Understanding IBD Medications - Atrium Health · may experience signs of IBD in other parts of the...

UnderstandingIBD Medications

and Side Effects

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About Crohn’s Disease and Ulcerative Colitis 2

Treatment 4

Over-the-Counter (OTC) Medications 5

Prescription Medications 6

Off-Label 8

Pediatric Patients 8

Pregnancy and Male Fertility 11

Making the Most of Your Treatment 12

Tips to Help Manage Your Medications 13

What to Ask Your Healthcare Provider About Medications 14

Remember to Tell the Doctor 15

Participating in Clinical Trials 16

Pregnancy Drug Safety Chart 18

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

What’s Inside?

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

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Form (i.e., pill)and/or MethodTaken (i.e., oral)

StopDate

Symptoms or Side Effects

Name of Medication

Times Taken Daily

Medication Log

StartDate

Purpose (why do you take it?), Comments, or

Special Instructions

Dosage/Strength If you or someone you know

has just been diagnosed withCrohn’s disease or ulcerativecolitis, you may feel a bit over-whelmed by the news. In fact,you may not have even heardof these illnesses before. Butnow that you have, you willwant to learn as much as pos-sible about them—includingwhich medications can helpcontrol the diseases. That isthe purpose of this brochure.

Notes:

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Medication Log

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,such as dosage, number of times taken, symptoms, or side effects.

Physician Name: Physician Phone Number: Pharmacy Phone Number:

2 35


StopDate


Name of Medication

Times Taken Daily

StartDate



Dosage/Strength

About Crohn’s disease and ulcerative colitisCrohn’s disease and ulcerativecolitis belong to a group ofconditions known as inflam-matory bowel diseases, or IBD.

These disorders affect the gastrointestinal (GI)tract, the area of the body where digestion takesplace. As the name implies, the diseases causeinflammation of the intestine. When a part of thebody is inflamed, it becomes red and swollen.Sores, or ulcers, may also form within the wallsof the intestine. The ongoing inflammation leadsto symptoms that may already be familiar toyou: abdominal pain, cramping, diarrhea, rectalbleeding, and fatigue. For some people, symp-toms are not just restricted to the GI tract. Theymay experience signs of IBD in other parts of the body, such as the eyes, joints, skin, bones,kidney, and liver. These are referred to as ex-traintestinal manifestations of IBD, because theyoccur outside of the intestine.

Although Crohn’s disease and ulcerative colitisshare a lot of symptoms, they do have somemarked differences. While inflammation relatedto Crohn’s disease may involve any part of the GI tract from the mouth to the anus (including theesophagus, stomach, small intestine, and largeintestine), ulcerative colitis is limited to just thelarge intestine (including the colon and rectum).Another distinguishing feature of ulcerative colitis is that it starts in the rectum and extendsfrom there in a continuous line of inflammation.In contrast, Crohn’s disease may appear in“patches,” affecting some areas of the GI tractwhile leaving other sections in between com-

NSAIDs: Nonsteroidal anti-inflammatory drugssuch as aspirin, ibuprofen, ketoprofen, andnaproxen.

Off-label: Use of an FDA-approved drug for an indication other than that for which the drugwas approved originally.

Oral: By mouth.

Perianal: Located around the anus, the openingof the rectum, to the outside of the body.

Pouchitis: Inflammation of the lining of the in-ternal pouch (formed from the small intestine).

Rectal: Having to do with the rectum.

Rectum: Lowest portion of the colon.

Remission: Periods in which symptoms disappearor decrease and good health returns.

Small intestine: Connects to the stomach andlarge intestine; absorbs nutrients.

Subcutaneous: Injected under the skin.

Teratogen: An agent or substance that maycause defects in the developing embryo.

Teratogenic: Capable of causing birth defects.

Toxicity: The degree to which a substance is harmful.

Ulcer: A sore on the skin or in the lining of the GI tract.

Ulceration: The process or fact of being erodedaway, as by an ulcer.

Ulcerative colitis: A relatively common diseasethat causes inflammation of the large intestine(the colon).


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pletely untouched. These are known as “skip”areas. These differences are important for decid-ing whether inflammation of the intestinal tractis from Crohn’s disease or ulcerative colitis.

Although you may have never heard of these diseases, approximately 1.4 million Americanadults and children suffer from Crohn’s diseaseor ulcerative colitis. Most people develop thesediseases between the ages of 15 and 35. Thenumber of newly diagnosed people has explodedover the last 50 years. The exact reasons for thisincrease are unknown. To date, there is no knowncause of or cure for Crohn’s disease or ulcerativecolitis, and that’s what makes the Crohn’s & Colitis Foundation of America’s (CCFA) researchso critical. CCFA has pioneered the field of re-search into these difficult digestive diseases fornearly a half-century. Some of our major projectshave included human genome (study of genesassociated with IBD), microbiome (study of bac-terial species), and genetic research.

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TreatmentTo date, there is no knowncause of or cure for IBD, but fortunately there are many effective treatments to helpcontrol these diseases.

The three main goals of treatments for IBD are:

Achieving remission (defined as the absenceof symptoms).

Maintaining remission (defined as preventingflare-ups of disease).

Improving quality of life (defined personally).

