Crohn's Medication

One of the main goals for Crohn's disease treatment is to achieve and then maintain remission (few or no symptoms). To realize this goal, some treatments are aimed at controlling the inflammation that causes Crohn's symptoms; others specifically treat infection or relieve symptoms as they occur.

A variety of treatments are available to treat Crohn's disease.

Conventional treatment options

Conventional therapies have been traditionally used to relieve symptoms and decrease inflammation. As a Crohn's patient, you may have tried one or more of the following treatment options, because one type of medication does not always work for every patient:

Aminosalicylates: Aminosalicylates are a group of medicines that contain 5-aminosalicylic acid (5-ASA) to help reduce mild-to-moderate inflammation in the digestive tract. Common drugs that fall under this category include those containing mesalamine.
Corticosteroids: Corticosteroids are powerful anti-inflammatory drugs for moderate to severe disease activity that are used to suppress the immune system anywhere in the body and are to be used until symptoms are controlled, and then usually tapered off. Some commonly prescribed corticosteroids include prednisone (Deltasone^®), methylprednisolone (Medrol^®), hydrocortisone (Cortef^®), and budesonide (Entocort^® EC).
Immunomodulators: Immunomodulators reduce inflammation in moderate to severe Crohn's disease and are often used as maintenance (long-term) treatment. Some commonly prescribed immunomodulators include 6-mercaptopurine (6-MP, Purinethol^®), azathioprine (Imuran^®, Azasan^®), and methotrexate (MTX, Rheumatrex^®, Mexate^®). A rare type of cancer called hepatosplenic T-cell lymphoma, often resulting in death has developed in some people taking HUMIRA along with azathioprine or 6-mercaptopurine.
Antibiotics: Antibiotics are sometimes used to treat infections that may come along with complications such as abscesses or inflammation around the anus (perianal involvement). Commonly prescribed antibiotics include metronidazole (Flagyl^®) and ciprofloxacin (Cipro^®).
Anti-diarrheal medications (over-the-counter): Some patients may rely on over-the-counter medications like Imodium^® (loperamide) to control their symptoms. While these medications can offer temporary relief, they do not treat Crohn's disease specifically and are not intended for long-term or frequent use.

Biologic treatment options

Some patients with moderate to severe Crohn's disease may be able to achieve their treatment goals with conventional treatments, but some patients do not. Some biologic treatments were created specifically to target a protein in the body, called tumor necrosis factor or TNF, to help reduce the inflammation of Crohn's disease.

HUMIRA is a prescription biologic medication approved by the FDA to reduce signs and symptoms, and to achieve and maintain clinical remission in adults with moderate to severe Crohn’s disease who have not responded well to conventional treatments, and in these adults who have also lost response to or are unable to tolerate infliximab.

Important Safety Information About HUMIRA^® (adalimumab)¹

What is the most important information I should know about HUMIRA?

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA. If your doctor feels you are at risk, you may be treated with medicine for TB.
Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting HUMIRA?

Tell your doctor about all of your health conditions, including if you:

Have an infection, are being treated for infection, or have symptoms of an infection
Get a lot of infections or infections that keep coming back
Have diabetes
Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis
Have or have had hepatitis B
Are scheduled for major surgery
Have or have had cancer
Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
Have or had heart failure
Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines
Are allergic to rubber, latex, or any HUMIRA ingredients
Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed

Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA^® (abatacept), KINERET^® (anakinra), REMICADE^® (infliximab), ENBREL^® (etanercept), CIMZIA^® (certolizumab pegol), or SIMPONI^® (golimumab). Tell your doctor if you have ever used RITUXAN^® (rituximab), IMURAN^® (azathioprine), or PURINETHOL^® (mercaptopurine, 6-MP).

What should I watch for AFTER starting HUMIRA?

HUMIRA can cause serious side effects, including:

Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
Blood problems. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen).
Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

Fever, sweats, or chills
Muscle aches
Cough
Shortness of breath
Blood in phlegm
Weight loss
Warm, red, or painful skin or sores on your body
Diarrhea or stomach pain
Burning when you urinate
Urinating more often than normal
Feeling very tired

HUMIRA is given by injection under the skin.

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

Uses

HUMIRA is a prescription medicine used:

To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
- Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. HUMIRA is also for these adults who have lost response to or are unable to tolerate infliximab.
In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) for assistance.