Abrilada (Adalimumab-afzb) - Subcutaneous

What Is Abrilada?

Abrilada is an injection given under the skin that is used to treat several types of autoimmune diseases in children and adults. The drug is called a tumor necrosis factor inhibitor, or a TNF inhibitor. TNF is a protein that assists with metabolism and blood clotting, but too much of it can cause inflammation and joint damage, like in rheumatoid arthritis and other autoimmune conditions. Abrilada blocks the activity of this protein, decreasing inflammation.

The generic name for Abrilada is adalimumab-afzb. Abrilada is a biosimilar product for the biologic drug, Humira. Humira is made from living cells and is very expensive to manufacture, making it difficult for people to purchase. Abrilada is highly similar to Humira but not as expensive, as it's less expensive to manufacture. It has the same mechanism of action, clinical effects, and safety as Humira.

Abrilada is not yet available for sale in the United States, but it is considered a specialty drug. Therefore, you will need to get it from a specialty pharmacy once it becomes available.

The drug is administered via subcutaneous (under the skin) injections.

What Is Abrilada Used For?

Abrilada is approved by the FDA to treat a variety of autoimmune diseases. Specifically, Abrilada treats:

• Moderate to severe rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis (pJIA) in children ages 4 and older
• Psoriatic arthritis: Arthritis that is accompanied by psoriasis symptoms
• Ankylosing spondylitis: Arthritis that affects the spine
• Crohn’s disease: Inflammation in the gastrointestinal tract that causes abdominal pain, bloody stool, cramps, and diarrhea
• Ulcerative colitis: A type of inflammatory bowel disease similar to Crohn’s disease
• Moderate to severe plaque psoriasis: an autoimmune disease that causes scaly and itchy patches on the skin

Autoimmune diseases occur when the body’s immune system, meant to protect you from foreign bodies like viruses and bacteria, attacks your cells instead and causes conditions like rheumatoid arthritis, Crohn’s disease, and psoriasis.

How to Take Abrilada

In most cases, you will receive your Abrilada injection every other week. However, depending on what you’re using Abrilada for, you may get an injection more often when you first start taking the medicine.

While it can be intimidating or scary to think about having to inject your medicine yourself, Abrilada comes with devices that make the process simple. It is available in prefilled syringes or pen injectors. Neither of these requires you to attach needles or draw up liquid. You will also be shown how to give the drug to yourself by a healthcare provider and won’t have to self-inject until you feel comfortable with the process.

The drug is given subcutaneously, which means the medicine is injected right under your skin, as opposed to into a muscle or a vein. The needles are small, only about a quarter of an inch long. You can use your thighs or stomach area for subcutaneous injections, as these areas commonly have the most fat to work with. Avoid a 2-inch area around your belly button. Do not inject into the cut, tender, bruised, or scarred skin, and do not inject through clothing.

For Abrilada prefilled pen injector:

1. Remove the pen from your refrigerator and let it come to room temperature for about 15 to 30 minutes. This will make injecting more comfortable. Have your sharps container handy. Do not try to warm the medicine up by shaking it or using any external heating source.
2. Hold the pen injector in the middle of the pen body. You can take a look at the medicine through the small window to make sure it is clear to pale yellow in color, without any lumps or flakes in it.
3. Wash your hands and clean the area of skin you plan to inject with an alcohol swab. Allow your skin to dry without blowing on it or touching it again.
4. Once you’re ready to inject, remove the pen cap by twisting it off. Do not try to put the cap back on.
5. Hold the pen in your fist against your skin at a 90-degree angle. Then press down firmly and hold the pen against your skin. Press the injection button until you hear a click. You can stop pressing the injection button but continue holding the pen firmly against your skin for five seconds. You will hear a second click. Keep holding the button down for five more seconds.
6. Check to make sure the orange indicator fills the viewing window completely.
7. Lift the pen off your skin and place the entire pen into your sharps container.
8. If you see any blood, you can lightly press a cotton ball over the injection site, but do not rub your skin.
9. Keep track of where you inject each dose of Abrilada, as you’ll want to rotate sites each time you administer the drug.

For Abrilada prefilled syringes:

1. Remove the carton from your refrigerator and remove one syringe by peeling the paper seal back. Let it come to room temperature for about 15 to 30 minutes, as this will make injecting more comfortable. Put the carton containing the other syringe back in the fridge. Have your sharps container handy. Do not try to warm the medicine up by shaking it or using any external heating source.
2. Hold the syringe in the middle at the clear part where you can see the medicine. Take a quick look to make sure the medicine is clear to pale yellow in color with no large lumps or flakes in it.
3. Wash your hands and clean the area of skin you plan to inject with an alcohol swab. Allow your skin to dry without blowing on it or touching it again.
4. Remove the needle cap with the needle pointing away from yourself. You may see a drop of liquid at the end of the needle. This is normal.
5. Pinch a section of your skin between your thumb and other fingers, and insert the needle completely at about a 45-degree angle.
6. Relax the hand that is pinching the skin and slowly push the plunger down all the way to inject the medicine. Hold the syringe in place for five seconds.
7. Keep the plunger fully pressed down and carefully pull the needle straight out from the injection site.
8. Place the entire syringe into your sharps container. Do not attempt to put the cap back on the needle.
9. If you see any blood, you can lightly press a cotton ball over the injection site, but do not rub your skin.
10. Keep track of where you inject each dose of Abrilada, as you’ll want to rotate sites each time you administer the drug.
    

