DARZALEX 100mg/5ml Infusion/Concentrate for Solution for

What is DARZALEX 100mg/5ml

DARZALEX 100mg/5ml is a concentrate for solution used for infusion, containing Daratumumab, a monoclonal antibody designed to target the CD38 protein on the surface of certain cancerous cells. It is primarily used in the treatment of multiple myeloma, a type of blood cancer.

Daratumumab works by binding to CD38, a protein found on the surface of myeloma cells, triggering the immune system to attack and destroy these cells. DARZALEX is often used in combination with other medications to enhance its therapeutic effects.

How to use DARZALEX 100mg/5ml

DARZALEX 100mg/5ml is administered as an intravenous infusion. The usage instructions are as follows:

• Administration Route: Given through intravenous infusion under the supervision of a healthcare professional.
• Infusion Schedule: Treatment usually starts with weekly infusions, then progresses to biweekly or monthly sessions, depending on the patients response to the therapy.
• Pre-medication: Patients are typically premedicated with corticosteroids, antihistamines, and acetaminophen to reduce the risk of infusion-related reactions.

Close monitoring during the infusion is necessary to manage any potential side effects or reactions.

Mode of Action DARZALEX 100mg/5ml

DARZALEX 100mg/5ml acts by targeting CD38, a protein overexpressed on the surface of myeloma cells. By binding to this protein, Daratumumab activates the immune system to destroy the cancer cells through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).

This targeted action makes DARZALEX a vital treatment in multiple myeloma, especially in patients who have relapsed or are refractory to other therapies.

• Mechanism of Action: Daratumumab binds to CD38 and triggers immune-mediated destruction of myeloma cells.
• Other Indications: In combination with other agents, it can improve overall survival in patients with multiple myeloma.

DARZALEX plays an important role in the management of multiple myeloma by improving disease control and prolonging survival.

DARZALEX 100mg/5ml Interactions DARZALEX 100mg/5ml

Before using DARZALEX 100mg/5ml, it is important to consider potential drug interactions:

• Immunosuppressants: Combining Daratumumab with other immunosuppressants may increase the risk of infections due to lowered immune defenses.
• Live Vaccines: Avoid live vaccines during treatment, as Daratumumab may weaken the immune response to the vaccine.
• Blood Transfusion Compatibility: Daratumumab may interfere with certain blood tests and cross-matching procedures for blood transfusions, so inform healthcare providers about ongoing treatment.

Careful monitoring and communication with your healthcare team are essential when using DARZALEX.

Dosage of DARZALEX 100mg/5ml

The dosing for DARZALEX 100mg/5ml is tailored based on the patients condition and treatment plan:

• Initial Dosing: Typically, an initial dose is administered over several hours during the first infusion session, followed by reduced infusion times for subsequent doses.
• Maintenance Dosing: After the initial phase, patients may receive biweekly or monthly infusions as maintenance therapy.
• Consultation: Dosing schedules should always be customized according to the patient's response and clinical status.

Strict adherence to the prescribed dosing schedule is crucial for the effective management of multiple myeloma.

Possible side effects of DARZALEX 100mg/5ml

Common side effects of DARZALEX 100mg/5ml include:

• Infusion-related reactions such as fever, chills, and shortness of breath
• Fatigue
• Upper respiratory infections
• Nausea
• Decreased blood cell counts (e.g., neutropenia, thrombocytopenia)

If severe side effects occur, such as difficulty breathing or severe allergic reactions, seek immediate medical attention.

DARZALEX 100mg/5ml Contraindications DARZALEX 100mg/5ml

Prior to starting treatment with DARZALEX 100mg/5ml, consider the following contraindications:

• Hypersensitivity to Daratumumab or any of its excipients.
• Pregnancy and breastfeeding: The safety of Daratumumab during pregnancy or breastfeeding has not been established.
• Patients with pre-existing infections should be treated for the infection before initiating therapy.

A thorough discussion of your medical history with your healthcare provider ensures the safe use of DARZALEX.

Storage of DARZALEX 100mg/5ml

Proper storage conditions for DARZALEX 100mg/5ml are important to maintain its stability and effectiveness:

• Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
• Do not freeze or shake the vial.
• Once diluted, the solution should be used within the recommended time frame as specified by the healthcare provider.

Follow all storage guidelines to ensure the safe administration of DARZALEX.