Leadership in multiple myeloma treatment

More FDA-approved regimens for DARZALEX FASPRO^® and DARZALEX^® than any other monoclonal antibody in multiple myeloma^1-4

Newly diagnosed

Transplant ineligible

DARZALEX^® + Rd/

DARZALEX FASPRO^® + Rd

View DRd dosing

DARZALEX^® + VMP/

DARZALEX FASPRO^® + VMP

View DVMP dosing

Transplant eligible

DARZALEX^® + VTd/

DARZALEX FASPRO^® + VTd

View DVTd dosing

Relapsed or refractory

After ≥1 prior therapy

DARZALEX^® + Rd/

DARZALEX FASPRO^® + Rd

View DRd dosing

DARZALEX^® + Vd/

DARZALEX FASPRO^® + Vd

View DVd dosing

DARZALEX FASPRO^® + Pd

Prior line of therapy including lenalidomide and a proteasome inhibitor (PI).

View DPd dosing

After 1-3 prior lines of therapy

DARZALEX^® + Kd/

DARZALEX FASPRO^® + Kd

View DKd dosing

After ≥2 prior therapies

DARZALEX^® + Pd

Prior therapies included lenalidomide and a PI.

View DPd dosing

After ≥3 prior therapies

DARZALEX^® monotherapy/

DARZALEX FASPRO^® monotherapy

Prior therapies included a PI and an immunomodulatory agent, or patients were double refractory to a PI and an immunomodulatory agent.

View monotherapy dosing

DKd=DARZALEX FASPRO^®/DARZALEX^® (D) + carfilzomib (K) + dexamethasone (d); DPd=DARZALEX FASPRO^®/DARZALEX^® (D) + pomalidomide (P) + dexamethasone (d); DRd=DARZALEX FASPRO^®/DARZALEX^® (D) + lenalidomide (R) + dexamethasone (d); DVd=DARZALEX FASPRO^®/DARZALEX^® (D) + bortezomib (V) + dexamethasone (d); DVMP=DARZALEX FASPRO^®/DARZALEX^® (D) + bortezomib (V) + melphalan (M) + prednisone (P); DVTd=DARZALEX FASPRO^®/DARZALEX^® (D) + bortezomib (V) + thalidomide (T) + dexamethasone (d); Kd=carfilzomib (K) + dexamethasone (d); Pd=pomalidomide (P) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d); Vd=bortezomib (V) + dexamethasone (d); VMP=bortezomib (V) + melphalan (M) + prednisone (P); VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).

Dosing schedules for DARZALEX FASPRO^® and DARZALEX^®

Newly diagnosed

DRd regimen

Once-monthly dosing over time—a key milestone for patients to reach in newly diagnosed, transplant-ineligible multiple myeloma^1,2*

Starting at Cycle 7, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO^® or DARZALEX^®

Continue DRd until disease progression or unacceptable toxicity

DRd=DARZALEX FASPRO^®/DARZALEX^® (D) + lenalidomide (R) + dexamethasone (d).

^†Cycle=28 days.

DARZALEX FASPRO^® in combination with lenalidomide and dexamethasone (4-week cycle) has the same dosing schedule as DARZALEX^® in combination with lenalidomide and dexamethasone.^1,2‡

For more detailed information on dosing and administration, including management of infusion-related reactions (IRRs) and administration-related reactions (ARRs), please review the links below.

See DARZALEX FASPRO^® administration details

Dosing and administration guide for DARZALEX FASPRO^®

Download guide

See DARZALEX^® administration details

Dosing and administration guide for DARZALEX^®

Download guide

First dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.^1,2

*See the Dosage and Administration section of the full Prescribing Information for more detail. When DARZALEX FASPRO^® or DARZALEX^® is administered as part of a combination therapy, see the Prescribing Information for dosage recommendations for the other drugs.

^‡The option of splitting the first dose for DARZALEX^® is not applicable to DARZALEX FASPRO^®.^1,2

DVMP regimen

Once-monthly dosing over time—a key milestone for patients to reach in newly diagnosed, transplant-ineligible multiple myeloma^1,2*

Starting at Cycle 10, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO^® or DARZALEX^®

Continue DVMP until disease progression or unacceptable toxicity

DVMP=DARZALEX FASPRO^®/DARZALEX^® (D) + bortezomib (V) + melphalan (M) + prednisone (P).

^†Cycle=42 days.

DARZALEX FASPRO^® in combination with bortezomib + melphalan + prednisone (6-week cycle) has the same dosing schedule as DARZALEX^® in combination with bortezomib + melphalan + prednisone.^1,2‡

For more detailed information on dosing and administration, including management of infusion-related reactions (IRRs) and administration-related reactions (ARRs), please review the links below.

