COLUMBA Safety

Fewer systemic ARRs

Nearly 3x reduction in systemic administration-related reactions* (ARRs) with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) vs DARZALEX® (daratumumab) were observed in the COLUMBA trial.1

Systemic ARRs were 13% for DARZALEX FASPRO® (n=260) vs 34% for DARZALEX® (n=258)

Both systemic ARRs, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®.1

Most common systemic ARRs1,2

Most systemic ARRs were Grade 1 or 2 and occurred with the first injection.

The most common systemic ARRs (DARZALEX FASPRO® vs DARZALEX®) were chills (5% vs 12%), pyrexia (5% vs 3%), and dyspnea (1% vs 7%).

Grade 3 systemic ARRs occurred in 2% of patients using DARZALEX FASPRO® vs 5% of patients on DARZALEX®.

No Grade 4 systemic ARRs were reported.

ARRs=administration-related reactions.

*In clinical trials of DARZALEX FASPRO® and DARZALEX®, and the Prescribing Information for DARZALEX®, the terms “infusion reactions” and “infusion-related reactions” were used instead of “systemic administration-related reactions.”

Systemic ARRs causing severe reactions included hypoxia, dyspnea, hypertension, and tachycardia. Other signs and symptoms of systemic ARRs may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, and hypotension.1

In a pooled safety population of 490 patients, the rate of systemic ARRs was 11% for DARZALEX FASPRO®1

  • The median time to onset of systemic ARRs following an injection of DARZALEX FASPRO® was 3.7 hours (range: 9 minutes to 3.5 days). The majority of systemic ARRs occurred on the day of treatment. Delayed systemic ARRs, those occurring after the day of administration, have occurred in less than 1% of patients
  • The incidence of any grade systemic ARRs was 10% with the first injection of DARZALEX FASPRO® at Week 1, 0.2% with the second injection at Week 2, and cumulatively 0.8% with subsequent injections

Local reactions1

  • In this pooled safety population, injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 0.6%. The most frequent (>1%) injection-site reaction was injection site erythema
  • These local reactions occurred a median of 7 minutes (range: 0 minutes to 4.7 days) after starting administration of DARZALEX FASPRO®. Monitor for local reactions and consider symptomatic management

Safety generally consistent with DARZALEX®

In the COLUMBA clinical study, the safety of DARZALEX FASPRO® was demonstrated to be generally consistent with DARZALEX®.

Adverse reactions reported in ≥10% of patients treated with either DARZALEX FASPRO® or DARZALEX®1

Most common adverse reactions for DARZALEX FASPRO® and DARZALEX®

aUpper respiratory tract infection includes acute sinusitis, nasopharyngitis, pharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, rhinovirus infection, sinusitis, and upper respiratory tract infection.

bPneumonia includes lower respiratory tract infection, lung infection, pneumocystis jirovecii pneumonia, and pneumonia.

cFatigue includes asthenia and fatigue.

dSystemic ARRs includes terms determined by investigators to be related to infusion. In clinical trials of DARZALEX FASPRO® and DARZALEX®, and the Prescribing Information for DARZALEX®, the term "infusion-related reactions" was used instead of "systemic ARRs."

eCough includes cough and productive cough.

fDyspnea includes dyspnea and dyspnea exertional.

gOnly Grade 3 adverse reactions occurred.

hGrade 5 adverse reactions occurred.

  • Serious adverse reactions occurred in 26% of patients who received DARZALEX FASPRO® vs 29% of patients who received DARZALEX®. Fatal reaction occurred in 5% of patients receiving DARZALEX FASPRO®. Fatal adverse reactions occurring in more than 1 patient were general physical health deterioration, septic shock, and respiratory failure. Fatal adverse reactions occurred in 7% of patients receiving DARZALEX®1,2

In the clinical trial, select laboratory abnormalities worsening from baseline were also found to be consistent in patients receiving either DARZALEX FASPRO® or DARZALEX®.1

Laboratory abnormalities for DARZALEX FASPRO® and  DARZALEX®

aDenominator is based on the safety population treated with DARZALEX FASPRO® (n=260) or with DARZALEX® (n=258).

Review dosing schedules for DARZALEX FASPRO® in newly diagnosed multiple myeloma

Review dosing schedules for DARZALEX FASPRO® in relapsed or refractory multiple myeloma