Darzalex (daratumumab) is a brand-name prescription medication. The Food and Drug Administration (FDA) has approved it to treat multiple myeloma in adults who:
- are newly diagnosed and don’t meet the criteria for an autologous stem cell transplant (ASCT).
- In this case, Darzalex may be given in combination with lenalidomide and dexamethasone.
- Darzalex may also be given along with bortezomib, melphalan, and prednisone.
- are newly diagnosed and are eligible for ASCT. In this case, Darzalex is given along 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 along with carfilzomib and dexamethasone in this instance.
- have previously received at least two treatments, including lenalidomide and a proteasome inhibitor. In this case, Darzalex is used along with pomalidomide and dexamethasone.
- have previously received at least three treatments, including a proteasome inhibitor and an immunomodulatory drug, that did not work. In this case, Darzalex is given by itself.
Darzalex comes as a solution that’s given as an IV infusion by a healthcare professional.
The active ingredient in Darzalex is daratumumab, which is a biologic. 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 kinds of multiple myeloma, but Darzalex Faspro is also used to treat light chain amyloidosis. This article focuses on Darzalex.
For information about Darzalex dosing, including its strengths and how to take the drug, keep reading. For a comprehensive look at Darzalex, see this article.
This article describes typical dosages for Darzalex provided by the drug’s manufacturer. However, your doctor will prescribe the Darzalex dosage that’s right for you.
Read below for important information about the dosage of Darzalex for its approved uses.
Darzalex form
Darzalex comes as a solution in a single-dose vial. A healthcare professional will give it as an IV infusion.
Darzalex strengths
Darzalex comes in single-dose vials in the following strengths:
- 100 milligrams (mg) per 5 milliliters (mL)
- 400 mg/20 mL
Typical dosages
The typical dosage of Darzalex 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 healthcare professional. For example, a 150-pound person weighs about 68.2 kg. That means their Darzalex dose would be 68.2 kg multiplied by 16 mg per kg, which is 1,091 mg. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
* One kilogram is equal to about 2.2 pounds.
Dosage for adults whose past treatment wasn’t effective enough or who can’t receive an autologous stem cell transplant
The recommended dose of Darzalex for adults whose past treatment wasn’t effective enough or who can’t receive an autologous stem cell transplant is 16 mg/kg of body weight. The following tables show dosing guides for Darzalex when given in combination with other drugs or by itself.
Darzalex with lenalidomide and dexamethasone
| Weeks | Dosing schedule |
| Weeks 1 to 8 | 1 dose given once per week for a total of 8 doses |
| Weeks 9 to 24* | 1 dose given every other week for a total of 8 doses |
| Week 25 through when the drug stops working† | 1 dose given every 4 weeks |
* The first dose of the every-other-week schedule is given at Week 9.
† The first dose of the every-4-weeks schedule is given at Week 25.
Darzalex with pomalidomide and dexamethasone
| Weeks | Dosing schedule |
| Weeks 1 to 8 | 1 dose given once per week for a total of 8 doses |
| Weeks 9 to 24* | 1 dose given every other week for a total of 8 doses |
| Week 25 through when the drug stops working† | 1 dose given every 4 weeks |
* The first dose of the every-other-week schedule is given at Week 9.
† The first dose of the every-4-weeks schedule is given at Week 25.
Darzalex by itself, after certain other treatments
| Weeks | Dosing schedule |
| Weeks 1 to 8 | 1 dose given once per week for a total of 8 doses |
| Weeks 9 to 24* | 1 dose given every other week for a total of 8 doses |
| Week 25 through when the drug stops working† | 1 dose given every 4 weeks |
* The first dose of the every-other-week schedule is given at Week 9.
† The first dose of the every-4-weeks schedule is given at Week 25.
Darzalex with bortezomib, melphalan, and prednisone
| Weeks | Dosing schedule |
| Weeks 1 to 6 | 1 dose given once per week for a total of 6 doses |
| Weeks 7 to 54* | 1 dose given once every 3 weeks for a total of 16 doses |
| Week 55 through when the drug stops working† | 1 dose given once every 4 weeks |
* The first dose of the every-3-weeks schedule is given at Week 7.
† The first dose of the every-4-weeks schedule is given at Week 55.
Dosage for newly diagnosed multiple myeloma and eligible for a stem cell transplant
The recommended dose of Darzalex for newly diagnosed multiple myeloma and eligible for a stem cell transplant is 16 mg/kg of body weight. The following tables show treatment phases for Darzalex when given in combination with other drugs or by itself.
Darzalex with bortezomib, thalidomide, and dexamethasone
| Treatment phase | Weeks | Dosing schedule |
| induction phase (step 1) | Weeks 1 to 8 | 1 dose given once weekly for a total of 8 doses |
| induction phase (step 2) | Weeks 9 to 16* | 1 dose given once every other week for a total of 4 doses |
* The first dose of the every-other-week schedule is given at Week 9.
