Introducing DARZALEX FASPRO ™ (daratumumab and hyaluronidase-fihj):
subcutaneous administration in ~3 to 5 minutes 1
SAME POWERFUL EFFICACY.
FASTER ADMINISTRATION. 1,2 *
Approved across 5 indications spanning a wide range
of multiple myeloma patients 1
INDICATIONS
DARZALEX FASPRO ™ is indicated for the treatment of adult patients
with multiple myeloma:
• in combination with bortezomib, melphalan and prednisone in
newly diagnosed patients who are ineligible for autologous stem
cell transplant
• in combination with lenalidomide and dexamethasone in newly
diagnosed patients who are ineligible for autologous stem cell
transplant and in patients with relapsed or refractory multiple
myeloma who have received at least one prior therapy
• in combination with bortezomib and dexamethasone in patients
who have received at least one prior therapy
• as monotherapy, in patients who have received at least three
prior lines of therapy including a proteasome inhibitor (PI) and an
immunomodulatory agent or who are double-refractory to a PI
and an immunomodulatory agent
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
DARZALEX FASPRO ™ (daratumumab and hyaluronidase-fihj) is
contraindicated in patients with a history of severe hypersensitivity
to daratumumab, hyaluronidase or any of the components of
the formulation.
WARNINGS AND PRECAUTIONS
Hypersensitivity and Other Administration Reactions
Both systemic administration-related reactions, including severe
or life-threatening reactions, and local injection-site reactions can
occur with DARZALEX FASPRO ™ .
Systemic Reactions
In a pooled safety population of 490 patients who received
DARZALEX FASPRO ™ as monotherapy or in combination,
11% of patients experienced a systemic administration-related
reaction (Grade 2: 3.9%, Grade 3: 1.4%). Systemic administration-related
reactions occurred in 10% of patients with the first injection, 0.2%
with the second injection, and cumulatively 0.8% with subsequent
injections. The median time to onset was 3.7 hours (range:
9 minutes to 3.5 days). Of the 84 systemic administration-related
reactions that occurred in 52 patients, 73 (87%) occurred on
the day of DARZALEX FASPRO ™ administration. Delayed systemic
administration-related reactions have occurred in less than
1% of the patients.
Severe reactions included hypoxia, dyspnea, hypertension
and tachycardia. Other signs and symptoms of systemic
administration-related reactions may include respiratory
symptoms, such as bronchospasm, nasal congestion, cough,
throat irritation, allergic rhinitis, and wheezing, as well as
anaphylactic reaction, pyrexia, chest pain, pruritis, chills,
vomiting, nausea, and hypotension.
Pre-medicate patients with histamine-1 receptor antagonist,
acetaminophen and corticosteroids. Monitor patients for systemic
administration-related reactions, especially following the first
and second injections. For anaphylactic reaction or life-threatening
(Grade 4) administration-related reactions, immediately and
permanently discontinue DARZALEX FASPRO ™ . Consider
administering corticosteroids and other medications after
the administration of DARZALEX FASPRO ™ depending on dosing
regimen and medical history to minimize the risk of delayed
(defined as occurring the day after administration) systemic
administration-related reactions.
Local Reactions
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.