These goals may be achieved either with a com-bination of over-the-counter and prescriptionmedications, or surgery depending on each individual case. (For more on surgery, visitwww.ccfa.org). When considering medicationoptions, you should remember the following key points:

Symptoms of these long-term diseases mayrange from mild to severe and may include, butare not limited to, diarrhea, abdominal cramp-ing, nausea, pain, rectal bleeding, and fever.

People will go through periods in which theillness is active and is causing symptoms. Suchperiods are known as flares. These episodesare usually followed by times of remission.Remission occurs when symptoms either disappear completely or lessen considerablyand good health returns. These disease-freeperiods can last months or even years.

Because each person with IBD is different, thetreatment used to control his or her illness isunique, as well. There is no “one-size-fits-all”

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approach. Doctors will customize treatment to the individual’s needs based on the typeand severity of symptoms. It may be given in different dosages, formulations, and for different lengths of time.

Medications can be given in oral form (bymouth), intravenously (through a vein), or subcutaneous (by injection under the skin).Topical therapies are administered rectally, assuppositories, enemas, creams, and ointments.

It is important to keep in mind that a person’stherapeutic needs may change over time. Whatworks at one point during the illness may notbe effective during another stage. It is importantfor the patient and doctor to discuss thoroughlywhich course of therapy is best—bearing inmind that a combination of therapies may bethe optimal treatment plan.

Over-the-Counter (OTC) Medications Prescription medications reduce intestinal inflam-mation and form the core of IBD treatment. Evenso, these important prescription medications maynot eliminate all of your symptoms. Naturally,you may want to take over-the-counter medica-tions in an effort to feel better. Before doing so,speak with your doctor, or other healthcare pro-fessional, as sometimes these symptoms mayindicate a worsening of the inflammation thatmay require either hospitalization or a change in your prescription IBD medication.

Other times these symptoms do not reflect aworsening of the condition and can be treatedwith over-the-counter medications. Your doctormay recommend loperamide (Imodium®) to re-lieve diarrhea, or anti-gas products for bloating.To reduce joint pain and fever, your doctor mayrecommend acetaminophen (Tylenol®) or non-steroidal anti-inflammatory drugs (NSAID)—such as aspirin, ibuprofen (Advil®, Motrin®), ornaproxen (Aleve®). NSAIDs will work to alleviatejoint symptoms but can irritate the small intes-tine or colon, thus promoting inflammation, so


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these should be used with great care. Make surethat you follow instructions with all OTC products,but again, speak with your healthcare professionalfirst before you take any of these medications.

Prescription Medications Some medications used to treat Crohn’s diseaseand ulcerative colitis have been around foryears. Others are more recent breakthroughs.The most commonly prescribed medications fallinto five basic categories:

Aminosalicylates: These include aspirin-likecompounds that contain 5-aminosalicylic acid(5-ASA), such as sulfasalazine, balsalazide,mesalamine, and olsalazine. These drugs, whichcan be given either orally or rectally, do notsuppress the immune system but decrease inflammation at the wall of the intestine itself,and help heal both in the short- and long-term.They are effective in treating mild-to-moderateepisodes of IBD. They also are useful in pre-venting relapses (return of symptoms).

Corticosteroids: These medications, which include prednisone, prednisolone, andbudesonide, affect the body’s ability to beginand maintain an inflammatory process. In ad-dition, they work to keep the immune systemin check. Prednisone and prednisolone areused for people with moderate-to-severeCrohn’s disease and ulcerative colitis. Budes-onide is used for people with mild to moderateileal Crohn’s disease, and right-sided colonCrohn’s disease. They can be administeredorally, rectally, or intravenously. Effective forshort-term control of acute episodes (flares),they are not recommended for long-term ormaintenance use because of their side effects.If you cannot discontinue steroids withoutsuffering a relapse of symptoms, your doctormay add some other medications to helpmanage your disease. It is important not tosuddenly stop taking this medication.

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Immunomodulators: These include azathio-prine, 6-mercaptopurine (6-MP), methotrexate,and cyclosporine. This class of medicationsmodifies the body’s immune system so that itcannot cause ongoing inflammation. Usuallygiven orally (methotrexate is injectable), im-munomodulators are typically used in peoplefor whom aminosalicylates and corticosteroidshaven’t been effective, or have been only par-tially effective. They may be useful in reducingor eliminating reliance on corticosteroids.They also may be effective in maintaining remission in people who haven’t responded to other medications given for this purpose.Immunomodulators may take up to threemonths to begin working.

Biologic therapies: These therapies are genet-ically engineered to target very specific mole-cules involved in the inflammatory process.The newest class of therapy to be used in IBD,these include adalimumab, certolizumabpegol, infliximab, and natalizumab. These arenot drugs, but proteins (antibodies) that targetthe action of certain other proteins that causeinflammation.

These medications are indicated for peoplewith moderately to severely active diseasewho haven’t responded well to conventionaltherapy. They also are effective for reducingfistulas. (Fistulas, which may occur with Crohn’sdisease, are small tunnels connecting one loopof intestine to another or two organs in thebody that are usually not connected.) Biologicsmay be an effective strategy for reducing steroiduse, as well as for maintaining remission.

