Key takeaways
- Darzalex is administered through intravenous infusion at a dose calculated based on body weight. The first infusion takes up to 7 hours, and subsequent infusions last 3 to 4 hours.
- The dosing schedule varies depending on the treatment combination and stage of therapy, starting with weekly infusions for the first several weeks, then transitioning to every 2 weeks, and eventually moving to once every 4 weeks for maintenance.
- Patients receive pre-treatment medications to prevent infusion reactions and post-treatment medications, including corticosteroids, antivirals to prevent shingles reactivation, and bronchodilators for those with a history of COPD.
Darzalex (daratumumab) is a targeted immunotherapy drug used in adults to treat multiple myeloma. It can be prescribed on its own or in combination with other multiple myeloma treatments.
This article describes the dosages of Darzalex, its strengths, and how it’s given.
Darzalex comes as a liquid solution in a single-dose vial. A healthcare professional will mix it with another liquid solution before it’s injected into your vein as an intravenous (IV) infusion.
Darzalex comes in single-dose vials in the following strengths:
- 100 milligrams (mg) per 5 milliliters (mL)
- 400 mg/20 mL
Doctors may prescribe Darzalex on its own or in combination with other medications. Your dosing schedule and how long you take Darzalex is based on:
- your diagnosis
- your treatment history
- any other medications you take with it
The recommended dosage of Darzalex for treating multiple myeloma is 16 mg per kilogram (kg) of body weight. This means your doctor will calculate your dose by multiplying 16 mg by every kilogram you weigh. One kg is equal to about 2.2 pounds (lb).
For example, the Darzalex dose for a person who weighs 50 kg (about 110 pounds) would be 800 mg.
Your doctor will determine the best dosage and dosing schedule to fit your needs.
Doctors may prescribe Darzalex on its own or in combination with other medications. The same dosing schedule is used in the following three situations:
Darzalex with lenalidomide and dexamethasone
This combination is used for adults newly diagnosed with multiple myeloma who cannot receive a stem cell transplant, or for adults whose cancer has relapsed or not responded after receiving at least one prior therapy.
Darzalex with pomalidomide and dexamethasone
This combination is used for adults who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
Darzalex by itself (monotherapy)
Darzalex is used on its own for adults who have received at least three prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent), or whose cancer did not respond to both a proteasome inhibitor and an immunomodulatory agent.
Note: A “line of therapy” refers to a treatment regimen, which may consist of multiple cancer medications taken together.
For all three of these treatment paths, your doctor will calculate your dose based on your body weight (16 mg per kg). The recommended dosing schedule is:
| Dosing schedule | |
|---|---|
| Weeks 1 to 8 | once per week (total of 8 doses) |
| Weeks 9 to 24 | once every 2 weeks (total of 8 doses) |
| Weeks 25 and beyond | once every 4 weeks |
Darzalex with Velcade (bortezomib), melphalan, and prednisone
The dosing guide below explains the dose and schedule for adults receiving Darzalex in combination with Velcade (bortezomib), melphalan, and prednisone. This drug combination and dosing schedule are used for adults who are newly diagnosed with multiple myeloma and can’t receive a stem cell transplant using their own stem cells.
| Dosing schedule | |
|---|---|
| Weeks 1 to 6 | once per week (total of 6 doses) |
| Weeks 7 to 54 | once every 3 weeks (total of 16 doses) |
| Weeks 55 and beyond | once every 4 weeks |
Dosage for newly diagnosed multiple myeloma
Darzalex is given together with bortezomib, thalidomide, and dexamethasone for adults:
- with newly diagnosed multiple myeloma, and
- who can receive a stem cell transplant using their own stem cells
The dosing schedule has multiple parts:
- The first 16 weeks of dosing (called induction) aim to help induce (cause) your cancer to go into remission.
