DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)

Visit DARZALEX® (daratumumab) for more information about this drug’s original formulation and its intravenous (IV, into the vein) administration. 

What Is Darzalex Faspro?

Darzalex Faspro® is a newer formulation of Darzalex that is administered as an injection under the skin (subcutaneously, SQ). The injection is given by a healthcare professional under the skin of your abdomen, and it takes only a few minutes. Darzalex Faspro has been determined to be equally effective when compared to the original formulation of Darzalex. You must first consult with your doctor if you’re thinking about switching from IV to SQ administration..

What Are Some FDA-Approved Treatment Regimens with Darzalex Faspro SQ? 

• For patients with high-risk (HR) smoldering multiple myeloma (SMM):
  • Darzalex Faspro monotherapy in adults with HR-SMM.
• For patients with newly diagnosed multiple myeloma (NDMM):
  • Darzalex Faspro, Velcade, Revlimid, and dexamethasome [DVRd] in patients with NDMM who are eligible for ASCT, used for induction therapy and consolidation therapy.
  • Darzalex Faspro, Revlimid, and dexamethasome [DRd] in patients with NDMM who are ineligible for ASCT.
  • Darzalex Faspro, Velcade, melphalan, and prednisone [DVMP] in patients with NDMM who are ineligible for ASCT. 
  • Darzalex Faspro, Velcade, thalidomide, and dexamethasone [DVTd] in patients with NDMM who are eligible for ASCT. 
• For patients with relapsed or refractory multiple myeloma (RRMM): 
  • Tecvayli® (teclistamab-cqyv) and Darzalex Faspro [Tec-Dara] in patients with RRMM who have received at least 1 prior line of therapy.
  • Darzalex Faspro, Revlimid, and dexamethasome [DRd] in patients with RRMM who have received at least 1 prior therapy.
  • Darzalex Faspro, Velcade, and dexamethasone [DVd] in patients with RRMM who have received at least 1 prior therapy.
  • Darzalex Faspro, Pomalyst, and dexamethasone [DPd] in patients with RRMM who have received at least 1 prior line of therapy, including Revlimid and a proteasome inhibitor (Velcade, Kyprolis, or Ninlaro).
  • Darzalex Faspro, Kyprolis, and dexamethasone [DKd] in patients with RRMM who have received 1 to 3 prior lines of therapy.
  • Darzalex Faspro monotherapy in patients with RRMM who have received at least 3 prior lines of therapy, including a proteasome inhibitor (Velcade, Kyprolis, or Ninlaro) and an immunomodulatory agent (Revlimid, Pomalyst, or thalidomide), or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent. 

How Is Darzalex Faspro Given?

Darzalex Faspro SQ can be given on the same schedule as Darzalex IV. Yet, it is administered as an abdominal injection that takes only a few minutes.  

The risk of infusion-related reaction (IRR) is much lower with Darzalex Faspro SQ than with Darzalex IV. However, patients are still monitored for a few hours after the first one or two doses.  

The recommended dosage of Darzalex Faspro is 1,800 mg Darzalex plus 30,000 units hyaluronidase per 15 mL (120 mg and 2,000 units/mL) solution in a single-dose vial.  

Patients are pre-medicated with a corticosteroid, acetaminophen, and a histamine-1 receptor antagonist. Post-injection medications may also be recommended. 

Tecvayli and Darzalex Faspro

In March 2026, the FDA approved the combination therapy of Tecvayli and Darzalex Faspro [Tec-Dara] in patients with RRMM who have received at least 1 prior line of therapy. The application for FDA approval was granted priority review and was expedited. The approval is based on the efficacy of this combination evaluated in the MajesTEC-3 clinical trial. A total of 587 patients were randomized to receive either Tec-Dara (291 patients) or the study investigator’s choice of treatment (296 patients) received either DPd or DVd).

The major outcome measure was PFS, the length of time during and after treatment that a patient lives with the disease, but the myeloma does not get worse. The benefit in the Tec-Dara group of patients was dramatic. At 3 years, PFS was 83.4% in the Tec-Dara group vs. 29% in the DPd/DVd group. Overall survival (OS) was an additional efficacy outcome measure. Median PFS was not reached in the Tec-Dara group and was 18.1 months in the DPd/DVd group. Median OS was not reached in any study group.