Antibiotics: Metronidazole, ciprofloxacin, andother antibiotics may be used when infections—such as an abscess—occur. They treat Crohn’s,colitis and perianal Crohn’s disease. They arealso used for post-surgical problems such as pouchitis.


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Off-LabelSometimes doctors will prescribe medicationsthat the Food & Drug Administration (FDA) hasnot specifically approved for the treatment ofCrohn’s or colitis. Nonetheless, these medicationshave been shown to be very effective in reducingsymptoms. Prescribing medications for other thanFDA-approved conditions is known as “off-label”use. Your healthcare provider may have to obtainprior approval from insurance companies beforeprescribing a medication for off-label use. Patientsshould be aware that they or their doctor mightneed to make a special appeal to get third-partyinsurance payment for off-label medication.

The use of substances found in nature, such asherbs, foods, and vitamins, is considered bio-logically-based practice. Unlike pharmaceuticalproducts, natural remedies are not regulated bythe FDA.

Pediatric IBD PatientsCustomizing treatment for theindividual with IBD is critical,but it is especially importantwhen that patient is a child orteenager.

Most pediatric treatment choices were developedafter initial research on adults. As a result, drugdosages for a child must be carefully tailored tosuit their age, size, and weight—in addition toexisting symptoms, location of inflammation,and previous response to treatment.

The same medications that are used to treatadults with IBD are also used for children. Still,there are some special considerations in treat-ment because children and teenagers are goingthrough a period of physical and emotional


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growth and development. Here are some of therecommendations for the various medicationcategories:

Aminosalicylates: These aspirin-like compoundsthat contain 5-aminosalicylic acid (5-ASA) aregenerally the first step in therapy for childrenwith mild-to-moderate ulcerative colitis orCrohn’s disease. Mesalamine and olsalazinehave fewer side effects than sulfasalazine. The drugs can be given either orally or rectally.The number of pills may be as many as 10 to16 per day, which may be difficult with a child’sschool schedule. Also, some children havetrouble swallowing pills. In cases where swal-lowing capsules is a concern, your child’s doctor may advise that specific capsules beopened and the contents mixed with food.

Corticosteroids: When a child has not re-sponded to treatment with 5-ASA, then oralcorticosteroids may be prescribed on an outpatient basis. For more severe cases, intravenous corticosteroids may be used—necessitating a hospital stay. Once remissionis achieved, then corticosteroid dosage is tapered gradually. The goal is to discontinuethese medications as quickly as possible andthereby minimize side effects, which may in-clude facial swelling, excessive weight gain,hair growth, and acne. Long-term steroid usein children can also lead to growth problemsand weakened bones (osteoporosis). To mini-mize the chance of osteoporosis, adequatecalcium and vitamin D intake is essential.

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Immunomodulators: Both azathioprine and 6-mercaptopurine (6-MP) are widely prescribedfor children with Crohn’s disease and ulcerativecolitis who do not respond to standard med-ications. They may minimize symptoms andenhance growth. Treatment with 6-MP hasbeen shown to work well for controlling activedisease in children, as well as reducing oreliminating dependency on corticosteroids.They also may be effective in maintaining remission in people who haven’t respondedto other medications given for this purpose.Methotrexate is another immunomodulatorwith similar advantages in limiting corticos-teroid use that is increasingly being used inchildren and adolescents with Crohn’s disease,with somewhat less success so far in ulcera-tive colitis. All patients on immunomodulatorsneed to be monitored closely for side effects,which include bone marrow problems as wellas irritation of the liver or pancreas.

Biologic therapies: Infliximab was the first bi-ologic therapy to be FDA-approved for Crohn’sdisease in children, and is now also commonlyused to treat ulcerative colitis. Infliximab isusually reserved to treat more advanced oraggressive disease. Other biologic therapiesare being tested in children, and are currentlyused in special situations.

Antibiotics: Metronidazole is used in childrenand teenagers with perianal Crohn’s disease.It may also be used as an alternative treatmentto 5-ASA or steroids for Crohn’s or colitis. An-other antibiotic option is ciprofloxacin, whichhas been shown to be effective in adults withcolitis and inflammatory changes around theanus, including fistulas and abscesses in Crohn’sdisease. The use of ciprofloxacin and otherdrugs in the same class, called fluorquinolones,has been associated with an increased risk oftendonitis and joint discomfort or pain. Its usein children has been controversial in the past,although studies have not demonstrated anyincreased risk of complications in childrencompared to adults.

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Pregnancy and MaleFertilityIf you are considering becom-ing pregnant, it is recommend-ed to try to have your IBD inremission before you do so.

Recent studies have shown that women do betterduring pregnancy if their disease is not active atthe time of conception. Active disease requiresmedication, and most doctors prefer that theirpatients restrict medication during pregnancy.Still, most experts agree that the major threat to the pregnancy seems to come from the activedisease itself, rather than the medication.

If you are pregnant and have IBD symptoms, yourdoctor will advise you as to which of the medica-tions mentioned previously are safe to take. TheFDA ranking system for drug safety during preg-nancy categorizes all medications from “A” to“D” (safest to least safe), in addition to an extracategory, “X.”

Category A: Drugs have been tested andfound to be safe for use in pregnancy duringthe first trimester.

Category B: Used in pregnancy and does notappear to cause birth defects or other problems.

