Class: Biosimilar

Generic Name: adalimumab-atto

Trade Name: Amjevita™

For which conditions is this drug indicated? Amjevita is indicated for use in several types of arthritis: rheumatoid (RA), juvenile idiopathic (JIA), psoriatic (PsA), and ankylosing spondylitis (AS). It is also used for adult Crohn’s disease (CD) and ulcerative colitis (UC) where conventional therapies have been inadequate; and for the treatment of adult patients with moderate to severe chronic plaque psoriasis (Ps).

What is the mechanism of action? Amjevita is a biosimilar to Humira®. A biosimilar is a drug that is very similar to an FDA approved biologic drug. The similarities include how the drug is composed, how it works, and its safety. So, like Humira, Amjevita works by blocking the inflammatory effects of a protein called tumor necrosis factor (TNF) that the body produces when there is inflammation.

How is Amjevita given (administered)? Amjevita is administered by subcutaneous injection. Regimens and dosages depend on which disease is being treated, and whether or not other drugs like methotrexate (for RA) are also being taken. Patients with UC may continue regimen only if there is evidence of clinical remission.

How are patients typically monitored?

• Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Amjevita.
• Physicians will pay close attention to any signs or symptoms of infection during and after treatment, including administering a test for tuberculosis for patients who tested negatively prior to treatment.
• If a patient does develop a serious infection or sepsis, they will be monitored closely along with receiving a complete diagnostic workup appropriate for an immunocompromised patient.
• Patients who are carriers of hepatitis B virus (HBV) will be monitored during and several months after therapy. If reactivation occurs, stop Amjevita and begin anti-viral therapy.

What are the most common side effects of treatment with Amjevita?

• Infections (e.g. upper respiratory, sinusitis)
• Injection site reactions
• Headache
• Rash

What are some of the potentially serious side effects of Amjevita?

Opportunistic infections due to:

• Bacterial
• Mycobacterial
• Invasive fungal
• Viral
• Parasitic

Or other opportunistic pathogens including:

• Aspergillosis
• Blastomycosis
• Candidiasis
• Coccidioidomycosis
• Histoplasmosis
• Legionellosis
• Listeriosis
• Pneumocystosis
• Tuberculosis

Malignancies such as:

• Lymphoma
• Leukemia
• Non-melanoma skin cancer
• Breast
• Colon
• Prostate
• Lung
• Melanoma

And other reactions such as:

• Anaphylaxis and other severe allergic reactions
• Central nervous system demyelinating disease (including multiple sclerosis (MS) and optic neuritis), and peripheral demyelinating disease (including Guillain-Barré syndrome)
• Heart failure
• Autoimmune lupus-like syndrome

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

Are there any special precautions or warnings patients should be aware of before starting treatment?

• If you are taking the drug abatacept or anakinra, there is an increased risk of serious infections.
• Avoid receiving live vaccines when taking Amjevita.
• Worsening or new onset of heart failure or demyelinating disease (a nerve disease) may occur.
• Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products.
• Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.
• Do not start Amjevita therapy during an active infection. There is an increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue Amjevita if a patient develops a serious infection or sepsis during treatment.
• For patients who develop a systemic illness on Amjevita, consider anti-fungal therapy if traveling to regions where fungal infections are endemic.
• Stop taking Amjevita if a lupus-like syndrome occurs.
• Anaphaylaxis or severe allergic reactions may occur.
• Blood deficiencies may occur.
• Worsening or new onset of heart failure or demyelinating disease (a nerve disease) may occur.

When should patients notify their physician?

Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, or pallor).

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 10/16.

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