Cyltezo
Cyltezo (adalimumab or adalimumab-adbm) is an injectable medication used to treat several autoimmune conditions, including plaque psoriasis, ulcerative colitis, Crohn's disease, and certain types of arthritis. It's the first interchangeable biosimilar to Humira (adalimumab). It was approved by the FDA in 2017, but it's not expected to be available until July 2023.
What is Cyltezo (adalimumab)?
What is Cyltezo (adalimumab) used for?
- 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 (HS) - adults only
- Uveitis - adults only
How Cyltezo (adalimumab) works
Cyltezo (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, Cyltezo (adalimumab) lowers inflammation to relieve symptoms in different parts of your body.
Drug facts
Side effects of Cyltezo (adalimumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Injection site reaction (20%)
- Upper respiratory tract infection (17%)
- Headache (12%)
- Rash (12%)
- Sinus inflammation (11%)
- Accidental injury (10%)
- Nausea (9%)
- Urinary tract infection (UTI) or bladder infection (8%)
Less Common Side Effects
- High cholesterol
- High blood pressure
- Back pain
- Stomach pain
- Hair loss
- Blood in the urine
- Flu-like symptoms
Cyltezo (adalimumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infection: fever, cough, weight loss, muscle aches, dark urine, chills, vomiting
- Severe allergic reaction: rash, trouble breathing, swelling of your face, eyes, lips, or mouth, hives
- Low blood cell counts: fever that doesn't go away, easy bruising or bleeding, pale skin
- Heart failure: shortness of breath, swelling in the legs, ankles, or feet, irregular heartbeat, tiredness, sudden weight gain
- Liver problems: feeling tired, vomiting, yellow skin or whites of the eyes, stomach pain
The following Cyltezo (adalimumab) side effects have also been reported
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.
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Pros and cons of Cyltezo (adalimumab)
Pros
- Works treat many autoimmune conditions
- Can be injected at home, if your provider says it's safe to do so
- Doesn't contain citrate, so injections might be less painful compared to some other adalimumab products
- Can be stored at room temperature for up to 14 days if needed
Cons
- Raises risk for infections
- The needle caps contain natural rubber latex, which might not be the best option for people with a latex allergy
- Might be difficult to use for some people
- Only FDA approved for use in children for JIA and CD
Pharmacist tips for Cyltezo (adalimumab)
- Before using Cyltezo (adalimumab) at home, you should receive injection training from your healthcare provider or care team. Don't try to give yourself an injection until you've been shown how to do it correctly. If you have questions, call your provider or 1-800-542-6257.
- Mark when your doses of Cyltezo (adalimumab) are due on your calendar. This medication works best when it's taken consistently.
- When you're ready for your dose, take Cyltezo (adalimumab) out of the refrigerator and let it warm up to room temperature for about 15 to 30 minutes. This can lower 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 Cyltezo (adalimumab) in the refrigerator in its original container to protect it from light. But you can store it at room temperature for 14 days, just make sure to throw it away after that time.
- Throw away used needles, syringes, and autoinjectors in a sharps container to prevent needlestick injuries. You can use an FDA-cleared container or 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 Cyltezo (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 Cyltezo (adalimumab).
Common questions about Cyltezo (adalimumab)
Cyltezo (adalimumab) is the first interchangeable biosimilar to Humira (adalimumab). This means it meets additional requirements by the FDA that allows it to be substituted for the original approved biologic (Humira). In other words, in some states your pharmacist could dispense Cyltezo (adalimumab) for you instead of Humira (adalimumab) without needing a new prescription from your provider. This is similar to how generics can be dispensed in place of brand name products, as long as your provider didn't specify otherwise.
While Humira (adalimumab) biosimilars work the same way, there are some differences between them. (1) Some Humira biosimilars are available as different strengths and dosage forms compared to Cyltezo (adalimumab). For example, Cyltezo (adalimumab) is available as prefilled syringes, while other Humira biosimilars are available as autoinjectors to help make giving the injection easier. (2) Another difference is that Cyltezo (adalimumab) is approved to treat JIA and CD in children, whereas other biosimilars haven't been approved in children with CD. (3) Also, Cyltezo (adalimumab) is latex-free and citrate-free while other biosimilars contain them.
