Abrilada

Abrilada is a prescription medication used to relieve the symptoms of certain autoimmune disorders. It is used to treat certain kinds of arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis and ulcerative colitis. The United States (U.S.) Food and Drug Administration (FDA) has approved Abrilada as a biosimilar to Humira, meaning that there are no clinically meaningful differences between the biosimilar product and the reference product.

Abrilada belongs to a group of drugs called tumor necrosis factor (TNF) inhibitors. It works by blocking the action of TNF, a substance in the body that causes inflammation. 

This medication comes in an injectable form in prefilled syringes. Abrilada is injected just under the skin (subcutaneously) once every other week.

Common side effects include infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

Biosimilar: The United States (U.S.) Food and Drug Administration (FDA) has approved Abrilada as a biosimilar to Humira for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.

Abrilada is used:

• To reduce the signs and symptoms of:

  • moderate to severe rheumatoid arthritis (RA) in adults. Abrilada can be used alone, with methotrexate, or with certain other medicines.

  • moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years and older. Abrilada can be used alone, with methotrexate, or with certain other medicines.

  • psoriatic arthritis (PsA) in adults. Abrilada can be used alone or with certain other medicines.

  • ankylosing spondylitis (AS) in adults.

  • moderate to severe Crohn’s disease (CD) in adults when other treatments have not worked well enough.

• In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.

• To treat moderate-to-severe chronic (lasting a long time) plaque psoriasis (Ps) 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).

Serious side effects have been reported. See "Abrilada Precautions" section.

Common side effects with Abrilada include:

• injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your healthcare provider right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse.
• upper respiratory infections (including sinus infections).
• headaches. 
• rash.

These are not all the possible side effects with Abrilada. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you use:

• Orencia (abatacept), Kineret (anakinra), Remicade (infliximab), Enbrel (etanercept), Cimzia (certolizumab pegol) or Simpomi (golimumab), because you should not use Abrilada while you are also using one of these medicines.

• Rituxan (rituximab). Your healthcare provide may not want to give you Abrilada if you have received Rituxan (rituximab) recently.

• Imuran (azathioprine) or Purinethol (6–mercaptopurine, 6-MP).

This is not a complete list of Abrilada drug interactions. Ask your doctor or pharmacist for more information.

Abrilada is a medicine that affects your immune system. Abrilada can lower the ability of your immune system to fight infections. Serious infections have happened in people taking Abrilada. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections.

• Your doctor should test you for TB before starting Abrilada.
• Your doctor should check you closely for signs and symptoms of TB during treatment with Abrilada.

You should not start taking Abrilada if you have any kind of infection unless your doctor says it is okay.

• Serious Infections. Your healthcare provider will examine you for TB and perform a test to see if you have TB. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Abrilada and during treatment with Abrilada. Even if your TB test is negative your healthcare provider should carefully monitor you for TB infections while you are taking Abrilada. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your healthcare provider if you have any of the following symptoms while taking or after taking Abrilada:
  • cough that does not go away 
  • weight loss
  • low grade fever 
  • loss of body fat and muscle (wasting)

• Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Abrilada. Your healthcare provider should do blood tests before you start treatment, while you are using Abrilada, and for several months after you stop treatment with Abrilada. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:

  • muscle aches
  • feel very tired
  • dark urine
  • skin or eyes look yellow 
  • little or no appetite
  • clay-colored bowel movements 
  • fever
  • chills
  • stomach discomfort
  • skin rash
  • vomiting

• Allergic reactions. Allergic reactions can happen in people who use Abrilada. Call your healthcare provider or get medical help right away if you have any of these symptoms of a serious allergic reaction:

  • hives 
  • swelling of your face, eyes, lips or mouth
  • trouble breathing

• Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.

• Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.

• New heart failure or worsening of heart failure you already have. Call your healthcare provider right away if you get new worsening symptoms of heart failure while taking Abrilada, including:

  • shortness of breath 
  • swelling of your ankles or feet
  • sudden weight gain

• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop Abrilada.

• Liver problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your healthcare provider right away if you have any of these symptoms:

  • feel very tired 
  • skin or eyes look yellow
  • poor appetite or vomiting 
  • pain on the right side of your stomach (abdomen)

• Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your healthcare provider if you develop red scaly patches or raised bumps that are filled with pus. Your healthcare provider may decide to stop your treatment with Abrilada.

Call your healthcare provider or get medical care right away if you develop any of the above symptoms. Your treatment with Abrilada may be stopped.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Abrilada are no specific foods that you must exclude from your diet when receiving this medication.

