Amjevita

Amjevita (adalimumab-atto) is an interchangeable biosimilar of Humira, which is a TNF alfa blocker used to reduce pain, inflammation, and skin symptoms in autoimmune conditions. Amjevita is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

Amjevita is an interchangeable biosimilar to Humira. This means it may be dispensed when the prescription has been written for Humira without consulting the prescriber, subject to state laws. Amjevita is available as an autoinjector or a prefilled syringe.

Amjevita (adalimumab-atto) is a biologic medication that is a fully human monoclonal antibody, which targets tumor necrosis factor-alpha (TNFα).

Normally, your immune system defends your body against diseases by fighting harmful bacteria or viruses. However, in autoimmune disorders, the immune system becomes hyperactive and mistakenly attacks its own tissues, leading to symptoms of the autoimmune condition. Tumor necrosis factor (TNF) is a protein that is involved in causing inflammation. Amjevita is a TNF blocker that inhibits TNF, helping to reduce pain, inflammation, and skin symptoms.

Amjevita is FDA-approved to be used for:

• rheumatoid arthritis (RA)(moderate to severe) in adults to reduce the signs and symptoms of RA and slow the progression of structural damage.
• juvenile idiopathic arthritis (JIA)(moderate to severe polyarticular) for children 2 years and older, to reduce the signs and symptoms of active polyarticular JIA.
• psoriatic arthritis (PsA)in adults to be reduce the signs and symptoms of PsA and reduce the progression of structural damage.
• ankylosing spondylitis (AS) in adults to reduce the signs and symptoms.
• hidradenitis suppurativa (HS) (moderate to severe) in adults and children 12 years of age and older.
• Crohn’s disease (moderate to severe) in adults and children 6 years of age and older.
• ulcerative colitis (UC) (moderate to severe) in adults. It is not known if Amjevita products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
• plaque psoriasis (Ps) (chronic and severe) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). Only give to patients who will be closely monitored with regular physician follow-up.
• uveitis (UV), which is non-infectious intermediate, posterior, and panuveitis, for adults and children 2 years and older.

Use Amjevita exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Amjevita is injected under the skin (subcutaneous injection) using an autoinjector or a prefilled syringe.

The dose schedule for Amjevita depends on the severity and the condition that you are treating. Follow your doctor's dosing instructions very carefully.

A healthcare provider will teach you how to properly use Amjevita by yourself. Do not use Amjevita if you do not fully understand the instructions for proper use. Ask your doctor or pharmacist if you have any questions.

Do not use this medicine if you have any signs of an infection. Call your doctor for instructions.

Prepare your injection only when you are ready to give it. Do not use it if the medicine looks cloudy, has changed color, or has particles in it. Call your pharmacist for new medicine.

Leave the Auto-injector or Prefilled Syringe at room temperature 68°F to 77°F (20°C to 25°C) for 15 to 30 minutes to allow it to warm up. Do not warm the Prefilled Syringe using heat sources such as hot water or a microwave. Do not remove the cap or cover while allowing it to reach room temperature.

Choose an injection site. You may inject into the front of your thighs, your abdomen except for the 2 in (5 cm) around the belly button (navel). Rotate the injection site each time you give an injection. Each new injection site should be at least 1.2 in (3 cm) away from the injection site you used before.

Do NOT inject in skin that is red, hard, tender, damaged, bruised, or scarred, and do NOT inject through your clothes.

Amjevita affects your immune system, so you may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Amjevita affects your immune system. You may get infections more easily, even serious or fatal infections.

Before or during treatment with Amjevita, tell your doctor if you have signs of infection such as fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.

Your doctor should test you for tuberculosis (TB) before starting taking Amjevita and also monitor you closely for signs and symptoms of TB during treatment.

The chances of getting cancer may be increased for children and adults taking TNF-blockers.

Before you start using Amjevita, tell your doctor if you have signs of infection--fever, chills, sweats, muscle aches, tiredness, cough, bloody mucus, skin sores, diarrhea, burning when you urinate, or feeling constantly tired.

Amjevita should only be used in age groups for the specific conditions that Amjevita is FDA-approved to treat. Children using Amjevita should be current on all childhood immunizations before starting treatment.

Tell your doctor if you have ever had:

• tuberculosis (or if anyone in your household has tuberculosis);
• a chronic infection;
• cancer;
• hepatitis B (Amjevita can cause hepatitis B to come back or get worse);
• diabetes;
• heart failure;
• any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome;
• if you are scheduled to have major surgery; or
• if you have recently received or are scheduled to receive any vaccine.

