WARNING

Brodalumab is a medication used to treat moderate to severe plaque psoriasis in adults. While it can be effective, like any medication, it comes with potential risks. Here are some of the main risks associated with taking Brodalumab Injection:

• Increased Risk of Infections: Brodalumab can suppress the immune system, which may increase the risk of infections. Serious infections, such as tuberculosis, may occur.
• Allergic Reactions: Some individuals may experience allergic reactions to Brodalumab, which can range from mild to severe and may include rash, itching, swelling, or difficulty breathing.
• Risk of Suicidal Thoughts or Behavior: Brodalumab has been associated with an increased risk of suicidal thoughts or behavior. People with a history of depression or suicidal tendencies may be at higher risk.
• Inflammatory Bowel Disease (IBD): In some cases, Brodalumab may exacerbate or lead to the development of inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis.
• Potential Cardiovascular Risks: There have been reports of cardiovascular events, such as heart attack or stroke, in individuals taking Brodalumab, although the exact relationship is not fully understood.
• Injection Site Reactions: Common side effects of Brodalumab include reactions at the injection site, such as pain, redness, itching, or swelling.

It’s important for individuals considering Brodalumab to discuss these risks with their healthcare provider and weigh them against the potential benefits of the medication. Monitoring for side effects and regular follow-ups with a healthcare provider are essential for those taking Brodalumab.

Why is this medication prescribed?

Brodalumab Injection is prescribed for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Psoriasis is a chronic autoimmune condition characterized by red, itchy, and scaly patches on the skin. Brodalumab belongs to a class of medications known as interleukin inhibitors, which work by targeting specific proteins in the body’s immune system involved in the inflammatory response that leads to psoriasis.

How should this medicine be used?

Here’s how Brodalumab Injection is typically used:

• Dosage: The recommended dose of Brodalumab is usually administered as a subcutaneous injection. The initial dose is typically given as two injections, followed by a single injection every two weeks thereafter.
• Administration: Brodalumab is injected under the skin (subcutaneously) by a healthcare professional or self-administered by the patient after proper training. The injection site can vary but is commonly administered in the thigh, abdomen, or upper arm.
• Monitoring: Patients receiving Brodalumab should be monitored for signs of infection, including tuberculosis, during treatment. They should also be monitored for signs of depression or suicidal thoughts, as well as for any potential side effects.
• Duration of Treatment: The duration of treatment with Brodalumab can vary depending on the individual’s response and the severity of their psoriasis. Some patients may experience significant improvement in their symptoms within a few weeks of starting treatment, while others may require longer-term therapy.
• Combination Therapy: Brodalumab can be used alone or in combination with other psoriasis medications, depending on the patient’s needs and treatment goals.

It’s important for patients to follow their healthcare provider’s instructions carefully when using Brodalumab Injection and to report any side effects or concerns promptly. Additionally, regular follow-up appointments with a healthcare provider are essential to monitor the patient’s response to treatment and adjust the dosage or treatment plan as needed.

Other uses for this medicine

Brodalumab Injection is primarily indicated for the treatment of moderate to severe plaque psoriasis in adults. However, it may also have potential off-label uses or investigational uses in other conditions involving immune-mediated inflammatory diseases, such as psoriatic arthritis or ankylosing spondylitis. Off-label use refers to the use of a medication for a purpose other than what it has been approved for by regulatory agencies.

What special precautions should I follow?

When using Brodalumab Injection, there are several special precautions that should be followed:

• Infections: Brodalumab can increase the risk of serious infections, including tuberculosis (TB). Prior to starting treatment, patients should be screened for TB. Individuals with active infections should not initiate treatment with Brodalumab. Patients should also be monitored for signs and symptoms of infection during treatment.
• Immunizations: Live vaccines should be avoided while receiving Brodalumab treatment due to the risk of infection. Patients should consult with their healthcare provider regarding vaccination schedules and which vaccines are safe to receive.
• Allergic Reactions: Patients should be monitored for allergic reactions during and after administration of Brodalumab. If signs of a severe allergic reaction (such as difficulty breathing or swelling of the face, lips, tongue, or throat) occur, immediate medical attention should be sought.
• Depression and Suicidal Ideation: Brodalumab has been associated with an increased risk of depression and suicidal thoughts or behavior. Patients should be monitored for signs of depression and suicidal ideation throughout treatment, particularly those with a history of depression or psychiatric disorders.
• Inflammatory Bowel Disease (IBD): Patients with a history of IBD should use Brodalumab with caution, as exacerbation of IBD symptoms or new onset of IBD has been reported with this medication.
• Cardiovascular Events: There have been reports of cardiovascular events, such as heart attack or stroke, in patients receiving Brodalumab. Patients with pre-existing cardiovascular disease should be monitored closely during treatment.
• Pregnancy and Lactation: The safety of Brodalumab during pregnancy and lactation has not been established. Women of childbearing potential should use effective contraception during treatment and for a period of time after discontinuation of therapy.

