Health Guide
Drug Guide

Adalimumab (Subcutaneous route)

Pronunciation:

a-da-LIM-ue-mab

Brand Names:

Dosage Forms:

Warnings:

Subcutaneous route(Kit)

Patients treated with adalimumab are at increased risk of infection, some of which may become serious and lead to hospitalization or death. These infections have included TB, invasive fungal infections, bacterial, viral, and those caused by opportunistic pathogens including Legionella and Listeria. The risks and benefits of therapy should be carefully considered prior to treatment initiation in patients with chronic or recurrent infection. Evaluate for latent TB and treat if necessary prior to initiating therapy. Monitor patients closely for signs and symptoms of infection during and after treatment, including the possible development of TB in patients who tested negative prior to treatment. Consider empirical antifungal therapy in at-risk patients who develop severe systemic illness. Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers such as adalimumab. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), usually fatal, have been reported in patients treated with TNF blockers including adalimumab, primarily in adolescent and young adult males with Crohn disease and ulcerative colitis. Most cases occurred in patients receiving concomitant treatment with azathioprine or 6-mercaptopurine .

Classifications:

Therapeutic

Antirheumatic

Pharmacologic

Monoclonal Antibody

Uses of This Medicine:

Adalimumab injection is used to treat the symptoms and prevent the progression of active rheumatoid arthritis and ankylosing spondylitis. It is used in children 2 years of age and older for juvenile idiopathic arthritis. This medicine is also used to treat psoriatic arthritis, which is a type of arthritis that causes pain and swelling in the joints along with patches of scaly skin on some areas of the body. Psoriatic arthritis usually occurs with a skin condition called psoriasis. Adalimumab may be used alone or in combination with medicines such as methotrexate.

Adalimumab injection is also used to treat the symptoms of active Crohn's disease in patients who have not been helped by other medicines, such as infliximab. It is also used to treat moderate to moderate to severe ulcerative colitis in patients who have been treated with other medicines (eg, azathioprine, corticosteroids, or 6-mercaptopurine) that did not work well.

Adalimumab injection may also be used to treat chronic plaque psoriasis, which is a skin disease with red patches and white scales that don't go away. It is also used to treat moderate to severe hidradenitis suppurativa, a chronic skin disease that has small, painful lumps under the skin. This medicine is also used to treat non-infectious intermediate, posterior and panuveitis in adults.

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

Before Using This Medicine:

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.

Children

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of adalimumab injection for the treatment of juvenile idiopathic arthritis in children 2 to 17 years of age. However, safety and efficacy have not been established in children younger than 2 years of age for juvenile idiopathic arthritis, in children younger than 6 years of age for Crohn's disease, and safety and efficacy have not been established for other uses in children.

Older adults

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

Pregnancy

Pregnancy CategoryExplanation
All TrimestersBAnimal 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.

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.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

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:

Proper Use of This Medicine:

This medicine is given as a shot under your skin. Adalimumab may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

This medicine comes with a Medication Guide and a Patient Instructions for Use leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

This medicine is available in 2 forms. You may use a Pen or a prefilled syringe.

To use thepen or syringe:

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.

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

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.

Store in the refrigerator. Do not freeze.

Protect the medicine from direct light. Keep your medicine and supplies in the original packages until you are ready to use them. Also, when traveling, store the medicine in a cool carrier with an ice pack.

Precautions While Using This Medicine:

If you will be using this medicine for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if this medicine is working properly and to decide whether you should continue to use it. Blood tests may be needed to check for unwanted effects.

You or your child 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 skin test.

Adalimumab can temporarily lower the number of white blood cells in your blood, which may increase 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:

Do not take other medicines unless they have been discussed with your doctor. Using abatacept (Orencia®) or anakinra (Kineret®) together with this medicine may increase your risk of having serious side effects.

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 (including children and teenagers) who have used this type of medicine have developed certain types of cancer (eg, leukemia). Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you or your child 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.

Adalimumab may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, swelling of the face, throat, legs, or feet, troubled breathing, or chest pain after you receive the medicine.

Check with your doctor right away if you or your child have more than one of these symptoms: shortness of breath, swelling of the face, fingers, feet, or lower legs, or sudden weight gain. These may be signs of a heart condition called congestive heart failure (CHF).

Some people who have used this medicine developed lupus-like symptoms during treatment and got better after the medicine was stopped. Check with your doctor right away if you or your child start having chest pains, shortness of breath, joint pain, or a rash on your cheeks or arms that is sensitive to the sun.

Do not have any live vaccines (immunizations) while you or your child are being treated with adalimumab. Your child's vaccines need to be current before he or she begins using adalimumab. Be sure to ask your child's doctor if you have any questions about this.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you start using this medicine.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Side Effects of This Medicine:

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 or stomach fullness
body aches or pain
cough or hoarseness
ear congestion
gas with abdominal or stomach pain
lightheadedness
loss of voice
lower back or side pain
muscle aches and pains
nasal congestion
pain or tenderness around the eyes or cheekbones
rapid and sometimes shallow breathing
shivering
sunken eyes
thirst
trouble sleeping
warmth on the skin
wrinkled skin
Less common
Abdominal or stomach pain
abnormal vaginal bleeding or discharge
agitation
arm, back, or jaw 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 or rash
light colored stools
loss of appetite
lump in the breast or under your arm
lump or swelling in the abdomen or stomach
mole that leaks fluid or bleeds
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
redness or swelling of the breast
seizures
sharp back pain just below your ribs
shiny bump on your skin
slurred speech or problems with swallowing
sneezing
sore on the skin of the breast that does not heal
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
Incidence not known
Blistering, peeling, or loosening of the skin
diarrhea
joint or muscle pain
pinpoint red spots on the skin
red skin lesions, often with a purple center
red, irritated eyes
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:

More common
Bladder pain
bleeding
burning
coldness
discoloration of the skin
feeling of pressure
general feeling of discomfort or illness
hives
lumps
numbness
pounding in the ears
redness
scarring
soreness
stinging
swelling
tenderness
tingling
ulceration
warmth
Less common
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
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.


Last Updated: 10/12/2016

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