See page 6.

AntiboAntibody: An immunoglobulin, (a specialized immuimmune protein), produced because of the introdintroduction of an antigen (foreign substance) into ththe body.

AntibiAntibiotics: Drugs that ﬁght infections, such as metrometronidazole and ciproﬂoxacin.

Anus: Opening at the end of the rectum that allows solid waste to be eliminated.

BiologBiologic therapies: See page 7.

BowelBowel: Another name for the intestine. The small bowel and the large bowel are the small intestine and lalarge intestine, respectively.

ChronChronic: Long-lasting or long-term.

ColitisColitis: Inﬂammation of the large intestine (the cocolon).

ColonColon: The large intestine.

CorticCorticosteroids: See page 6.

Crohn’sCrohn disease: A chronic inﬂammatory disease that pprimarily involves the small and large intestine, butb that can affect other parts of the digestive sysystem as well. It is named for Burrill Crohn, the AmericanAm gastroenterologist who ﬁrst de- scribedscribe the disease in 1932.

Diarrhea:Diarrh Passage of excessively frequent or excexcessively liquid stools.

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Nonsteroidal anti-inflammatory drugs Extraintestinal complications: Complications NSAIDNSAIDs: that occur outside of the intestine, such as suchsuch a as aspirin, ibuprofen, ketoprofen, and Medication Log arthritisAbout or skin rashes.Crohn’s In some people, these napronaproxen. may actually be the first signs of IBD, appearing Use of an FDA-approved drug for an disease and Off-laOff-label: even before the bowel symptoms. In others, they indication other than that for which the drug may occur right before a flare-up of the disease. indica waswas a approved originally. ulcerative colitis Keep track of your medication regimen on a daily basis. Fill in your medication information under each category and leave some space to record any changes, FDA: Food & Drug Administration. Oral: By mouth. Crohn’s disease and ulcerative Oral: B such as dosage, number of times taken, symptoms, or side effects. Fistula: A tunnel that leads from one loop of in- Located around the anus, the opening PerianPerianal: testinecolitis to another, belong or that to connects a group the intestine of of the rectum, to the outside of the body. to the bladder, vagina, or skin. Fistulas occur of the Form (i.e., pill) Purpose (why do you take it?), Name of Start Stop Dosage/ Times Taken Symptoms or most commonly around the anal area. If this Pouchitis: Inflammation of the lining of the in- and/or Method Comments, or conditions known as inflam- Pouch Medication Date Date Strength Daily Side Effects complication arises, you may notice drainage Taken (i.e., oral) Special Instructions ternalternal pouch (formed from the small intestine). ofmatory mucus, pus, bowel or stool diseasesfrom this opening., or IBD. Having to do with the rectum. RectaRectal: FlareThese or disordersflare-up: Presenceaffect the of gastrointestinal inflammation and (GI) Lowest portion of the colon. symptoms.tract, the area of the body where digestion takes RectuRectum: place. As the name implies, the diseases cause Gastrointestinal: Adjective referring collectively Remission: Periods in which symptoms disappear inflammation of the intestine. When a part of the Remis to the stomach and small and large intestines. or decrease and good health returns. body is inflamed, it becomes red and swollen. or dec Sores, or ulcers, may also form within the walls Connects to the stomach and GI tract: Short for gastrointestinal tract. SmallSmall intestine: of the intestine. The ongoing inflammation leads largelarge intestine; absorbs nutrients. Immuneto symptoms system: thatThe may body’s already natural be familiar defense to Injected under the skin. systemyou: abdominal that fights pain, against cramping, disease. diarrhea, rectal SubcuSubcutaneous: bleeding, and fatigue. For some people, symp- An agent or substance that may Immunomodulators:toms are not just restrictedSee page to 7. the GI tract. They TeratoTeratogen: may experience signs of IBD in other parts of causecause defects in the developing embryo. Immunosuppressive: The suppression of the the body, such as the eyes, joints, skin, bones, immune system; an agent that reduces the Teratogenic: Capable of causing birth defects. kidney, and liver. These are referred to as ex- Terato function of the immune system. traintestinal manifestations of IBD, because they The degree to which a substance ToxiciToxicity: occur outside of the intestine. Inflammation: A response to tissue injury that isis har harmful. causes redness, swelling, and pain. A sore on the skin or in the lining of the Although Crohn’s disease and ulcerative colitis Ulcer:Ulcer: Inflammatoryshare a lot of bowelsymptoms, diseases they (IBD): do haveA term some used GIGI trac tract. tomarked refer to differences. a group of disorders—includingWhile inflammation related The process or fact of being eroded Crohn’sto Crohn’s disease disease (inflammation may involve in any the part gastroin- of the UlceraUlceration: testinalGI tract tract) from theand mouth ulcerative to the colitis anus (inflammation (including the away,away, as by an ulcer. inesophagus, the colon). stomach, small intestine, and large A relatively common disease UlceraUlcerative colitis: intestine), ulcerative colitis is limited to just the that causes inflammation of the large intestine Intestine: The long, tubelike organ in the ab- that c large intestine (including the colon and rectum). (the colon). domenAnother that distinguishing completes the feature process of ulcerative of digestion. (the co Itcolitis consists is that of the it starts small in and the large rectum intestines. and extends from there in a continuous line of inflammation. Large intestine: Also known as the colon. Its In contrast, Crohn’s disease may appear in primary function is to absorb water and get rid “patches,” affecting some areas of the GI tract of solid waste. while leaving other sections in between com-