Category C: Drugs that have warnings and are more likely to cause a problem for motheror fetus.

Category D: Drugs that have clear healthrisks, but benefits may outweigh the risk.

Category X: Drugs that cause birth defectsand should not be used during pregnancy.


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Drugs that fall into this last category have beenshown to cause birth defects and should never betaken during pregnancy. Please note: Althoughthe rating system provides valuable information,it will no longer be used for new drug therapies,under a March 2008 policy change by the FDA.However, some healthcare professionals arecontinuing to use this helpful data for existingdrug therapies. Information on all known preg-nancy and nursing experience will soon appearin the prescribing insert of any medication. [See page 18 for recommendations.]

Because pregnancy is such a personal matter andthere are so many factors that go into how a preg-nancy may turn out, the choice of what medicinesto take before and during pregnancy should bediscussed with the healthcare provider treatingyour disease, as well as your obstetrician.

While most of the recommendations regardingmedication use and pregnancy focus on women,there are some for men as well. For three monthsbefore conception, men should avoid taking the drug methotrexate. Because the medication sulfasalazine decreases sperm count and there-fore may cause infertility, a man taking this drugshould switch to another 5-ASA compound (withhis doctor’s approval). Discuss all medicationswith your doctor.

Making the most ofyour treatmentCrohn’s disease and ulcerativecolitis are long-term diseases.

This means that people with these conditionsmay need to take medication indefinitely. Whilenot every person with IBD will be on medicationall of the time, most people will require therapymost of the time.

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For many individuals—particularly children andteenagers—this may seem like a major concern,especially when some of those medications pro-duce unwanted side effects. If you are experiencingunpleasant side effects or interactions with otherdrugs, don’t stop taking your prescribed medica-tion. Speak with your doctor and ask about pos-sible adjustments that might reduce those effects.

Even when there are no side effects, or just mini-mal ones, it may still seem like a nuisance to beon a steady regimen of medication. Seek supportfrom your healthcare provider. Remember, though,that taking maintenance medication can signifi-cantly reduce the risk of flares in both Crohn’sdisease and ulcerative colitis. In between flares,most people feel quite well and free of symptoms.

Tips to Help You Manage Your Medications:

Taking medication correctly means more thanjust taking the right amount at the right time.Talk to your doctor or pharmacist and learn asmuch as possible about the medications youtake and how they may affect you.

Take medications as directed. Remember,more is not necessarily better.

Some medications require close monitoringfor side effects. Don’t forget to completeblood work and follow-up visits as requestedby your provider.

Read drug labels carefully. If the print on thecontainer is difficult to read, ask your pharma-cist if it can be made larger.

Use the same pharmacy every time you getyour prescription filled. Pharmacies can helpyou keep track of what you are taking.

Don’t take any medications that have expired.

Don’t take anyone else’s medications or shareyours with others.

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Tell your doctor or pharmacist about all medicines you take, including OTC, vitamins,and herbs.

Don’t forget to take your medications with youwhen you travel or will be away from home.Before you leave, make sure you have plenty incase of delays.

Above all, do not stop taking your medicationswithout your doctor’s approval even if you feelyou cannot afford them. It is important that youtake medications as prescribed, as some cannotbe safely stopped abruptly. If the cost of treat-ment presents a problem for you, that is still nota reason to cut back or discontinue it. A numberof patient assistance programs can help. Contactthe Crohn’s & Colitis Foundation of America(www.ccfa.org) for more information.

What to Ask Your Healthcare ProviderAbout Your MedicationsIt is only natural that you will have some concernsabout the treatment that you (or your child) willbe receiving for IBD. What should you ask yourdoctor? What do you need to know about yourtreatment or your child’s treatment? Followingare some of the questions you may want to ask:

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

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

What kind of side effects might I experience?Which are cause for alarm, and what should Ido if these occur?

Which OTC products would you recommendfor me to take if I have pain or other symptoms?

What kind of interactions does this IBD medication have with other medications I may be taking for other conditions?

What should I do if I miss a dose?

What should I do if I have a negative reactionimmediately after taking my medication?

Is it safe to drink alcoholic beverages while on this medication?

What should I do if I can’t afford my medication?

Remember to Tell the DoctorBefore starting new medications, it is importantfor you to tell your doctor and other healthcareproviders (including dentists or emergency roomstaff) about other medications you may be taking.Tell them whether you:

Have taken this drug before (even if there wasno unusual reaction).

Have had an unusual or allergic reaction to this drug, or other medications.


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Take any other medication or drugs (prescription or over-the-counter).

Take any vitamins, minerals, herbs, or other supplements.

Participation in clinical trialsResearchers working in labo-ratories all over the world aredevoted to the scientific in-vestigation of Crohn’s diseaseand ulcerative colitis in thehope of finding a cure.

That is good news when it comes to the develop-ment of new therapies for these conditions. New discoveries over the past decade have ledto huge strides in the fields of immunology, thestudy of the body’s immune defense system; mi-crobiology, the study of microscopic organismswith the power to cause disease; and genetics,the study of how various tendencies and traits—including diseases—are passed on from onegeneration to another.