Storage

Store your Abrilada pens and prefilled syringes in the refrigerator (36-46 degrees F). If needed, you can store pens and syringes at room temperature (68-77 degrees F) for up to 30 days. After 30 days outside of the fridge, Abrilada will have to be thrown away.

Store pens and syringes in the cartons they came in to protect the medicine from light. Don’t expose Abrilada to extremely hot or cold temperatures, such as by freezing it or leaving it in your car on a hot day.

What Are the Side Effects of Abrilada?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

As with all medications, Abrilada can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication.

Common Side Effects

These are the most common side effects of Abrilada. If you experience these side effects and think they are severe or do not go away, you should notify your healthcare provider.

• Upper respiratory bacterial and viral infections, such as sinusitis (sinus infections), pharyngitis (a sore throat), or influenza
• Injection site reactions, such as mild pain, itching, or redness in the area where you received your Abrilada injection
• Nausea or abdominal pain
• Headache
• Back pain
  

Severe Side Effects

The FDA has issued a boxed warning for Abrilada. Boxed warnings are the agency’s strongest warnings for serious and potentially life-threatening risks. Review these warnings and discuss your concerns with your healthcare provider before starting treatment.

The boxed warning:

• Abrilada should be stopped if a person develops a serious infection or sepsis during treatment.
• Perform a test for latent tuberculosis (TB); if positive, start treatment for TB prior to starting Abrilada.
• Monitor all people for active TB during treatment, even if the initial latent TB test is negative.
• Lymphoma and other malignancies, some fatal, have been reported in children and younger individuals treated with TNF blockers, including adalimumab products (arthritis drugs).
• Later cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescents and young adults with inflammatory bowel disease (IBD) treated with TNF blockers including adalimumab products.
• Increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other dangerous pathogens.

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

• Infections: Since TNF blockers like Abrilada work by affecting your immune system, you may be more vulnerable to various types of infections while you take the medicine. This may be especially true if you have a suppressed immune system, or are a carrier of some viruses like hepatitis B or tuberculosis. Your healthcare provider should check for these infections before starting you on Abrilada.
• Cancers: Abrilada’s effect on your immune system may cause it to be less able to fight cancerous cells. However, the risk is only slightly increased for certain types of cancer, such as melanoma (skin cancer), lymphoma (cancer of the lymphatic system), and leukemia (blood cancer). Discuss this risk with your healthcare provider and any concern you may have over cancer risks. For many, the potential benefits of Abrilada will outweigh a slight increase in cancer risk.
• Heart failure: There have been some reports of worsening congestive heart failure (CHF) in people taking Abrilada, as well as some rare reports of new-onset CHF. Discuss with your healthcare provider any known heart issues.
  

Dosage: How Much Abrilada Should I Take?

Modifications

Users should be aware of the following before beginning Abrilada:

In pregnancy: There is not enough conclusive data regarding the use of Abrilada in pregnant people to make a solid recommendation on the risk of birth defects, miscarriage, or adverse outcomes.

There is a registry called MotherToBaby that is focused on establishing more actionable data surrounding drugs being used during pregnancy. The percentage of birth defects in people treated with adalimumab was slightly higher than in those not treated. However, various study limitations prevented drawing an association between adalimumab and major birth defects.

Studies have shown that adalimumab does get transferred from the pregnant person to the fetus in small amounts via the placenta, but the effect this has on human babies is not well established. Speak with your healthcare provider about whether to use Abrilada if you’re planning to become pregnant.

In breastfeeding: Limited data indicate that Abrilada is present in human milk in small amounts. A breastfed baby may absorb a small amount of the drug. The effects this may have are unknown due to a lack of data. As in pregnancy, the clinical benefit of Abrilada for pregnant people should be weighed against any risk the drug and the pregnant person's autoimmune condition may pose to a newborn.

In pediatric users: Abrilada is approved to treat pJIA in children 4 years and older. It hasn’t been studied in children younger than 2 or weighing less than 22 pounds (10 kilograms), and its safety and effectiveness in that population are unknown.

In older users: No differences in side effects were seen between younger and older people (over the age of 65). However, not enough older adults were included in trials to know for sure if they may be affected differently.

Missed Dose

You will most likely be using Abrilada once every other week. Make sure you understand how often you’re supposed to give an injection. It can help to set phone or calendar reminders to give your regular doses.

If you forget to use Abrilada, inject your dose as soon as you remember, then take your next dose at your normally scheduled time. In case you’re not sure when to inject, ask your healthcare provider or pharmacist.

Overdose: What Happens If I Take Too Much Abrilada?

