What to Know About Amjevita (Adalimumab-atto)

Amjevita is approved for rheumatoid arthritis, inflammatory diseases

In This Article

Amjevita (adalimumab-atto), a biosimilar to Humira (adalimumab), gained approval by the U.S. Food and Drug Administration (FDA) in 2016 for treating rheumatoid arthritis (RA) and various other inflammatory diseases. It comes in liquid form that is self-injected under the skin and works to stop inflammation from increasing.

Uses

Amjevita is approved for the treatment of the following diseases:

  • Rheumatoid arthritis: To reduce signs and symptoms, inhibit progression of structural damage, and improve physical function in adults with moderately to severely active disease
  • Juvenile idiopathic arthritis (JIA): To reduce the signs and symptoms of moderately to severely active polyarticular JIA (formerly called juvenile rheumatoid arthritis) in children age 4 and older
  • Psoriatic arthritis (PsA): To reduce signs and symptoms, inhibit progression of structural damage, and improve physical function in adults with active disease
  • Ankylosing spondylitis (AS): To reduce signs and symptoms in adults with active disease
  • Adult Crohn's disease (CD): To reduce signs and symptoms; to induce and maintain clinical remission in adults with moderately to severely active disease who had an inadequate response to conventional treatment, stopped responding to Remicade, or simply could not tolerate Remicade
  • Ulcerative colitis (UC): To induce and maintain clinical remission in adults with moderately or severely active disease who had an inadequate response to immunosuppressants
  • Plaque psoriasis (Ps): For adults with moderate to severe chronic disease who are suitable candidates for systemic therapy or phototherapy; also used when other systemic therapies are deemed less appropriate

Amjevita is a specific type of biologic known as a recombinant human IgG1 monoclonal antibody. It, like all biologics, is created from living cells. And because it has no clinically meaningful differences from the previously FDA-approved biologic drug Humiria (adalimumab), it is also called a biosimilar.

Amjevita is also a TNF blocker because it works by binding to specialized immune-system cells called tumor necrosis factor-alpha (TNFα). TNFα is known to be involved in the inflammatory process and to be present in high amounts in several inflammatory diseases. By binding with TNFα, Amjevita prevents it from creating inflammation.

You can identify a biosimilar by the presence of a four-letter suffix at the end of its generic name. For example, Humira's generic name is adalimumab, while Amjevita's generic name is adalimumab-atto.

Since 2016, numerous biosimilars have come on the market, including:

Why Haven't I Heard About Amjevita?

Biosimilars are supposed to be equivalent to the original drug they're similar to (called the "reference product"). However, doctors and patients may both be hesitant to switch to a biosimilar when the reference product is providing effective treatment. Because of that, biosimilar use in the U.S. is relatively low.

It may be worth inquiring about with your doctor, however, especially since biosimilars are generally more affordable than their reference products.

A biosimilar cannot be substituted for its reference product at the pharmacy in the way a generic, with a doctor's approval, can be given instead of a brand name drug. A biosimilar must be specifically prescribed by your doctor.

Before Taking

Amjevita may be used as a first-line treatment for RA, JIA, PsA, and AS, or it may be given to you after you've tried other drugs without success.

It's generally a second-line (or later) treatment for CD, UC, and Ps, which means you'll likely need to fail on one or more drugs before your doctor prescribes Amjevita.

Be sure your doctor knows all medications you're taking, whether they're prescription or over-the-counter. This also includes herbal and nutritional supplements, as they may interact negatively with Amjevita or cause you to need monitoring while you take them together.

Precautions and Contraindications

While no absolute contraindications are listed for Amjevita, if your doctor suggests this drug for you, be sure to mention whether you:

  • Have a serious infection, as you shouldn't start this drug until it clears up
  • Have had exposure to tuberculosis
  • Have had a tuberculosis or hepatitis B infection, as it could cause a reactivation
  • Have a demyelinating disease (such as multiple sclerosis) or congestive heart failure, as Amjevita may make it worse
  • Have malignancies (cancer), as Amjevita may make them worse
  • Are over 65 years old and also taking immunosuppressants (e.g., corticosteroids or methotrexate), due to a possible increased risk of infection
  • Have recently traveled to or lived in areas where endemic tuberculosis or endemic mycoses (histoplasmosis, coccidiomycosis, blastomycosis) are common
  • Have other conditions that predispose you to infections
  • Have an allergy to adalimumab

If any of these apply to you, your doctor may want to delay starting Amjevita, monitor you closely while you take it, or consider another drug.

Your doctor will likely test you for latent tuberculosis before you start taking this drug.

Use in Pregnant and Nursing Women

Limited information is available about the safety of taking Amjevita while pregnant or breastfeeding. In an animal study using extremely high doses of adalimumab, no harm to the baby was observed.

However, a study published in 2020 suggested TNF blockers were associated with increased risks of:

Researchers couldn't say whether these finders were due to the medication or the underlying disease the drug was prescribed for.

A review of existing data showed that, in studies involving a total of 2,100 pregnancies, adalimumab was not associated with an increased risk of birth defects or other unfavorable outcomes.

Studies show that it is transferred through the placenta during the third trimester. While it's not associated with known short-term or long-term health effects, it's possible that it may alter your baby's immune response before and after birth.

Interestingly, adalimumab has been tested as a potential treatment for a pregnancy-related condition called intrauterine inflammation, which is a major cause of preterm birth. Further research of this use for the drug could lead to a significant increase in data on its safety during pregnancy.