With new information being amassed all the time,there is good reason to be hopeful about futuretreatment for IBD. While we all wish for bettertreatments today, we need to understand that ittakes a long time for a promising developmentin the laboratory to become a drug ready forconsumer use. In fact, the process of getting adrug to market, from first testing to final ap-proval by the Food & Drug Administration (FDA),sometimes may take as long as 10 years.


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Before a new drug or a new type of treatment isapproved, it must go through a series of clinicaltrials. Clinical trials are well-organized studiesthat evaluate the treatment’s efficacy and safety.Most clinical trials are classified into one ofthree phases:

Phase I trials evaluate how a new drug shouldbe given (by mouth, injected into the blood,or injected into the muscle), how often, andwhat doses are safe to use.

Phase II trials also test the safety of the drug,as well as evaluate how well the new drugworks. Finally,

Phase III trials test how well the new drugworks. Trial participants are divided into groupswhere one receives the medication and a “con-trol” group receives a placebo (no chemicalproperties). So, while it is possible that you’ll getthe benefit of the new therapy, it is also possiblethat you will not receive the medication.

Patients often find participation in a clinical triala rewarding experience. Anyone can participateas long as they meet the criteria for that particu-lar trial. Those criteria may include type of symp-toms, location or stage of disease, and age. Yourhealthcare provider may recommend a trial oryou can find out about them yourself from CCFAat http://www.ccfa.org/trials/ or other sourcesincluding http://www.clinicaltrials.gov/. All clini-cal trials, no matter how big or small, have to beregistered with this clinical trials Web site.

Should you participate in a clinical trial of a newdrug for Crohn’s disease or ulcerative colitis? Tomake that decision, you need to be fully informedabout that trial and the drug that is being tested.All clinical trials have both benefits and risks as-sociated with them. The advances in current IBDtreatment are possible only because people before you offered to participate in clinical trials.

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DrugFDA pregnancycategory

Recommendations for pregn

Adalimumab B Low risk

Alendronate C Limited human data

Amoxicillin/clavulanic acid B Low risk

Azathioprine/ 6-mercaptopurine D Data in IBD, transplant litera

Balsalazide B Low risk

Budensonide C Low risk in pregnancy: limite

Certolizumab pegol B Limited human data: low ris

Ciprofloxacin C Avoid: potential toxicity to ca

Corticosteroids CLow risk: possible increasedrenal insufficiency, prematur

Cyclosporine C Low risk

Fish oil supplements --- Low risk: possibly beneficial

Infliximab B Low risk

Mesalamine B Low risk

Methotrexate X Contraindicated: teratogenic

Natalizumab C Limited human data: likely lo

Metronidazole BWould avoid, given limited eof cleft palate

Olsalazine C Low risk

Rifaximin C Animal teratogen: no human

Risedronate C Limited human data

Sulfasalazine BConsidered low risk;give folate 2 mg daily

Tacrolimus C Use if mother’s health mand

Thalidomide X Contraindicated: teratogenic

Table I. Pregnancy Drug Safety Chart


yRecommendations for pregnancy

Recommendations for breast-feeding

Low riskNo human data: probably compatible

Limited human data Safety unknown

Low risk Probably compatible

Data in IBD, transplant literature suggest low riskLimited human data: probably compatible

Low riskNo human data: potential diarrhea

Low risk in pregnancy: limited human dataCompatible with breastfeeding

Limited human data: low riskNo human data: probably compatible

Avoid: potential toxicity to cartilageLimited human data:probably compatible

Low risk: possible increased risk of cleft palate, ad-renal insufficiency, premature rupture of membranes

Compatible

Low riskLimited human data:potential toxicity

Low risk: possibly beneficial No human data

Low riskNo human data: probably compatible

Low riskLimited human data:potential diarrhea

Contraindicated: teratogenic Contraindicated

Limited human data: likely low risk No human data

Would avoid, given limited efficacy in IBD and riskof cleft palate

Limited human data:potential toxicity

Low riskLimited human data:potential diarrhea

Animal teratogen: no human dataNo human data: probably compatible

Limited human data Safety unknown

Considered low risk;give folate 2 mg daily

Limited human data:potential diarrhea

Use if mother’s health mandatesLimited human data:potential toxicity

Contraindicated: teratogenicNo human data: potential toxicity

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Improving quality of lifeCCFA has established a rangeof educational brochures, factsheets, and programs designedto increase awareness aboutthese digestive diseases.

We know living with Crohn’s or colitis can be difficult, but the right resources and support canmake day-to-day living more comfortable. That’swhy CCFA has developed a comprehensive, freeonline community (www.ccfacommunity.org) toprovide the support individuals need in managingtheir condition. Support groups are also avail-able in many locations. Find groups in your areaat: www.ccfa.org/chapters, or call 1-888-694-8872.

We recognize the importance of distributing un-biased, accurate, and authoritative informationin order to provide education of the finest quality.One avenue used to accomplish this is the Infor-mation Resource Center (IRC). Through a toll-freenumber (1-888-694-8872), e-mail, or live chat onour Web site (www.ccfa.org), Master’s degreelevel health education professionals answerquestions and direct people to resources impor-tant to their quality of life. The IRC has truly be-come an important lifeline for patients, families,friends, healthcare professionals, and the media.


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Tools and resourcesYou and your healthcareprovider share one importantgoal: to get your IBD undercontrol and keep it that way.

