WARNING

Before its withdrawal from the market, Daclizumab Injection was associated with several risks, and its use came with certain safety concerns. It’s important to note that Daclizumab Injection was withdrawn voluntarily in 2018 due to these safety concerns, particularly related to severe liver injury. Here’s a brief summary of the risks associated with Daclizumab Injection based on information available before its withdrawal:

• Severe Liver Injury: Daclizumab was associated with an increased risk of severe liver injury, which could manifest as elevated liver enzymes or more serious liver problems. Regular monitoring of liver function was essential during treatment.
• Serious Infections: Due to its immunomodulatory effects, Daclizumab suppressed the immune system, increasing the risk of serious infections. Patients were advised to report any signs of infection, such as persistent cough, fever, or other symptoms.
• Hypersensitivity Reactions: Rare cases of hypersensitivity reactions, including anaphylaxis, were reported. Patients were instructed to seek immediate medical attention if they experienced signs of an allergic reaction, such as rash, itching, swelling, severe dizziness, or difficulty breathing.
• Inflammatory Brain Disorders: Cases of inflammatory brain disorders, including encephalitis and meningoencephalitis, were reported.
• Autoimmune Conditions: Daclizumab use was associated with the development of other autoimmune conditions.
• Other Common Side Effects: Common side effects included flu-like symptoms, rash, elevated liver enzymes, and upper respiratory tract infections.

Given these risks and the withdrawal of Daclizumab Injection from the market, patients and healthcare providers were advised to discontinue its use and explore alternative treatments for multiple sclerosis. If you have concerns or questions about a specific medication or if you are considering alternative treatments, it’s important to consult with your healthcare provider for the most up-to-date and relevant information based on your individual health status.

Why is this medication prescribed?

Daclizumab Injection is a medication that has been used for the treatment of certain autoimmune conditions, specifically relapsing forms of multiple sclerosis (MS). It has been prescribed for individuals with relapsing forms of MS to reduce the frequency of relapses and to manage the symptoms associated with this neurological condition.

Multiple sclerosis is a chronic autoimmune disorder where the immune system mistakenly attacks the protective covering of nerve fibers (myelin) in the central nervous system. This can lead to communication problems between the brain and the rest of the body, resulting in various symptoms such as fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination.

Daclizumab is a monoclonal antibody that works by modulating the activity of the immune system. It targets a specific receptor, called the interleukin-2 receptor, and inhibits its activation. By doing so, Daclizumab aims to regulate the immune response and reduce the inflammatory processes that contribute to the development of MS.

How should this medicine be used?

The use of Daclizumab Injection and Zinbryta (daclizumab) should be directed by a healthcare professional, and patients should strictly follow their prescribed dosage and administration instructions. The following information is a general guideline and may not cover all individual cases:

• Dosage: The specific dosage and administration schedule would have been determined by the prescribing healthcare provider based on individual patient factors and the severity of the disease.
• Administration: Daclizumab was typically administered as a subcutaneous injection, meaning it was injected under the skin.
• Frequency: The frequency of administration and the duration of treatment would have been prescribed by the healthcare provider. Patients would have received instructions on how often to administer the injections.
• Monitoring: Regular monitoring, including assessments of liver function, would have been a part of the treatment plan due to potential risks associated with the medication.

It’s crucial to note that Daclizumab Injection and Zinbryta (daclizumab) were related medications, and both were voluntarily withdrawn from the market in 2018 due to safety concerns, particularly regarding severe liver injury. As a result, these medications are no longer available for use.

If you are currently considering treatment options for multiple sclerosis or any other medical condition, it’s essential to consult with your healthcare provider. They can provide information on the latest available medications, discuss potential risks and benefits, and tailor the treatment plan to your individual health needs.

Other uses for this medicine

Daclizumab Injection was primarily used for the treatment of relapsing forms of multiple sclerosis (MS) in adults. It was not typically prescribed for other medical conditions. Monoclonal antibodies like daclizumab are designed to target specific components of the immune system and modulate the immune response, making them suitable for diseases with an autoimmune or inflammatory component, such as MS.

What special precautions should I follow?