Darzalex Faspro Monotherapy for High-Risk Smoldering Multiple Myeloma (HR-SMM) 

In November 2025, the FDA granted its first approval of a treatment for adult patients with HR-SMM based on data from the AQUILA clinical trial, which compared treatment with Darzalex Faspro for 3 years vs. active monitoring (observation) in 390 patients. 

Patients randomized to the Darzalex group were treated once-weekly from weeks 1 to 8, once every 2 weeks from weeks 9 to 24, and once every 4 weeks starting with week 25 until 39 cycles of treatment or up to 36 months or until diagnosis of myeloma or unacceptable toxicity. 

Darzalex Faspro is approved for patients with HR-SMM; it is not approved for other risk categories of SMM. For more information, read the IMF’s publication Understanding MGUS and Smoldering Multiple Myeloma

Special Precautions with Darzalex Faspro

All treatments for myeloma require close monitoring. As documentedin clinical trials with Darzalex or Darzalex Faspro, both drugs have the potential to cause Grade 3 or 4 side effects. A side effect is an unwanted or unexpected effect caused by a drug. In the U.S., the National Cancer Institute (NCI) toxicity is categorized as follows:

• Grade 0 – no symptoms,
• Grade 1 – mild symptoms,
• Grade 2 – moderate symptoms,
• Grade 3 – symptoms requiring treatment,
• Grade 4 – symptoms requiring urgent intervention,
• Grade 5 – symptoms resulting in death.

What Are Some Common Side Effects of Darzalex Faspro?

Administration-related reaction (ARR)

ARR is a systemic immune/hypersensitivity reactions that occur in response to the subcutaneous injection of the drug. In clinical trials of Darzalex Faspro, the terms "infusion reactions" and "infusion-related reactions" (IRRs) — used for the IV formulation (Darzalex) — were replaced with the term "systemic administration-related reactions" to reflect the subcutaneous route of administration. Clinical trial data documented ARR in 7-11% of patients receiving Darzalex Faspro. Learn more on pp. 10-11 of this booklet: Understanding Darzalex and Darzalex Faspro.

Risk of herpes zoster infection

Darzalex Faspro can reactivate varicella-zoster virus (VZV), which causes chickenpox and shingles. To prevent this, patients should start antiviral medication within 1 week of beginning Darzalex Faspro and continue for 3 months after the last dose.

Neutropenia, lymphopenia, and thrombocytopenia

Darzalex commonly causes low blood cell counts, including neutropenia (low neutrophils), lymphopenia (low B, T, and NK cells), and thrombocytopenia (low platelets). Low platelets can increase bleeding risk, particularly below 50,000/µL, with major bleeding risk below 10,000/µL.

Your doctor will monitor your blood counts regularly with a CBC. If counts drop too low, your dose may be delayed. Alternatively, you may receive transfusions or medications to stimulate blood cell production.

Embryo-fetal toxicity

Females of reproductive potential and males with female partners of reproductive potential must use effective contraception during treatment. Ask your doctor how long to continue using effective contraception after the last dose of treatment is administered.

Interference with blood tests

Darzalex Faspro can interfere with blood compatibility testing (including cross-matching for transfusions) and myeloma monitoring tests (SPEP and IFE). Before starting treatment, your doctor should establish your blood type, and blood banks should be notified of your Darzalex Faspro use. For myeloma monitoring, an FDA-approved test (2018) is available to more accurately detect M-protein in patients on Darzalex Faspro.

Hypersensitivity

Medication can produce an undesirable hypersensitivity reaction by the immune system. Your doctor will permanently discontinue Darzalex Faspro for life-threatening reactions. A mild hypersensitivity reaction may be uncomfortable, but a severe reaction may be damaging or fatal.

Darzalex Assistance Program

If you are prescribed Darzalex or Darzalex Faspro, you can sign up for the “DARZALEX withMe” program. Visit darzalex.com or call 1.833.565.9631 Monday–Friday, 8 a.m.–8 p.m. (ET) for help with personalized appointment reminders, access to nurse educators, and referrals to organizations that may provide assistance relevant to the patient’s needs.