This is also known as achieving and maintainingremission. One of the best ways to accomplish thatis by carefully following the medication regimenyour doctor has prescribed for you. To help you,we have provided a medication log toward theend of this brochure to track your treatment andcare over time. To use the log, fill in the medica-tion information under each category. You maywant to leave blank lines under each medicationto enable you to record any changes—such aswhich dosage, times taken, symptoms, or sideeffects—and additional comments or special di-rections. We suggest you keep it somewherehandy so you can access it easily. The log alsoserves as a convenient reference for when youspeak with your healthcare providers. Also in-cluded on the next page are medication profiles.The profiles include information about com-monly used IBD medications.

These profiles do not contain all available infor-mation about the risks, benefits, and additionalwarnings for each medication listed. Pleasespeak with your healthcare provider for moredetailed information. This information is not intended to replace medical advice from yourdoctor or other healthcare provider.

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Generic Name: Adalimumab

Brand Name(s): Humira®

Drug class: Biologics

FDA Pregnancy Category: B

How taken: Injection under the skin (subcutaneous)

Used For: Moderate to severe Crohn’s disease

Medication indication: Reduces signs and symptomsand induces and maintains clinical remission in adultpatients with moderately to severely active Crohn’s disease who have had an inadequate response to con-ventional therapy. Reduces signs and symptoms and induces clinical remission in patients who have lost response to or are intolerant to infliximab.

Most common side effects: Injection site reactions suchas redness, rash, swelling, itching, pain, or bruising;upper respiratory infections (including sinus infections);headaches, rash, nausea.

Other: Biologics may reduce the body’s ability to fightother infections. There have been reports of serious in-fections associated with adalimumab, including tuber-culosis (TB) and sepsis (a life-threatening bloodinfection). On rare occasions certain types of cancer, including lymphoma, have been reported.

Generic Name: Azathioprine

Brand Name(s): Azasan®, Imuran®

Drug class: Immunomodulators

FDA Pregnancy Category: D

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

Used For: Ulcerative colitis and Crohn’s disease

Medication indication: Off-label use for the managementof moderate and active inflammatory bowel disease toreduce signs and symptoms.

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

Other: Periodic blood work is necessary when takingImuran to monitor the liver and blood counts. Infection,a small risk of lymphoma, and a small risk of pancreatitisis noted.

23


24

Generic Name: Balsalazide

Brand Name(s): Colazal®

Drug class: Aminosalicylates (5-ASA)


How taken: Oral

Used For: Mild to moderate ulcerative colitis

Medication indication: Used to treat the signs andsymptoms of mild to moderately active ulcerative colitisin patients five years of age and older. Also, off-labeluse for treatment of Crohn’s disease.

Most common side effects: Headaches, abdominal pain,diarrhea, nausea, vomiting, respiratory infection, andarthralgia.

Other: Avoid Colazal® if you are allergic to medicines containing salicylates, such as aspirin, or mesalamine(Rowasa®, Asacol®, Pentasa®, Canasa®, Lialda™, andApriso™).

Generic Name: Budesonide

Brand Name(s): Entocort® EC

Drug class: Corticosteroids

FDA Pregnancy Category: C

How taken: Oral

Used For: Mild to moderate Crohn’s disease

Medication indication: Used for the treatment of mild tomoderate active Crohn’s disease involving the ileumand/or the ascending colon.

Most common side effects: Headache, respiratory infec-tion, nausea, and symptoms of hypercorticism (toomuch steroids in your body). These symptoms includean increase in the size of the face and neck, acne, andbruising.

Other: Entocort® EC is a nonsystemic corticosteroid,which means it is released primarily in the gastrointesti-nal (GI) tract, therefore causing fewer side effects.

Avoid drinking grapefruit juice regularly as it can increase the amount of Entocort® EC in your body.

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Generic Name: Ciprofloxacin

Brand Name(s): Cipro®, Proquin®

Drug class: Antibiotics


How taken: Oral and intravenous (IV)

Used For: Active Crohn’s disease and pouchitis

Medication indication: May help control symptoms ofIBD by reducing intestinal bacteria and by directly sup-pressing the intestine’s immune system. Effective as along-term therapy for some patients with Crohn’s dis-ease who have fistulas or recurrent abscesses near theiranus. Also effective for people who develop pouchitis.

Most common side effects: Nausea, vomiting, stomachpain, indigestion, diarrhea, headache, nervousness, agitation, anxiety, difficulty falling asleep or stayingasleep.

Other: Contains fluoroquinolone, an ingredient associatedwith an increased risk of tendonitis and tendon rupture.


Generic Name: Certolizumab pegol

Brand Name(s): Cimzia®



How taken: Injection under the skin (subcutaneous)


Medication indication: Reduces signs and symptoms,and maintains clinical remission in adult patients withmoderately to severely active Crohn’s disease, whohave had an inadequate response to conventionaltherapy.

Most common side effects: Swelling, weight gain, rash,upper respiratory tract infection, urinary tract infection,and joint pain.

Other: Biologics may reduce the body’s ability to fightother infections. Cases of serious infections includingtuberculosis (TB) and sepsis (a life threatening blood infection) have been reported. Lymphoma and othercancers have been reported on rare occasions.

