Hyrimoz (adalimumab or adalimumab-adaz) is an injection used to treat many different autoimmune conditions (e.g., different types of arthritis, Crohn's disease (CD), ulcerative colitis (UC), and plaque psoriasis). Hyrimoz (adalimumab) is a biosimilar to Humira (adalimumab), but it's not FDA approved to treat all of the same conditions. But it won't be available in the United States until September 2023.
Rheumatoid arthritis (RA) - adults only
Juvenile idiopathic arthritis (JIA) - people age 4 and older
Psoriatic arthritis (PsA) - adults only
Ankylosing spondylitis (AS) - adults only
Crohn's disease (CD) - adults only
Ulcerative colitis (UC) - adults only
Plaque psoriasis - adults only
Hidradenitis suppurativa - adults only
Uveitis - adults only
Hyrimoz (adalimumab) is a biologic disease-modifying antirheumatic drug (DMARD). It works by blocking tumor necrosis factor (TNF), a protein in your body that plays a role in inflammation. By blocking TNF, Hyrimoz (adalimumab) lowers inflammation in different parts of your body.
Source: FDA
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.
Works to treat many autoimmune conditions
Can be stored at room temperature for up to 14 days if needed, like for traveling
Typically only injected a few times a month
Can be given at home (if your provider says it's safe to do so)
Available as prefilled syringes and pen for convenience
Raises risk for infections
Might be difficult to use for some people
Some products contain latex, which might not be the best option for people with a latex allergy
Unknown if safe in pregnant or breastfeeding females
Can't receive live vaccines when taking the medication
Before using Hyrimoz (adalimumab) at home, you should receive injection training from your healthcare provider or care team. If you haven't, contact the clinic or call 1-800-525-8747. Don't try to give yourself an Hyrimoz (adalimumab) injection until you've been shown how to do it safely.
Mark your calendar when your dose of Hyrimoz (adalimumab) is due to help you remember to take it. If you happen to miss a dose, inject a dose as soon as possible and then continue with your regular dosing schedule.
When ready for your injection, take Hyrimoz (adalimumab) out of the refrigerator and let it warm up to room temperature for about 15 to 30 minutes. This will help lower discomfort with the injection. Never warm it up by putting it in the microwave or in hot water because this could damage the medication.
Keep unused Hyrimoz (adalimumab) in its original container and in the refrigerator. You can also keep Hyrimoz (adalimumab) at room temperature for up to 14 days. Throw it away if it hasn't been used after keeping it at room temperature for this time because it might not work well anymore.
Throw away used needles, syringes, and pens in a sharps container to prevent needlestick injuries. You can also use a heavy-duty plastic container you have at home. Check your local laws and guidelines for how to dispose of your container once it's almost full.
Before getting any vaccines, let your provider or pharmacist know you're taking Hyrimoz (adalimumab). It's recommended to avoid live vaccines while you're taking this medication.
Hyrimoz (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
Hyrimoz (adalimumab) can raise your risk of serious or life-threatening infections. 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 Hyrimoz (adalimumab), discuss your medical history with your provider, especially 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 Hyrimoz (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
There was a greater number of cancers in people taking a medication like Hyrimoz (adalimumab) when compared to people not taking them in clinical trials. 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 Hyrimoz (adalimumab) and monitor you while you're taking it. Speak to your provider if you have any concerns.
Rarely, Hyrimoz (adalimumab) can cause severe allergic reactions, like anaphylaxis (closing of the throat). If you experience rash, hives, trouble breathing, itching, or swelling in your face or throat, get medical help right away.
Risk factors: Currently have or recently developed a nervous system condition
Although rare, Hyrimoz (adalimumab) can cause you to develop conditions that affect your nervous system, such as multiple sclerosis (MS) and Guillain-Barré syndrome. Let your provider know if you currently have nerve problems. They'll want to monitor you closely while you're taking Hyrimoz (adalimumab), since it can make them worse. If you notice numbness or tingling, weakness in your arms or legs, vision problems, or dizziness, call your provider right away.
Although rare, some people taking medications like Hyrimoz (adalimumab) experienced having low amounts of blood cells. This can lower your body's ability to fight infections and raise your risk for bleeding. Contact your provider if you develop a fever that doesn't go away, easy bruising, pale skin, or bleeding.
People taking medications like Hyrimoz (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 Hyrimoz (adalimumab) is right for you. Let your provider know 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, Hyrimoz (adalimumab) can cause a condition called lupus-like syndrome. Contact 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 starting 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 on 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: 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 4 and older
Psoriatic arthritis (PsA) - adults only
Ankylosing spondylitis (AS) - adults only
Crohn's disease (CD) - adults only
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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