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How is Darzalex administered?

Medically reviewed by Carmen Fookes, BPharm Last updated on May 20, 2020.

Official Answer

by Drugs.com
  • Darzalex is administered by an intravenous infusion (a bag of the solution is transfused directly into a vein).
  • Preinfusion medications, such as corticosteroids, acetaminophen, and antihistamines need to be administered one to three hours before an infusion of Darzalex.
  • The first infusion of Darzalex takes around seven to eight hours. This is because there is a risk of infusion reactions with the very first infusion of Darzalex. This risk diminishes with subsequent infusions.
  • Subsequent infusions of Darzalex take around three to four hours.

Darzalex (daratumumab) is a targeted treatment that may be used to treat adult patients with multiple myeloma (bone marrow cancer). It works by blocking a certain protein on stem cells causing cell death and reducing the numbers of other cells. It also helps your immune system identify and destroy multiple myeloma cells.

Darzalex is usually given after other treatments have failed and are sometimes used in combination with other cancer medicines.

How is Darzalex given?

Darzalex is administered by infusion directly into a vein. Other medications, such as corticosteroids, antipyretics, and antihistamines are given before and after the infusion to help prevent serious side effects or an allergic reaction.

The first infusion needs to be given slowly (over approximately 7 to 8 hours) because there is a risk of allergic reactions associated with Darzalex. The risk of reactions decreases with subsequent infusions which can be given over about 4 hours for the second infusion and 3 hours for subsequent infusions.

Darzalex is usually given every one to three weeks for the first few weeks of treatment, depending on what other treatments you have received for multiple myeloma. Then the frequency of infusions is reduced to once every four weeks until your body no longer responds to Darzalex (indicated by the progression of multiple myeloma).

The effects of Darzalex on blood-typing tests may last for up to 6 months after stopping this treatment. Darzalex is usually given at a dosage of 16mg/kg of actual body weight.

How is Darzalex infused?

  1. Administer preinfusion medications one to three hours before the Darzalex administration to reduce the risk of infusion reactions. These may consist of a corticosteroid (such as methylprednisolone, dexamethasone), oral acetaminophen, and an antihistamine (such as diphenhydramine).
  2. Prepare the solution for infusion by calculating the correct dosage of Darzalex and diluting with 0.9% sodium chloride. The volume of sodium chloride should be 1000ml for the first infusion and 500ml for subsequent infusions.
  3. Gently invert the bag/container to mix. Inspect the bag for particles. Because Darzalex is a protein, small translucent particles might be visible; however, if the solution is discolored or opaque particles or foreign matter are present do not use.
  4. Administer the diluted solution immediately at room temperature (15-25°C [59-77°F]). Diluted solution may be kept at room temperature for 15 hours (includes infusion time) or refrigerated and protected from light for 24 hours. If refrigerated allow to come to room temperature before using.
  5. Administer the diluted Darzalex by intravenous infusion using an inline filter (0.2-0.22 micrometer). Do not infuse in the same line as other agents.
  6. The rate of infusion varies depending on how many infusions the person has had before. For the first infusion, it should be administered at a rate of 50ml/hour for the first 60 minutes. This can be increased to 100 ml/hour for the next hour, then 150ml an hour for the next hour, then to the maximum of 200ml/hour for the subsequent hours.
  7. The first infusion is generally administered over 7 to 8 hours. Future infusions usually take approximately 4 hours if they are well tolerated by the patient.
  8. If an infusion reaction occurs, stop the Darzalex infusion until symptoms have resolved. Once symptoms have resolved the infusion may be restarted at half the previous rate which may be increased if no other symptoms are experienced.
  9. Darzalex will need to be discontinued if three Grade 3 or higher infusion reactions are experienced.
  10. Give post-infusion medication to reduce the risk of delayed infusion reactions. This may consist of an oral corticosteroid, such as methylprednisolone for one to two days following the infusion. In people with COPD, for the first four infusions prescribe short and long-acting bronchodilators and inhaled corticosteroids post-infusion; however, these additional medications may be discontinued if no major infusion reactions occur.

Also, antiviral prophylaxis may be given within a week after starting Darzalex and continued for three months to prevent herpes zoster reactivation in those with a previous herpes zoster infection.

How does Darzalex work?

A protein called CD38 exists on the surface of hematopoietic cells – these are the stem cells that give rise to other blood cells. CD38 has multiple functions, such as cell binding (including during inflammation), cell signaling, and regulating enzyme activity.

Darzalex binds strongly and specifically to CD38, and once bound induces an immune response that results in the death of myeloid cancer cells.

Darzalex also reduces the numbers of myeloid-derived suppressor cells – these are immune cells that originate from bone marrow stem cells whose numbers are significantly increased during chronic infections and cancer, as a result of hematopoiesis (the formation of a range of different blood cells from bone marrow stem cells).

Antibodies are proteins that are used by the immune system to protect our body against foreign invaders, such as bacteria and viruses. They can be classified into five main subtypes IgA, IgD, IgE, IgG, and IgM based on the sequence and structure. Darzalex is an IgG monoclonal antibody.

References
  • Darzalex (daratumumab) [Package Insert] jansenn https://www.drugs.com/pro/darzalex.html
  • Anne Pierres, Anne-Marie Benoliel & Pierre Bongrand (1998) Studying
  • Receptor-Mediated Cell Adhesion at the Single-Molecule Level, Cell Adhesion and Communication,
  • 5:5, 375-395, DOI: 10.3109/15419069809010783
  • Darzalex janssen oncology https://www.darzalex.com/multiple-myeloma-treatment/what-is-darzalex
  • Grieve s. Type of Multiple Myeloma May Affect Responses to Darzalex, Study Finds. Oct 20, 2017. https://myelomaresearchnews.com/2017/10/20/characteristics-myeloma-disease-may-impact-exposure-darzalex-study-reports/

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