See DARZALEX FASPRO^® administration details

Dosing and administration guide for DARZALEX FASPRO^®

Download guide

See DARZALEX^® administration details

Dosing and administration guide for DARZALEX^®

Download guide

First dose of the every-3-week dosing schedule is given at Week 7. First dose of the every-4-week dosing schedule is given at Week 55.^1,2

^‡The option of splitting the first dose for DARZALEX^® is not applicable to DARZALEX FASPRO^®.^1,2

DVTd regimen

Fixed-cycle dosing for patients in newly diagnosed, transplant-eligible multiple myeloma^1,2*

DVTd=DARZALEX FASPRO^®/DARZALEX^® (D) + bortezomib (V) + thalidomide (T) + dexamethasone (d).

^†Cycle=28 days.

DARZALEX FASPRO^® in combination with bortezomib + thalidomide + dexamethasone (4-week cycle) has the same dosing schedule as DARZALEX^® in combination with bortezomib + thalidomide + dexamethasone.^1,2‡

For more detailed information on dosing and administration, including management of infusion-related reactions (IRRs) and administration-related reactions (ARRs), please review the links below.

See DARZALEX FASPRO^® administration details

Dosing and administration guide for DARZALEX FASPRO^®

Download guide

See DARZALEX^® administration details

Dosing and administration guide for DARZALEX^®

Download guide

First dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-2-week dosing schedule is given at Week 1 upon re-initiation of treatment following autologous stem cell transplant (ASCT).^1,2

^‡The option of splitting the first dose for DARZALEX^® is not applicable to DARZALEX FASPRO^®.^1,2

Relapsed or refractory

DRd regimen

Once-monthly dosing over time—a key milestone for patients to reach in relapsed or refractory multiple myeloma^1,2*

Starting at Cycle 7, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO^® or DARZALEX^®

Continue DRd until disease progression or unacceptable toxicity

DRd=DARZALEX FASPRO^®/DARZALEX^® (D) + lenalidomide (R) + dexamethasone (d).

^†Cycle=28 days.

DARZALEX FASPRO^® in combination with lenalidomide and dexamethasone (4-week cycle) has the same dosing schedule as DARZALEX^® in combination with lenalidomide and dexamethasone.^1,2‡

For more detailed information on dosing and administration, including management of infusion-related reactions (IRRs) and administration-related reactions (ARRs), please review the links below.

See DARZALEX FASPRO^® administration details

Dosing and administration guide for DARZALEX FASPRO^®

Download guide

See DARZALEX^® administration details

Dosing and administration guide for DARZALEX^®

Download guide

First dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.^1,2

^‡The option of splitting the first dose for DARZALEX^® is not applicable to DARZALEX FASPRO^®.^1,2

DVd regimen

Once-monthly dosing over time—a key milestone for patients to reach in relapsed or refractory multiple myeloma^1,2*

Starting at Cycle 9, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO^® or DARZALEX^®

Continue DVd until disease progression or unacceptable toxicity

DVd=DARZALEX FASPRO^®/DARZALEX^® (D) + bortezomib (V) + dexamethasone (d).

^†Cycle=21 days.

DARZALEX FASPRO^® in combination with bortezomib and dexamethasone (3-week cycle) has the same dosing schedule as DARZALEX^® in combination with bortezomib and dexamethasone.^1,2‡

For more detailed information on dosing and administration, including management of infusion-related reactions (IRRs) and administration-related reactions (ARRs), please review the links below.

See DARZALEX FASPRO^® administration details

Dosing and administration guide for DARZALEX FASPRO^®

Download guide

See DARZALEX^® administration details

Dosing and administration guide for DARZALEX^®

Download guide

First dose of the every-3-week dosing schedule is given at Week 10. First dose of the every-4-week dosing schedule is given at Week 25.^1,2

^‡The option of splitting the first dose for DARZALEX^® is not applicable to DARZALEX FASPRO^®.^1,2

DPd regimen

Once-monthly dosing over time—a key milestone for patients to reach in relapsed or refractory multiple myeloma^1,2*

Starting at Cycle 7, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO^® or DARZALEX^®

Continue DPd until disease progression or unacceptable toxicity

DPd=DARZALEX FASPRO^®/DARZALEX^® (D) + pomalidomide (P) + dexamethasone (d).

^†Cycle=28 days.

DARZALEX FASPRO^® in combination with pomalidomide and dexamethasone (4-week cycle) has the same dosing schedule as DARZALEX^® in combination with pomalidomide and dexamethasone.^1,2‡

For more detailed information on dosing and administration, including management of infusion-related reactions (IRRs) and administration-related reactions (ARRs), please review the links below.

