Amjevita
Amjevita, the brand name for adalimumab-atto, is an injectable medication that treats many different autoimmune and inflammatory conditions, including rheumatoid arthritis (RA) psoriatic arthritis (PsA), and Crohn's disease (CD). Although the medication is a biosimilar to Humira (adalimumab), it's not yet FDA approved to treat all age groups for some of the conditions Humira (adalimumab) is approved for. The typical dosing is one injection given under the skin every other week. Common side effects include infections and injection site reactions.
What is Amjevita (adalimumab-atto)?
What is Amjevita (adalimumab-atto) 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 (Ps) - adults only
- Hidradenitis suppurativa (HS) - adults only
- Uveitis (UV) - adults only
How Amjevita (adalimumab-atto) works
Amjevita (adalimumab-atto) is a tumor necrosis factor (TNF) blocker. It works by blocking TNF, a protein in your body that plays a role in inflammation. By stopping TNF, the medication helps lower inflammation and relieve symptoms in various parts of the body.
Drug facts
Side effects of Amjevita (adalimumab-atto)
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
Note: Side effects reported above are from studies with Humira (adalimumab)
Amjevita (adalimumab-atto) 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
- Low blood cell counts: fever that doesn't go away, easy bruising or bleeding, pale skin
- Severe allergic reaction: rash, trouble breathing, swelling of your face, eyes, lips, or mouth, hives
- 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, poor appetite
The following Amjevita (adalimumab-atto) 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 Amjevita (adalimumab-atto)
Pros
- Works to treat many different autoimmune conditions
- Can be given at home (if your prescriber says it's safe to do so)
- Only needs to be injected a few times per month
- Conveniently available as a prefilled syringe or autoinjector
- Not made with natural rubber latex, which is good for people with allergies
Cons
- Raises the risk for serious infections
- Can take weeks to months to notice symptom improvement
- Must avoid live vaccines while taking the medication
- Only manages symptoms, doesn't cure the condition
- Not known if it's safe in pregnancy or breastfeeding
Pharmacist tips for Amjevita (adalimumab-atto)
- Mark your calendar when your dose of Amjevita (adalimumab-atto) is due to help you remember to take it.
- If you miss a dose of Amjevita (adalimumab-atto), inject it as soon as you remember. Then, continue with your regular injection schedule.
- Before using Amjevita (adalimumab-atto) at home, you should receive injection training from your prescriber or care team. If you haven't, contact the clinic or your pharmacist. Don't try to give yourself an injection until you're comfortable doing it safely and properly.
- Store unused Amjevita (adalimumab-atto) in the refrigerator. If refrigeration isn't available or you're traveling, you can keep it at room temperature for up to 14 days. Throw it away after 14 days at room temperature, as it might not work properly anymore.
- Throw away used needles, syringes, and autoinjectors in a sharps container to prevent needlestick injuries. Check your local laws and guidelines for how to dispose of your container once it's almost full.
- Amjevita (adalimumab-atto) can weaken your immune system, making it harder to fight infections. Let your prescriber know if you experience symptoms of an infection like fever, muscle aches, shortness of breath, cough, or fatigue.
- You can get some vaccines while taking Amjevita (adalimumab-atto), but avoid live vaccines, as it’s not clear how they interact with this medication. Make sure your child is up to date on their vaccines before starting Amjevita (adalimumab-atto). And talk to your prescriber before getting any vaccines.
How to inject Amjevita (adalimumab-atto):
- When ready for your injection, take Amjevita (adalimumab-atto) out of the refrigerator and let it warm up to room temperature for about 15 to 30 minutes. This will help reduce discomfort with the injection. Never try to warm it up by putting it in the microwave or in hot water.
- Wash your hands with soap and water and clean your chosen injection site with an alcohol swab before injecting Amjevita (adalimumab-atto). This will help prevent infection.
- Inject Amjevita (adalimumab-atto) under the skin in the front of your thighs or at least 2 inches away from your belly button if injecting in your stomach area. Be sure to rotate injection sites each time to allow your skin to heal.
Common questions about Amjevita
Not normally. Amjevita doesn't typically cause acne. If you notice acne after starting this medication and are concerned, talk to your prescriber.
You can inject Amjevita under the skin either on the front of your thighs or your stomach. If you inject it into your stomach, make sure the area is at least 2 inches away from your belly button. Rotate your injection sites each time to allow your skin to heal. And avoid injecting the medication into skin that's red, bruised, or broken.
Yes, Amjevita is citrate-free. Citrate is an ingredient sometimes found in injectable medications. Studies have shown that injections containing citrate might cause more pain than those without.
Amjevita is a biosimilar to Humira (adalimumab), meaning it has a comparable structure and works similarly to Humira. Biosimilars aren't identical to the original biologic. Although both medications treat similar autoimmune and inflammatory conditions, Amjevita isn't FDA approved for all age groups that Humira (adalimumab) covers. For example, Humira (adalimumab) is approved to treat uveitis (UV) in children and adults, but Amjevita is only approved for adults. Amjevita isn't interchangeable with Humira, so a new prescription is needed to switch between them.
