Adalimumab is a prescription medication used to treat certain kinds of arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, and ulcerative colitis. Adalimumab belongs to a group of drugs called tumor necrosis factor (TNF) blockers, which help reduce inflammation.
This medication comes in an injectable form in prefilled syringes. Adalimumab is injected just under the skin usually once every other week.
Common side effects of adalimumab include reaction at the injection site, sinus infections, and headaches.
- Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.
- Adalimumab should be discontinued if a patient develops a serious infection or sepsis during treatment.
- Perform test for latent TB; if positive, start treatment for TB prior to starting adalimumab.
- Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which adalimumab is a member.
- Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab.
Adalimumab is a prescription medication used to:
- Reduce the signs and symptoms of:
- moderate to severe rheumatoid arthritis (RA) in adults. Adalimumab can be used alone, with methotrexate, or with certain other medicines.
- moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. Adalimumab can be used alone, with methotrexate, or with certain other medicines. It is recommended that JIA patients should be up to date with appropriate vaccinations before starting adalimumab. Those taking adalimumab may receive vaccinations except for live ones.
- psoriatic arthritis (PsA) in adults. Adalimumab can be used alone or with certain other medicines.
- ankylosing spondylitis (AS) in adults.
- moderate to severe Crohn’s disease (CD) in adults and children when other treatments have not worked well enough.
- Treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
- Treat moderate to severe ulcerative colitis in adults who have not been helped by corticosteroids and other immunosuppressant medicines.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with adalimumab and during treatment with adalimumab. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking adalimumab. People who had a negative TB skin test before receiving adalimumab have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking adalimumab:
- cough that does not go away
- low grade fever
- weight loss
- loss of body fat and muscle (wasting)
Hepatitis B infection in people who carry the virus in their blood.
If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use adalimumab. Your doctor may do blood tests before you start treatment with adalimumab and while you are using adalimumab. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:
- muscle aches
- feel very tired
- dark urine
- skin or eyes look yellow
- little or no appetite
- clay-colored bowel movements
- stomach discomfort
- skin rash
Allergic reactions. Allergic reactions can happen in people who use adalimumab. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction:
- swelling of your face, eyes, lips or mouth
- trouble breathing
Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
New heart failure or worsening of heart failure you already have. Call your doctor right away if you get new worsening symptoms of heart failure while taking adalimumab, including:
- shortness of breath
- swelling of your ankles or feet
- sudden weight gain.
Immune reactions including a lupus-like syndrome. Symptoms include 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. Symptoms may improve when you stop adalimumab.
Liver Problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:
- feel very tired
- skin or eyes look yellow
- poor appetite or vomiting
- pain on the right side of your stomach (abdomen)
Psoriasis. Some people using adalimumab had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with adalimumab.
Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with adalimumab may be stopped.
Common side effects with adalimumab include:
- injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your doctor right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse.
- upper respiratory infections (including sinus infections)
These are not all the possible side effects with adalimumab. Tell your doctor if you have any side effect that bothers you or that does not go away.
Tell your doctor about all the medicines you take includine prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you receive any of the following:
- Orencia (abatacept)
- Enbrel (etanercept)
- Kineret (anakinra)
- Rituxan (rituximab)
- Remicade (infliximab)
- Cimzia (certolizumab pegol)
- Simponi (golimumab)
- Imuran (azathioprine)
- Purinethol (mercaptopurine, 6-MP)
This is not a complete list of adalimumab drug interactions. Ask your doctor or pharmacist for more information.
Adalimumab is a medicine that affects your immune system. Adalimumab can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections.
- Your doctor should test you for TB before starting adalimumab.
- Your doctor should check you closely for signs and symptoms of TB during treatment with adalimumab.
You should not start taking adalimumab if you have any kind of infection unless your doctor says it is okay.
- For children and adults taking TNF-blockers, including adalimumab, the chances of getting cancer may increase.
- There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers.
- People with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
- If you use TNF blockers including adalimumab your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that doesn’t heal.
- Some people receiving TNF blockers including adalimumab developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with another medicine called Imuran (azathioprine) or Purinethol (6-mercaptopurine).
Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of adalimumab, there are no specific foods that you must exclude from your diet when receiving this medication. Do not drink alcohol while taking this medication.
Before starting adalimumab, tell your doctor about all of your health conditions, including if you:
- have an infection.
- have or have had cancer.
- have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome.
- have or had heart failure.
- have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using adalimumab. Children with juvenile idiopathic arthritis should be brought up to date with all vaccines before starting adalimumab.
- are allergic to rubber or latex. The needle cover on the prefilled syringe contains dry natural rubber. Tell your doctor if you have any allergies to rubber or latex.
