Adalimumab (Subcutaneous Route)

Drug Information provided by: Micromedex

ARTICLE SECTIONS

US Brand Names

Humira

Description

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 .

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

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Solution

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 geriatrics-specific problems that would limit the usefulness of adalimumab in the elderly. However, this medicine causes more serious infections and malignancies in the elderly, which may require caution in patients receiving adalimumab .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

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.

Drug Interactions

Using this medicine 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

Other Interactions

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Demyelinating disorders or
Tuberculosis—This medicine may make these conditions worse .

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

Infections—This medicine 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. This medicine may need to be stopped if you develop an infection .

Proper Use

Dosing

The dose of this medicine 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 this medicine. 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 psoriatic arthritis, rheumatoid arthritis, or ankylosing spondylitis:
  - Adults—40 milligrams (mg) given under the skin by injection 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 given under the skin by injection every week for patients with rheumatoid arthritis who are not taking methotrexate .
  - Children—Use and dose must be determined by your doctor.
- For Crohn's disease:
  - Adults—At first (week 0), 160 milligrams (mg) given under the skin by injection 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) given under the skin by injection, then 40 mg one week after the initial dose and every other week thereafter.
  - Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, 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

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly. Your doctor can then decide if you should continue to take it.

You will need to have a skin test for tuberculosis before you start using this medicine. 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 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 this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

This medicine may cause other unwanted effects that may not occur until months or years after this medicine is used. A small number of people who have used this medicine have developed lymphoma or skin cancer. Discuss these possible effects with your doctor .

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: 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 .

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:

More common

Abdominal 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 eyes or cheekbones
Rapid sometimes shallow breathing
Runny nose
Shivering
Stuffy nose
Sunken eyes
Thirst
Trouble sleeping
Warmth on skin
Wrinkled skin

Less common

A sore on the skin of the breast that does not heal
Abdominal pain
Abnormal vaginal bleeding or discharge
Agitation
Anxiety
Arm, back, or jaw pain
Back pain
Black, tarry stools
Bleeding from gums or nose
Blindness
Bloating or swelling of face, arms, hands, lower legs, or feet
Blood in 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 nipple
Cold hands and feet
Confusion
Constipation
Cough
Coughing or spitting up blood
Decreased urination
Decreased vision
Depression
Difficult or frequent urination
Difficulty breathing
Difficulty, burning, or painful urination
Dimpling of 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 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 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 swallowing
Sneezing
Sore throat
Sores, ulcers, or white spots on 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 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

Incidence not known

Blistering, peeling, or loosening of skin
Diarrhea
Joint or muscle pain
Pinpoint red spots on skin
Red irritated eyes
Red skin lesions, often with a purple center
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:

More common