adalimumab (Subcutaneous route)

a-da-LIM-ue-mab

Commonly used brand name(s):

In the U.S.

• Humira

Available Dosage Forms:

• Solution

Therapeutic Class: Antirheumatic

Pharmacologic Class: Monoclonal Antibody

Uses For adalimumab

Adalimumab is used to decrease signs, symptoms, and progression of moderately to severely active rheumatoid arthritis and ankylosing spondylitis. It is also used to treat psoriatic arthritis which is a type of arthritis that causes pain and swelling of the joints and patches of scaly skin on some areas of the body. Psoriatic arthritis is related to the skin condition, psoriasis. Adalimumab can be used in combination with methotrexate or other Disease Modifying Antirheumatic Drugs (DMARDs).

Adalimumab is also used to decrease signs and symptoms of Crohn's disease in patients who have not been helped by other medicines, such as infliximab.

adalimumab may also be used to treat moderate to severe chronic plaque psoriasis.

adalimumab is available only with your doctor's prescription.

Before Using adalimumab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For adalimumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to adalimumab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of adalimumab in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of adalimumab in the elderly. However, adalimumab causes more serious infections and malignancies in the elderly, which may require caution in patients receiving adalimumab.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using adalimumab with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Anakinra
• Bacillus of Calmette and Guerin Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rilonacept
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of adalimumab. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer, active or history of—May increase the chance of getting new cancers.

• Demyelinating disorders or
• Psoriasis (skin disease) or
• Tuberculosis—Use with caution. May make these conditions worse.

• Heart failure—adalimumab may cause heart failure to become worse or for new heart failure symptoms and side effects to occur. Caution should be used and your doctor should monitor you carefully.

• Infections—adalimumab should not be started in patients who have active infections of any type. It may also cause reactivation of previous infections such as hepatitis B. adalimumab may need to be stopped if you develop an infection.

Proper Use of adalimumab

adalimumab comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of adalimumab will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of adalimumab. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For Crohn's disease:
    • Adults—At first (week 0), 160 milligrams (mg) injected under the skin in divided doses (four shots in one day or two shots per day for two days), then 80 mg two weeks after the initial dose (week 2). A maintenance dose of 40 mg is given at week 4 and every other week thereafter.
    • Children—Use and dose must be determined by your doctor.
  • For plaque psoriasis:
    • Adults—At first, 80 milligrams (mg) injected under the skin, then 40 mg one week after the initial dose and every other week thereafter.
    • Children—Use and dose must be determined by your doctor.
  • For psoriatic arthritis, rheumatoid arthritis, or ankylosing spondylitis:
    • Adults—40 milligrams (mg) injected under the skin every other week alone or in combination with methotrexate, glucocorticoids, aspirin, non-steroidal anti-inflammatories (NSAIDS), analgesics, or other disease modifying antirheumatic drugs (DMARDS); or 40 mg injected under the skin every week for patients with rheumatoid arthritis who are not taking methotrexate.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of adalimumab, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using adalimumab

If you will be taking adalimumab for a long time, it is very important that your doctor check you at regular visits to make sure that adalimumab is working properly. Blood tests may be needed to check for unwanted effects.

You will need to have a skin test for tuberculosis before you start using adalimumab. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test.

Adalimumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Do not take other medicines unless they have been discussed with your doctor. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions.

Make sure you know how you react to adalimumab before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

adalimumab may cause other unwanted effects that may not occur until months or years after adalimumab is used. A small number of people (including children and teenagers) who have used adalimumab have developed certain types of cancer. Some patients developed a rare type of cancer called lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness; swollen lymph nodes in the neck, underarms, or groin; or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.

Serious skin reactions can occur during treatment with adalimumab. Check with your doctor right away if you have any of the following symptoms while using adalimumab: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in your mouth or lips; or unusual tiredness or weakness.

