Humira

DRUG DESCRIPTION

HUMIRA (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). HUMIRA (adalimumab) was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.

HUMIRA (adalimumab) is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The drug product is supplied as either a single-use, prefilled pen (HUMIRA (adalimumab) Pen) or as a single-use, 1 mL prefilled glass syringe. Enclosed within the pen is a single-use, 1 mL prefilled glass syringe. The solution of HUMIRA (adalimumab) is clear and colorless, with a pH of about 5.2.

Each prefilled syringe delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains 40 mg adalimumab, 4.93 mg sodium chloride, 0.69 mg monobasic sodium phosphate dihydrate, 1.22 mg dibasic sodium phosphate dihydrate, 0.24 mg sodium citrate, 1.04 mg citric acid monohydrate, 9.6 mg mannitol, 0.8 mg polysorbate 80, and Water for Injection, USP. Sodium hydroxide added as necessary to adjust pH.

Each pediatric prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HUMIRA contains 20 mg adalimumab, 2.47 mg sodium chloride, 0.34 mg monobasic sodium phosphate dihydrate, 0.61 mg dibasic sodium phosphate dihydrate, 0.12 mg sodium citrate, 0.52 mg citric acid monohydrate, 4.8 mg mannitol, 0.4 mg polysorbate 80, and Water for Injection, USP. Sodium hydroxide added as necessary to adjust pH.

What are the possible side effects of adalimumab (Humira, Humira Pen, Humira Pen Crohn's Disease Starter Package)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with adalimumab. Stop using adalimumab and call your doctor right away if you have signs of infection such as:

  • fever, sweating, chills, tired feeling;
  • feeling short of breath;
  • cough, sore throat; or
  • flu symptoms,...

Read All Potential Side Effects and See Pictures of Humira

What are the precautions when taking adalimumab (Humira)?

See also Warnings section.

Before using adalimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an active infection, TB infection, certain fungal infection (histoplasmosis), a certain type of heart disease (congestive heart failure), lupus.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recurrent infections, hepatitis B infection, decreased bone...

Read All Potential Precautions of Humira


Humira Consumer (continued)

SIDE EFFECTS: Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, stomach pain, blood in the stools, mental/mood changes, severe headache, easy bruising or bleeding, dark urine, yellowing eyes and skin, leg pain or swelling, numbness or tingling of the hands or feet, unsteadiness, unexplained muscle weakness, vision changes, extreme fatigue, joint pain, butterfly-shaped rash on the nose and cheeks.

Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, chest pain.

Tell your doctor immediately if you develop signs of infection while using this drug, such as: fever, chills, night sweats, persistent sore throat, trouble breathing, painful or frequent urination, persistent cough, unusual vaginal discharge, white patches in the mouth (oral thrush).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warnings section.

Before using adalimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an active infection, TB infection, certain fungal infection (histoplasmosis), a certain type of heart disease (congestive heart failure), lupus.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recurrent infections, hepatitis B infection, decreased bone marrow function, seizures, certain brain/spinal cord disorders (demyelinating disorders such as multiple sclerosis), history of cancer (e.g., lymphoma), scheduled surgery.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine. Consult your doctor about the risks of exposure to chickenpox and other infections.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.


Humira Patient Information Including Side Effects

Brand Names: Humira, Humira Pen, Humira Pen Crohn's Disease Starter Package

Generic Name: adalimumab (Pronunciation: ay da LIM yoo mab)

  • What is adalimumab (Humira)?
  • What are the possible side effects of adalimumab (Humira)?
  • What is the most important information I should know about adalimumab (Humira)?
  • What should I discuss with my healthcare provider before using adalimumab (Humira)?
  • How should I use adalimumab (Humira)?
  • What happens if I miss a dose (Humira)?
  • What happens if I overdose (Humira)?
  • What should I avoid while using adalimumab (Humira)?
  • What other drugs will affect adalimumab (Humira)?
  • Where can I get more information?

What is adalimumab (Humira)?

Adalimumab reduces the effects of a substance in the body that can cause inflammation.

Adalimumab is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. It is also used to treat Crohn's disease after other drugs have been tried without successful treatment of symptoms.

Adalimumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of adalimumab (Humira)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with adalimumab. Stop using adalimumab and call your doctor right away if you have signs of infection such as:

  • fever, sweating, chills, tired feeling;
  • feeling short of breath;
  • cough, sore throat; or
  • flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

  • shortness of breath with swelling of your ankles or feet;
  • confusion, seizure (convulsions);
  • pain or burning when you urinate;
  • chest pain, ongoing cough, coughing up blood;
  • easy bruising or bleeding, pale skin, unusual weakness;
  • numbness or tingly feeling, weakness in your legs;
  • jaundice (yellowing of the skin or eyes);
  • red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores;
  • joint pain or swelling with fever, swollen glands, muscle aches, vomiting, unusual thoughts or behavior, and/or seizure (convulsions); or
  • patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious side effects may include:

  • headache;
  • stuffy nose, sinus pain;
  • nausea, stomach pain; or
  • pain, redness, itching, swelling, or bleeding where you injected the medication.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about adalimumab (Humira)?

Before you start treatment with adalimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Treatment with adalimumab may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes) or autoimmune disorders (such as a lupus-like syndrome). This risk may be greater in children and young adults. Talk with your doctor about your individual risk.

Adalimumab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Serious and sometimes fatal infections may occur during treatment with adalimumab. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or feeling short of breath.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Do not receive a "live" vaccine while you are being treated with adalimumab.

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