Description

Darzalex (Daratumumab) Injection – Uses, Dosage, Side Effects, Storage

Darzalex (daratumumab) is a prescription monoclonal antibody used in the treatment of multiple myeloma and light chain (AL) amyloidosis. It is supplied as a 100 mg/5 mL single-dose vial for intravenous (IV) infusion and is administered only by a healthcare professional.

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Product Information

• Brand Name: Darzalex

• Generic Name: Daratumumab

• Strength & Formulation: 100 mg/5 mL injection (single-dose vial)

• Appearance: Colorless to pale yellow, preservative-free solution

• Drug Class: Human monoclonal antibody (CD38-targeting)

• Route of Administration: Intravenous infusion (must be diluted before use)

• Storage: Refrigerate at 2°C – 8°C; protect from light

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Mechanism of Action – How Darzalex Works

Darzalex targets CD38, a protein highly expressed on the surface of multiple myeloma cells.

• Binding to CD38: Daratumumab attaches to the CD38 protein.

• Immune Activation: Triggers immune-mediated killing of cancer cells.

• Cell Death (Apoptosis): Induces programmed cell death through cytotoxic pathways.

This makes Darzalex an effective targeted therapy against multiple myeloma and related blood cancers.

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Indications & Approved Uses

Darzalex is FDA-approved and used for:

• Multiple Myeloma (MM):

  • As monotherapy in previously treated patients.

  • In combination with other drugs for newly diagnosed or relapsed/refractory multiple myeloma.

• AL Amyloidosis:

  • Approved for adults with newly diagnosed light chain (AL) amyloidosis, a rare blood disease.

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Dosage & Administration

Darzalex must be diluted with 0.9% sodium chloride injection before infusion. The dosing schedule depends on whether it’s used alone or with other therapies.

Typical Infusion Schedule:

• Weekly for the first 8 weeks.

• Every 2 weeks for the next 16 weeks.

• Every 4 weeks thereafter until disease progression.

💉 Infusion is performed in a hospital or clinic under medical supervision due to risk of infusion-related reactions.

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Ingredients

• Active Ingredient: Daratumumab

• Inactive Ingredients: Glacial acetic acid, sodium acetate trihydrate, sodium chloride, mannitol, polysorbate 20, and water for injection.

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Storage & Stability

• Unopened vials: Refrigerate at 2–8°C, protect from light.

• Room temperature: Can be stored up to 30°C for 24 hours.

• Diluted solution: Stable up to 24 hours refrigerated or 15 hours at room temperature.

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Side Effects & Safety Information

Common side effects include:

• Infusion-related reactions (fever, chills, breathing difficulty)

• Fatigue

• Nausea

• Diarrhea or constipation

• Cough or upper respiratory infections

Serious Risks:

• Low blood cell counts (anemia, neutropenia, thrombocytopenia)

• Severe infusion reactions

• Interference with blood typing (patients may need special testing before transfusion)