Humira

The active ingredient in Humira is the monoclonal antibody adalimumab. Adalimumab belongs to a class of medications known as TNF blockers or tumor necrosis factor blockers. TNF plays an important role in the body by activating our immune system in response to infection or injury. Although it serves a protective role, it can lead to damage when it fails to shut down in the absence of infection or injury, as seen in autoimmune conditions.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Humira. However, the following is a synopsis of the general guidelines for the use of Humira:

• Your nurse, pharmacist, or another healthcare provider will demonstrate how to use Humira before you administer it for the first time.
• Humira is a subcutaneous injection that is administered right under the skin of the abdomen or thigh with or without food. Typically, Humira is used on a weekly or biweekly basis. Your schedule will depend on what is being treated and your response to Humira.
• Use Humira exactly as prescribed. Do not use more often than or for longer than you were prescribed. The dose you start at will depend on what is being treated. Depending on your response, the dose of Humira may be adjusted over time.
• Each time you inject, change the injection site to prevent injection site reactions. Do not inject on skin that is tender bruised, red, or hard.
• The day you inject Humira should be the same each time. If you miss a dose, inject as soon as you remember and take your next dose at the regular time. If you are unsure about when to inject, consult your healthcare provider.
• Before starting Humira, your doctor may screen and treat you for certain infections to prevent them from reactivating or worsening during treatment with Humira. Your doctor may also recommend certain immunizations to ensure you are up to date before starting Humira.
• Humira is not indicated for use in all pediatric patients. For certain medical conditions, Humira may be only approved for use in adults.

The most common side effects of Humira seen in clinical trials include:

• Injection site reactions such as redness, skin rash, swelling, itching, or bruising where you injected
• Upper respiratory infections, including sinus infections
• Headaches
• Rash
• Urinary tract infections
• Back pain in clinical studies with rheumatoid arthritis patients

Some individuals may experience serious side effects while using Humira. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Injection site reactions that worsen or do not improve within a few days
• Symptoms of a serious allergic reaction such as hives, trouble breathing, or swelling of the face, eyes, or lips
• Symptoms of a serious infection such as a persistent cough, fever, or weight loss
• In carriers, reactivation of hepatitis B virus resulting in muscle aches, fatigue, jaundice or yellowing of the skin or eyes, dark urine, loss of appetite, clay-colored stools, or fever
• Symptoms of a liver problem such as jaundice or yellowing of the skin or eyes, fatigue, loss of appetite, dark urine, or right-sided abdominal pain
• Symptoms of a nervous system problem such as a numbing or tingling sensation, changes in vision, weakness in your extremities, and dizziness
• Symptoms of low blood cell counts such as increased bruising and bleeding, pale skin, or a persistent fever
• Symptoms of heart failure such as shortness of breath, swelling of the ankles and feet, or sudden weight gain
• Symptoms of a lupus-like syndrome such as chest pain, joint pain, shortness of breath, or a rash on the cheeks that worsens with sun exposure
• New or worsening psoriasis
• Increased risk of cancers, including lymphoma, leukemia, and skin cancer

These are not all of the possible side effects of Humira. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Humira, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Past or current diagnosis of cancer
• Multiple sclerosis
• Guillain-Barré syndrome
• Diabetes
• Heart failure
• Tuberculosis or in close contact with someone with TB or are from a country or region where TB is common
• Past or current hepatitis B infection
• Have lived in parts of the US where certain fungal infections are more common (Ohio, Mississippi River valleys)
• Have recently received or are scheduled to receive a vaccine
• Rubber or latex allergy
• An allergy to Humira
• Are scheduled for surgery
• Signs of an infection such as fever, sweats, chills, cough, shortness of breath, bloody phlegm, skin sores that are warm and painful, diarrhea, burning sensation when urinating, increased urination, or weight loss
• Are being treated for an infection
• Have a recurring infection
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Boxed Warning

• Using Humira can result in an increased risk of serious infections including tuberculosis, sepsis, invasive fungal infections, and opportunistic infections. Most of these infections developed in patients who were also using methotrexate or corticosteroids. Humira should not be used if a serious infection develops.
• Using Humira has been associated with an increased incidence of malignancy, otherwise known as cancer. In clinical studies and postmarketing observation, the most common appear to be lymphoma, leukemia, and skin cancer.

There are no contraindications to using Humira.

Humira does take some time to work. Depending on what you are using Humira for, it may take several weeks to see the benefits. For some people, it can take several months to get the full effects of this medication.

When Humira is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Abatacept (brand name Orencia)
• Certolizumab
• Etanercept
• Golimumab
• Infliximab
• Rituximab
• Anakinra
• Live vaccines
• Azathioprine
• 6-mercaptopurine
• Warfarin
• Cyclosporine
• Theophylline

Humira is available as a single dose in either prefilled pens or prefilled syringes.

Humira prefilled pens are available in the following strengths:

• 80 mg/0.8 mL
• 40 mg/0.8 mL
• 40 mg/0.4 mL

Humira prefilled syringes are available in the following strengths:

• 80 mg/0.8 mL
• 40 mg/0.8 mL
• 40 mg/0.4 mL
• 20 mg/0.4 mL
• 20 mg/0.2 mL
• 10 mg/0.2 mL
• 10 mg/0.1 mL

Humira should be stored in the fridge away from heat and in its original packaging to protect from light. Do not freeze Humira. Do not use it if it has thawed after being frozen. If necessary, Humira can be kept at room temperature for up to 14 days. If it is past 14 days or past the expiration date, do not use it and properly dispose of it. Keep out of reach of children.

Humira is manufactured by the pharmaceutical company AbbVie.

Since Humira is a biologic, there is no generic version of Humira. There are, however, biosimilars available of Humira that are very similar to Humira but not an exact copy. Consult your healthcare provider on which option would be best for you.

Because Humira is used for chronic autoimmune conditions where stopping may result in relapse, it is important you consult your doctor or pharmacist before starting, stopping, or changing medications while taking Humira.

Humira can cross the placenta and reach the unborn child. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Humira can pass into breast milk, but there are no reports of adverse effects on breastfed infants and no effects on milk production. However, talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.