Adalimumab

Dosage form: Subcutaneous injection by Autoinjector, Pre-Filled Syringe, Single-Dose Vial

Usage of Adalimumab

Adalimumab is the generic name for the medicine Humira and the biosimilars of Humira. Adalimumab is a TNF alfa inhibitor used to reduce pain, inflammation, and skin symptoms in chronic autoimmune conditions. Adalimumab is used to treat certain types of rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis (Ps), Crohn's disease, ulcerative colitis, juvenile idiopathic arthritis, ankylosing spondylitis, and uveitis. Adalimumab works by reducing a substance in the body that can cause inflammation.

Adalimumab is a biologic medication that is a fully human monoclonal antibody, which targets tumor necrosis factor alpha (TNFa).

There are 9 biosimilars of Humira, the brand names are Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, and Yusimry. The interchangeable biosimilars of Humira are Cyltezo (Boehringer Ingelheim) and Abrilada (Pfizer).

Humira was approved by the FDA on December 31, 2002. Humira was the first brand of adalimumab, so it is called the reference product. Biosimilars of Humira are now also available, see below for a full list of adalimumab biosimilars, indications, and companies.

A biosimilar is a biologic medicine that is a very close copy of the original product made by another company. An interchangeable biosimilar has undergone an additional Interchangeability Study, meaning that patients can be confident in the safety and effectiveness of the interchangeable biosimilar product, just as they would be for the FDA-approved original product, in this case, Humira.

Adalimumab side effects

Common adalimumab side effects of 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.

Serious adalimumab side effects of may include:

Get emergency medical help if you have any of these signs of an allergic reaction: 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;

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 adalimumab.

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.

Before taking Adalimumab

Before you start using adalimumab, 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.

Adalimumab should only be given to children if the brand is indicated for their condition and age group. Children using adalimumab 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 (adalimumab 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;

an allergy to latex rubber;

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 to certain areas of the world.

Adalimumab 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 adalimumab 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 adalimumab while you were pregnant, and especially before your baby receives any vaccines.

Breastfeeding

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

How to use Adalimumab

Different brands of adalimumab are available in different dosage forms and strengths, these are the approved forms and strengths for each brand.

Humira is available as:

Humira Pen 80mg/0.8 mL, 40mg/0.8 mL, 40mg/0.4 mL

Humira Prefilled Syringe 80mg/0.8 mL, 40mg/0.8 mL, 40mg/0.4 mL, 20mg/0.4 mL, 20mg/0.2 mL, 10mg/0.2 mL, 10mg/0.1 mL

Humira Single-Dose Institutional Use Vial 40mg/0.8 mL

Abrilada is available as:

Abrilada Pen 40 mg/0.8 mL

Abrilada Prefilled Syringe Injection: 40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL

Abrilada Single-Dose Institutional Use Vial Injection 40 mg/0.8 mL

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

Cyltezo is available as:

Cyltezo Pen 40 mg/0.8 mL

Cyltezo Prefilled Syringe 40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL

Hadlima is available as:

Hadlima PushTouch autoinjector 40 mg/ 0.8 mL, 40 mg/ 0.4 mL

Hadlima Prefilled Syringe 40 mg/0.8 mL, 40 mg/0.4 mL

Hadlima Single-Dose Institutional Use Vial Injection 40 mg/0.8 mL

Hulio is available as:

Hulio Pen 40 mg/0.8 mL

Hulio prefilled plastic syringe 40 mg/0.8 mL, 20 mg/0.4 mL

Hyrimoz is available as:

Hyrimoz Sensoready Pen 40 mg/0.8 mL, 40 mg/0.4 mL, 80 mg/0.8 mL

Hyrimoz Single-dose prefilled glass syringe with BD UltraSafe Passiv Needle 20 mg/0.4 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 80 mg/0.8 mL

Hyrimoz glass syringe 10 mg/0.2 mL, 10 mg/0.1 mL, 20 mg/0.2 mL

Idacio is available as:

Idacio 40 mg/0.8 mL

Idacio Prefilled Syringe 40 mg/0.8 mL

Yuflyma is available as:

Yuflyma Prefilled Auto-injector (Yuflyma AI) 40 mg/0.4 mL

Yuflyma Prefilled syringe with safety guard 40 mg/0.4 mL

Yuflyma Prefilled Syringe 40 mg/0.8 mL

Yusimry is available as:

Yusimry Pen Injection 40 mg/0.8 mL

Yusimry Prefilled Glass Syringe 40 mg/0.8 mL.

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

Warnings

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

Before or during treatment with adalimumab, 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 you start taking adalimumab 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.

What other drugs will affect Adalimumab

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

abatacept, etanercept;

anakinra;

azathioprine, 6-mercaptopurine; or

certolizumab, golimumab, infliximab, rituximab.

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

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