Generic Name: Cyclosporine

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



How taken: Oral and intravenous (IV) Infusion

Used For: Ulcerative colitis

Medication indication: Off-label use for the managementof moderate to severe ulcerative colitis.

Most common side effects: Headache; diarrhea; heart-burn; gas; increased hair growth; acne; flushing; shakingof a part of your body that you cannot control; burningor tingling in the hands, arms, feet, or legs; muscle orjoint pain; cramps.

Other: Avoid drinking grapefruit juice or eating grapefruit,as this can alter drug levels.

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Generic Name: Infliximab

Brand Name(s): Remicade®



How taken: Intravenous (IV) Infusion

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

Medication indication: Indicated for reducing signs andsymptoms, and inducing and maintaining clinical remis-sion in adult and pediatric patients with moderately toseverely active Crohn’s disease, who have had an inade-quate response to conventional therapy. Remicade® isindicated for reducing the number of draining enterocu-taneous and rectovaginal fistulas and maintaining fis-tula closure in adult patients with fistulizing Crohn’sdisease. Remicade® is indicated for reducing signs andsymptoms, achieving clinical remission and mucosalhealing, and eliminating corticosteroid use in patientswith moderately to severely active ulcerative colitis whohave had an inadequate response to conventional therapy.

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

Other: As with all biologics, infliximab may lower thebody’s ability to fight infection. Infections including tuber-culosis (TB) and sepsis (a life-threatening blood infection)have been reported. On rare occasions other cancers suchas lymphoma have been reported.

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Generic Name: Mercaptopurine (6-MP)

Brand Name(s): Purinethol®


FDA Pregnancy Category: D

How taken: Oral

Used For: Ulcerative colitis and Crohn’s disease

Medication indication: Off-label use for the managementof moderate and active inflammatory bowel diseases toreduce signs and symptoms.

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

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


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Generic Name: Methotrexate

Brand Name(s): Rheumatrex®


FDA Pregnancy Category: X

How taken: Oral or injection under the skin

Used For: Active Crohn’s disease

Medication indication: Off-label use for the managementof active Crohn’s disease to reduce signs and symptoms.

Most common side effects: Nausea, hair loss,headache, dizziness, drowsiness, and mouth sores.

Other:• Not recommended for individuals with pre-existing

liver disease. • Known to cause birth defects.• It is recommended for patients to stop methotrexate

at least three months prior to planned conception.• Reduces the absorption of folic acid.

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Generic Name: Mesalamine

Brand Name(s): Apriso™, Asacol®, Asacol HD®, Canasa®,Lialda™, Pentasa®, Rowasa®



How taken: Oral or rectal

Used For: Mild to moderate ulcerative colitis

Medication indication: Mesalamine delayed-releasetablets or capsules and extended-release capsules maybe used to treat ulcerative colitis that affects any part of the colon. Mesalamine suppositories and enemasshould only be used to treat inflammation of the lowerpart of the colon. It works by stopping the body fromproducing a certain substance that may cause pain or inflammation.

Most common side effects: Headache; muscle or jointpain, aching, tightness, or stiffness; back pain; nausea;vomiting; heartburn; burping; constipation; gas; drymouth; sore throat; cough; flu-like symptoms; stuffyhead or runny nose; ear pain; anxiety; sweating; acne;slight hair loss.


29

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Generic Name: Metronidazole

Brand Name(s): Flagyl®

Drug class: Antibiotics


How taken: Oral

Used For: Active Crohn’s disease and pouchitis

Medication indication: Off-label use of metronidazolemay help control symptoms of IBD by reducing intestinalbacteria and by directly suppressing the intestine’s im-mune system. Effective as a long-term therapy for somepatients with Crohn’s disease who have fistulas or re-current abscesses near their anus. Also effective forpeople who develop pouchitis.

Most common side effects: Nausea, vomiting, loss of ap-petite, a metallic taste, diarrhea, dizziness, headaches,and discolored urine (dark or reddish brown).

Generic Name: Natalizumab

Brand Name(s): Tysabri®



How taken: Intravenous (IV) infusion


Medication indication: Reduces signs and symptoms,and induces and maintains clinical remission in adultpatients with moderately to severely active Crohn’s dis-ease who have had an inadequate response to conven-tional therapy, including inhibitors of TNF-alpha.

Most common side effects: Infections such as in the urinary tract or upper respiratory tract, headache, tired-ness, depression, joint pain, diarrhea, and stomacharea pain.

Other: Natalizumab increases the risk of progressivemultifocal leukoencephalopathy (PML), a rare brain in-fection. Natalizumab may also cause liver damage andallergic reactions.

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Generic Name: Prednisolone

Brand Name(s): Medrol®, Pediapred Oral Liquid®



How taken: Oral


Medication indication: For the management of activeCrohn’s disease and ulcerative colitis to reduce signsand symptoms.

Most common side effects: Upset stomach, stomach irritation, vomiting, headache, dizziness, insomnia,restlessness, depression, anxiety, and acne.

Generic Name: Prednisone

Brand Name(s): Deltasone®



How taken: Oral


Medication indication: For the management of activeCrohn’s disease and ulcerative colitis to reduce signsand symptoms.