Physician Name: Physician Phone Number: Pharmacy Phone Number: 342 35 187767_WF1_Form:Layout 1 11/13/09 7:27 PM Page 2 187767_WF1_CVR_R1.qxp:Layout 1 11/19/09 5:05 PM Page i

Medication Log Notes: About CCFA

Founded in 1967, the Crohn’s & Colitis Foundation of America (CCFA) is a non-proﬁt,volunteer-driven organization dedicated to ﬁnding a cure for Crohn’s Form (i.e., pill) Purpose (why do you take it?), Name of Start Stop Dosage/ Times Taken Symptoms or disease and ulcerative colitis. Today, the organi- and/or Method Comments, or Medication Date Date Strength Daily Side Effects Ifzation you has or grown someone to 40 local chapters,you know with more Taken (i.e., oral) Special Instructions than $136 million invested in research for a cure hasand improved just been treatments. diagnosed This funding haswith en- Crohn’sabled many ground-breakingdisease or treatments,ulcerative improved the quality of care for individuals with colitis,these conditions, you mayand brought feel hope a bit to countless over- whelmedlives. But there’s by still the plenty news. of work leftIn tofact, do. you may not have even heard of Wethese can illnesses help! Contact before. us at: But now888.MY.GUT.PAIN that you have, you will want(888.694.8872) to learn as much as pos- [email protected] about them—including which medications can help control the diseases. That is the purpose of this brochure.

36 1 199544_WF1_CVR 7/13/10 10:15 AM Page ii

This brochure is supported by an unrestricted educational grant from Abbott.

National Office 386 Park Avenue South, 17th Floor New York, NY 10016-8804 212.685.3440 www.ccfa.org

The Crohn’s & Colitis Foundation of America is a non-profit organization that relies on the generosity of private contribu- tions to advance its mission to find a cure for Crohn’s disease and ulcerative colitis.

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NSAIDs: Nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, ketoprofen, and About Crohn’s naproxen. Medication Log disease and Off-label: Use of an FDA-approved drug for an indication other than that for which the drug was approved originally. ulcerative colitis Keep track of your medication regimen on a daily basis. Fill in your medication information under each category and leave some space to record any changes, Oral: By mouth. Crohn’s disease and ulcerative such as dosage, number of times taken, symptoms, or side effects. Perianal: Located around the anus, the opening colitis belong to a group of of the rectum, to the outside of the body. Form (i.e., pill) Purpose (why do you take it?), Name of Start Stop Dosage/ Times Taken Symptoms or Pouchitis: Inflammation of the lining of the in- and/or Method Comments, or conditions known as inflam- Medication Date Date Strength Daily Side Effects matory bowel diseases, or IBD. ternal pouch (formed from the small intestine). Taken (i.e., oral) Special Instructions Rectal: Having to do with the rectum. These disorders affect the gastrointestinal (GI) tract, the area of the body where digestion takes Rectum: Lowest portion of the colon. place. As the name implies, the diseases cause Remission: Periods in which symptoms disappear inflammation of the intestine. When a part of the or decrease and good health returns. body is inflamed, it becomes red and swollen. Sores, or ulcers, may also form within the walls Small intestine: Connects to the stomach and of the intestine. The ongoing inflammation leads large intestine; absorbs nutrients. to symptoms that may already be familiar to you: abdominal pain, cramping, diarrhea, rectal Subcutaneous: Injected under the skin. bleeding, and fatigue. For some people, symptoms are not just restricted to the GI tract. They Teratogen: An agent or substance that may may experience signs of IBD in other parts of cause defects in the developing embryo. the body, such as the eyes, joints, skin, bones, Teratogenic: Capable of causing birth defects. kidney, and liver. These are referred to as extraintestinal manifestations of IBD, because they Toxicity: The degree to which a substance occur outside of the intestine. is harmful.

Although Crohn’s disease and ulcerative colitis Ulcer: A sore on the skin or in the lining of the share a lot of symptoms, they do have some GI tract. marked differences. While inflammation related to Crohn’s disease may involve any part of the Ulceration: The process or fact of being eroded GI tract from the mouth to the anus (including the away, as by an ulcer. esophagus, stomach, small intestine, and large Ulcerative colitis: A relatively common disease intestine), ulcerative colitis is limited to just the that causes inflammation of the large intestine large intestine (including the colon and rectum). (the colon). Another distinguishing feature of ulcerative colitis is that it starts in the rectum and extends from there in a continuous line of inflammation. In contrast, Crohn’s disease may appear in “patches,” affecting some areas of the GI tract while leaving other sections in between com-

Physician Name: Physician Phone Number: Pharmacy Phone Number: 2 35 187767_WF1_Form:Layout 1 11/13/09 7:27 PM Page 2

Medication Log Notes:

Form (i.e., pill) Purpose (why do you take it?), Name of Start Stop Dosage/ Times Taken Symptoms or and/or Method Comments, or Medication Date Date Strength Daily Side Effects If you or someone you know Taken (i.e., oral) Special Instructions has just been diagnosed with Crohn’s disease or ulcerative colitis, you may feel a bit over- whelmed by the news. In fact, you may not have even heard of these illnesses before. But now that you have, you will want to learn as much as possible about them—including which medications can help control the diseases. That is the purpose of this brochure.

36 1