What Is Amjevita?
How is Amjevita used to treat RA?1
Amjevita (adalimumab-atto) is a monoclonal antibody that acts as a tumor necrosis factor inhibitor (TNF-inhibitor). Amjevita is also classified as a biologic disease modifying antirheumatic drug (DMARD), and is indicated for use in adults with moderate to severe RA. Amjevita can be used in addition to methotrexate or other non-biologic DMARDs. It is also indicated for other inflammation-related conditions such as Juvenile Idiopathic Arthritis (JIA), Adult Crohn’s Disease, Ulcerative Colitis, Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis. For RA, Amjevita works to reduce signs and symptoms of RA, as well as improve physical function and inhibit the progression of structural damage.
Amjevita is a biosimilar for Humira (adalimumab), and was approved by the FDA in September 2016. A medication is considered a biosimilar when it has no clinically meaningful differences in effectiveness and safety to its reference product, in this case, Humira. However, Amjevita is not a generic for Humira. There is an increased risk of developing serious infections while on Amjevita, and individuals receiving the medication should report all possible signs of infection to their provider.
What are the ingredients in Amjevita?
Amjevita comes as a single-dose prefilled syringe or as a single-dose prefilled Sensoready Pen. The active ingredient in Amjevita is adalimumab-atto, the tumor necrosis factor inhibitor.
How does Amjevita work?
Amjevita’s active ingredient is a tumor necrosis factor inhibitor, working specifically to neutralize the tumor necrosis factor protein in the body. Conditions like RA are produced by an abnormal immune response, where the body mistakenly attacks healthy tissue, causing joint pain, stiffness, and swelling. In these instances, the body often produces a significant amount of TNF, which can help drive the inappropriate immune response. A TNF-inhibitor works to neutralize this protein product, to drive down the abnormal immune response happening in the body, thus, reducing inflammatory-related symptoms such as joint pain, swelling, and stiffness.
What are the possible side effects of Amjevita?
Multiple clinical trials evaluated the safety and efficacy of Amjevita across many different conditions. The most common side effects of Amjevita are upper respiratory infections, rash, and headache. Infusion reactions are also possible while receiving Amjevita. Although infusions can be preceded by medications that decrease the risk of infusion reaction, there is still a possibility of reaction after administration. Alert your doctor immediately if you have any signs of reaction, including:
This is not an exhaustive list of all potential side effects of Amjevita. Talk to your healthcare provider or pharmacist for further information.
Things to note about Amjevita
Several rare but more serious side effects can accompany Amjevita including worsening of previous heart failure, and the development of liver failure, blood problems, or nervous system disorders. Alert your doctor if you experience any of the following.
- Shortness of breath, swelling of ankles or feet, sudden weight gain
- Jaundice, poor appetite, pain on the right side of your stomach, and extreme fatigue
- Fever that does not go away, very pale skins, or bruising or bleeding very easily
- Changes in your vision, numbness or tingling in body, weakness of limbs, or seizures
Amjevita weakens the immune system during treatment, and therefore, could lead to an increased risk of infection, including respiratory, skin, fungal, viral, and bacterial infection which can spread throughout the body. Alert your doctor if you have the following signs of infection, including open sores or cuts, blood in your phlegm, weight changes, muscle aches, warm or red areas on your body, chronic infections, burning when urinating, diarrhea or stomach pain, cold sores, flu-like symptoms, cough, or fever.
There is also a risk of developing cancers or malignancies while on Amjevita, especially for children and young adults who are taking Amjevita for conditions other than RA. Follow your provider’s recommendations for regular malignancy and cancer screenings. There is an increased risk in developing malignancies for those taking Amjevita who have very active RA or who have been treated with Amjevita for an extended period of time. It is not known how Amjevita affects pregnant or breastfeeding woman. It is important to tell your provider about all other medications, vitamins, and herbal supplements you take before starting Amjevita.
Before staring Amjevita talk to your provider if you:
- Think you have an infection or are being treated for an infection
- Have signs of an infection such as flu-like symptoms, cough, or fever
- Frequently get infections or have infections that keep coming back
- Have any immune system problems, diabetes, heart failure, HIV, liver failure, or a history of cancer
- Have TB or have been in close contact with someone who has TB or Chicken Pox
- Are allergic to rubber or latex, as the internal needle cover of the Sensoready Pen and the needle cap of the syringe contain latex
- Live in an area where there is an increased risk in fungal infections
- Have or have had Hepatitis B
- Are allergic to adalimumab-atto or any of the other ingredients in Amjevita
- Have recently received or are scheduled to receive a vaccine
- Are scheduled to have surgery
- Are pregnant or are planning to become pregnant. It is not known if Amjevita will affect an unborn baby.
- Are breastfeeding or planning to breastfeed. It is not known if Amjevita can pass through breast milk.
Amjevita is administered subcutaneously. Your doctor will determine the appropriate dosage for you. You or a caregiver will receive training on how to administer the medication, and should not administer the medication without this training. Detailed instructions are included in the prescribing information on how to store, prepare, and administer your medication. You can also call Amgen at 1-800-77-AMGEN (1-800-772-6436) for additional information and help. If you miss a dose of Amjevita, take the next dose as soon as you remember, then take your next dose at the regularly scheduled time. Do not take more doses of Amjevita than prescribed.
- 1. Amjevita Prescribing Information. FDA.gov. Aug 2016. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761024lbl.pdf