Eleftha 150mg Injection

Product Description

Eleftha 150 mg Injection contains Efalizumab, a monoclonal antibody primarily used in the treatment of moderate to severe psoriasis, particularly psoriatic arthritis or chronic plaque psoriasis. Efalizumab works by modifying the immune response, targeting specific proteins involved in the immune system's activity.

Indications

Eleftha (Efalizumab) is used for:

1. Psoriasis: It is primarily indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Psoriasis is an autoimmune condition that causes the rapid turnover of skin cells, resulting in scaly, inflamed patches on the skin.

2. Psoriatic Arthritis: In some cases, it may also be used to treat psoriatic arthritis, where the skin and joints are affected by inflammation due to the immune system attacking healthy tissues.

Mechanism of Action

Efalizumab is a monoclonal antibody that works by binding to CD11a, a subunit of the LFA-1 (Lymphocyte Function-Associated Antigen-1) protein, found on the surface of white blood cells. LFA-1 is involved in the interaction between immune cells (T-cells) and other cells, including those in the skin, and plays a key role in the inflammatory response.

By blocking the activity of LFA-1, Efalizumab prevents T-cells from migrating to the skin and causing the inflammatory response seen in psoriasis. This reduces inflammation and the rapid turnover of skin cells, helping to control the skin symptoms of psoriasis.

Dosage and Administration

• Typical Dosage:

  • Initial Dose: The usual dose for Eleftha (Efalizumab) is 1 mg/kg, administered as a subcutaneous injection (under the skin). This is typically given once a week.
  • Maintenance Dose: After the initial dose, the maintenance dose is 1 mg/kg once a week. The injection is usually administered in a clinical setting, but it may also be given at home under medical supervision.

• Administration:

  • Subcutaneous Injection: Efalizumab is injected subcutaneously, which means it is injected into the fatty tissue under the skin, typically in the thigh, abdomen, or upper arm.
  • Injection Sites: The injection site should be rotated to avoid irritation.

• Renal or Hepatic Impairment: There are no specific dose adjustments required for patients with renal or hepatic impairment, but regular monitoring of liver and kidney function is recommended during treatment.

Side Effects

Common side effects of Eleftha (Efalizumab) include:

• Headache
• Fever
• Nausea
• Fatigue
• Injection site reactions: Such as redness, pain, or swelling at the injection site.
• Rashes: Some patients may experience rashes that are part of the drug's effect or related to the underlying condition.

Serious side effects (though less common) may include:

• Infections: Efalizumab works by suppressing parts of the immune system, which may increase the risk of infections, including upper respiratory infections, urinary tract infections, or even more serious infections like tuberculosis.
• Progressive Multifocal Leukoencephalopathy (PML): This is a rare but serious brain infection that can occur when the immune system is significantly suppressed. Patients should be monitored for any neurological symptoms.
• Hepatitis B Reactivation: In rare cases, Efalizumab can lead to the reactivation of hepatitis B infection. Liver function tests are essential during treatment.
• Allergic Reactions: Anaphylaxis (severe allergic reactions) is a rare side effect that requires immediate medical attention.

Precautions and Warnings

• Infections: Since Efalizumab suppresses the immune system, it can increase the susceptibility to infections. Patients should be screened for tuberculosis and other infections before starting treatment.
• Neurological Effects: Neurological symptoms such as confusion, changes in vision, or difficulty speaking should be reported to a healthcare provider immediately as they could indicate PML or other serious complications.
• Hepatitis B: Patients with a history of hepatitis B should be carefully monitored, as the drug can trigger a reactivation of the virus in some cases.
• Vaccinations: Patients should avoid live vaccines while on Efalizumab due to the suppression of the immune system. Non-live vaccines may be recommended before treatment begins.
• Pregnancy: Efalizumab is categorized as a Category C drug, meaning its safety during pregnancy has not been fully established. It should only be used during pregnancy if the potential benefits outweigh the risks.
• Breastfeeding: It is not known if Efalizumab passes into breast milk. It should be used cautiously in breastfeeding mothers, and alternative treatments may be considered.

Important Considerations

• Regular Monitoring: Because Eleftha (Efalizumab) can affect the immune system, regular blood tests and monitoring for signs of infection are essential during treatment. This includes monitoring for signs of PML, liver issues, and infections.
• Adherence to Treatment: Patients are encouraged to adhere strictly to the prescribed weekly dosing schedule for the best results.
• Injection Technique: It is important that injections are performed correctly to avoid complications like infection at the injection site. Training may be provided for patients who will administer the injections at home.

Conclusion

Eleftha 150 mg Injection (Efalizumab) is a monoclonal antibody used to treat moderate to severe chronic plaque psoriasis and possibly psoriatic arthritis by modifying the immune response. It works by blocking T-cell migration to the skin, reducing inflammation and cell turnover in psoriasis. Although effective, Efalizumab can suppress the immune system, increasing the risk of infections and requiring careful monitoring throughout treatment.