Since Abrilada is an injection that just uses one pen or syringe every other week, it would be very difficult to overdose on this medication. If you do keep Abrilada at home and someone in your household like a child or pet gets ahold of the medicine, contact the Poison Control Center.

Most importantly, remember and mark down when you have taken Abrilada as it is an injection that just uses one pen or syringe every other week.

Precautions

What Are Reasons I Shouldn't Take Abrilada?

You should not take Abrilada, or it may not be the best choice for you if any of the following apply to you.

• Neurological disorders. Central or peripheral nervous system demyelinating disorders, such as multiple sclerosis, optic neuritis, Guillain-Barré syndrome, and peripheral neuropathies may be worsened by Abrilada.
• Infection. If you have an active, chronic, or recurrent infection of any organ or if you have sepsis, you should wait until the infection has cleared to start taking Abrilada. Make sure to let your healthcare provider know if you’re experiencing symptoms of infection such as chills, fever, sweats, muscle aches, or cough.
• Congestive heart failure (CHF). Rarely new cases of CHF occurred in people taking Abrilada, even without preexisting heart disease. However, if you already have existing heart failure, you and your healthcare provider should discuss any increased risk and establish a plan for monitoring your heart disease carefully.
  

What Other Medications May Interact With Abrilada?

There are some medicines that may need to be evaluated, adjusted, or avoided while you’re also taking Abrilada:

• Live vaccines, such as chickenpox (varicella), FluMist (flu vaccine nasal spray), MMR (measles, mumps, rubella), yellow fever vaccine, and others. Let anyone who may be giving you a vaccine know that you take Abrilada. Non-live or inactivated vaccinations are satisfactory.
• Other biologic or biosimilar drugs, such as Remicade (infliximab), Kineret (anakinra), Enbrel (etanercept), Cimzia (certolizumab pegol), Simponi (golimumab), or Orencia (abatacept). Taking other biologic drugs at the same time as Abrilada can increase your risk for serious infections more than taking Abrilada alone does.
• Methotrexate
• Certain CYP450 substrates, such as Jantovin (warfarin), theophylline, or Cequa (cyclosporine). These CYP450 substrates are metabolized (or cleared) by certain proteins called cytochromes. Taking Abrilada may cause these proteins to be more active, processing drugs and potentially clearing them from your body more quickly, causing them to not work as well. This means that some dose adjustments may need to be made.
  

What Medications Are Similar?

There are many other medications like Abrilada that are either biologics or biosimilars. They all have slightly different mechanisms but work similarly in that they mimic or improve a certain part of the function of your immune system.

• Humira (adalimumab) is the biologic drug for which Abrilada is a biosimilar. It is a TNF inhibitor that is very expensive and injected subcutaneously.
• Eticovo (etanercept-ykro) is another biosimilar for Enbrel, like Abrilada.
• Enbrel (etanercept) is another biologic drug that is also a TNF inhibitor. It is also used to treat rheumatoid arthritis, as well as several types of psoriasis.
• Remicade (infliximab) is given intravenously rather than subcutaneously, every eight weeks in an infusion clinic. Biosimilars for Remicade include Avsola (infliximab-axxq), Inflectra (infliximab-dyyb), Ixifi (infliximab-qbtx) and Renflexis (infliximab-abda).
• Cimzia (certolizumab pegol), is another biologic used to treat many autoimmune conditions. No biosimilars exist for Cimzia.
• Simponi (golimumab) is a monoclonal antibody that is injected subcutaneously. It’s also available as Simponi Aria, which is given intravenously at an infusion clinic. No biosimilars exist for Simponi.
• Kineret (anakinra) is an interleukin-1 antagonist used to treat rheumatoid arthritis and other more rare autoimmune diseases.

This is a list of drugs also prescribed for immune-mediated conditions such as arthritis, digestive issues, or skin conditions. It is NOT a list of drugs recommended to take with Abrilada. In fact, you should not take these drugs together. Ask your pharmacist or a healthcare provider if you have questions.

How Can I Stay Healthy While Taking Abrilada?

Conditions caused by an overactive immune system–autoimmune diseases–are difficult to understand because our immune systems are so complicated. Uncontrolled rheumatoid arthritis and skin conditions like psoriasis can be very frustrating to deal with because they have such a profound impact on your everyday life. It can be hard to work efficiently or enjoy things you normally do when your joint pain is out of control or you feel self-conscious about exposing parts of your skin.

Fortunately, in the last decade or so, the advancement of drugs called monoclonal antibodies has made enormous differences in treating many conditions such as cancer, arthritis, asthma, gastrointestinal conditions like Crohn’s disease and ulcerative colitis, and skin conditions like psoriasis and eczema. Though biologics can be very expensive, biosimilar drugs that are just as safe and effective can be made and accessed by people much more cheaply.

While it may seem scary at first to be prescribed a medicine that has to be injected, subcutaneous injections are very easy, quick, and cause little to no pain. Being patient and sticking to your dosing schedule while continuing to use other medicines you have been prescribed will all help you fight your condition and give you the best shot at reducing your symptoms.