- are allergic to adalimumab or to any of its ingredients.
- are pregnant or planning to become pregnant. It is not known if adalimumab will harm your unborn baby. Adalimumab should only be used during a pregnancy if needed.
Pregnancy Registry: Abbott Laboratories has a registry for pregnant women who take adalimumab. The purpose of this registry is to check the health of the pregnant mother and her child. Talk to your doctor if you are pregnant and contact the registry at 1–877–311–8972.
- breastfeeding or plan to breastfeed. You and your doctor should decide if you will breastfeed or use adalimumab. You should not do both.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your doctor if you are pregnant or planning to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Adalimumab falls into category B. Adalimumab can cross the placenta during the third trimester of pregnancy. No harm was observed in studies performed in pregnant animals. Because animal studies cannot always predict how this medications may affect humans, adalimumab should be used during pregnancy only if clearly needed.
Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if adalimumab is excreted in human breast milk or if it will harm your nursing baby.
Adalimumab is given by an injection under the skin. Your doctor will tell you how often to take an injection of adalimumab. This is based on your condition to be treated. Do not inject adalimumab more often than you were prescribed. See the Patient Instructions for Use inside the carton for complete instructions for the right way to prepare and inject adalimumab.
Make sure you have been shown how to inject adalimumab before you do it yourself. You can call your doctor or 1-800-4Humira (1-800-448-6472) if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after he/she has been shown how to prepare and inject adalimumab. Do not try to inject adalimumab yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of adalimumab at home, you should receive training on the right way to prepare and inject adalimumab.
Do not miss any doses of adalimumab unless your doctor says it is okay. If you forget to take adalimumab, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject adalimumab, call your doctor or pharmacist.
If you take more adalimumab than you were told to take, call your doctor.
Take adalimumab exactly as it is prescribed by your doctor. Your doctor will determine the best dose for you.
Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
The recommended dose of adalimumab for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) is 40 mg administered every other week. Methotrexate (MTX), other non-biologic DMARDS, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with adalimumab. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosing frequency of adalimumab to 40 mg every week.
Juvenile Idiopathic Arthritis
The recommended dose of Humira for pediatric patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) is based on weight.
- 10 kg (22 lbs) to <15 kg (33 lbs): 10 mg every other week
- 15 kg (33 lbs) to < 30 kg (66 lbs): 20 mg every other week
- ≥ 30 kg (66 lbs): 40 mg every other week
The recommended adalimumab dose regimen for adult patients with Crohn’s disease is 160 mg initially on Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week. Aminosalicylates and/or corticosteroids may be continued during treatment with adalimumab. Azathioprine, 6-mercaptopurine (6-MP) or MTX may be continued during treatment with adalimumab if necessary. The use of adalimumab in Crohn’s disease beyond one year has not been evaluated in controlled clinical studies.
Crohn's Disease in children
17 kg (37 lbs) to < 40 kg (88 lbs):
- Initial dose (Day 1): 80 mg (two 40 mg injections in one day)
- Second dose two weeks later (Day 15): 40 mg
- Two weeks later (Day 29): Begin a maintenance dose of 20 mg every other week.
≥ 40 kg (88 lbs):
- Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days)
- Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day)
- Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week.
The recommended dose of adalimumab for adult patients with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. The use of adalimumab in moderate to severe chronic plaque psoriasis beyond one year has not been evaluated in controlled clinical studies.
If you take too much adalimumab, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.
- Store adalimumab in a refrigerator at 36ºF to 46ºF (2ºC to 8ºC) in the original container until it is used. Protect from light.
- When traveling, adalimumab should be stored in a cool carrier with an ice pack.
- Do not freeze adalimumab. Do not use adalimumab if frozen, even if it has been thawed.
- Refrigerated adalimumab may be used until the expiration date printed on the adalimumab carton, dose tray, Pen or prefilled syringe.
- Do not use a Pen or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.
- Do not drop or crush adalimumab. The prefilled syringe is glass.
- Keep adalimumab, injection supplies, and all other medicines out of the reach of children.
Tell your doctor if you have any allergies to rubber or latex. The needle cover on the prefilled syringe contains dry natural rubber.
Adalimumab is a medicine that affects your immune system. Adalimumab can lower the ability of your immune system to fight infections.
Your doctor should test you for TB before starting adalimumab.
Your doctor should check you closely for signs and symptoms of TB during treatment with adalimumab.
Before starting adalimumab, tell your doctor about all of your health conditions, including if you have recently received or are scheduled to receive a vaccine.
- You may receive vaccines, except for live vaccines while using adalimumab.