Before starting Abrilada, tell your healthcare provider about all of your health conditions, including if you:

• have an infection.
• have or have had cancer.
• have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome.
• have or had heart failure.
• have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using Abrilada. Children should be brought up to date with all vaccines before starting Abrilada.
• are allergic to Abrilada or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in Abrilada.
• are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should take Abrilada while you are pregnant or breastfeeding.
• have a baby and you were using Abrilada during your pregnancy. Tell your baby’s healthcare provider before your baby receives any vaccines.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you are pregnant or plan to become pregnant. You and your healthcare provider should decide if you should take Abrilada while you are pregnant.

There are no well-done studies that have been done in humans with Abrilada. In animal studies, pregnant animals were given this medication and the babies did not show any medical issues related to this medication.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. You and your healthcare provider should decide if you should take Abrilada while you are breastfeeding.

• Abrilada is given by an injection under the skin. Your healthcare provider will tell you how often to take an injection of Abrilada. This is based on your condition to be treated. Do not inject Abrilada more often than you were prescribed.

• See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject Abrilada.

• Make sure you have been shown how to inject Abrilada before you do it yourself. You can call your healthcare provider or 1-800-438-1985 if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after they have been shown how to prepare and inject Abrilada.

• Do not try to inject Abrilada yourself until you are shown the right way to give the injections and read and understand the Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of Abrilada at home, you should receive training on the right way to prepare and inject Abrilada.

• Do not miss any doses of Abrilada unless your healthcare provider says it is okay. If you forget to take Abrilada, 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 healthcare provider or pharmacist.

Take Abrilada exactly as it is prescribed by your doctor. Your doctor will determine the best dose for you.

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

The recommended dose of Abrilada for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) is 40 mg administered every other week. Methotrexate (MTX), other non-biologic DMARDS, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with Abrilada. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosing frequency of Abrilada to 40 mg every week.

Juvenile Idiopathic Arthritis

The recommended dose of Abrilada for pediatric patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) is based on weight.

• 10 kg (22 lbs) to <15 kg (33 lbs): 10 mg every other week
• 15 kg (33 lbs) to < 30 kg (66 lbs): 20 mg every other week
•  ≥ 30 kg (66 lbs): 40 mg every other week

Crohn's Disease and Ulcerative Colitis 

The recommended Abrilada dose regimen for adult patients with Crohn’s disease is 160 mg initially on Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week.

For patients with Ulcerative Colitis only: Only continue this medication in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy. 

Aminosalicylates and/or corticosteroids may be continued during treatment with Abrilada. Azathioprine, 6-mercaptopurine (6-MP) or MTX may be continued during treatment with Abrilada if necessary. The use of Abrilada in Crohn’s disease beyond one year has not been evaluated in controlled clinical studies.

Plaque Psoriasis

The recommended dose of Abrilada for adult patients with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. The use of Abrilada in moderate to severe chronic plaque psoriasis beyond one year has not been evaluated in controlled clinical studies.

If you take too much Abrilada, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Store Abrilada in the refrigerator at 36°F to 46°F (2°C to 8°C). Store Abrilada in the original carton until use to protect it from light.
• Do not freeze Abrilada. Do not use Abrilada if frozen, even if it has been thawed.
• Refrigerated Abrilada may be used until the expiration date printed on the Abrilada carton, pen or prefilled syringe. Do not use Abrilada after the expiration date.
• If needed, for example when you are traveling, you may also store Abrilada 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.
• Throw away Abrilada if it has been kept at room temperature and not been used within 30 days.
• Record the date you first remove Abrilada from the refrigerator in the spaces provided on the Abrilada pen carton or the prefilled syringe carton.
• Do not store Abrilada in extreme heat or cold.
• The medicine in Abrilada should be clear and colorless to very light brown. Do not use a pen or 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.
• Keep Abrilada, injection supplies, and all other medicines out of the reach of children.

WARNING: SERIOUS INFECTIONS and MALIGNANCY

SERIOUS INFECTIONS
Patients treated with adalimumab products including ABRILADA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue ABRILADA if a patient develops a serious infection or sepsis.

Reported infections include:

• Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently

  presented with disseminated or extrapulmonary disease. Test patients for latent TB before

  ABRILADA use and during therapy. Initiate treatment for latent TB prior to ABRILADA use.

• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis,

  blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

• Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

  Carefully consider the risks and benefits of treatment with ABRILADA prior to initiating therapy in patients with chronic or recurrent infection.

  Monitor patients closely for the development of signs and symptoms of infection during and after treatment with ABRILADA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  MALIGNANCY
  Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.