Do not change or stop using adalimumab without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

adalimumab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach fullness
• body aches or pain
• cough or hoarseness
• ear congestion
• gaseous abdominal pain
• infection
• lightheadedness
• loss of voice
• lower back or side pain
• muscle aches and pains
• nasal congestion
• pain or tenderness around the eyes or cheekbones
• rapid sometimes shallow breathing
• runny nose
• shivering
• stuffy nose
• sunken eyes
• thirst
• trouble sleeping
• warmth on the skin
• wrinkled skin

• A sore on the skin of the breast that does not heal
• abdominal or stomach pain
• abnormal vaginal bleeding or discharge
• agitation
• anxiety
• arm, back, or jaw pain
• back pain
• black, tarry stools
• bleeding from the gums or nose
• blindness
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the stool or change in bowel habits
• bloody or cloudy urine
• blurred vision
• broken bones
• change in size, shape, or color of an existing mole
• change in skin color
• chest pain
• chest tightness or heaviness
• chills
• clear or bloody discharge from the nipple
• cold hands and feet
• confusion
• constipation
• cough
• coughing or spitting up blood
• decreased urination
• decreased vision
• depression
• difficult or frequent urination
• difficulty with breathing
• difficulty, burning, or painful urination
• dimpling of the breast skin
• dizziness
• drowsiness
• eye pain
• fainting
• fast, slow, or irregular heartbeat
• fever
• forgetfulness
• frequent urge to urinate
• general feeling of illness
• hair loss
• hallucinations
• headache
• increased thirst
• inverted nipple
• irregular breathing
• irregular pulse
• irritability
• itching
• light colored stools
• loss of appetite
• lump in the breast or under your arm
• lump or swelling in the abdomen
• mole that leaks fluid or bleeds
• mood or mental changes
• muscle cramps or spasms
• nausea
• new mole
• night sweats
• no blood pressure or pulse
• noisy breathing
• numbness or tingling in your arms, legs, or face
• pain, redness, or swelling in the arms or legs without any injury present
• pale skin
• persistent non-healing sore on your skin
• pink growth
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• raised, firm, or bright red patch
• rash
• redness or swelling of the breast
• seizures
• sharp back pain just below your ribs
• shiny bump on your skin
• shortness of breath
• skin rash
• slurred speech or problems with swallowing
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or mouth
• spitting up blood
• stiff neck
• stopping of the heart
• sudden high fever or low grade fever for months
• sweating
• swelling of the face, fingers, feet, or lower legs
• swollen glands
• swollen neck veins
• tightness in the chest
• tiredness
• trouble breathing with activity
• trouble thinking
• unconsciousness
• unexplained bruising or bleeding
• unpleasant breath odor
• unusual tiredness or weakness
• unusual weight gain or loss
• visual disturbances
• vomiting
• vomiting of blood or material that looks like coffee grounds
• yellow skin or eyes
• wheezing

• Blistering, peeling, or loosening of the skin
• diarrhea
• joint or muscle pain
• pinpoint red spots on the skin
• red irritated eyes
• red skin lesions, often with a purple center
• red, scaling, or crusted skin
• unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bladder pain
• bleeding
• burning
• coldness
• discoloration of the skin
• feeling of pressure
• general feeling of discomfort or illness
• hives
• infection
• inflammation
• large amount of cholesterol in your blood
• large amount of fat in your blood
• lumps
• numbness
• pounding in the ears
• redness
• scarring
• soreness
• stinging
• swelling
• tenderness
• tingling
• ulceration
• warmth

• Abnormal healing
• decrease in height
• difficulty with moving
• difficulty with swallowing
• difficulty with walking
• dry mouth
• heartburn
• indigestion
• loss of hearing
• loss of strength or energy
• menstrual changes
• muscle or joint stiffness, tightness, or rigidity
• muscle pain or weakness
• pain in the back, ribs, arms, or legs
• pain or burning in the throat
• passing of gas
• shakiness in the legs, arms, hands, and feet
• sores
• stomach pain, fullness, or discomfort
• swelling or redness in the joints
• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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