Amgevita (Adalimumab)

Warnings and Precautions

Your immune system is affected by Amjevita. It may be easier for you to get serious or fatal infections.

When you experience any symptoms of infection, such as fever, chills, aches, tiredness, cough, sores, diarrhea, or burning when you urinate, tell your doctor.

During treatment, your doctor should closely monitor you for signs or symptoms of tuberculosis (TB). Your doctor should test you for TB before you start taking Amjevita.

Children and adults taking TNF-blockers may have increased cancer chances.

If you have a fever, chills, sweats, muscle aches, fatigue, cough, bloody mucus, skin sores, diarrhea, or a burning sensation when you urinate, tell your doctor before you begin using Amjevita.

FDA-approved conditions for which Amjevita is indicated should be treated with Amjevita only. Before beginning treatment with Amjevita, children should be current on all childhood immunizations.

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

A rare form of lymphoma (cancer) of the liver, spleen, and bone marrow can be fatal when caused by amjevita. Most cases have occurred in teenagers and young men with Crohn’s disease or ulcerative colitis. Lymphoma is more likely to occur in people with inflammatory autoimmune disorders. Consult your doctor about your own risk

You should tell your doctor if you have ever suffered from:

• The presence of tuberculosis in your household (or if anyone in your family has tuberculosis);
• A chronic infection;
• A cancerous condition;
• Hepatitis B (Amjevita can make hepatitis B worse);
• Diabetes (one or two)
• Failure of the heart;
• Multiple sclerosis or Guillain-Barre syndrome, or any numbness or tingling in the hands or feet;
• A major surgery is scheduled for you, or
• If you have recently received or are expected to receive a vaccine.

How is Amgevita Used?

The treatment of the conditions for which Amgevita is authorized should be initiated and supervised by a specialist doctor familiar with the diagnosis and treatment of those conditions. It is also a good idea for doctors treating uveitis to seek advice from doctors with experience using Amgevita.

In children, the dose is usually determined by the child’s weight and height, depending on the condition to be treated. In most cases, Amgevita is given every two weeks after the first dose, but sometimes, it may be given every week. If their doctor deems it appropriate, patients or their caregivers can inject Amgevita. During treatment with Amgevita, patients may also receive methotrexate or corticosteroids (other anti-inflammatory medications).

Amgevita Forms & Dosages

Pre-filled syringes or auto-injectors are available for purchase through Insulin Outlet with a valid prescription.

Syringes (Pre-filled)

Amgevita is available in prefilled syringes in two different strengths.

20 mg/0.4 mL

20 mg of adalimumab is contained in each 0.4 mL sterile, preservative-free solution. For injection, nonmedicinal ingredients include glacial acetic acid, polysorbate 80, sodium hydroxide for pH adjustment, and sucrose, 9.0% (w/v).

40 mg/0.8 mL

Adalimumab is contained in each 0.8 mL sterile, preservative-free solution. Sodium hydroxide for pH adjustment, ten mM glacial acetic acid, 0.10% polysorbate 80, and 9.0% sucrose in water.

Latex is present in the needle cap.

Autoinjector

Amgevita is also available in a single-use autoinjector.

40 mg/0.8 mL

Adalimumab is contained in each 0.8 mL of sterile, preservative-free solution. Injection water contains ten mM glacial acetic acid, 0.10% (w/v) polysorbate 80, sodium hydroxide for pH adjustment, and 9.0% (w/v) sucrose.

Side Effects

Please note: this webpage does not contain all possible side effects, and others may occur. Check with your physician for additional information about side effects. If you feel you need to speak to a licensed pharmacist, please contact us. 

There are serious side effects associated with Amjevita, including:

• Hives,
• Breathing difficulties,
• Enlargement of your face, lips, tongue, or throat,
• The flu,
• A swollen gland,
• Sweating at night,
• Illness, in general,
• Pain in the joints and muscles,
• A rash on the skin,
• Bruising is easy,
• Bleeding that is unusual,
• Pale skin,
• Feeling lightheaded,
• Breathing difficulties,
• Hands and feet that are cold,
• An upper stomach pain that may spread to your shoulder,
• Appetite loss,
• A small amount of food makes you feel full,
• Loss of weight,
• A new or worsening case of psoriasis (raised, silvery flaking of the skin),
• An unhealed sore or bump on your skin,
• Pain in the body,
• Fatigue,
• Pain in the stomach,
• Upper stomach pain on the right side,
• Vomiting,
• Urine that is dark,
• The stools are clay-colored,
• Skin or eye yellowing (jaundice),
• Swelling or pain in the joints,
• Pain in the chest,
• Sunlight worsens patchy skin color,
• Feeling numb,
• A tingling sensation,
• Feeling dizzy,
• Problems with vision,
• Your arms or legs are weak, and
• Coughing with fever

Severe Side Effects

Seek medical care or call 911 at once if you have the following serious side effects:

• If your vision is blurry, your vision is tunnel vision, or you can see halos around lights, these are severe eye symptoms you should report to your doctor;
• An irregular heartbeat, fluttering in the chest, shortness of breath, or passing out suddenly are all severe heart symptoms.
• There may be severe headaches, confusion, slurred speech, arm or leg weakness, coordination loss, unsteadiness, very stiff muscles, high fever, profuse sweating, or tremors.

Drug Interactions

You may experience serious side effects if you have drug interactions with your medications. Drug interactions are not covered in this document. Inform your doctor and pharmacist about all the products you use (including prescriptions, nonprescriptions, and herbal products). Without your doctor’s approval, don’t start, stop, or change the dosage of any medicines.

The following products may interact with this drug: other TNF blockers (such as etanercept, infliximab), other immune-suppressants (such as abatacept, anakinra).

Amgevita Clinical Studies

The chemical structure, purity, and biological activity of adalimumab in Amgevita and Humira have been extensively compared in laboratory studies.

Biosimilar medicines such as Amgevita do not require the same studies as Humira for their effectiveness and safety.

In a study involving 526 patients with moderate to severe rheumatoid arthritis and 350 patients with moderate to severe psoriasis, the drug was found to have similar effects to Humira.

After 24 weeks of treatment, 75% of those given Amgevita responded, compared with 72% of those given Humira, in the rheumatoid arthritis study. According to the study on psoriasis symptoms, Amgevita improved symptoms by 81% compared to Humira by 83% after 16 weeks.

Pregnancy

Amjevita cannot harm unborn babies. If you are pregnant or plan to become pregnant, tell your doctor. Before your baby receives vaccinations, tell your doctor if you used Amjevita during pregnancy.

If you are using Amjevita, you should not breastfeed a baby. While taking Amjevita, ask your doctor about any risks and the best way to feed your baby.

Missed Dose

Take Amjevita as soon as you remember if you miss a dose at home. Once you have taken your next dose, take it at the usual time. Ask your doctor when to take Amjevita if you missed a dose. If you forget your Amjevita appointment, contact your doctor’s office as soon as possible to reschedule.

How to Store Amgevita

Amjevita should be stored in its original carton at 36°F to 46°F (2°C to 8°C) in the refrigerator.

Do not freeze. If Amjevita becomes frozen, throw it away immediately.

Keep your medicine in a cool, dry place while traveling if you are traveling.

Temperatures above or below freezing should not be stored.