After 16 weeks, treatment with Darzalex is stopped, and a healthcare professional administers high dose chemotherapy and an autologous stem cell transplant. Next, a person starts a consolidation phase of Darzalex as follows:
| Treatment phase | Weeks | Dosing schedule |
| consolidation phase | Weeks 1 to 8 | 1 dose given once every other week for a total of 4 doses |
Dosage for adults whose past treatment with certain drugs wasn’t effective enough
The recommended dose of Darzalex for adults who have had previous treatments is 16 mg/kg of body weight. The following tables show dosing guides for Darzalex when given in combination with other drugs or by itself.
Darzalex with bortezomib and dexamethasone (3-week cycle)
| Weeks | Dosing schedule |
| Weeks 1 to 9 | 1 dose given once weekly for a total of 9 doses |
| Weeks 10 to 24* | 1 dose given once every 3 weeks for a total of 5 doses |
| Week 25 through when the drug stops working† | 1 dose given once every 4 weeks |
* The first dose of the every-3-weeks schedule is given at Week 10.
† The first dose of the every-4-weeks schedule is given at Week 25.
Darzalex with carfilzomib and dexamethasone
| Weeks | Dose of Darzalex | Dosing schedule |
| Week 1 | 8 mg/kg | 1 dose given on Days 1 and 2 for a total of 2 doses |
| Weeks 2 to 8 | 16 mg/kg | 1 dose given once weekly for a total of 7 doses |
| Weeks 9 to 24* | 16 mg/kg | 1 dose given once every other week for a total of 8 doses |
| Week 25 through when the drug stops working† | 16 mg/kg | 1 dose given once every 4 weeks |
* The first dose of the every-other-weeks schedule is given at Week 9.
† The first dose of the every-4-weeks 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’ll likely take it long term.
The Darzalex dosage your doctor prescribes will depend on several factors. These include:
- if you’ve had other treatments for multiple myeloma
- if you’ve had an autologous stem cell transplant
- if your doctor has prescribed other medications along with Darzalex
- what your body weight is
Other medical conditions you have can also affect your Darzalex dosage.
Below are some frequently asked questions about Darzalex’s dosage and their answers.
What is split dosing for Darzalex?
Because 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 (back-to-back) days. You’ll receive the same total amount of medication either way.
If your doctor recommends split dosing, 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 questions about split dosing for Darzalex, talk with your doctor.
Will my Darzalex infusion time always be the same?
Your first infusion will take longer than the infusions you’ll get later. If you have certain reactions during your treatment with Darzalex, your doctor may stop or slow down the infusion. Some of these reactions can include:
- changes in blood pressure or heart rate
- coughing or feeling short of breath
- headache
- swelling in the throat or lungs
- certain eye problems
- chills
- vomiting and nausea
Your doctor may also give you medications before your infusion to decrease the chance of having a reaction. These can include a steroid, antihistamine, or acetaminophen. And after your infusion, you may receive another steroid to prevent any reactions that could happen later.
If you have questions about your Darzalex infusion time, talk with your doctor.
To learn more about Darzalex’s side effects, see this article.
Darzalex comes as a solution that’s given as an IV infusion by a healthcare professional. You will receive your infusion in your doctor’s office or an infusion clinic.
Your doctor will start your first infusion at a slow rate and then increase it to a rate that works for you. Your first infusion will likely take up to 7 hours. The next doses you receive will likely take less time, usually from 3 to 5 hours.
Your doctor may also give you other medications, such as a steroid, antihistamine, or acetaminophen, before your Darzalex infusion. These medications can help prevent a reaction to your Darzalex infusion.
If you miss an appointment for your Darzalex infusion, let your doctor know as soon as possible. They’ll likely adjust future appointments to line up with the new dosing schedule.
To help make sure that you don’t miss an appointment, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
The dosages in this article are typical dosages provided by the drug’s manufacturer. If your doctor recommends Darzalex for you, they will prescribe the dosage that’s right for you.
If you have questions about the dosage of Darzalex that’s best for you, talk with your doctor.
Besides learning about dosage, you may want other information about Darzalex. These additional resources might be helpful to you:
- More about Darzalex. For information about other aspects of Darzalex, refer to this article.
- Side effects. To learn about side effects of Darzalex, see this article. You can also look at the Darzalex prescribing information.
- Drug comparison. Find out how Darzalex compares with Empliciti and with Kyprolis.
- Details about your condition. For details about multiple myeloma, see this article about Darzalex for multiple myeloma, as well as our cancer hub.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, 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 another 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 all specific uses.