Daclizumab Injection was associated with certain precautions and considerations:

• Liver Function Monitoring: Regular monitoring of liver function was crucial due to the potential risk of severe liver injury associated with daclizumab. Patients were typically required to undergo liver function tests before and during treatment.
• Infections: Daclizumab could suppress the immune system, which might increase the risk of infections. Patients were advised to report any signs of infection, such as fever, persistent cough, or other symptoms, to their healthcare provider.
• Hypersensitivity Reactions: Like many medications, daclizumab had the potential to cause allergic reactions. Patients were instructed to seek immediate medical attention if they experienced signs of an allergic reaction, such as rash, itching, swelling, severe dizziness, or difficulty breathing.
• Pre-existing Conditions: Individuals with pre-existing liver disease were generally advised not to use daclizumab. It was important to inform the healthcare provider of any existing health conditions before starting the medication.
• Pregnancy and Breastfeeding: The safety of daclizumab during pregnancy and breastfeeding was not well-established. Patients were advised to discuss the potential risks and benefits with their healthcare provider if they were pregnant, planning to become pregnant, or breastfeeding.

The information provided here is based on the status of the drug before its withdrawal. If you have any specific concerns or questions about a similar medication or alternative treatments, it’s important to consult with your healthcare provider for the latest and most relevant information based on your individual health status.

What special dietary instructions should I follow?

There were no specific dietary instructions associated with daclizumab. However, it’s always a good idea to maintain a healthy and balanced diet, and if you have any concerns about potential interactions with specific foods or supplements, consult with your healthcare provider.

What should I do if I forget a dose?

Since Daclizumab Injection was administered under the supervision of healthcare professionals, patients were unlikely to self-administer doses at home. In clinical settings, healthcare providers typically ensured that patients received their scheduled doses as part of their treatment plan.

What side effects can this medication cause?

Before its withdrawal from the market in 2018, Daclizumab Injection was associated with a range of potential side effects, and patients were advised to be aware of these and promptly report any unusual or severe symptoms to their healthcare provider. Keep in mind that since the medication is no longer available, the information provided here is based on the status of the drug before its withdrawal:

Common Side Effects:

• Infections: Daclizumab could suppress the immune system, leading to an increased risk of infections. Common symptoms of infections, such as upper respiratory infections, urinary tract infections, or the flu, were reported.
• Elevated Liver Enzymes: Abnormal liver function tests were a known side effect, and regular monitoring of liver function was typically part of the treatment plan.
• Rash: Skin reactions, including rash, were reported in some patients.
• Flu-like Symptoms: Fever, chills, muscle aches.
• Headache: Headache was a common side effect reported by some individuals.

Serious Side Effects:

• Severe Liver Injury: Daclizumab was associated with an increased risk of severe liver injury, which could manifest as elevated liver enzymes or more serious liver problems.
• Serious Infections: The suppression of the immune system increased the risk of serious infections, including opportunistic infections. Symptoms such as persistent cough, fever, or signs of infection should be promptly reported.
• Hypersensitivity Reactions: Rare cases of hypersensitivity reactions, including anaphylaxis, were reported.
• Inflammatory Brain Disorders: Cases of inflammatory brain disorders, including encephalitis and meningoencephalitis, were reported.
• Autoimmune Conditions: Daclizumab use was associated with the development of autoimmune conditions.

It’s crucial to note that the withdrawal of Daclizumab Injection from the market was prompted by safety concerns, particularly related to severe liver injury. If you have questions about side effects associated with a specific medication or if you are considering alternative treatments, it’s important to consult with your healthcare provider for the most up-to-date and relevant information based on your individual health status.

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

Storage and Disposal of Daclizumab Injection:

• Storage:
  • Follow the storage instructions provided by your healthcare provider or pharmacist.
  • Typically, Daclizumab Injection should be stored in the refrigerator, but not frozen. Do not use the medication if it has been frozen.
  • Keep it in its original packaging to protect it from light.
• Disposal:
  • Dispose of Daclizumab Injection according to local regulations.
  • Do not flush medications down the toilet or pour them into a drain unless instructed to do so.
  • Consult your pharmacist or local waste disposal company for information on the proper disposal of medications.

In case of emergency/overdose

In case of an emergency or suspected overdose, seek immediate medical attention or contact your local poison control center. The symptoms of an overdose are not well-documented for Zenapax, but it’s important to get prompt medical attention if you have concerns.

What other information should I know?

• Administration: Daclizumab Injection is usually administered by a healthcare professional. Follow your healthcare provider’s instructions carefully.
• Missed Dose: If you miss a dose, contact your healthcare provider for guidance on what to do.
• Medical History: Inform your healthcare provider about your medical history, especially if you have a history of certain conditions or allergies.
• Other Medications: Inform your healthcare provider about all the medications, supplements, and herbal products you are taking. This includes prescription and over-the-counter medications.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding.
• Regular Check-ups: Attend regular check-ups with your healthcare provider to monitor your response to the medication and address any concerns or side effects.

Always follow the advice and instructions of your healthcare provider or pharmacist regarding the storage, disposal, and usage of Daclizumab Injection. This information is for general knowledge and may not cover all aspects of your specific situation.