Humira (adalimumab) reduces the effects of a substance in the body that can cause inflammation.
Humira is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. It is also used to treat Crohn"s disease or ulcerative colitis, after other drugs have been tried without successful treatment of symptoms.
Humira may also be used for purposes not listed in this medication guide.
Important information
Some people using Humira have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. Humira can also lower blood cells that help your body fight infections and help your blood to clot. Serious and sometimes fatal infections may occur during treatment with Humira.
Call your doctor at once if you have symptoms such as fever, night sweats, weight loss, feeling full after eating only a small amount, pain in your upper stomach, easy bruising or bleeding, dark urine, or jaundice (yellowing of the skin or eyes).
Humira can lower blood cells that help your body fight infections and help your blood to clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with Humira. Tell your doctor at once if you develop signs of infection.
Before taking this medicine
You should not use Humira if you are allergic to adalimumab, or if you have an active infection.
Some people using Humira have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using Humira or similar medicines to treat Crohn"s disease or ulcerative colitis. However, people with autoimmune disorders may have a higher risk of lymphoma.
Before you start treatment with Humira, your doctor may perform tests to make sure you do not have tuberculosis or other infections. To make sure Humira is safe for you, tell your doctor if you have:
-
recent or chronic infections;
-
past or present cancer;
-
a history of hepatitis B;
-
congestive heart failure;
-
an allergy to latex rubber;
-
any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome; or
-
if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.
FDA pregnancy category B. Humira is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether adalimumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Humira should not be given to a child younger than 2 years old (or 6 years old if treating Crohn"s disease). Children using Humira should be current on all childhood immunizations before starting treatment.
Using this medicine may increase your risk of certain types of cancer, such as lymphoma (cancer of the lymph nodes), or melanoma (a tumor that usually affects the skin). This risk may be greater in children and young adults, or in anyone with rheumatoid arthritis. You may also develop an autoimmune disorder such as a lupus-like syndrome. Talk with your doctor about your specific risk.
How should I use Humira?
Use Humira exactly as prescribed by your doctor. Follow the directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Use Humira regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
The dose schedule for Humira is highly variable and depends on the condition you are treating. You may need an injection only every other week. Or you may need up to 4 injections in 1 day for 2 days in a row. Follow your doctor"s dosing instructions very carefully.
Do not start using Humira if you have any signs of an infection (fever, chills, night sweats, weight loss, body aches, tiredness, cough with mucus, feeling short of breath, skin sores, stomach pain, diarrhea, pain or burning when you urinate). Call your doctor for instructions.
Humira is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes. Do not inject Humira into skin that is bruised, red, tender, or hard.
Each prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose. Do not use a prefilled syringe if the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
Adalimumab can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Serious and sometimes fatal infections may occur during treatment with Humira. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, or flu symptoms.
If you need surgery, tell the surgeon ahead of time that you are using Humira.
If you have ever had hepatitis B, Humira can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.
Store in a refrigerator. If you travel with a prefilled syringe, keep it in a small cooler with an ice pack and protect it from light. Do not remove the prefilled syringe from the refrigerator or cooler until you are ready to give yourself an injection.
Do not freeze, and throw away the medicine if it has become frozen.
Humira dosing information
Usual Adult Dose of Humira for Ankylosing Spondylitis:
40 mg subcutaneously every other week
In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.
Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease modifying agents may be given concomitantly.
Usual Adult Dose for Rheumatoid Arthritis:
40 mg subcutaneously every other week
In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.
Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease modifying agents may be given concomitantly.
Usual Adult Dose of Humira for Psoriatic Arthritis:
40 mg subcutaneously every other week
In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.
Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease modifying agents may be given concomitantly.
Usual Adult Dose for Crohn"s Disease -- Acute:
Initial dose: 160 mg subcutaneously on Day 1.
The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).
Week 2: 80 mg subcutaneously on Day 15.
Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.
Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with adalimumab.
The use of adalimumab for Crohn"s disease beyond one year had not been evaluated in controlled clinical studies.
Usual Adult Dose of Humira for Crohn"s Disease -- Maintenance:
Initial dose: 160 mg subcutaneously on Day 1.
The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).
Week 2: 80 mg subcutaneously on Day 15.
Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.
Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with adalimumab.
The use of adalimumab for Crohn"s disease beyond one year had not been evaluated in controlled clinical studies.
Usual Adult Dose for Ulcerative Colitis:
Initial dose: 160 mg subcutaneously on Day 1.
The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).
Week 2: 80 mg subcutaneously on Day 15.
Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.
Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with adalimumab.
The use of adalimumab for Crohn"s disease beyond one year had not been evaluated in controlled clinical studies.
Usual Adult Dose for Plaque Psoriasis:
Initial dose: 80 mg subcutaneously.
Maintenance dose: 40 mg subcutaneously every other week, starting one week after initial dose.
Usual Pediatric Dose for Juvenile Idiopathic Arthritis:
4 to 17 years:
Limited data are available for adalimumab treatment in pediatric patients with a weight below 15 kg.
15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
Greater than or equal to 30 kg (66 lbs): 40 mg every other week
Methotrexate, glucocorticoids, salicylates, NSAIDs, or analgesics may be continued during treatment with adalimumab.
What happens if I miss a dose?
Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Humira?
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while using Humira. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Humira side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Humira: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Humira and call your doctor right away if you have any of these symptoms of lymphoma:
-
fever, night sweats, weight loss, tiredness;
-
feeling full after eating only a small amount;
-
pain in your upper stomach that may spread to your shoulder;
-
easy bruising or bleeding, pale skin, feeling light-headed, rapid heart rate; or
-
liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Also call your doctor at once if you have:
-
signs of infection - fever, chills, sore throat, vomiting, diarrhea, flu symptoms, pain or burning when you urinate;
-
signs of tuberculosis - fever with ongoing cough, weight loss (fat or muscle);
-
pale skin, easy bruising or bleeding (nosebleeds, bleeding gums);
-
numbness, tingly feeling, weakness or prickly feeling;
-
vision problems;
-
shortness of breath with swelling of your ankles or feet; or
-
new or worsening psoriasis (raised, silvery flaking of the skin).
Older adults may be more likely to develop an infection while using Humira.
Common Humira side effects may include:
-
headache;
-
nausea;
-
cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat;
-
rash; or
-
redness, bruising, itching, or swelling where the injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Humira?
Some drugs should not be used together with Humira. Tell your doctor about all medicines you use, and those you start or stop using during your treatment, especially:
This list is not complete. Other drugs may interact with adalimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
