Idacio (adalimumab or adalimumab-aacf) is an injectable medication belonging to a class called TNF blockers. It's used to treat many autoimmune conditions, including ulcerative colitis, Crohn's disease, certain types of arthritis, and plaque psoriasis. This medication got FDA approval in 2022 as a biosimilar to Humira (adalimumab). Side effects include raising your risk of infection and causing injection site reactions. Because of potential interactions with live vaccines, it's recommended to avoid them while taking Idacio (adalimumab).
Rheumatoid arthritis (RA) - adults only
Juvenile idiopathic arthritis (JIA) - people age 2 and older
Psoriatic arthritis (PsA) - adults only
Ankylosing spondylitis (AS) - adults only
Crohn's disease (CD) - people age 6 and older
Ulcerative colitis (UC) - adults only
Plaque psoriasis - adults only
Hidradenitis suppurativa - adults only
Uveitis - adults only
Idacio (adalimumab) is a biologic disease-modifying antirheumatic drug (DMARD). It blocks tumor necrosis factor (TNF), which is a protein in your body that plays a role in inflammation. By blocking TNF, Idacio (adalimumab) can help relieve symptoms caused by inflammation like pain, swelling, and stiffness.
Source:Â DailyMed
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
Body aches or pain
ear congestion
hoarseness
lightheadedness
loss of voice
lower back or side pain
muscle aches and pains
pain or tenderness around the eyes or cheekbones
rapid and sometimes shallow breathing
shivering
stomach fullness
sunken eyes
thirst
trouble sleeping
warmth on the skin
wrinkled skin
Less common
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, tightness, or heaviness
chills
clear or bloody discharge from the nipple
cold hands and feet
confusion
coughing or spitting up blood
decreased urination
decreased vision
difficulty with breathing
difficulty, burning, or painful urination
dimpling of the breast skin
dizziness
drowsiness
fainting
fast, slow, or irregular heartbeat
forgetfulness
frequent urge to urinate
general feeling of illness
headache
increased thirst
inverted nipple
irregular breathing
irregular pulse
irritability
light colored stools
loss of appetite
lump in the breast or under your arm
lump or swelling in the stomach
mole that leaks fluid or bleeds
muscle cramps or spasms
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
seeing or hearing things that are not there
seizures
sharp back pain just below your ribs
shiny bump on your skin
slurred speech or problems with swallowing
sore on the skin of the breast that does not heal
sores, ulcers, or white spots on the lips or mouth
spitting up blood
stiff neck
stomach pain
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
tiredness
trouble breathing
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
inability to move the arms and legs
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
sudden numbness and weakness in the arms and legs
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, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
pounding in the ears
Less common
Abnormal healing
decrease in height
difficulty with moving
difficulty with walking
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
swelling or redness in the joints
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.
Can be used at home, if your provider says it's safe to do so
Not made with natural rubber latex, which might be a good option for people with latex allergies
Can be stored at room temperature for up to 28 days if needed
Doesn't contain citrate, so injections might be less painful compared to some other adalimumab products
Available as prefilled syringes and pens for convenience
Raises the risk of serious infection
Can cause unpleasant side effects like nausea, stomach pain, headache, and rash
Injections might be uncomfortable for some people
Live vaccines aren't recommended while taking the medication
Unknown if safe to use during pregnancy or breastfeeding
Before using Idacio (adalimumab) at home, you should receive injection training from your healthcare provider or care team. Don't try to give yourself an Idacio (adalimumab) injection until you've been shown how to do it correctly.
To help you remember to take Idacio (adalimumab), mark when your doses are due on your calendar. If you happen to forget to take your dose, inject a dose as soon as possible and then continue taking your next dose at your regularly scheduled time.
Take Idacio (adalimumab) out of the refrigerator and let it warm up to room temperature for about 15 to 30 minutes to help reduce discomfort with the injection. Don't warm it up by putting it in the microwave or in hot water because this could damage the medication.
Keep unused Idacio (adalimumab) in the refrigerator in its original container to protect it from light. But you can keep it at room temperature for 28 days, just remember to throw it out after that.
Before getting any vaccines, let your provider or pharmacist know you're taking Idacio (adalimumab). It's recommended to avoid live vaccines while you're taking this medication. Make sure your child gets all of their appropriate shots before starting Idacio (adalimumab).
Idacio (adalimumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Taking other medications that weaken the immune system | Older adults | Active, long-term, or an infection that keeps coming back | Traveling to high risk areas | Having other conditions that raise the risk of infection
Idacio (adalimumab) blocks TNF, a protein that plays an important role in your immune system. As a result, it can raise your risk of serious infections. Some infections can be life-threatening. Your risk is higher if you're an older adult, taking other medications that can weaken the immune system (e.g., methotrexate, Orencia (abatacept), Kineret (anakinra), corticosteroids), or if you have other health conditions.
Before starting Idacio (adalimumab), discuss your medical history with your provider. And especially let them know if you've ever had tuberculosis or hepatitis B. They'll review your risk before starting the medication. If you develop a serious infection while taking Idacio (adalimumab), you might have to stop the medication in order to give your immune system a chance to fight the infection.