See DARZALEX FASPRO^® administration details

Dosing and administration guide for DARZALEX FASPRO^®

Download guide

See DARZALEX^® administration details

Dosing and administration guide for DARZALEX^®

Download guide

First dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.^1,2

^‡The option of splitting the first dose for DARZALEX^® is not applicable to DARZALEX FASPRO^®.^1,2

DKd regimen

Once-monthly dosing over time—a key milestone for patients to reach in relapsed or refractory multiple myeloma^1,2*

Starting at Cycle 7, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO^® or DARZALEX^®

Continue DKd until disease progression or unacceptable toxicity

DKd=DARZALEX FASPRO^®/DARZALEX^® (D) + carfilzomib (K) + dexamethasone (d).

^†Cycle=28 days.

DARZALEX FASPRO^® in combination with carfilzomib and dexamethasone (4-week cycle) has the same dosing schedule as DARZALEX^® in combination with carfilzomib and dexamethasone, with the exception of Week 1.^1,2

For more detailed information on dosing and administration, including management of infusion-related reactions (IRRs) and administration-related reactions (ARRs), please review the links below.

See DARZALEX FASPRO^® administration details

Dosing and administration guide for DARZALEX FASPRO^®

Download guide

See DARZALEX^® administration details

Dosing and administration guide for DARZALEX^®

Download guide

First dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.^1,2

Monotherapy

Once-monthly dosing over time—a key milestone for patients to reach in relapsed or refractory multiple myeloma^1,2*

Starting at Cycle 7, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO^® or DARZALEX^®

Continue monotherapy treatment until disease progression or unacceptable toxicity

^†Cycle=28 days.

DARZALEX FASPRO^® monotherapy (4-week cycle) has the same dosing schedule as DARZALEX^® monotherapy.^{1,2 ‡}

For more detailed information on dosing and administration, including management of infusion-related reactions (IRRs) and administration-related reactions (ARRs), please review the links below.

See DARZALEX FASPRO^® administration details

Dosing and administration guide for DARZALEX FASPRO^®

Download guide

See DARZALEX^® administration details

Dosing and administration guide for DARZALEX^®

Download guide

First dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.^1,2

^‡The option of splitting the first dose for DARZALEX^® is not applicable to DARZALEX FASPRO^®.^1,2

National Comprehensive Cancer Network^® (NCCN^®) Guidelines recommendations for daratumumab-containing regimens

Review recommendations

CONTRAINDICATIONS

DARZALEX FASPRO^® 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^®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO^®.

Systemic Reactions

In a pooled safety population of 898 patients with multiple myeloma (N=705) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO^® as monotherapy or in combination, 9% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 1%). Systemic administration-related reactions occurred in 8% of patients with the first injection, 0.3% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days). Of the 140 systemic administration-related reactions that occurred in 77 patients, 121 (86%) occurred on the day of DARZALEX FASPRO^® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.

Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. 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, pruritus, chills, vomiting, nausea, hypotension, and blurred vision.

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.

Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO^® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO^®.

Local Reactions

In this pooled safety population, injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 0.7%. The most frequent (>1%) injection-site reaction was injection-site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO^®. Monitor for local reactions and consider symptomatic management.

Neutropenia

Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO^® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO^®, higher rates of Grade 3-4 neutropenia were observed.

Thrombocytopenia

Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Consider withholding DARZALEX FASPRO^® until recovery of platelets.

Embryo-Fetal Toxicity

Based on the mechanism of action, DARZALEX FASPRO^® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO^® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO^® and for 3 months after the last dose.

The combination of DARZALEX FASPRO^® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy.

Interference With Serological Testing

Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type are not impacted.

Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO^®. Type and screen patients prior to starting DARZALEX FASPRO^®.

Interference With Determination of Complete Response

Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO^®-treated patients with IgG kappa myeloma protein.

ADVERSE REACTIONS

In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO^® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema.

The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO^® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

Please click here to see the full Prescribing Information.

cp-143279v7

Leadership in multiple myeloma treatment

More FDA-approved regimens for DARZALEX FASPRO^® and DARZALEX^® than any other monoclonal antibody in multiple myeloma^1-4

Dosing schedules for DARZALEX FASPRO^® and DARZALEX^®

Newly diagnosed

DRd regimen

DVMP regimen

DVTd regimen

Relapsed or refractory

DRd regimen

DVd regimen

DPd regimen

DKd regimen

Monotherapy

IMPORTANT SAFETY INFORMATION

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

Leadership in multiple myeloma treatment

More FDA-approved regimens for DARZALEX FASPRO® and DARZALEX® than any other monoclonal antibody in multiple myeloma1-4

Dosing schedules for DARZALEX FASPRO® and DARZALEX®

More FDA-approved regimens for DARZALEX FASPRO^® and DARZALEX^® than any other monoclonal antibody in multiple myeloma^1-4

Dosing schedules for DARZALEX FASPRO^® and DARZALEX^®