Humira 20mg/0.2ml Prefilled Syringe Kit - 2 Syringe Pack

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ADALIMUMAB - INJECTION

(AY-da-LIM-ue-mab)

COMMON BRAND NAME(S): Humira

WARNING: This medication can decrease your body\'s ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). Tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. Tell your doctor right away if you develop signs of infection (see Side Effects section). Your doctor will test you for tuberculosis (TB) infection before and during treatment with this drug. If you are diagnosed with TB, your doctor will first prescribe treatment for this to prevent a serious TB infection while using adalimumab. Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin cancer) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as a fever that doesn\'t go away, unusual lumps/growths, swollen glands, unexplained weight loss, or night sweats.

USES: Adalimumab is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic, ankylosing spondylitis). This medication is also used to treat certain skin disorders (such as plaque-type psoriasis, hidradenitis suppurativa). It works by blocking a protein (tumor necrosis factor or TNF) found in the body\'s immune system that causes joint swelling and damage in arthritis as well as red scaly patches in psoriasis. Adalimumab belongs to a class of drugs known as TNF blockers. By reducing joint swelling, this medication helps to reduce further joint damage and preserve joint function. Adalimumab is also used to treat certain bowel conditions (Crohn\'s disease, ulcerative colitis) and a certain eye disease (uveitis).

HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using adalimumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist. If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Do not shake this product. If you are removing this medication from the refrigerator, leave it at room temperature for 15 to 30 minutes before injecting. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water. Use this medication exactly as prescribed. Inject this medication under the skin on the thigh or abdomen as directed by your doctor, usually every other week or once a week in some cases. If you are using this medication to treat psoriasis, hidradenitis suppurativa, Crohn\'s disease, ulcerative colitis, or uveitis, your doctor may prescribe a different schedule/higher dose at the start of your treatment. Carefully follow your doctor\'s directions for using this medication. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. New injections should be given at least 1 inch (2.5 centimeter) from an old site. Do not inject into any areas of the skin that are sore, bruised, red, or hard. Learn how to store and discard medical supplies safely. The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. Use this medication regularly to get the most benefit from it. To help you remember, mark the day on the calendar when you need to receive this medication. Do not increase your dose or use this drug more often or for longer than prescribed. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: See also Warning section. Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, tell 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 right away if you develop signs of infection while using this drug, such as: sore throat that doesn\'t go away, cough that doesn\'t go away, fever, chills, night sweats, trouble breathing, painful or frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush). Tell your doctor right away if you have any serious side effects, including: fast/irregular/pounding heartbeat, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), blood in the stools, mental/mood changes, severe headache, easy bruising or bleeding, leg pain or swelling, numbness or tingling of the arms/hands/legs/feet, unsteadiness, unexplained muscle weakness, difficulty with speaking/chewing/swallowing/facial movements, vision changes, joint pain, butterfly-shaped rash on the nose and cheeks. Adalimumab may rarely cause serious (possibly fatal) liver disease in people exposed to hepatitis B virus. Your doctor may order blood tests and watch for symptoms during treatment and for several months after your last treatment. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn\'t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. Get medical help right away if you have any very serious side effects, including: seizures, chest pain. A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch. 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 Warning 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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent/repeated infections (such as hepatitis B, TB infection, histoplasmosis), blood/bone marrow problems (such as low red/white blood cells and platelets), seizures, certain brain/nerve disorders (such as multiple sclerosis, Guillain-Barre syndrome), cancer, heart disease (especially heart failure), lupus. Adalimumab can make you more likely to get infections or may worsen any current infections. Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be at greater risk for infections while using this drug. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug include: other TNF blockers (such as etanercept, infliximab), other drugs that weaken the immune system (such as abatacept, anakinra).

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as complete blood count, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

STORAGE: Store in the refrigerator. Do not freeze. Pen injectors and prefilled syringes may also be stored at room temperature away from moisture but must be thrown away after 14 days. Some vials may also be stored at room temperature. Ask your pharmacist or read the product package to see if your vial can be stored at room temperature and for how long. Once the medication has been stored at room temperature, it should not be put back in the refrigerator. Keep the medication in the original container to protect from light. Discard any unused portion of the medication. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised December 2017. Copyright(c) 2017 First Databank, Inc.