WARNING

Amjevita is a biologic medication used to treat various conditions, such as rheumatoid arthritis, psoriasis, and Crohn’s disease. Like all medications, it has potential risks and side effects. Here’s a detailed overview of the risks associated with taking Amjevita:

• Injection Site Reactions: Redness, itching, pain, or swelling at the injection site.
• Headache: A frequent but usually mild symptom.
• Upper Respiratory Infections: Symptoms like a sore throat, nasal congestion, or cough.
• Increased Risk of Infections: Adalimumab suppresses the immune system, making you more susceptible to serious infections like tuberculosis (TB), bacterial, fungal, and viral infections. Regular screening for TB and other infections is usually recommended.
• Risk of Cancer: There may be an increased risk of certain cancers, including lymphoma and skin cancer, particularly in people with a history of malignancy or who are on long-term therapy.
• Hepatitis B Reactivation: If you have a history of hepatitis B, the virus can become active again, potentially leading to liver problems.
• Autoimmune Reactions: Rarely, adalimumab can induce autoimmune conditions such as lupus-like syndrome or exacerbate existing autoimmune diseases.
• Heart Failure: There is a risk of worsening or new onset of heart failure in some patients.
• Nervous System Disorders: Rarely, adalimumab can cause demyelinating disorders, such as multiple sclerosis or optic neuritis.
• Regular Check-ups: Periodic monitoring for signs of infection, liver function, and other health parameters is essential.
• Vaccinations: Certain live vaccines should be avoided while on adalimumab. Consult your healthcare provider for appropriate vaccinations.
• Pre-existing Conditions: Inform your healthcare provider of any existing health conditions, especially infections, cancer history, or heart issues.
• Severe Allergic Reactions: Although rare, severe allergic reactions (anaphylaxis) can occur, presenting as difficulty breathing, rash, or swelling.

It’s crucial to discuss these risks with your healthcare provider, who can provide guidance based on your individual health profile and needs. They will help weigh the benefits of the medication against the potential risks and determine the best course of action for your treatment.

Why is this medication prescribed

Amjevita (generic name: adalimumab) is prescribed to treat a variety of autoimmune conditions by targeting and inhibiting tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. Here are some conditions for which Amjevita might be prescribed:

• Rheumatoid Arthritis: To reduce inflammation, pain, and damage to joints.
• Juvenile Idiopathic Arthritis: To treat arthritis in children.
• Psoriatic Arthritis: To help with joint symptoms and skin plaques.
• Ankylosing Spondylitis: To reduce inflammation and pain in the spine.
• Crohn’s Disease: To reduce inflammation in the digestive tract.
• Ulcerative Colitis: To manage symptoms and induce remission in the colon.
• Plaque Psoriasis: To improve skin symptoms associated with psoriasis.
• Hidradenitis Suppurativa: To reduce inflammation and lesions in this chronic skin condition.

The medication helps to control symptoms and improve quality of life by addressing underlying inflammation.

How should this medicine be used?

Amjevita (adalimumab) is typically administered via subcutaneous injection. Here’s a general guide on how it should be used:

• Preparation: Follow the instructions provided with your medication and consult with your healthcare provider. Wash your hands thoroughly before handling the medication. Remove the Amjevita prefilled syringe or pen from the refrigerator and let it reach room temperature for about 30 minutes before injection. Do not warm it using other methods.
• Injection Site: Choose an injection site, such as the abdomen (except for a 2-inch area around the navel) or the thigh. Avoid injecting into areas where the skin is bruised, tender, red, or hard.
• Administering the Injection: For a prefilled syringe: Clean the injection site with an alcohol swab. Remove the needle cap, pinch the skin, and insert the needle at a 45 to 90-degree angle. Push the plunger down slowly until the syringe is empty, then remove the needle. For an auto-injector pen: Clean the injection site. Press the pen firmly against the skin and activate the device according to the instructions. Hold it in place for the recommended time to ensure the full dose is delivered.
• After Injection: Dispose of the used syringe or pen in a sharps container. Apply gentle pressure to the injection site if needed and cover it with a bandage if desired.
• Dosing Schedule: Your healthcare provider will prescribe the specific dosing schedule, which can vary depending on the condition being treated. It’s important to follow the schedule precisely.

Always follow the specific instructions provided by your healthcare provider or included with the medication. If you have any questions or experience any issues, consult your healthcare provider for guidance.

Other uses for this medicine

Off-label uses may include:

• Behçet’s Disease: To manage symptoms associated with this rare autoimmune condition.
• Uveitis: To help control inflammation in the eye.
• Sarcoidosis: For cases that do not respond to standard treatments.

What special precautions should I follow?

