WARNING

Taking Abrilada (adalimumab-adbm) involves several risks:

• Infection Risk: Abrilada can weaken the immune system, increasing susceptibility to serious infections like tuberculosis, bacterial, fungal, and viral infections.
• Allergic Reactions: Serious allergic reactions can occur, including rash, swelling, and difficulty breathing.
• Cancer Risk: There is a potential increased risk of certain cancers, such as lymphoma and skin cancer.
• Heart Problems: Abrilada may worsen or lead to new heart failure issues.
• Nervous System Issues: It may exacerbate or trigger conditions such as multiple sclerosis or peripheral neuropathy.
• Hepatitis B Reactivation: For those with a history of hepatitis B, Abrilada can cause the virus to reactivate.
• Blood Disorders: Serious blood conditions like anemia or low blood cell counts can occur.

Always discuss these risks with your healthcare provider to understand how they may affect you and to ensure proper monitoring during treatment.

Why is this medication prescribed?

Abrilada (adalimumab-afzb) is a biosimilar to the drug Humira (adalimumab). It is prescribed to treat several autoimmune conditions by reducing inflammation and modulating the immune response. Some of the conditions Abrilada is commonly used to treat include:

• Rheumatoid Arthritis: To reduce pain, swelling, and joint damage.
• Psoriatic Arthritis: To alleviate symptoms such as joint pain and skin plaques.
• Ankylosing Spondylitis: To reduce inflammation and improve mobility in the spine.
• Crohn’s Disease: To manage symptoms and maintain remission in inflammatory bowel disease.
• Ulcerative Colitis: Similar to Crohn’s disease, it helps control symptoms and maintain remission.
• Plaque Psoriasis: To treat moderate to severe cases where systemic therapy or phototherapy is appropriate.
• Juvenile Idiopathic Arthritis: To reduce symptoms in children with certain forms of arthritis.

Abrilada works by inhibiting a specific protein (tumor necrosis factor-alpha or TNF-alpha) that plays a key role in the inflammatory process associated with these autoimmune diseases.

How should this medicine be used?

Abrilada is a biosimilar to the medication adalimumab, which is used to treat various autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Here’s how Abrilada is typically used:

• Administration: Abrilada is administered via subcutaneous injection (under the skin). It usually comes in pre-filled syringes or pens for self-administration.
• Dosage: The dosage and frequency of Abrilada depend on the specific condition being treated. For rheumatoid arthritis, the common dose is 40 mg every other week, but the dosage can vary based on the doctor’s prescription. Some conditions may require an initial higher dose (loading dose) followed by regular maintenance doses.
• Injection Sites: Common injection sites include the abdomen or thigh. Avoid injecting into areas of skin that are red, bruised, tender, or hard. Rotate the injection site to avoid skin irritation.
• Storage: Store Abrilada in the refrigerator at 2°C to 8°C (36°F to 46°F). If needed, Abrilada can be stored at room temperature (up to 25°C or 77°F) for up to 14 days, but once it reaches room temperature, it should not be refrigerated again.
• Precautions: Wash your hands before administering the injection. Do not use the medication if the solution is cloudy, discolored, or contains particles. Follow the instructions provided by your healthcare provider or the manufacturer.
• Monitoring: Regular monitoring by a healthcare provider is important while using Abrilada to assess the effectiveness and any potential side effects. It’s important to keep all medical appointments and follow your healthcare provider’s instructions.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it’s almost time for the next dose, skip the missed dose and return to your regular schedule. Do not double up doses.

Always follow your healthcare provider’s specific instructions when using Abrilada, and consult them if you have any concerns or questions.

Other uses for this medicine

• Hidradenitis Suppurativa: Reduces painful lumps in moderate to severe cases.
• Plaque Psoriasis: For moderate to severe chronic plaque psoriasis in adults.
• Uveitis: Used for non-infectious uveitis affecting the eye.

What special precautions should I follow?

When using Abrilada, it is important to take certain precautions:

• Infections:
  • Serious Infections: Abrilada can lower your immune system’s ability to fight infections. You should be screened for tuberculosis (TB) before starting treatment and monitored for signs of TB during treatment. Avoid using Abrilada if you have an active infection or if you are prone to infections.
  • Signs of Infection: Contact your healthcare provider if you develop symptoms such as fever, cough, sore throat, shortness of breath, weight loss, or fatigue.
• Allergic Reactions: Do not use Abrilada if you are allergic to adalimumab or any of its ingredients. Watch for signs of an allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.
• Cancer Risk: There may be an increased risk of developing certain types of cancer, including lymphoma and skin cancer, particularly in children and young adults using Abrilada. Discuss the risks with your healthcare provider.
• Vaccinations: Avoid live vaccines while using Abrilada. If possible, bring your vaccinations up to date before starting treatment. Consult your doctor about any vaccines you may need.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of using Abrilada with your healthcare provider. The effects of Abrilada on an unborn baby or nursing infant are not fully known.
• Blood Disorders: Notify your doctor if you experience symptoms of blood disorders such as persistent fever, bruising, bleeding, or paleness.
• Heart Disease: If you have heart problems, inform your doctor. Abrilada may cause or worsen heart failure in some patients.
• Nervous System Problems: Inform your healthcare provider if you have a history of demyelinating disorders (such as multiple sclerosis) or other nervous system issues. Abrilada may cause or worsen these conditions.
• Hepatitis B: If you are a carrier of hepatitis B virus (HBV), using Abrilada could cause the virus to become active. Your doctor should test you for HBV before starting treatment and monitor you during and after treatment.

