Form, strengths, instructions for use, etc.

Darzalex (daratumumab) is a brand name prescription drug. The Food and Drug Administration (FDA) has approved it to treat multiple myeloma in adults who:

  • are newly diagnosed and do not meet the criteria for an autologous stem cell transplant (ASCT).
  • are newly diagnosed and eligible for ASCT. In this case, Darzalex is administered together with bortezomib, thalidomide and dexamethasone.
  • have multiple myeloma that has relapsed or has not responded after at least one treatment in the past. Darzalex is given in combination with lenalidomide and dexamethasone in this case.
  • have tried at least one therapy in the past. Darzalex is given in combination with bortezomib and dexamethasone in this case.
  • have multiple myeloma that has relapsed or has not responded after one to three treatments in the past. Darzalex is given with carfilzomib and dexamethasone in this case.
  • have already received at least two treatments, including lenalidomide and a proteasome inhibitor. In this case, Darzalex is used together with pomalidomide and dexamethasone.
  • have already received at least three treatments, including a proteasome inhibitor and an immunomodulatory drug, which have not worked. In this case, Darzalex is given alone.

Darzalex comes as a solution given as an IV infusion by a healthcare professional.

The active ingredient in Darzalex is daratumumab, which is a biological product. It belongs to a class of drugs called monoclonal antibodies. There is no generic form of Darzalex.

Darzalex vs. Darzalex Faspro

Darzalex and Darzalex Faspro contain the same active drug, daratumumab. Darzalex Faspro also contains hyaluronidase-fihj. Both drugs are used for certain types of multiple myeloma, but Darzalex Faspro is also used to treat light chain amyloidosis. This article focuses on Darzalex.

For more information on Darzalex dosage, including its strengths and how to take the drug, keep reading. For a complete overview of Darzalex, check out this article.

This article outlines typical doses of Darzalex provided by the drug’s manufacturer. However, your doctor will prescribe the dose of Darzalex that is right for you.

Read below important information about Darzalex dosage for its approved uses.

Darzalex form

Darzalex comes as a solution in a single-dose vial. A healthcare professional will administer it as an IV infusion.

The strengths of Darzalex

Darzalex is presented in single-dose vials at the following dosages:

  • 100 milligrams (mg) per 5 milliliters (mL)
  • 400mg/20mL

Typical dosages

The typical Darzalex dosage for most of its approved uses is 16 milligrams per kilogram (mg/kg)* of body weight. This is given as an IV infusion by a medical professional. For example, a 150 pound person weighs approximately 68.2 kg. This means that their dose of Darzalex would be 68.2 kg multiplied by 16 mg per kg, or 1091 mg. Your doctor will ultimately prescribe the smallest dose that provides the desired effect.

The following information describes commonly used or recommended dosages. However, be sure to take the dose prescribed by your doctor. Your doctor will determine the best dosage to meet your needs.

* One kilogram equals approximately 2.2 pounds.

Dosage for adults whose previous treatment was not effective enough or who cannot receive an autologous stem cell transplant

The recommended dose of Darzalex for adults whose previous treatment has not been sufficiently effective or who cannot receive an autologous stem cell transplant is 16 mg/kg body weight. The following tables provide dosing guides for Darzalex when given in combination with other medications or alone.

Darzalex with lenalidomide and dexamethasone

* The first dose of the every other week schedule is given at week 9.
† The first dose of the every 4 week schedule is given at week 25.

Darzalex with pomalidomide and dexamethasone

* The first dose of the every other week schedule is given at week 9.
† The first dose of the every 4 week schedule is given at week 25.

Darzalex alone, after certain other treatments

* The first dose of the every other week schedule is given at week 9.
† The first dose of the every 4 week schedule is given at week 25.

Darzalex with bortezomib, melphalan and prednisone

* The first dose of the every 3 week schedule is given at week 7.
† The first dose of the every 4 week schedule is given at week 55.

Dosage for Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplantation

The recommended dose of Darzalex for newly diagnosed multiple myeloma eligible for stem cell transplantation is 16 mg/kg body weight. The following tables show the treatment phases for Darzalex when given in combination with other medicines or alone.

Darzalex with bortezomib, thalidomide and dexamethasone

* The first dose of the every other week schedule is given at week 9.

After 16 weeks, Darzalex treatment is stopped and a healthcare professional administers high-dose chemotherapy and an autologous stem cell transplant. Then, a person begins a consolidation phase of Darzalex as follows:

Dosage for adults whose previous treatment with certain drugs was not effective enough

The recommended dose of Darzalex for treatment-experienced adults is 16 mg/kg body weight. The following tables provide dosing guides for Darzalex when given in combination with other medications or alone.

Darzalex with bortezomib and dexamethasone (3 week cycle)

* The first dose of the every 3 week schedule is given at week 10.
† The first dose of the every 4 week schedule is given at week 25.

Darzalex with carfilzomib and dexamethasone

* The first dose of the every other week schedule is given at week 9.
† The first dose of the every 4 week schedule is given at week 25.

Long term treatment

Darzalex is meant to be a long-term treatment. If you and your doctor determine that Darzalex is safe and effective for you, you are likely to take it long term.

The Darzalex dosage prescribed by your doctor will depend on several factors. These include:

Other medical conditions you have may also affect your Darzalex dosage.

Below are some frequently asked questions about Darzalex dosage and their answers.

What is split dosing for Darzalex?

Since the first dose of Darzalex takes 7 hours to infuse, your doctor may decide to split this dose over two days. This is known as “split dosing” and allows you to receive two shorter IV infusions on two consecutive days (back to back). You will receive the same total amount of medication both ways.

If your doctor recommends divided administration, you will receive:

  • 8 milligrams per kilogram (mg/kg) infused over 4.2 hours on day 1
  • 8 mg/kg infused over 4.2 hours on day 2

If you have any questions about the divided administration of Darzalex, talk to your doctor.

Will the duration of my Darzalex infusion always be the same?

Your first infusion will take longer than the infusions you receive later. If you have certain reactions during your treatment with Darzalex, your doctor may stop or slow down the infusion. Some of these reactions may include:

Your doctor may also give you medicine before your infusion to reduce the risk of a reaction. These may include a steroid, antihistamine, or acetaminophen. And after your infusion, you may be given another steroid to prevent any reactions that may occur later.

If you have any questions about how long your Darzalex infusion will last, talk to your doctor.

To learn more about the side effects of Darzalex, check out this article.

Darzalex comes as a solution given as an IV infusion by a healthcare professional. You will receive your infusion at your doctor’s office or at an infusion clinic.

Your doctor will start your first infusion at a slow rate and then increase it to a rate that is right for you. Your first infusion will probably take up to 7 hours. The next doses you receive will probably take less time, usually 3 to 5 hours.

Your doctor may also give you other medicines, such as a steroid, antihistamine, or acetaminophen, before your Darzalex infusion. These medicines can help prevent a reaction to your Darzalex infusion.

If you miss an appointment for your Darzalex infusion, tell your doctor as soon as possible. They will likely adjust future appointments to align with the new dosing schedule.

To make sure you don’t miss an appointment, try using a medication reminder. This may include setting an alarm or using a timer. You can also download a reminder app on your phone.

The dosages in this article are typical dosages provided by the drug manufacturer. If your doctor recommends Darzalex, he will prescribe the dosage that is right for you.

If you have any questions about which Darzalex dosage is right for you, talk to your doctor.

Apart from learning the dosage, you may want other information about Darzalex. These additional resources you may find helpful:

Disclaimer: Medical News Today has made every effort to ensure that all information is factually correct, complete and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or for all specific uses.

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