Adalimumab-Adaz(Cf)

Store in the refrigerator. Do not freeze. If needed, some brands of this medication may also be stored at room temperature. Ask your pharmacist or read the product package to see if your medication can be stored at room temperature and for how long. 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.

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.

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).

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.

See also Warning section.

Redness, itching, pain, or swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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/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/bleeding, leg pain/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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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

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).

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

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. 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.

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 centimeters) from an old site. Do not inject into any areas of the skin that are sore, bruised, red, or hard.

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. The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. 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.

Learn how to store and discard medical supplies safely.

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 lasts or gets worse.

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.