Tell your doctor where you live and if you have recently traveled or plan to travel. You may be exposed to infections that are common in certain areas of the world.

Amjevita may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

Pregnancy

It is not known whether Amjevita will harm an unborn baby. Tell your doctor if you are pregnant or planning a pregnancy. Make sure any doctor caring for your newborn baby knows if you used Amjevita while you were pregnant, especially before your baby receives any vaccines.

Breastfeeding

It may not be safe to breastfeed a baby while you are using Amjevita. Ask your doctor about any risks and the best way to feed your baby while on Amjevita.

Get emergency medical help if you have any of these signs of an allergic reaction to Amjevita: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have any symptoms of lymphoma:

• fever, swollen glands, night sweats, general feeling of illness;
• joint and muscle pain, skin rash, easy bruising or bleeding;
• pale skin, feeling light-headed or short of breath, cold hands and feet;
• pain in your upper stomach that may spread to your shoulder; or
• loss of appetite, feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• new or worsening psoriasis (raised, silvery flaking of the skin);
• a sore or bump on your skin that does not heal;
• symptoms of sepsis - confusion, chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• liver problems - body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like syndrome - joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;
• signs of blood dyscrasias - persistent fever, bruising, bleeding, pallor.
• autoimmune hepatitis - tiredness, nausea, yellowing of the skin or eyes, dark urine;
• nerve problems - numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or
• signs of tuberculosis - fever with ongoing cough, weight loss (fat or muscle).

Older adults may be more likely to develop infections or cancer while using Amjevita.

Common side effects of Amjevita may include:

• headache;
• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat;
• rash; or
• redness, bruising, itching, or swelling where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

The dose and frequency of Amjevita are dependent on age, severity, and condition treated. For more information on specific dosing schedules, click the link below.

Amjevita is available as:

• Amjevita SureClick Autoinjector 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL
• Amjevita Prefilled Syringe 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.4 mL, 20 mg/0.2 mL, 10 mg/0.2 mL.

For more information on dosing, click the link below.

Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use extra medicine to make up for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not inject into skin that is bruised, red, tender, or hard.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using Amjevita. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).

Some drugs should not be used together with Amjevita. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Amjevita especially:

• abatacept, etanercept;
• anakinra;
• azathioprine, 6-mercaptopurine; or
• certolizumab, golimumab, infliximab, rituximab.

Avoid the use of live vaccines.

Medications with a narrow therapeutic index, such as warfarin, cyclosporine, and theophylline, may need monitoring on starting or stopping.

This list is not complete. Other drugs may interact with Amjevita including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed.

• Store this medicine in its original carton in a refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze.
• If you are traveling, carefully follow all patient instructions for storing your medicine during travel.
• Throw away if it has become frozen.
• Do not store in extreme heat or cold.
• When traveling, Amjevita may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light. Amjevita should be discarded if not used within the 14-day period. Record the date when the medicine is first removed from the refrigerator in the spaces provided on the carton and dose pack.

ManufacturerManufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799 U.S.A

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Amjevita.

Humira (adalimumab) - AbbVie Inc.

View Humira information in detail.

Humira interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Abrilada (adalimumab-afzb) - Pfizer Inc.

View Abrilada information in detail.

Amjevita (adalimumab-atto) - Amgen Inc.

Cyltezo (adalimumab-adbm) - Boehringer Ingelheim Pharmaceuticals, Inc.

View Cyltezo information in detail.

Hadlima (adalimumab-bwwd) - Samsung Bioepis Co., Ltd.

View Hadlima information in detail.

Hulio (adalimumab-fkjp) - Biocon Biologics Inc.

View Hulio information in detail.

Hyrimoz (adalimumab-adaz) - Sandoz Inc.

View Hyrimoz information in detail.

Simlandi (adalimumab-ryvk) - Alvotech USA Inc.

View Simlandi information in detail.

Yuflyma (adalimumab-aaty) - CELLTRION, Inc.

View Yuflyma information in detail.

Yusimry (adalimumab-aqvh) - Emerge Bioscience Pte. Ltd.

View Yusimry information in detail.

Humira biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Idacio (adalimumab-aacf) - Fresenius Kabi USA, LLC

View Idacio information in detail.

Active ingredient: adalimumab-atto.

Inactive ingredients: glacial acetic acid, polysorbate 80, sucrose, and Water for Injection. Sodium hydroxide is added as necessary to adjust the pH to 5.2. Note that some strengths contain L-lactic acid instead of glacial acetic acid.

The Amjevita prefilled syringe and prefilled SureClick autoinjector are not made with natural rubber latex.