DARZALEX 100 mg per 5 ml 20 mg/ml Concentrate for solution for infusion 5ml Vial

DARZALEX (Daratumumab) 100 mg per 5 ml Concentrate for solution for infusion is a prescription medication designed for the treatment of adult patients with multiple myeloma.

Developed by Janssen Biotech, Inc., a Johnson & Johnson company, DARZALEX works as a CD38-directed cytolytic antibody, targeting and helping to destroy multiple myeloma cells that express the CD38 protein.

This advanced therapy is administered intravenously by healthcare professionals in a controlled clinical setting.

Benefits of Use

• DARZALEX offers a targeted approach to treating multiple myeloma by specifically attacking CD38-expressing cancer cells.
• It has been shown to be effective in various treatment settings, including newly diagnosed and relapsed/refractory multiple myeloma patients.
• When used in combination with other therapies, DARZALEX can significantly improve progression-free survival and overall survival rates.
• It provides a valuable treatment option for patients seeking advanced therapeutic solutions.

How to Use

1. DARZALEX is administered solely by a qualified healthcare professional.
2. It is given as an intravenous (IV) infusion into a vein.
3. The specific dosage, frequency, and duration of treatment will be determined by your physician based on your weight, condition, and the specific treatment regimen.
4. Pre-medication, typically including corticosteroids, antihistamines, and antipyretics, is required before each infusion to help reduce the risk and severity of infusion-related reactions.
5. The infusion rate is carefully controlled and may be adjusted during administration.

Caution & Warnings

• Infusion-Related Reactions: DARZALEX can cause infusion-related reactions, which can be severe or even fatal. These reactions may occur during or up to 48 hours after infusion and may include respiratory symptoms, hypertension, chills, fever, and chest pain.
• Hematological Toxicity: Treatment with DARZALEX may lead to decreases in blood cell counts, including neutropenia (low white blood cells), thrombocytopenia (low platelets), and lymphopenia (low lymphocytes). Regular blood count monitoring is essential.
• Infections: Patients receiving DARZALEX may have an increased risk of serious infections, including bacterial, viral, and fungal infections.
• Hepatitis B Virus Reactivation: Screening for Hepatitis B virus (HBV) is recommended before starting treatment, as reactivation of HBV can occur.
• Interference with Cross-Matching and Antibody Screening: Daratumumab can interfere with indirect antiglobulin tests (e.g., cross-matching and antibody screening) for up to 6 months after the last dose, potentially leading to false-positive results.
• Pregnancy and Lactation: DARZALEX is not recommended during pregnancy or breastfeeding due to potential harm to the fetus or infant. Women of childbearing potential should use effective contraception during and for a period after treatment.
• This medication must be administered under strict medical supervision in a clinical setting equipped to manage potential adverse reactions.

Ingredients

• Active Ingredient: Daratumumab
• Excipients: Glacial acetic acid, sodium acetate trihydrate, mannitol, polysorbate 20, water for injection.

Product Details

• Form: Concentrate for solution for infusion
• Strength: 100 mg per 5 ml (20 mg/ml)
• Package Size: 5 ml Vial
• Manufacturer: Janssen Biotech, Inc., a Johnson & Johnson company
• Drug Type: Prescription Only Medicine (POM)