You can inject Cyltezo (adalimumab) into the fatty area under the skin of your lower stomach (at least 2 inches away from your belly button) or on the front of your thighs. To allow your skin to heal, rotate injection sites each time. Don't inject it into skin that's sore, hard, red, or bruised.
If you forget to take your dose of Cyltezo (adalimumab), inject a dose as soon as possible. Then, take your next dose at your regularly scheduled time. If you aren't sure when you should inject Cyltezo (adalimumab), contact your provider.
Whether or not you can take other medications with Cyltezo (adalimumab) depends on which type of arthritis you have and your treatment plan. For RA, Cyltezo (adalimumab) can be used alone or with methotrexate or other non-biologic DMARDs. For JIA, Cyltezo (adalimumab) can be used alone or together with methotrexate. And for PsA, it can be used alone or together with non-biologic DMARDs. Speak to your provider about which medications are safe to take together with Cyltezo (adalimumab).
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Risks and warnings for Cyltezo (adalimumab)
Cyltezo (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.
Serious infections
- 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
Cyltezo (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. For your safety, discuss your medical history with your provider. Be sure to 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 Cyltezo (adalimumab), you might have to stop the medication in order to give your immune system a chance to fight the infection.
Cancers
- 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
During clinical studies with a medication like Cyltezo (adalimumab), there was a greater number of people who developed cancer while taking that medication when compared to people not taking it. Lymphoma, leukemia, and skin cancers were some of the most commonly reported types of cancer in people who used that medication. Your provider will determine your risk before starting Cyltezo (adalimumab) and monitor you while you're taking it. Speak to your provider if you have any concerns.
Severe allergic reactions
Products containing adalimumab (the active ingredient in Cyltezo) have caused allergic reactions. Although rare, some reactions can be life threatening (e.g., anaphylaxis). If you experience rash, trouble breathing, or swelling in your face, lips, tongue, or throat, get medical help right away.
Nervous system effects
- Risk factors: Currently have or recently developed a nervous system condition
Although rare, people taking medications like Cyltezo (adalimumab) have developed conditions that affect the 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 Cyltezo (adalimumab), since it can make them worse. Contact your provider if you notice any vision problems, numbness or tingling, weakness in your arms or legs, or dizziness.
Low blood cell counts
Although rare, some people taking medications like Cyltezo (adalimumab) have had low amounts of blood cells. This 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.
Heart failure
People taking medications like Cyltezo (adalimumab) have had new or worsening cases of heart failure. Talk to your provider if you currently have heart failure. They'll weigh the benefits and risks to determine if Cyltezo (adalimumab) is right for you. Get medical help 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.
Lupus-like syndrome
Rarely, Cyltezo (adalimumab) can cause a condition called lupus-like syndrome. Call your provider if you feel more tired than usual, experience easy bruising or bleeding, or a rash.
Cyltezo (adalimumab) dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 2 syringes of 40mg/0.8ml | 1 carton | $6,319.69 | $6,319.69 |
| 2 pens of 40mg/0.8ml | 1 carton | $6,319.69 | $6,319.69 |
| 2 syringes of 20mg/0.4ml | 1 carton | $6,319.69 | $6,319.69 |
| 2 syringes of 10mg/0.2ml | 1 carton | $6,319.69 | $6,319.69 |
| Psoriasis starter pack of 40mg/0.8ml | 1 carton | $12,633.13 | $12,633.13 |
| Crohn's starter pack of 40mg/0.8ml | 1 carton | $18,946.52 | $18,946.52 |
| 2 pens of 40mg/0.4ml | 1 carton | $6,319.69 | $6,319.69 |
| 2 syringes of 40mg/0.4ml | 1 carton | $6,319.69 | $6,319.69 |
| Crohn's starter pack of 40mg/0.4ml | 1 carton | $18,946.52 | $18,946.52 |
| Psoriasis starter pack of 40mg/0.4ml | 1 carton | $12,633.13 | $12,633.13 |
Typical dosage for Cyltezo (adalimumab)
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 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.
Interactions between Cyltezo (adalimumab) and other drugs
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.
- Abatacept
- Adenovirus Vaccine
- Anakinra
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Infliximab
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rilonacept
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Vaccine
- Tofacitinib
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
How much does Cyltezo (adalimumab) cost?
$550.00
What are alternatives to Cyltezo (adalimumab)?
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