Amjevita (Adalimumab)
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Product Details
Description
Amjevita (adalimumab-atto) is an injectable medication prescribed to treat:
- Rheumatoid arthritis
- Juvenile idiopathic arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn’s disease
- Ulcerative colitis
- Plaque psoriasis
- Hidradenitis suppurativa
- uveitis
Amjevita is available in single-dose prefilled syringes and autoinjectors that deliver the following concentrations:
- Single-dose prefilled syringes:
- 10 mg/0.2 mL
- 20 mg/0.2 mL
- 20 mg/0.4 mL
- 40 mg/0.4 mL
- 40 mg/0.8 mL
- 80 mg/0.8 mL
- Single-dose prefilled SureClick® autoinjectors:
- 40 mg/0.4 mL
- 40 mg/0.8 mL
- 80 mg/0.8 mL
Directions
Your healthcare provider will determine an appropriate Amjevita dosage for you based on your age, weight, and condition being treated. Your healthcare provider will also teach you or your caregiver how to properly prepare, administer, and dispose of Amjevita. For detailed information, refer to the medication guide that comes with Amjevita.
Amjevita should be injected in the thigh or abdomen. Injection sites should be rotated. Do not share needles or syringes with other people.
If you have any questions or concerns, talk to your healthcare provider or pharmacist.
Storing Amjevita:
Amjevita should be stored in its original container in the refrigerator between 36°F and 46°F (2°C to 8°C). It should not be frozen or used even if it has been thawed.
If necessary, you may store Amjevita at room temperature (maximum of 77°F, or 25°C) and away from light exposure for up to 14 days.
Ingredients
The active ingredient in Amjevita is adalimumab-atto. Inactive ingredients include glacial acetic acid, polysorbate 80, sucrose, and Water for Injection. Sodium hydroxide may be included to adjust pH.
Contraindications
According to the most recent Prescribing Information, there are no contraindications, or reasons why a person should not receive Amjevita. However, patients should talk to their healthcare provider about their treatment options.
Cautions
- Amjevita contains the following FDA Boxed Warnings:
- Increased risk of serious infections, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and other opportunistic infections, that can result in hospitalization or death.
- Amjevita should be stopped if a patient develops an infection or sepsis.
- Patients should be evaluated for latent TB. Treatment should be initiated if positive.
- Patients should be monitored for TB while being treated with Amjevita.
- Potentially fatal lymphoma and other cancers have occurred in children and adolescents who received TNF-blockers such as adalimumab.
- Adolescents and young adults with inflammatory bowel disease who received TNF-blockers such as adalimumab have developed a rare type of T-cell lymphoma called hepatosplenic T-cell lymphoma.
- Before you begin Amjevita treatment, talk to your healthcare provider about:
- All the medications you take, including prescription and over-the-counter medications
- Your allergies
- Your current health problems and past medical history
- Your pregnancy or breastfeeding status
- Amjevita may cause the following:
- Serious infections, including invasive fungal infections; therefore, you should not start treatment with Amjevita if you have a current infection. If you develop an infection during Amjevita treatment, it may need to be stopped.
- Increased risk of cancers
- Serious allergic reactions, including anaphylaxis
- Reactivation of hepatitis B. Carriers of the virus should be monitored during and months after Amjevita therapy. Amjevita should be discontinued and hepatitis B treatment should be started if hepatitis B is reactivated.
- Worsening or new development of demyelinating disease
- Low levels of red blood cells, white blood cells, and platelets
- Worsening or new development of heart failure
- Lupus-like syndrome
Side Effects
Infections, injection site reactions, headache, and rash are common Amjevita side effects. However, other side effects may also occur. Tell your healthcare provider right away if you have side effects that bother you or won’t go away.
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Reference
Amjevita. Thousand Oaks, CA: Amgen, Inc.; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14452
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