Always follow the guidance of your healthcare provider regarding these precautions and report any unusual symptoms or concerns during your treatment with Abrilada.

What special dietary instructions should I follow?

There are no specific dietary restrictions or special dietary instructions for using Abrilada. However, maintaining a balanced and healthy diet can support overall health, especially when managing an autoimmune condition. It’s always a good idea to discuss any dietary concerns or supplements with your healthcare provider, especially if you have other medical conditions or are taking additional medications.

What should I do if I forget a dose?

• Take the Missed Dose: As soon as you remember, take the missed dose unless it’s almost time for your next scheduled dose.
• Skip if Close to Next Dose: If it’s nearly time for your next dose, skip the missed dose. Do not double up on doses to make up for the missed one.
• Resume Regular Schedule: Continue with your regular dosing schedule moving forward.

What side effects can this medication cause?

Abrilada (adalimumab-adbm) can cause various side effects, some of which might be serious. Here’s a summary of potential side effects:

Common Side Effects:

• Injection Site Reactions: Redness, pain, itching, or swelling at the injection site.
• Headache: Mild to moderate headaches are relatively common.
• Upper Respiratory Infections: Symptoms may include sore throat, runny or stuffy nose, or cough.
• Nausea: Some people may experience mild nausea.

Serious Side Effects:

• Infections: Abrilada can increase the risk of serious infections, including tuberculosis (TB), bacterial, fungal, or viral infections. Symptoms to watch for include fever, persistent cough, weight loss, and unusual tiredness.
• Allergic Reactions: Severe allergic reactions, including rash, itching, swelling of the face or throat, and difficulty breathing.
• Cancer: There is a potential increased risk of certain types of cancer, such as lymphoma and skin cancer. Symptoms may include unexplained weight loss, night sweats, or swollen lymph nodes.
• Heart Problems: Abrilada may worsen or cause new heart failure. Symptoms to watch for include shortness of breath, swelling of the legs or ankles, and sudden weight gain.
• Nervous System Issues: Conditions such as multiple sclerosis, optic neuritis, or peripheral neuropathy. Symptoms may include vision changes, tingling or numbness, or muscle weakness.
• Liver Problems: Symptoms of liver problems include yellowing of the skin or eyes (jaundice), dark urine, or severe abdominal pain.
• Hematologic Reactions: Serious blood disorders such as anemia, thrombocytopenia (low platelet count), or leukopenia (low white blood cell count). Symptoms might include unusual bleeding or bruising, fatigue, or infections.
• Hepatitis B Reactivation: For those who are HBV carriers, Abrilada can cause reactivation of hepatitis B. Symptoms include jaundice, dark urine, or abdominal pain.

Always discuss potential side effects and any concerns with your healthcare provider before starting treatment with Abrilada.

What should I know about storage and disposal of this medication?

Storage and Disposal of Abrilada:

Storage:

• Refrigeration: Abrilada should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.
• Room Temperature: If necessary, Abrilada can be kept at room temperature (up to 25°C or 77°F) for up to 14 days. Once it has been at room temperature, it should not be put back in the refrigerator.
• Protection from Light: Keep Abrilada in its original carton to protect it from light.
• Out of Reach: Store Abrilada out of reach of children and pets.

Disposal:

• Do Not Flush: Do not flush Abrilada down the toilet or pour it down the drain.
• Disposal: Follow the local guidelines for the disposal of medications. You can also ask your pharmacist for advice on how to properly dispose of unused or expired Abrilada.

In case of emergency/overdose

Emergency:

• Contact Emergency Services: If you experience severe allergic reactions such as difficulty breathing, swelling of the face or throat, or severe rash, seek emergency medical attention immediately.
• Symptoms of Serious Reactions: If you have symptoms of severe infections, heart problems, or liver issues, contact your healthcare provider or seek emergency care.

Overdose:

• Immediate Action: If you suspect an overdose of Abrilada, contact your healthcare provider or local poison control center immediately.
• Symptoms: Overdose symptoms are not well-documented but may include severe side effects such as serious infections, liver problems, or severe allergic reactions.

What other information should I know?

• Follow Instructions: Always follow the specific instructions given by your healthcare provider regarding dosage and administration.
• Medical History: Inform your healthcare provider of your full medical history, including any existing conditions, medications, and allergies.
• Drug Interactions: Inform your healthcare provider about all other medications, including over-the-counter drugs, supplements, and herbal products, to avoid potential interactions.
• Regular Check-ups: Regular monitoring by your healthcare provider is essential to check for effectiveness and side effects. Keep all scheduled appointments.
• Consistent Use: Take Abrilada exactly as prescribed and do not stop using it without consulting your healthcare provider, even if you feel better.
• Patient Information Leaflet: Review the patient information leaflet provided with your medication for additional guidance and information.

If you have any more specific questions or concerns, always consult your healthcare provider for personalized advice.