Darzalex (daratumumab)

Product Name:

Darzalex (daratumumab)

Categories: Hematology, Oncology

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Table of Contents

Darzalex (daratumumab)

1. Product Category

Oncology / Hematology

2. Brand Name

Darzalex

3. Generic Name or Biosimilar

No

4. Active Ingredient

Daratumumab

5. Prescription Status

Prescription-only in the United States, Mexico, and Canada.

Targeted Conditions

  • Multiple myeloma (various lines of therapy, in combination or monotherapy).

  • Light chain (AL) amyloidosis (in combination therapy).

Off-Label Usage

  • Studied for chronic lymphocytic leukemia (CLL).

  • Investigated in non-Hodgkin lymphoma and autoimmune diseases (e.g., systemic lupus erythematosus).

Drug Classification Overview

Darzalex is a monoclonal antibody that targets CD38, a protein found on multiple myeloma cells. By binding to CD38, it triggers immune-mediated destruction of malignant plasma cells and interferes with tumor survival pathways.

Manufacturer in the USA, Mexico, and Canada

  • United States: Janssen Biotech, Inc. (Johnson & Johnson)

  • Canada: Janssen Inc. Canada

  • Mexico: Janssen-Cilag S.A. de C.V.

Available Strengths and Dosage Forms – United States, Mexico, and Canada

Country Comparison – United States vs Mexico and Canada

  • Approved in all three countries for multiple myeloma.

  • Canada and Mexico may have differences in funded lines of therapy and combination regimens.

Average Retail Price (Monthly Treatment) USA vs Mexico vs Canada

Canada: Typically 20–30% savings compared to U.S. pricing.
Mexico: Typically 25–35% savings compared to U.S. pricing.
Savings are approximate, based on 2025 data. They may vary depending on infusion center fees, hospital access, and distribution pathways.

Where to Buy USA

  • Costco

  • CVS

  • Rite Aid

  • Walgreens

  • Walmart

  • Kroger

  • Albertsons

  • Sam’s Club

  • Publix

  • Target (via CVS Pharmacy)

  • Online mail-order specialty care pharmacies

Note: Dispensed exclusively via oncology/hematology specialty pharmacies and infusion centers.

Storage Requirements

  • Refrigerate at 2°C–8°C (36°F–46°F).

  • Do not freeze or shake.

  • Protect from light and store in original carton.

Shipping from Canada

This medication is accessed through fully licensed Canadian pharmacies regulated by Health Canada. All pharmacies included in the MedicalMex network undergo a rigorous review and verification process to ensure compliance with national standards, patient safety, and medication authenticity.

MedicalMex facilitates:

  • Prescription verification and fulfillment coordination

  • Secure, compliant medication logistics

  • Access to licensed Canadian pharmacists

  • Access to our network of certified physicians if a Telehealth consultation is needed

  • Case management, payment handling, and personalized boutique-level support

  • Cold chain shipping with next-generation temperature-monitored coolers, when required

  • Refill tracking and patient adherence programs

You are working directly with MedicalMex Inc., a U.S.-based company that helps eligible patients safely access affordable medications from Canada — with compliance and full-service concierge support at every step.

Buying from Mexico

This medication is also available through certified pharmacies in Mexico regulated by COFEPRIS (Mexico’s national health authority). All partners in the MedicalMex network must pass a rigorous review and certification process before being approved for patient access.

MedicalMex facilitates:

  • Transportation support to our affiliate clinic in Tijuana, Mexico

  • Prescription handling through licensed physicians within our certified network

  • Access to our network of accredited physicians if a Telehealth consultation is needed

  • Travel coordination, including flights and/or hotel reservations when required

  • Travel insurance

  • Cold chain shipping with advanced temperature-monitored coolers, when applicable

  • Personalized, boutique-level service

  • Refill tracking and patient adherence support

You are working directly with MedicalMex Inc., a U.S.-based company that manages every detail — from medical and travel logistics to prescription compliance — providing secure, affordable access to life-saving medications from Mexico.

Key Benefits

  • Proven efficacy in prolonging progression-free survival in multiple myeloma.

  • Can be used across multiple lines of therapy, both frontline and relapsed.

  • Available in IV infusion and subcutaneous injection (Darzalex Faspro in some regions).

  • Synergistic when combined with other standard myeloma therapies (e.g., bortezomib, lenalidomide).

Side Effects

Common side effects:

  • Infusion-related reactions (cough, throat irritation, chills, fever).

  • Fatigue.

  • Nausea.

  • Back pain.

  • Upper respiratory tract infections.

Serious but less common side effects:

  • Severe infusion reactions, including bronchospasm and anaphylaxis.

  • Neutropenia, anemia, thrombocytopenia.

  • Risk of serious infections (pneumonia, sepsis).

  • Rare hepatitis B reactivation.

Warnings and Precautions

  • Pre-medication with corticosteroids, antihistamines, and antipyretics required to reduce infusion reactions.

  • Monitor for cytopenias (low blood counts).

  • Screen for hepatitis B virus before starting therapy.

  • Interference with blood typing tests (due to CD38 binding on red blood cells).

  • Not recommended during pregnancy or breastfeeding.

Alternative Medications (by Indication)

  • Kyprolis (carfilzomib): Proteasome inhibitor.

  • Revlimid (lenalidomide): Immunomodulatory drug.

  • Velcade (bortezomib): Proteasome inhibitor.

  • Empliciti (elotuzumab): SLAMF7-targeting monoclonal antibody.

  • Pomalyst (pomalidomide): Immunomodulatory drug used in relapsed myeloma.

Medication FAQs

Darzalex is prescribed for multiple myeloma, either as part of initial treatment or in relapsed/refractory disease.

It is given as an intravenous infusion or subcutaneous injection, usually in a clinic or hospital.

Schedules vary: weekly at first, then every 2–4 weeks depending on treatment phase.

Infusion-related reactions are most common with the first dose; pre-medications help reduce this risk.

No. It does not cure but can significantly prolong survival and improve quality of life.

Yes. It is often combined with bortezomib, lenalidomide, or dexamethasone.

Yes. It can lower blood counts and increase risk of infections.

Yes. Patients must be screened due to risk of viral reactivation.

No. Only the branded version is available.

Yes. Support programs exist in the U.S., Canada, and Mexico. MedicalMex helps patients explore safe and affordable access.