Special Precautions for Amjevita:

• Infection Risk: Amjevita can increase the risk of serious infections. Inform your healthcare provider if you have any signs of infection or if you are exposed to someone with tuberculosis (TB) or hepatitis B. Get tested for TB before starting treatment and follow up with your provider if you have any symptoms of TB or other infections.
• Vaccinations: Ensure that all vaccinations are up to date before starting Amjevita. Live vaccines should generally be avoided during treatment. Consult your healthcare provider about any vaccines you might need.
• Allergic Reactions: Report any signs of an allergic reaction, such as rash, itching, or swelling, to your healthcare provider.
• Liver Function: Amjevita may affect liver function. Regular monitoring of liver enzymes might be required.
• Heart Conditions: Inform your provider if you have a history of heart problems, including congestive heart failure.
• Immune System: Amjevita can affect the immune system, potentially leading to an increased risk of certain cancers or other immune system-related issues.
• Pregnancy and Breastfeeding: Discuss with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding, as Amjevita may have implications for both.
• Injection Site Reactions: Monitor for any unusual reactions at the injection site, such as severe redness, swelling, or pain.

Always follow the advice and instructions of your healthcare provider regarding the use of Amjevita.

What special dietary instructions should I follow?

There are no specific dietary restrictions or instructions associated with Amjevita. However, maintaining a balanced and healthy diet can help support overall well-being while on any medication. Always discuss with your healthcare provider if you have dietary concerns related to your condition or treatment.

What should I do if I forget a dose?

• Timing: If you remember soon after the missed dose, inject it as soon as possible. If it’s almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double up on doses to make up for a missed dose.
• Consult Your Provider: Contact your healthcare provider for specific guidance if you miss a dose or have questions about rescheduling your next dose.

What side effects can this medication cause?

Amjevita (adalimumab) can cause a range of side effects. Here are some common and serious side effects to be aware of:

Common Side Effects:

• Injection Site Reactions: Redness, swelling, pain, or itching at the injection site.
• Headache: Mild to moderate headaches.
• Upper Respiratory Infections: Symptoms such as a runny nose or sore throat.
• Nausea: Feelings of nausea or upset stomach.
• Rash: Mild skin rashes.

Serious Side Effects:

• Infections: Increased risk of serious infections, such as tuberculosis (TB), bacterial, fungal, or viral infections. Symptoms to watch for include fever, persistent cough, or severe fatigue.
• Allergic Reactions: Severe allergic reactions, including rash, itching, swelling, dizziness, or difficulty breathing.
• Liver Problems: Symptoms of liver issues may include jaundice (yellowing of the skin or eyes), dark urine, or abdominal pain.
• Heart Issues: Worsening of heart failure or symptoms like shortness of breath and swelling in the legs.
• Neurological Issues: Rare but serious conditions such as multiple sclerosis or other central nervous system disorders.
• Blood Disorders: Rarely, changes in blood counts, such as low red blood cells (anemia) or low white blood cells.
• Cancer Risk: Increased risk of certain types of cancer, such as lymphoma.
• Autoimmune Reactions: New or worsening autoimmune disorders.

If you experience any severe or unusual symptoms while taking Amjevita, contact your healthcare provider immediately. Regular check-ups and monitoring are important to manage potential side effects effectively.

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

Storage and Disposal of Amjevita:

• Storage:
  • Store Amjevita in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
  • If needed, Amjevita can be kept at room temperature (up to 77°F or 25°C) for up to 14 days before use. It should be discarded if it has been at room temperature for longer than 14 days.
  • Store Amjevita in its original carton to protect it from light. Keep it out of the reach of children.
• Disposal:
  • Dispose of used syringes or pens in a proper sharps container. Do not throw them in regular trash.
  • Follow local regulations or pharmacy guidelines for disposing of unused or expired medication. Do not flush medications down the toilet or sink unless instructed to do so.

In case of emergency/overdose

• Contact Healthcare Provider: If you experience severe symptoms such as difficulty breathing, swelling of the face or throat, or severe allergic reactions, seek emergency medical help immediately.
• Poison Control: For any serious concerns or if you suspect an overdose, contact your local poison control center or go to the nearest emergency room.

• Overdose Symptoms: While there’s limited information on Amjevita overdose, symptoms might include increased side effects like severe infections or unusual reactions.
• Action: Contact your healthcare provider or emergency services immediately if you suspect an overdose.

What other information should I know?

• Regular Monitoring: Regular check-ups with your healthcare provider are important to monitor your response to the medication and to check for any potential side effects or complications.
• Interactions: Inform your healthcare provider of all other medications, including over-the-counter drugs and supplements, to avoid potential interactions.
• Medical History: Provide your healthcare provider with a complete medical history, including any past infections, heart conditions, or other health issues.
• Treatment Adherence: Follow your prescribed dosing schedule and administration instructions carefully to ensure the effectiveness of the treatment.

Always consult your healthcare provider for personalized advice and instructions related to your specific health needs and Amjevita usage.