| Common Brands | Amjevita |
|---|---|
|
Drug Class |
Biologic DMARD |
|
Controlled Substance Classification |
Not a controlled medication |
|
Generic Status |
No Lower-cost generic available |
|
Availability |
Prescription only |
Amjevita is a biosimilar to Humira, both of which are monoclonal antibodies targeting TNF-alpha, the protein that plays a crucial role in inflammation. While Humira has been one of the best-selling drugs globally because of its efficacy in treating autoimmune diseases, it is also one of the most expensive biologics. Amjevita was developed as a biosimilar to offer patients a more affordable alternative with the same clinical benefits as the reference product.
The launch of Amjevita has been a great milestone in increasing the availability of biologic treatments for autoimmune diseases, particularly now that the patent for Humira has ended, which paved the way for biosimilars.
Amjevita is a biosimilar to adalimumab, which means it is a highly similar product to its reference product Humira without any clinically meaningful differences about safety, efficacy, or immunogenicity. Both of them are monoclonal antibodies designed to block the activity of TNF-alpha, a cytokine which is involved in the inflammation process of many autoimmune diseases.
Biosimilars are not generic drugs, but rather biologics that are highly similar to an approved reference product. Although biosimilars must demonstrate a similar safety and efficacy profile through rigorous clinical testing, they usually come at a lower cost than the reference biologic, making them a much more cost-effective treatment option for patients.
Amjevita is given via subcutaneous injection and should be used in the same manner and for the same conditions as Humira.
Amjevita works by inhibiting the action of TNF-alpha, a major cytokine that causes inflammation and dysfunction in the immune system of many autoimmune diseases. It is produced as an answer to infection, injury, and inflammation, but autoimmunity overproduces it, leading to the chronic inflammation and tissue injury of the autoimmune diseases in question.
Amjevita blocks the interaction of its bound TNF-alpha to TNF receptors on the cells, reducing the consequent inflammatory response.
The overall impact is modulation of the immune system, with reduction of symptoms of autoimmune diseases, and sometimes with long-term remission.
Amjevita is administered subcutaneously in a healthcare facility during initiation, but when adequately trained, patients are taught how to self-administer at home. This drug is available in a prefilled syringe and a pen for easy handling. Injection is usually made every other week, although it depends on the treated condition and the patient’s response to therapy.
Instructions for Injections:
Selection of injection site: Amjevita can be administered via injections in the thigh or the abdomen, and rotation between two sites should be followed each time.
Preparation for injection: The prefilled syringe or pen from the refrigerator should be let to reach room temperature and taken out for 15-30 minutes before applying for use.
Injection administration: The injection is administered to the cleaned skin using alcohol swab following the application instructions on the device.
Cost-effective alternative: An Amjevita biosimilar to Humira, thereby providing a more affordable form of treatment for patients. This can save them copays and out-of-pocket expenses and make treatment considerably more accessible.
Same clinical efficacy: Amjevita has the same safety and efficacy profile of Humira, which is a medicine used for more than ten years with proven efficacy.
Multiple indications: As in the case of Humira, Amjevita has approval for a vast range of autoimmune diseases. This offers patients multiple options for treatment.
Self-administration: Injection of Amjevita at home allows for more convenience for the patient and can lead to better adherence to the treatment plan.
No change over: Most patients switching from Humira to Amjevita expect to experience a seamless shift, with no loss of efficacy.
As with any biological drugs, Amjevita causes side effects. Those side effects most frequently attributed to the drug include;
Injection site reactions- characterized by redness and inflammation, pain, itching at the injection site among other symptoms.
Upper respiratory infections: Colds or flu-like symptoms that present with congestion, sore throat, and running nose.
Headache: Patients can present with headaches especially in the initial stages of treatment.
Nausea and fatigue: These occur, but they are generally mild and short-lived.
Rash: Some patients can experience skin rashes.
Infections: With TNF inhibitors, patients have a higher risk of infections including TB, bacterial infections, and opportunistic infections.
There are certain warnings and precautions that need to be taken into consideration when using Amjevita:
Infections: Patients are to be observed keenly in case of infection, particularly TB, fungal infections and sepsis. Pre-treatment usually screens a patient for latent TB among other infections.
