Abrilada

Pronunciation: AH brill-ah-dah
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

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 23, 2023.

What is 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.

How does Abrilada work?

Abrilada works by blocking tumor necrosis factor (TNF), a protein involved in causing inflammation; this helps to reduce pain, inflammation, and skin symptoms of these conditions.

Abrilada is used to treat chronic autoimmune conditions. 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 is involved in causing inflammation in autoimmune disorders, so by Abrilada blocking TNF reduces the symptoms of these conditions.

What is Abrilada used for?

Abrilada is an FDA-approved medicine to be used for: 

• rheumatoid arthritis (moderate to severe) in adults to reduce the signs and symptoms of RA, slow the progression of structural damage, and improve physical function.
• juvenile idiopathic arthritis (moderate to severe polyarticular) for children 2 years and older, to reduce the signs and symptoms of moderately to severely active polyarticular JIA.
• psoriatic arthritis in adults to be used to reduce the signs and symptoms of psoriatic arthritis, slow the progression of structural damage, and improve physical function.
• ankylosing spondylitis in adults to reduce signs and symptoms with active AS.
• hidradenitis suppurativa (moderate to severe) in adults
• Crohn’s disease (moderate to severe) in adults and children 6 years of age and older. 
• ulcerative colitis (chronic moderate to severe) in adults. It is not known if Abrilada products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines. 
• plaque psoriasis (moderate 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). 
• uveitis (UV) that is non-infectious intermediate, posterior, and panuveitis, for adult patients.

What are biosimilars and interchangeable biosimilars?

Biosimilars are biologic medicines that are 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. Abrilada is an interchangeable biosimilar which means it can be automatically substituted by a pharmacist for Humira, with individual state laws controlling how and whether physicians will be notified.

A reference product is the first brand of the biologic product approved by the FDA; Humira is the reference product for adalimumab.

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

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. 

Before taking this medicine

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.

How should I use Abrilada?

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

Abrilada is injected under the skin (subcutaneous injection) using a prefilled pen or a prefilled syringe.

The dose schedule for Abrilada will depend 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 this medicine by yourself. Do not use Abrilada 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 Abrilada f 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 Abrilada if it looks cloudy, has changed color, or has particles in it. Call your pharmacist for new medicine.

Leave the prefilled pen or prefilled syringe at room temperature 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 shake your pen. Shaking can damage your medicine.

Choose an injection site. You may inject into the front of your thighs, and 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 inch (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.

Abrilada 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.

Dosing information

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). 

What happens if I miss a dose?

If you forget to take your dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject Abrilada call your doctor or pharmacist. 

What happens if I overdose?

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

What should I avoid while using Abrilada?

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 Abrilada. 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).

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.

Ingredients

Active ingredient: adalimumab-adbm

Inactive ingredients:  glacial acetic acid, polysorbate 80, sodium acetate trihydrate, trehalose dihydrate, and Water for Injection.

The needle cover is not made with natural rubber latex.

Storage

• Store this medicine in its original carton in a refrigerator at 36°F to 46°F (2°C to 8°C). 
• Do not freeze. Do not use if it has become frozen, even after it has thawed.
• If you are traveling, carefully follow all patient instructions for storing your medicine during travel. 
• Do NOT shake.
• Avoid extreme heat or cold.
• If needed, for example when you are traveling, you may also store syringes at room temperature up to 86°F (30°C) for up to 30 days. Store Abrilada in the original carton until use to protect it from light.  Discard Abrilada if it has been kept at room temperature and not been used within 30 days.  Record the date you first remove syringes from the refrigerator in the spaces provided on the syringe carton. 
• Do not use a prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.  Do not drop or crush Abrilada. The prefilled syringe is glass.

Manufacturer

Manufactured by: Pfizer Inc. New York, NY 10001.

Distributed by: Pfizer Labs Division of Pfizer Inc. New York, NY 10001.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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