Abrilada

Generic name: Adalimumab-afzb
Dosage form: Abrilada pen (40 mg/0.8 mL), single-dose prefilled glass syringe (40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL), single-dose glass vial for institutional use only (40 mg/0.8 mL)
Drug class: TNF alfa inhibitors

Usage of Abrilada

Abrilada (adalimumab-afzb) is an interchangeable biosimilar of Humira, made by Pfizer. Abrilada is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. Abrilada is used to reduce pain, inflammation, and skin symptoms in these autoimmune conditions. Abrilada is a biologic medicine from the class of medicines called TNF alfa inhibitors (TNF blockers).

As Abrilada is an interchangeable biosimilar to Humira, it can be automatically substituted by a pharmacist for Humira, with individual state laws controlling how and whether physicians will be notified.

Pfizer received FDA approval for Abrilada on November 15, 2019, and on October 5, 2023, the FDA designated Abrilada as an interchangeable biosimilar to Humira.

Abrilada side effects

Common Abrilada side effects

Common side effects of Abrilada 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.

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.

Serious Abrilada side effects

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 Abrilada.

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 Abrilada

Before using Abrilada, 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.

Abrilada should only be used in age groups for the specific conditions it is FDA-approved to treat. Children using Abrilada 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 (Abrilada can cause hepatitis B to come back or get worse);

live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use Abrilada. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common;

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.

Abrilada 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 Abrilada 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 this medicine 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 Abrilada. Ask your doctor about any risks and the best way to feed your baby while on this medicine.

Relate drugs

How to use Abrilada

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

Abrilada is available as:

Abrilada pen (40 mg/0.8 mL)

Single-dose prefilled glass syringe (40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL)

Single-dose glass vial for institutional use only (40 mg/0.8 mL).

Warnings

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

Before or during treatment with Abrilada, 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 to take this medicine 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.

Do not take Abrilada if you are allergic to the active ingredient adalimumab or to any of the inactive ingredients.

What other drugs will affect Abrilada

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

abatacept, etanercept;

anakinra;

azathioprine, 6-mercaptopurine; or

certolizumab, golimumab, infliximab, rituximab.

Avoid the use of live vaccines.

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

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