It might take Amjevita a few weeks to work. And it can take months to see the full effects. Your results will depend on why you're taking the medication, how bad your symptoms are, and how well you respond to the treatment. Discuss with your prescriber when you should expect to notice an improvement in your symptoms after starting Amjevita.
Weight gain isn't a common side effect of Amjevita. But sudden weight gain can be a sign of heart failure, which has been rarely reported with similar medications. Speak with your prescriber if you experience weight gain with this medication.
Although rare, TNF blockers like Amjevita have been linked to liver damage. Most cases have been mild and often without symptoms. Since some people in studies were also taking other medications that can harm the liver, more research is needed to understand how Amjevita affects the liver. Before starting this medication, your prescriber will check for a history of hepatitis B, as the virus can become active again and affect your liver. Tell your prescriber if you notice any signs of liver problems, like nausea, stomach pain, clay-colored stools, or yellowing of your skin or whites of your eyes.
Yes, Amjevita should be stored in the refrigerator. But you can keep it at room temperature for up to 14 days if needed. Just make sure to protect the medication from light by keeping it in the original container. Write the date you took Amjevita out of the refrigerator, and throw it away after 14 days have passed.
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Risks and warnings for Amjevita (adalimumab-atto)
Amjevita (adalimumab-atto) 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 | Age 65 years or older | Active, long-term, or an infection that keeps coming back | Traveling to high risk areas | Having other conditions that raise the risk of infection
Amjevita (adalimumab-atto) can raise your risk of serious or life-threatening infections. Your risk might be higher if you're 65 years or older, taking other medications that can weaken the immune system (e.g., methotrexate, Orencia (abatacept), Kineret (anakinra), corticosteroids), or have other health conditions. Discuss your medical history with your prescriber before starting Amjevita (adalimumab-atto), especially if you've had tuberculosis or hepatitis B. They will review your risk before prescribing the medication. If you develop an infection while taking Amjevita (adalimumab-atto), 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
In clinical studies, more people developed cancer while taking a medication similar to Amjevita (adalimumab-atto) compared to those who weren't taking it. The most common types of cancer reported were lymphoma, leukemia, and skin cancers. Your prescriber will assess your risk before starting treatment and monitor you while you're taking the medication. If you notice any unusual symptoms, be sure to contact your prescriber.
Severe allergic reactions
Although rare, Amjevita (adalimumab-atto) can cause severe allergic reactions, including anaphylaxis, which can be life-threatening. If you notice symptoms like a rash, itching, trouble breathing, or swelling in your face or throat, stop the medication and get medical help right away.
Nervous system effects
- Risk factors: History of nerve problems
TNF blockers like Amjevita (adalimumab-atto) have been linked to rare cases of new or worsening nerve problems, including multiple sclerosis (MS) and Guillain-Barré syndrome. Let your prescriber know if you already have or recently developed a nerve condition. They will help to review the risks and benefits of taking this medication. If you notice numbness or tingling, weakness in your arms or legs, vision problems, or dizziness, contact your care team.
Low blood cell counts
There have been reports of people having low blood cells while taking Amjevita (adalimumab-atto). This can affect your body's ability to fight infections and raise your risk for bleeding. Contact your prescriber if you develop a fever that doesn't go away, easy bruising, pale skin, or bleeding.
Heart failure
People taking medications like Amjevita (adalimumab-atto) have had new or worsening cases of heart failure. Speak with your prescriber if you currently have heart failure. They'll help you decide if Amjevita (adalimumab-atto) is right for you. Also let them 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.
Lupus-like syndrome
Amjevita (adalimumab-atto) can rarely cause a condition called lupus-like syndrome. Contact your prescriber if you experience a rash, easy bruising or bleeding, or feel more tired than usual.
Amjevita (adalimumab-atto) dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 1 syringe of 20mg/0.4ml | 1 carton | $404.50 | $404.50 |
| 1 autoinjector of 40mg/0.8ml | 2 cartons | $1,017.21 | $508.61 |
| 2 autoinjectors of 40mg/0.8ml | 1 carton | $981.25 | $981.25 |
| 1 syringe of 40mg/0.8ml | 2 cartons | $1,038.00 | $519.00 |
| 1 syringe of 10mg/0.2ml | 3 cartons | $9,476.36 | $3,158.79 |
| 2 syringes of 40mg/0.4ml | 1 carton | $646.23 | $646.23 |
| 2 autoinjectors of 40mg/0.4ml | 1 carton | $1,332.05 | $1,332.05 |
| 1 autoinjector of 40mg/0.4ml | 2 cartons | $1,336.05 | $668.03 |
| 1 syringe of 40mg/0.4ml | 2 cartons | $661.84 | $330.92 |
| 1 syringe of 20mg/0.2ml | 2 cartons | $1,336.06 | $668.03 |
| 1 autoinjector of 80mg/0.8ml | 3 cartons | $1,905.31 | $635.10 |
| 2 autoinjectors of 80mg/0.8ml | 1 carton | $1,264.73 | $1,264.73 |
Typical dosage for Amjevita (adalimumab-atto)
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 (2 weeks later).
- 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 Amjevita (adalimumab-atto) 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 Amjevita (adalimumab-atto) cost?
$404.50
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