Risk factors: Taking other medications that weaken the immune system | History of cancer | People with chronic obstructive pulmonary disease (COPD) with a history of smoking
In clinical studies, there was a greater number of people who developed cancer while taking a medication like Idacio (adalimumab) compared to people who didn't take that medication. Some of the most commonly reported types of cancer in people who used that medication were lymphoma, leukemia, and skin cancers. Your provider will determine your risk before starting Idacio (adalimumab) and monitor you while you're taking the medication. Talk to your provider if you have any concerns.
Products containing adalimumab (the active ingredient in Idacio) have caused allergic reactions. Rarely, some reactions can be life threatening (e.g., anaphylaxis). If you experience rash, trouble breathing, itching, or swelling in your face, lips, tongue, or throat, get medical help right away.
Risk factors: Currently have or recently developed a nervous system condition
Although rare, people taking medications like Idacio (adalimumab) have developed conditions that affect the nervous system, such as multiple sclerosis (MS) and Guillain-Barré syndrome. Tell your provider if you currently have nerve problems. They'll want to monitor you closely while you're taking Idacio (adalimumab), since it can make them worse. Call your provider right away if you notice numbness or tingling, weakness in your arms or legs, vision problems, or dizziness.
Although rare, some people taking medications like Idacio (adalimumab) experienced low amounts of blood cells. Having low blood cell counts can raise your risk for bleeding and lower your body's ability to fight infections. Contact your provider if you develop a fever that doesn't go away, easy bruising, pale skin, or bleeding.
People taking medications like Idacio (adalimumab) have had new or worsening cases of heart failure. If you currently have heart failure, your provider will weigh the benefits and risks to determine if Idacio (adalimumab) is right for you. Get medical help right away if you start to have shortness of breath, swelling in the legs, ankles, or feet, irregular heartbeat, or tiredness or weakness, as these can be signs of heart failure.
Rarely, Idacio (adalimumab) can cause a condition called lupus-like syndrome. Call your provider if you experience easy bruising or bleeding, a rash, or feel unusually tired.
Adults
Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The typical dose is 40 mg injected under the skin every other week.
Crohn's disease and ulcerative colitis: The typical dose is 160 mg injected under the skin on Day 1, followed by 80 mg on Day 15, then 40 mg every other week starting Day 29.
Plaque psoriasis and uveitis: The typical dose is 80 mg injected under the skin on Day 1, followed by 40 mg every other week starting 1 week after the first dose.
Hidradenitis suppurativa: The typical dose is 160 mg injected under the skin on Day 1, followed by 80 mg on Day 15, then 40 mg every week OR 80 mg every other week starting Day 29.
Children
Juvenile idiopathic arthritis and Crohn's disease: The dose will be based on your child's body weight. Typically it will be injected under the skin once every other week.
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.
Rheumatoid arthritis (RA) - adults only
Juvenile idiopathic arthritis (JIA) - people age 2 and older
Psoriatic arthritis (PsA) - adults only
Ankylosing spondylitis (AS) - adults only
Crohn's disease (CD) - people age 6 and older
Ulcerative colitis (UC) - adults only
Plaque psoriasis - adults only
Hidradenitis suppurativa - adults only
Uveitis - adults only
Rheumatoid arthritis (RA)
Plaque psoriasis (PsO) and psoriatic arthritis (PsA)
Ankylosing spondylitis (AS)
Childhood arthritis (polyarticular juvenile idiopathic arthritis, JIA)
Rheumatoid arthritis (RA) - adults only
Juvenile idiopathic arthritis (JIA) - people age 2 and older
Psoriatic arthritis (PsA) - adults only
Ankylosing spondylitis (AS) - adults only
Crohn's disease (CD) - people age 6 and older
Ulcerative colitis (UC) - people age 5 and older
Plaque psoriasis - adults only
Hidradenitis suppurativa (HS) - people age 12 and older
Uveitis - people age 2 and older
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Alwawi, E. A., et al. (2008). Treating psoriasis with adalimumab. Therapeutics and Clinical Risk Management.
Fresenius Kabi USA, LLC. (2023). Idacio- adalimumab injection, solution [package insert]. DailyMed.
Gerriets, V., et al. (2023). Tumor necrosis factor inhibitors. StatPearls.
Haynes, K., et al. (2013). Tumor necrosis factor α inhibitor therapy and cancer risk in chronic immune-mediated diseases. Arthritis and Rheumatism.
Lichtenstein, G. R., et al. (2008). Efficacy and safety of adalimumab in Crohn's disease. Therapeutic Advances in Gastroenterology.
Mease, P. J. (2007). Adalimumab in the treatment of arthritis. Therapeutics and Clinical Risk Management.
Nash, P., et al. (2016). Randomized crossover comparison of injection site pain with 40 mg/0.4 or 0.8 ml formulations of adalimumab in patients with rheumatoid arthritis. Rheumatology and Therapy.
Solhjoo, M., et al. (2023). Drug-induced lupus erythematosus.
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