It’s important for patients to discuss these precautions with their healthcare provider before starting treatment with Brodalumab Injection. They should also inform their healthcare provider of any other medical conditions they have and any medications they are taking, including over-the-counter and herbal supplements.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Brodalumab Injection. However, maintaining a healthy and balanced diet can support overall health and well-being, which may complement your treatment.

What should I do if I forget a dose?

• If you forget to take a dose of Brodalumab Injection, administer it as soon as you remember.
• If it is close to the time of your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
• Do not take extra doses to make up for the missed one.
• If you’re unsure about what to do, contact your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Brodalumab Injection, like any medication, can cause side effects. Some common and less severe side effects may include:

• Injection Site Reactions: Pain, redness, itching, or swelling at the injection site are common reactions.
• Upper Respiratory Tract Infections: Symptoms such as cough, sore throat, and nasal congestion may occur.
• Headache: Mild to moderate headaches can occur.
• Fatigue: Feeling tired or fatigued may occur.
• Diarrhea: Some individuals may experience diarrhea as a side effect.
• Joint Pain: Pain or discomfort in the joints may occur.
• Nausea: Some people may experience nausea as a side effect.

While these side effects are relatively common and often mild, some individuals may experience more severe or less common side effects. These can include:

• Serious Infections: Brodalumab can increase the risk of serious infections, including tuberculosis (TB), which may be life-threatening if not promptly treated.
• Allergic Reactions: Severe allergic reactions, though rare, can occur. Symptoms may include rash, itching, swelling, severe dizziness, or trouble breathing.
• Depression and Suicidal Ideation: Brodalumab has been associated with an increased risk of depression and suicidal thoughts or behavior.
• Inflammatory Bowel Disease (IBD): Exacerbation of existing IBD or new onset of IBD symptoms, such as abdominal pain, diarrhea, or bloody stools, may occur.
• Cardiovascular Events: Reports of cardiovascular events, such as heart attack or stroke, have been associated with Brodalumab use, although the exact relationship is not fully understood.

It’s important to report any side effects to your healthcare provider promptly, especially if they are severe or persistent. Your healthcare provider can help manage any side effects and determine if any adjustments to your treatment plan are needed. Additionally, if you experience symptoms of a severe allergic reaction or any signs of infection, seek immediate medical attention.

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

Storage and Disposal:

• Store Brodalumab Injection in the refrigerator at a temperature between 2°C to 8°C (36°F to 46°F). Do not freeze.
• Keep the medication in its original carton to protect it from light.
• Do not shake the medication. Gently swirl the vial to dissolve any sediment before use.
• Do not use Brodalumab Injection beyond the expiration date printed on the carton.
• Dispose of used needles and syringes in a puncture-resistant container as per local regulations. Do not reuse needles or syringes.

In case of emergency/overdose

• In case of an emergency or overdose, such as accidentally injecting too much Brodalumab, seek immediate medical attention or contact a poison control center.
• It’s essential to have a healthcare provider or emergency medical services evaluate and manage any potential overdose promptly.

What other information should I know?

• Inform all healthcare providers involved in your care that you are receiving Brodalumab Injection, including dentists and pharmacists.
• Attend all scheduled appointments for follow-up monitoring and evaluation of your condition.
• Report any new or worsening symptoms to your healthcare provider, including signs of infection, depression, or allergic reactions.
• Inform your healthcare provider if you are planning to undergo surgery or any medical procedures, as Brodalumab may need to be temporarily discontinued.
• Keep a record of your injections, including the date, time, and injection site, to help monitor your treatment progress.

Following these guidelines can help ensure the safe and effective use of Brodalumab Injection. If you have any questions or concerns about storage, disposal, emergency procedures, or other aspects of your treatment, don’t hesitate to discuss them with your healthcare provider.