Answers to Frequently Asked Questions About Humira

Humira (adalimumab) is a human monoclonal antibody. It works by blocking tumor necrosis factor alpha (TNF-alpha), a cytokine that plays a role in the inflammatory process. People with inflammatory bowel disease (IBD) may have an abnormal amount of TNF-alpha, and it is thought that this plays a role in the disease process. Humira stops TNF-alpha from being used by the body.

How Humira Is Taken

Humira comes in the form of an injection and should be stored in a refrigerator. The injection is given under the skin (subcutaneously) either at home or in a healthcare provider's office.

Humira is given once every other week or sometimes every week. The dosage is normally 40 milligrams (mg).  However, in the induction phase when treatment is first started, the dose is higher in the first two injections (160mg, and 80 mg).

Humira should not be injected into the same location on the body two times in a row. Patients should rotate where they give the injection—normally the abdomen or the front of either thigh. The prescribing healthcare provider will provide any special instructions and describe how to administer the injection at home, if necessary.

If you have questions on how to give the injection, you can call 1-800-4HUMIRA (448-6472).

Uses

Humira may be prescribed for Crohn's disease or ulcerative colitis, the two main forms of IBD. Humira is approved for use in adults and in children over the age of 6.

Humira may reduce common IBD symptoms (pain, fatigue, rectal bleeding, urgency, and diarrhea) or may induce remission. In one clinical trial of patients with Crohn's disease, 40% to 47% of patients given Humira were in remission after 26 weeks of treatment. After 56 weeks, about 40% of the patients were still in remission.

Crohn's Disease

According to 2018 guidelines for Crohn's disease, anti-TNF therapy—Humira, Remicade (infliximab), or Cimzia (certolizumab pegol—is most often used for moderate or severe disease that is resistant to corticosteroids and/or immunomodulators (such as thiopurines or methotrexate).

Humira (or another anti-TNF therapy) may be used to treat severely active/fulminant disease. Humira should may also be considered in treating perianal fistulas associated with Crohn's disease.

Humira or another anti-TNF agent should also be used to maintain remission (maintenance treatment) in those who achieve remission while using an anti-TNF medication. When used for maintenance, adding an immunomodulator treatment to Humira therapy should be considered to decrease the risk of development of antibodies to Humira that can result in no response to therapy).

Humira can also be used to manage extraintestinal manifestations of Crohn's (including arthritis and anemia).

Ulcerative Colitis

For people with moderate to severe ulcerative colitis, healthcare providers may prescribe a biologic medication as a first-line therapy, according to the latest practice guidelines. These therapies are more likely to induce remission, and hence, reduce complications.

Biologic therapies (and small molecules) include Humira, as well as Remicade (infliximab), Simponi (golimumab), Entyvio (vedolizumab), Stelara (ustekinumab), Rinvoq (upadacitinib), Zeposia (ozanimod),and Xeljanz (tofacitinib).

Among people who have not yet been treated with a biologic medication, several biologic/small molecule therapies can be considered as a first line therapy. However, Humira may be preferred due to the ease of administration. Both Remicade and Humira have equal efficacy.

For people who achieve remission on a biologic medication, the continued use of a biologic is recommended to maintain the remission. Ideally, a biologic is combined with an immunomodulator medication for maximal control of the disease.

Warnings and Precautions About Humira

Tell your healthcare provider if you are scheduled for any kind of surgery or have had a recent vaccination. Also let your practitioner know if you have or ever had any of the following conditions:

• Allergic reactions to any medication
• Cancer (lymphoma) (or active history of other malignancies)
• Pregnancy (current)
• Fungal infection
• Heart failure
• Hepatitis B
• Lupus
• Multiple sclerosis (or other demyelinating disorders)
• Recurrent infections
• Seizures
• Tuberculosis

Side Effects

The most common side effects of Humira are pain, irritation, swelling, or itching at the site of the injection. Other common side effects include headache, rash, and nausea. There is a risk of developing a serious infection when taking Humira, although it is unlikely.

Also the chance of getting lymphoma or other cancers including non-melanoma skin cancer may increase.

Interactions

It is not recommended that Humira be taken with other TNF-blocking agents, such as Kineret (anakinra) or live vaccines.

Tell your healthcare provider if you are taking any drugs that suppress the immune system, such as cyclosporine.

Humira should not be taken with alcohol, as doing so can cause complications. There are no known food interactions.

Safety During Pregnancy

The U.S. Food and Drug Administration (FDA) has classified Humira as a Type B drug. Studies on animals show no evidence of harm to the fetus; however, there are no adequate, well-controlled studies in pregnant women.

Humira should only be used in pregnant women when clearly needed. Notify the prescribing healthcare provider if you become pregnant while taking Humira.

It is not known if Humira passes into breast milk; however, similar substances have been shown to pass into breast milk in small concentrations. Therefore, the decision to breastfeed should take in consideration the risk and benefit to the infant. However, the American Gastroenterological Association (AGA) guidelines suggest that Humira is compatible with breastfeeding.

One small study showed that Humira does cross the placenta and enter the bloodstream of a fetus during the last trimester of pregnancy. Humira could be found in the infant's bloodstream up to three months after birth. It is recommended that babies born to mothers taking Humira be checked closely for infection for the first six months of life and that they not receive any live-virus vaccinations during that time period.

What to Do About a Missed Dose

If you miss a dose, take it as soon as you remember. Then take your next dose at the regularly scheduled time. Don't double-up or take more than one dose at a time.