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Humira Pen 40mg/0.8ml 2 Prefilled Pen
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Serious and sometimes fatal infections including tuberculosis (TB), fungal infection, and other types of infection have occurred in patients using Humira . Most patients who developed these infections were also taking medicine that suppressed their immune system (eg, corticosteroids, methotrexate).

Patients should receive a TB skin test before using Humira . Patients who test positive for TB should begin treatment for TB before starting Humira . All patients should also be monitored for signs of TB while using Humira , even if their TB test is negative.

Contact your doctor immediately if you develop signs of TB or any other type of infection (eg, persistent cough; muscle weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin; increased or painful urination).

Humira is a tumor necrosis factor (TNF) blocker. Lymphoma and other types of cancer have been reported in children and teenagers treated with TNF blockers. This has been fatal in some cases. Talk with your doctor for more information.

Humira is used for:

Treating a variety of moderate to severe inflammatory conditions (eg, rheumatoid arthritis, juvenile idiopathic arthritis [JIA], psoriatic arthritis, ankylosing spondylitis). Humira is also used to treat certain patients with moderate to severe Crohn disease and certain patients with chronic plaque psoriasis. Humira may be used alone or in combination with other medicine. Humira may also be used for other conditions as determined by your doctor.

Humira is a TNF blocker. Humira works by blocking a protein (TNF-alpha) found in the body that causes inflammation.

Do NOT use Humira if:

  • you are allergic to any ingredient in Humira
  • you are using abatacept or anakinra
  • you have a severe infection (eg, sepsis) or any other active infection

Before using Humira :

Some medical conditions may interact with Humira . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances, including rubber or latex
  • if you have a history of an infection that keeps coming back; TB infection or positive TB skin test; hepatitis B infection; other liver problems; heart problems (eg, heart failure); high cholesterol; high blood pressure; diabetes; cancer; or numbness, tingling, or other nervous system problems (eg, multiple sclerosis [MS], Guillain-Barré syndrome, seizures)
  • if you have an autoimmune disorder (eg, lupus) or other immune system problems, have recently received a vaccine, are scheduled to receive a vaccine, or are scheduled to have surgery
  • if you have an infection, open cuts or sores on your body, flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or are using medicine to treat an infection
  • if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB
  • if you live or have lived in certain parts of the country (eg, Ohio or Mississippi river valleys) where certain types of fungal infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common. Check with your doctor if you are not sure if you have lived in an area where these infections are common
  • if you take medicine that may decrease your immune system (eg, cyclosporine)

Some MEDICINES MAY INTERACT with Humira . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Abatacept, anakinra, corticosteroids (eg, prednisone), methotrexate, or tocilizumab because the risk of serious infection may be increased

How to use Humira :

Use Humira as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Humira comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Humira refilled.
  • Humira is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Humira . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use Humira if it contains particles, is cloudy or discolored, or if the syringe or pen is cracked or damaged.
  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
  • Rotate injection sites. New injections should be given at least 1 inch from an old site. Do not inject into areas where the skin is tender, bruised, red, or hard, or where you have scars or stretch marks.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Humira , use it as soon as you remember. Then go back to your regular dosing schedule.

Important safety information:

  • Humira may cause dizziness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Humira with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Humira may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Humira may increase the risk of developing blood cancer (eg, leukemia, lymphoma) and other types of cancer. This may be fatal in some cases. Discuss any questions or concerns with your doctor. Tell your doctor if you have ever had cancer. Contact your doctor right away if you develop symptoms of leukemia or lymphoma such as unusual bruising, unusual lumps or swelling (eg, in your neck, armpit, or groin), night sweats, recurring fever, unusual tiredness or weakness, persistent unexplained itching, or unexplained weight loss.
  • Some patients who use Humira have developed new or worsening psoriasis. Tell your doctor right away if you notice any new or worsening skin problems (eg, red, flaky, or itchy skin patches)
  • Tell your doctor or dentist that you take Humira before you receive any medical or dental care, emergency care, or surgery.
  • Humira may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Humira . Talk with your doctor before you receive any vaccine.
  • Humira may interfere with certain lab tests, including tests for TB infection. Be sure your doctor and lab personnel know you are using Humira .
  • Lab tests, including TB, liver function, and complete blood cell counts, may be performed while you use Humira . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Humira with caution in the ELDERLY; they may be more sensitive to its effects, especially an increased risk of infection and certain types of cancer.
  • Caution is advised when using Humira in CHILDREN; they may be at increased risk for developing certain types of cancer with Humira , which may be fatal.
  • Humira should not be used in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Humira while you are pregnant. It is not known if Humira is found in breast milk. Do not breast-feed while taking Humira .

Possible side effects of Humira :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; headache; mild pain, redness, or swelling at the injection site; nausea; sinus inflammation; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blood in the urine or stools; butterfly-shaped rash on the nose and cheeks; chest pain; fainting; fast or irregular heartbeat; mental or mood changes; muscle pain or weakness; new or worsening joint pain; numbness, tingling, or pain in the hands or feet; open sore that does not heal; persistent pain, swelling, or redness at the injection site; red, swollen, or blistered skin; severe or persistent headache or dizziness; severe or persistent stomach pain; shortness of breath; signs of infection (eg, fever, chills, or persistent sore throat; persistent cough; flu-like symptoms; warm, red, or painful skin; increased or painful urination); swelling of the ankles, hands, or feet; unexplained weight loss or weight gain; unusual bruising or bleeding; unusual lumps; unusual skin growth or other skin changes; unusual tiredness or weakness; unusually pale skin; vision changes.

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