Adalimumab has been found at low levels in human breastmilk, meaning your child may be exposed to the drug during breastfeeding. No adverse effects associated with this exposure have been reported, though, and experts believe adalimumab is probably destroyed during digestion and is therefore unlikely to reach your child's bloodstream.

If you're pregnant or breastfeeding, be sure to tell your obstetrician and pediatrician what medications you're taking so they can help safeguard your and your child's health.

Dosage

Amjevita is administered by subcutaneous injection, which means "under the skin" (as opposed to in a vein). It is available as a:

  • 40 mg/0.8 mL dose in a single-use prefilled SureClick autoinjector
  • 40 mg/0.8 mL dose in a single-use prefilled glass syringe
  • 20 mg/0.4 mL in a single-use prefilled glass syringe

For RA, PsA, AS: The recommended dose of Amjevita is 40 mg every other week. If you have RA and do not take methotrexate, your doctor may prescribe 40 mg every week.

For CD, UC: People with these conditions use high initial doses before switching to a maintenance dose. The typical schedule is:

  • Day 1: 160 mg (or 80 mg per day for two consecutive days)
  • Day 15: 80 mg
  • Day 29: Begin maintenance dose of 40 mg every other week

If you have UC, you'll likely only continue on Amjevita if you show clinical evidence of remission after eight weeks of therapy.

Ps: This condition typically begins with a starting dose of 80 mg. One week later, a maintenance dose of 40 mg every other week begins.

Modifications

In the treatment of JIA, the pediatric dose of Amjevita is modified based on the child's weight.

Weight of JIA Patient Dosage
33-65 pounds 20 mg every 14 days
Above 65 pounds 40 mg every 14 days

How to Take and Store

Because Amjevita comes in pre-filled syringes or autoinjector pens, taking it is fairly simple. Directions vary based on which injection method you're using, so be sure to follow the packaging instructions and call your doctor if you have any questions or problems.

Amjevita needs to be protected from light, so keep it in the original carton until it's time for your dose.

This drug must also be kept refrigerated and stay between 36 degrees and 46 degrees F. If needed due to traveling or other circumstances, you can keep Amjevita at room temperature (not over 77 degrees F) for up to 14 days, at which point medication would need to be discarded if not already used.

Do not freeze Amjevita, and don't use it if it's ever been frozen (even after it thaws).

Before you inject yourself, take the drug out of the fridge and allow it to naturally come up to room temperature, as injecting something cold can be uncomfortable. (You can do this the day before your dosage is due, if convenient.) Do not try to heat up the medication to speed this process.

Side Effects

Common side effects of Amjevita, which were generally mild and went away with continued use in clinical trials, include:

  • Infections (non-serious, e.g., sinus, upper respiratory)
  • Injection site reactions (redness, itching, pain, swelling, or hemorrhage)
  • Headache

Less common side effects include:

  • Symptom flare
  • Rash
  • Pneumonia

While rare, these side effects were the most common reasons people withdrew from drug trials.

Warnings and Interactions

Amjevita comes with a black box warning, the most serious warning issued by the FDA.

Serious Infection

The warning, in part, relates to the fact that Amjevita is linked to an increased risk of serious infection that could lead to hospitalization or death, including:

  • Tuberculosis
  • Bacterial sepsis
  • Invasive fungal infections (e.g., histoplasmosis)
  • Infections caused by opportunistic pathogens

The warning also advises discontinuation of Amjevita if serious infection or sepsis develops during treatment.

You should be monitored for active tuberculosis while taking this drug, even if your latent tuberculosis test (before starting treatment) is negative.

Malignancy

In children and adolescents treated with TNF blockers, some cases of lymphoma and other malignancies—some of which were fatal—have been reported.

In adolescents and young adults taking TNF blockers for inflammatory bowel diseases (CD and UC), post-marketing reports have come in about a rare type of T-cell lymphoma, referred to as HSTCL (hepatosplenic T-cell lymphoma).

The risk of malignancies is also included in the black box warning for Amjevita.

The risk of serious infection and malignancy may be greater in people over 65 years of age, so doctors are urged to use caution when prescribing Amjevita. Your doctor may want to monitor you closely if you're taking this drug.

Other Warnings

Other serious health complications may arise while you're taking Amjevita that may cause your doctor to discontinue the drug.

If you suspect any of these are occurring, contact your doctor right away to see what tests and treatments you may need:

  • Infection that's become severe
  • Systemic illness that develops while living or traveling to regions where fungal infections are endemic
  • New-onset demyelinating disease, such as multiple sclerosis
  • Lupus-like syndrome

The following side effects require emergency medical attention:

  • An allergic reaction or anaphylaxis in response to Amjevita
  • Blood abnormalities, including cytopenias (low number of blood cells) and pancytopenia (low number of red blood cells, white blood cells, and platelets)
  • New-onset or worsening heart failure

In these instances, your doctor will likely take you off of Amjevita.

Drug Interactions

You shouldn't take Amjevita while also taking the TNF blockers Kineret (anakinra) or Orencia (abatacept) due to an increased risk of serious infection. Talk to your doctor about alternatives to these medications that may be safer.

Live vaccines should be avoided while taking Amjevita. Talk to your doctor about which vaccines are appropriate for you. In children, vaccines should be brought up-to-date before they start taking Amjevita.

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