- Weeks 1 to 8: One dose per week (total of eight doses)
- Weeks 9 to 16: One dose every 2 weeks (total of four doses)
- After this, your Darzalex treatment is paused while you get high dose chemotherapy and a stem cell transplant using your own stem cells.
- Finally, you’ll receive consolidation dosing (dosing to kill any cancer cells left after initial treatments). This consists of a Darzalex infusion every 2 weeks until you’ve had a total of four more doses.
Dosage when previous treatments have not worked
Darzalex is used along with bortezomib and dexamethasone in adults previously treated for multiple myeloma with at least one medication.
| Dosing schedule | |
|---|---|
| Weeks 1 to 9 | once per week (total of 9 doses) |
| Weeks 10 to 24 | once every 3 weeks (total of 5 doses) |
| Weeks 25 and beyond | once every 4 weeks |
Darzalex is used along with Kyprolis (carfilzomib) and dexamethasone in adults whose multiple myeloma has relapsed or not responded to prior treatments, and who have received one to three prior lines of therapy.
| Dosing schedule | Darzalex dose | |
|---|---|---|
| Week 1 | days 1 and 2 (total of 2 doses) | 8 mg/kg |
| Weeks 2 to 8 | once every week (total of 7 doses) | 16 mg/kg |
| Weeks 9 to 24 | once every 2 weeks (total of 8 doses) | 16 mg/kg |
| Weeks 25 and beyond | once every 4 weeks | 16 mg/kg |
Darzalex is given by IV infusion, an injection into your vein over several hours. You’ll receive it at an infusion center or doctor’s office.
The healthcare professional will start the infusion at a slow rate and then increase it to a rate that’s right for you. The first infusion may take up to 7 hours. Future infusions will take less time, usually from 3 to 4 hours.
You may be given other medications before Darzalex, such as:
- Benadryl (diphenhydramine) or a similar antihistamine
- corticosteroids, such as dexamethasone or Medrol (methylprednisolone)
- Tylenol (acetaminophen), to help prevent or reduce fever
These medications help prevent a reaction to the Darzalex infusion. Other cancer medications may also be infused with Darzalex.
Post-infusion medications
You will likely be administered medications after your infusion. This typically includes a post-infusion corticosteroid (like methylprednisolone) taken the day after your infusion to reduce the risk of a delayed reaction.
If you have a history of chronic obstructive pulmonary disease (COPD), your doctor may also prescribe short- and long-acting bronchodilators and inhaled corticosteroids to help manage respiratory complications.
Because Darzalex can increase the risk of a shingles (herpes zoster) flare-up, your doctor will likely start you on antiviral medications within a week of starting Darzalex. You will typically continue taking these antivirals for 3 months after your treatment ends to prevent shingles.
If you miss your Darzalex infusion appointment, call your doctor as soon as you remember. It’s important to follow your treatment schedule.
If you need help remembering to attend your Darzalex appointments, try using a medication reminder. This can include setting an alarm or downloading a reminder app on your phone. Try to schedule your next infusion appointment before you leave the office after each dose.
Your Darzalex treatment schedule is based on several factors. How long you’ll take Darzalex will be affected by:
- the type of combination drug therapy you receive
- when you were diagnosed with multiple myeloma
- how your cancer responds to treatment
If you and your doctor determine that Darzalex is safe and effective for you, you’ll likely receive these infusions long term.
Darzalex split dosing is when your doctor splits the first infusion over 2 consecutive days. Studies have shown similar results at the end of the first week, whether the first dose was split or given all at once. Split dosing can improve your first experience with Darzalex because of the shorter infusions.
There haven’t been any formal studies on Darzalex renal dosing in people with kidney disease. Your Darzalex dose doesn’t need to be adjusted if you have kidney problems.
Darzalex is a targeted immunotherapy drug that treats people with multiple myeloma. A person receives it as an IV infusion in an infusion center or hospital every 1 to 4 weeks. The exact schedule depends on a person’s specific diagnosis, treatment history, and use of other medications.
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