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

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Generic Name: Olsalazine

Brand Name(s): Dipentum®



How taken: Oral

Used For: Ulcerative colitis

Medication indication: For the maintenance of remissionof ulcerative colitis in patients who are intolerant of sulfasalazine.

Most common side effects: Stomach upset, bloating,loss of appetite, blurred vision, headache, pain in joints,and dizziness.

Other: Avoid Dipentum® if you are allergic to medicinescontaining salicylates, such as aspirin, or mesalamine.


31

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Generic Name: Sulfasalazine

Brand Name(s): Azulfidine®



How taken: Oral

Used For: Ulcerative Colitis

Medication indication: For the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and for the prolongation of the remission period between acute attacks of ulcerative colitis. Also, off-label use for treatment ofCrohn’s disease.

Most common side effects: Diarrhea, headache, loss ofappetite, upset stomach, vomiting, and stomach pain.

Other: Low sperm count and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects.

Generic Name: Tacrolimus

Brand Name(s): Prograf®



How taken: Oral and intravenous (IV)

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

Medication indication: Off-label use for the managementof active Crohn’s disease and ulcerative colitis to reducesigns and symptoms.

Most common side effects: Headache, hypertension, diarrhea, constipation, nausea, vomiting, heartburn,stomach pain, loss of appetite, difficulty falling asleepor staying asleep, dizziness, weakness, back or jointpain, burning, numbness, pain or tingling in the handsor feet, rash, and itching.

Other: Avoid eating grapefruit or drinking grapefruit juicewhile taking tacrolimus.

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33

Glossary of termsAbscess: A collection of pus (dead neutrophils)that has accumulated in a cavity formed by thetissue because of an infectious process (usually caused by bacteria or parasites).

Adherence: Sticking to a prescribed medical regimen.

Aminosalicylates: See page 6.

Antibody: An immunoglobulin, (a specialized immune protein), produced because of the introduction of an antigen (foreign substance)into the body.

Antibiotics: Drugs that fight infections, such asmetronidazole and ciprofloxacin.

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

Biologic therapies: See page 7.

Bowel: Another name for the intestine. The smallbowel and the large bowel are the small intestineand large intestine, respectively.

Chronic: Long-lasting or long-term.

Colitis: Inflammation of the large intestine (the colon).

Colon: The large intestine.

Corticosteroids: See page 6.

Crohn’s disease: A chronic inflammatory diseasethat primarily involves the small and large intes-tine, but that can affect other parts of the diges-tive system as well. It is named for Burrill Crohn,the American gastroenterologist who first de-scribed the disease in 1932.

Diarrhea: Passage of excessively frequent or excessively liquid stools.


34

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Extraintestinal complications: Complicationsthat occur outside of the intestine, such asarthritis or skin rashes. In some people, thesemay actually be the first signs of IBD, appearingeven before the bowel symptoms. In others, theymay occur right before a flare-up of the disease.

FDA: Food & Drug Administration.

Fistula: A tunnel that leads from one loop of in-testine to another, or that connects the intestineto the bladder, vagina, or skin. Fistulas occurmost commonly around the anal area. If thiscomplication arises, you may notice drainage of mucus, pus, or stool from this opening.

Flare or flare-up: Presence of inflammation andsymptoms.

Gastrointestinal: Adjective referring collectivelyto the stomach and small and large intestines.

GI tract: Short for gastrointestinal tract.

Immune system: The body’s natural defensesystem that fights against disease.

Immunomodulators: See page 7.

Immunosuppressive: The suppression of the immune system; an agent that reduces the function of the immune system.

Inflammation: A response to tissue injury thatcauses redness, swelling, and pain.

Inflammatory bowel diseases (IBD): A term usedto refer to a group of disorders—includingCrohn’s disease (inflammation in the gastroin-testinal tract) and ulcerative colitis (inflammationin the colon).

Intestine: The long, tubelike organ in the ab-domen that completes the process of digestion.It consists of the small and large intestines.

Large intestine: Also known as the colon. Its primary function is to absorb water and get ridof solid waste.


Medication Log



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StopDate


Name of Medication

Times Taken Daily

StartDate



Dosage/Strength






Oral: By mouth.















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Name of Medication

Times Taken Daily

Medication Log

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Notes:


About CCFA

Founded in 1967, the Crohn’s & Colitis Foundationof America (CCFA) is a non-profit,volunteer-drivenorganization dedicated to finding a cure for Crohn’sdisease and ulcerative colitis. Today, the organi-zation has grown to 40 local chapters, with morethan $136 million invested in research for a cureand improved treatments. This funding has en-abled many ground-breaking treatments, im-proved the quality of care for individuals withthese conditions, and brought hope to countlesslives. But there’s still plenty of work left to do.

We can help! Contact us at:

888.MY.GUT.PAIN(888.694.8872) [email protected]

187767_WF1_CVR_R1.qxp:Layout 1 11/19/09 5:05 PM Page i

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 diseaseand ulcerative colitis.

7/10

National Office386 Park Avenue South, 17th FloorNew York, NY 10016-8804212.685.3440www.ccfa.org

This brochure is supported by an unrestricted educationalgrant from Abbott.

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

Medication Log



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StopDate


Name of Medication

Times Taken Daily

StartDate



Dosage/Strength






Oral: By mouth.















136


StopDate


Name of Medication

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Notes:


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