Humira Information and Uses

Humira

Humira (generic: adalimumab) is a prescription medication used to treat certain kinds of arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, and ulcerative colitis in adults and children. Humira belongs to a group of drugs called tumor necrosis factor (TNF) blockers, which help prevent inflammation.

This medication comes in an injectable form in prefilled syringes. Humira is injected just under the skin usually once every other week.

Common side effects of Humira include reaction at the injection site, sinus infections, and headaches.

Uses of Humira

Humira is a prescription medication used to:

Reduce the signs and symptoms of:
- moderate to severe rheumatoid arthritis (RA) in adults. Humira can be used alone, with methotrexate, or with certain other medicines.
- moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years and older. Humira can be used alone, with methotrexate, or with certain other medicines.
- psoriatic arthritis (PsA) in adults. Humira can be used alone or with certain other medicines.
- ankylosing spondylitis (AS) in adults.
- moderate to severe Crohn’s disease (CD) in adults 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.

Side Effects of Humira

Serious Infections.

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 Humira and during treatment with Humira. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking Humira. People who had a negative TB skin test before receiving Humira have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking Humira:

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 Humira. Your doctor may do blood tests before you start treatment with Humira and while you are using Humira. 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
vomiting
clay-colored bowel movements
fever
chills
stomach discomfort
skin rash

Allergic reactions. Allergic reactions can happen in people who use Humira. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction:

hives
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 Humira, 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 Humira.

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 Humira 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 Humira.

Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with Humira may be stopped.

Common side effects with Humira 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)
headaches
rash
nausea

These are not all the possible side effects with Humira. Tell your doctor if you have any side effect that bothers you or that does not go away.

Humira Interactions

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 use the medicine Orencia (abatacept), Enbrel (etanercept), Kineret (anakinra), Rituxan (rituximab), Remicade (infliximab), Cimzia (certolizumab pegol),Simponi (golimumab), Imuran (azathioprine), or Purinethol (mercaptopurine, 6-MP).

Humira Precautions

Humira is a medicine that affects your immune system. Humira can lower the ability of your immune system to fight infections. Serious infections have happened in people taking Humira. 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 Humira.
Your doctor should check you closely for signs and symptoms of TB during treatment with Humira.

You should not start taking Humira if you have any kind of infection unless your doctor says it is okay.

Before starting Humira, tell your doctor if you:

think you have an infection or have symptoms of infection such as: fever, sweats, chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate, urinating more often than normal, feel very tired.
are being treated for an infection
get a lot of infections or have infections that keep coming back
have diabetes
have TB, or have been in close contact with someone with TB
were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure.
live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use Humira. Ask your doctor if you do not know if you have lived in an area where these infections are common.
have or have had hepatitis B
use the medicine Orencia (abatacept), Kineret (anakinra), Rituxan (rituximab), Imuran (azathioprine), or Purinethol (mercaptopurine, 6-MP).
are scheduled to have major surgery

Cancer

For children and adults taking TNF-blockers, including Humira, 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 Humira 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 Humira 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).

Inform MD

Humira may not be right for you. Before starting Humira, 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 Humira. Children with juvenile idiopathic arthritis should be brought up to date with all vaccines before starting Humira.
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 Humira or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in Humira.
are pregnant or planning to become pregnant. It is not known if Humira will harm your unborn baby. Humira should only be used during a pregnancy if needed.
Pregnancy Registry: Abbott Laboratories has a registry for pregnant women who take Humira. 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 Humira. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you use:

Orencia (abatacept), Kineret (anakinra), Remicade (infliximab), Enbrel (etanercept), Cimzia (certolizumab pegol) or Simponi (golimumab), because you should not use Humira while you are also taking one of these medicines.
Rituxan (rituximab). Your doctor may not want to give you Humira if you have received Rituxan (rituximab) recently.
Imuran (azathioprine) or Purinethol (mercaptopurine, 6-MP).

Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Humira and Pregnancy

Tell your doctor if you are pregnant or planning to become pregnant. It is not known if Humira will harm your unborn baby.

Humira and Lactation

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if Humira is excreted in human breast milk or if it will harm your nursing baby.

Humira Usage

Humira is given by an injection under the skin. Your doctor will tell you how often to take an injection of Humira. This is based on your condition to be treated. Do not inject Humira 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 Humira.

Make sure you have been shown how to inject Humira 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 Humira. Do not try to inject Humira 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 Humira at home, you should receive training on the right way to prepare and inject Humira.

Do not miss any doses of Humira unless your doctor says it is okay. If you forget to take Humira, 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 Humira, call your doctor or pharmacist.

If you take more Humira than you were told to take, call your doctor.

Humira Dosage

Take Humira 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 Humira 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 Humira. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosing frequency of Humira to 40 mg every week.

Juvenile Idiopathic Arthritis

The recommended dose of Humira for pediatric patients 4 to 17 years of age with polyarticular juvenile idiopathic arthritis (JIA) is based on weight. The dose is 20 mg every other week for patients weighing 15 kg (33 lbs) to less than 30 kg (66 lbs). The dose is increase to 40 mg every other week in patients 30 kg (66 lbs) or greater.

Crohn's Disease

The recommended Humira 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 Humira. Azathioprine, 6-mercaptopurine (6-MP) or MTX may be continued during treatment with Humira if necessary. The use of Humira in Crohn’s disease beyond one year has not been evaluated in controlled clinical studies.

Plaque Psoriasis

The recommended dose of Humira 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 Humira in moderate to severe chronic plaque psoriasis beyond one year has not been evaluated in controlled clinical studies.

Humira Overdose

If you take too much Humira (more than your doctor prescribes) call your doctor or local Poison Control Center right away.

Forms of Humira

Humira is supplied in prefilled syringes as a preservative-free, sterile solution for subcutaneous administration. The following packaging configurations are available.

Humira Pen Carton

Humira is dispensed in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-use pen, containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of Humira.

Humira Pen – Crohn's Disease Starter Package

Humira is dispensed in a carton containing 6 alcohol preps and 6 dose trays (Crohn’s Disease Starter Package). Each dose tray consists of a single-use pen, containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of Humira.

Humira Pen – Psoriasis Starter Package

Humira is dispensed in a carton containing 4 alcohol preps and 4 dose trays (Psoriasis Starter Package). Each dose tray consists of a single-use pen, containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of Humira.

Prefilled Syringe Carton – 40 mg

Humira is dispensed in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-use, 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of Humira.

Pediatric Prefilled Syringe Carton - 20 mg

Humira is supplied for pediatric use only in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-use, 1 mL pre-filled glass syringe with a fixed 27 gauge ½ inch needle, providing 20 mg (0.4 mL) of Humira.

The active ingredient in Humira is adalimumab.

Other Requirements

Store Humira in a refrigerator at 36ºF to 46ºF (2ºC to 8ºC) in the original container until it is used. Protect from light.
When traveling, Humira should be stored in a cool carrier with an ice pack.
Do not freeze Humira. Do not use Humira if frozen, even if it has been thawed.
Refrigerated Humira may be used until the expiration date printed on the Humira 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 Humira. The prefilled syringe is glass.
Keep Humira, injection supplies, and all other medicines out of the reach of children.

Humira FDA Warning

SERIOUS INFECTIONS

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.
Humira 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 Humira.
Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which Humira 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 Humira.