Posted on December 16th, 2015 by
Class: Disease modifying anti-rheumatic drug (DMARD)
Generic Name: Adalimumab
Trade Name: Humira®
For which conditions is this drug approved? Humira is approved to treat adults with moderate to severe rheumatoid arthritis (RA), alone or with methotrexate or with certain other medicines. Humira is also approved to treat psoriatic arthritis (alone or with certain other medicines), ankylosing spondylitis, and moderate to severe Crohn’s disease (CD) in adults who have not responded well to other treatments.
What is the mechanism of action? Humira works by blocking the inflammatory effects of a protein called tumor necrosis factor alpha (TNF alpha) in RA and other conditions associated with inflammation. The body produces TNF when there is inflammation. In RA, untreated inflammation can lead to joint damage.
How is Humira typically given (administered)? Humira is given by an injection under your skin. Your doctor will show you how to give these injections to yourself. It’s important that you carefully follow these your doctor’s instructions. Each dose of Humira comes in a single-use prefilled syringe or pen.
How are patients typically monitored? During treatment with Humira, your doctor will watch you for the following conditions:
- Signs of infection (Humira affects your immune system and can lower its ability to fight infections)
- Serious allergic reaction
- Cancer (including lymphoma)
- Reactivation of the hepatitis B virus
- Heart failure
- Lupus-like syndrome (chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun)
- Damage to the protective covering (myelin sheath) surrounding the nervous system
- Low blood cell counts
What are the some of the side effects of treatment with Humira (occur in 10% to 29% of patients)?
- Upper respiratory infection
- Inflammation of the tissue lining the sinuses (sinusitis)
- Injection site pain
- Accidental injury
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Before you start Humira, tell your doctor about all of your health conditions. This includes:
- Numbness or tingling
- A disease that affects your nervous system (such as multiple sclerosis or Guillain-Barré syndrome)
- Heart failure or other heart conditions
- Have recently received or are scheduled to receive a vaccine (you should not receive live vaccines during treatment with Humira)
- If you are allergic to rubber or latex (the needle cover on the prefilled syringe contains dry natural rubber)
- If you are allergic to Humira or to any of its ingredients (adalimumab, sodium phosphate, sodium citrate, citric acid, mannitol, and polysorbate 80)
- Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Be especially sure to tell your doctor if you take the RA medication Kineret® (anakinra) and other medicines that suppress the immune system.
- Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
Are there any special precautions patients should be aware of before starting treatment?
Tell your doctor if:
- You are pregnant, planning to become pregnant, or breastfeeding. Humira should only be used during pregnancy if your doctor decides it’s necessary. If you are breastfeeding, talk to your doctor about whether or not you should use Humira.
- You think you have an infection—even a very minor, such as an open sore.
- You are being treated for an infection.
- You have signs of an infection—such as a fever, cough, or flu-like symptoms or warm, red, or painful skin.
- You have a history of frequent infections or infections that keep coming back.
- You have or had hepatitis B infection. If you are a chronic carrier of the virus that causes hepatitis B, Humira can cause the hepatitis B virus to become an active infection again.
- You have tuberculosis (TB), or have been in close contact with someone who has TB. Your doctor should also test you for TB before starting Humira. If your doctor prescribes medicine to treat TB, you should start taking it before starting Humira and take the full course of TB medicine prescribed.
- You have lived in an area where TB or histoplasmosis (an infection caused by breathing in spores of a fungus often found in bird and bat droppings) is common. If you do not know if you have lived in an area where TB or histoplasmosis is common, ask your doctor.
- You were born in, lived in, or traveled to countries where there is higher risk for getting TB. Ask your doctor if you are not sure.
- You are scheduled to have major surgery.
When should patients notify their physician?
Contact your doctor right away if you:
- Have a fever.
- Feel very tired.
- Have a cough.
- Have flu-like symptoms.
- Have warm, red, or painful skin.
- Have open sores on your body.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Last updated 12/15
A, Drug Dictionary, Other, RA, Uncategorized