Risk of cancer: TNF inhibitor Amjevita has an increased risk of certain cancer, with slightly increased relative risk, notably lymphoma and skin cancers.
Heart failure: Amjevita should be used with caution in patients with heart failure, as it may exacerbate the condition.
Liver problems: Liver function should be monitored during treatment, particularly in patients with a history of liver disease.
Neurological conditions: Caution is advised in patients with a history of demyelinating diseases like multiple sclerosis, as TNF inhibitors can potentially worsen these conditions.
The typical dosing schedule for Amjevita varies depending on the specific condition being treated. Below are general guidelines:
Rheumatoid Arthritis: 160 mg (2 injections of 80 mg each) at Week 0, then 80 mg at Week 2, and then every other week 40 mg.
Psoriasis: Initiation with 80 mg at Week 0 followed by 40 mg every other week.
Crohn’s Disease: 160 mg at Week 0 followed by 80 mg at Week 2, then every other week 40 mg.
The dosage used may differ in different conditions, and the right dosing schedule will be determined by your healthcare provider depending on your condition and response to treatment.
Amjevita is an Rx-only drug. Its administration should be accompanied by follow-up from a healthcare professional, especially when initiating the treatment. Prior to beginning therapy, the patient needs to be screened for tuberculosis and other infections. Ongoing monitoring also needs to be conducted when on the treatment course because of infections or liver disease.
What is Amjevita?
Amjevita is a biosimilar medication to Humira (adalimumab), used to treat various inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease.
How does Amjevita work?
Amjevita works by inhibiting tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation in certain autoimmune diseases.
What conditions can Amjevita treat?
Amjevita is approved for conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
How is Amjevita administered?
Amjevita is administered as a subcutaneous injection. Patients can either receive it in a healthcare setting or administer it themselves after proper training.
What is the dosing schedule for Amjevita?
The dosing schedule can vary based on the condition being treated, but it often involves an initial loading dose followed by maintenance doses every two weeks or once a month.
What are the common side effects of Amjevita?
Common side effects may include injection site reactions, headache, nausea, and increased risk of infections. More serious side effects can occur but are less common.
Is Amjevita safe for everyone?
Amjevita may not be suitable for individuals with certain infections, tuberculosis, or a history of allergic reactions to adalimumab or its components. Always consult a healthcare provider.
Can Amjevita be used during pregnancy or breastfeeding?
Pregnancy and breastfeeding decisions should be made with a healthcare professional. Amjevita may cross the placenta and can be passed into breast milk.
How does Amjevita compare to Humira?
Amjevita is a biosimilar to Humira, meaning it is highly similar and has been shown to work the same way and produce the same effects, but it is typically prescribed at a lower cost.
What should I do if I miss a dose of Amjevita?
If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose and continue with your regular schedule.
Are there any special storage requirements for Amjevita?
Amjevita should be stored in the refrigerator and protected from light. It can be kept at room temperature for up to 14 days before use.
Can I switch from Humira to Amjevita?
Some patients may switch from Humira to Amjevita; however, this decision should always be made in consultation with a healthcare provider.
What should I discuss with my doctor before starting Amjevita?
Discuss any existing medical conditions, medications you’re currently taking, and any history of allergies or infections with your doctor.
What are biosimilars, and how are they regulated?
Biosimilars are biologic products that are highly similar to an already approved reference product. They are rigorously evaluated for safety, efficacy, and quality by regulatory authorities like the FDA.
Can Amjevita be used for children?
Amjevita is approved for use in certain pediatric populations with specific conditions. Consult a pediatric rheumatologist or specialist for guidance.
What should I do if I experience severe side effects?
If you experience severe side effects (e.g., signs of infection, allergic reaction), seek medical attention immediately and inform your healthcare provider.
Will Amjevita interact with other medications?
Amjevita can interact with other medications, particularly immunosuppressants. Always inform your doctor about all your medications and supplements.
Is there a patient assistance program for Amjevita?
Abbott, the manufacturer of Amjevita, offers patient assistance programs for those who qualify, to help cover the cost of medications.
Can I use Amjevita with other biological therapies?
Using Amjevita with other biologics is generally not recommended. Always follow your doctor’s advice regarding combined therapies.
Where can I find more information about Amjevita?
For detailed information, visit the official website or consult your healthcare provider for personalized advice and educational resources.
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