Generic Name
Daratumumab
Brand Names
Darzalex Faspro, Darzalex
FDA approval date: November 16, 2015
Classification: CD38-directed Cytolytic Antibody
Form: Injection
What is Darzalex Faspro (Daratumumab)?
DARZALEX is indicated for the treatment of adult patients with multiple myeloma: 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, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma: 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, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
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Related Latest Advances
Brand Information
Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant))
1DOSAGE FORMS AND STRENGTHS
Injection: 1,800 mg daratumumab and 30,000 units hyaluronidase per 15 mL (120 mg and 2,000 units/mL) colorless to yellow and clear to opalescent solution in a single-dose vial.
2CONTRAINDICATIONS
DARZALEX FASPRO is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase or any of the components of the formulation
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity and Other Administration Reactions
- Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis
- Infections
- Neutropenia
- Thrombocytopenia
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Newly Diagnosed Multiple Myeloma Eligible for Autologous Stem Cell Transplant
In Combination with Bortezomib, Lenalidomide and Dexamethasone
The safety of DARZALEX FASPRO in combination with bortezomib, lenalidomide and dexamethasone (n=351) from the start of induction to the end of consolidation compared to bortezomib, lenalidomide and dexamethasone (VRd) (n=347) was evaluated in PERSEUS
The median duration of treatment for induction and consolidation was 9.9 months (0.5 to 18.5 months) for DARZALEX FASPRO-VRd.
Serious adverse reactions occurred in 37% of patients who received DARZALEX FASPRO-VRd. The most frequent serious adverse reaction in >5% of patients who received DARZALEX FASPRO-VRd was pneumonia (6%). Fatal adverse reactions occurred in 1.7% of patients who received DARZALEX FASPRO-VRd.
Permanent treatment discontinuation due to an adverse reaction occurred in 2% of patients who received DARZALEX FASPRO-VRd. An adverse reaction which resulted in permanent discontinuation of DARZALEX FASPRO-VRd in more than 1 patient included sepsis.
The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, upper respiratory infection, constipation, musculoskeletal pain, insomnia, rash, diarrhea, edema, and pyrexia.
Table 8 summarizes the adverse reactions in patients who received DARZALEX FASPRO in PERSEUS.
Clinically relevant adverse reactions in <10% of patients who received DARZALEX FASPRO with bortezomib, lenalidomide and dexamethasone include:
- Gastrointestinal disorders: vomiting, hemorrhoids
- Musculoskeletal and connective tissue disorders: arthralgia
- Infections: bronchitis, sepsis, urinary tract infection, herpes zoster, Covid-19, cytomegalovirus infection
- Respiratory, thoracic, and mediastinal disorders: dyspnea, pulmonary edema
- Metabolism and nutrition disorders: hypocalcemia, decreased appetite, hyperglycemia, dehydration
- Vascular disorders: hypotension, hypertension, orthostatic hypotension
- General disorders and administration site conditions: infusion reactions, injection site reaction, chills
- Nervous system disorders: dizziness, headache, syncope
- Cardiac disorders: thrombosis, atrial fibrillation, tachycardia
- Skin and subcutaneous tissue disorders: pruritus
Table 9 summarizes the laboratory abnormalities in patients who received DARZALEX FASPRO in PERSEUS.
Newly Diagnosed Multiple Myeloma Ineligible for Autologous Stem Cell Transplant
In Combination with Bortezomib, Melphalan and Prednisone
The safety of DARZALEX FASPRO with bortezomib, melphalan and prednisone was evaluated in a single-arm cohort of PLEIADES
Serious adverse reactions occurred in 39% of patients who received DARZALEX FASPRO. Serious adverse reactions in >5% of patients included pneumonia and pyrexia. Fatal adverse reactions occurred in 3% of patients.
Permanent discontinuation of DARZALEX FASPRO due to an adverse reaction occurred in 4.5% of patients. The adverse reaction resulting in permanent discontinuation of DARZALEX FASPRO in more than 1 patient was neutropenic sepsis.
Dosage interruptions (defined as dose delays or skipped doses) due to an adverse reaction occurred in 51% of patients who received DARZALEX FASPRO. Adverse reactions requiring dosage interruptions in >5% of patients included thrombocytopenia, neutropenia, anemia, and pneumonia.
The most common adverse reactions (≥20%) were upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, and back pain.
Table 10 summarizes the adverse reactions in patients who received DARZALEX FASPRO in PLEIADES.
Clinically relevant adverse reactions in <10% of patients who received DARZALEX FASPRO with bortezomib, melphalan and prednisone included:
- General disorders and administration site conditions: infusion reaction, injection site reaction, chills
- Infections: herpes zoster, urinary tract infection, influenza, sepsis
- Musculoskeletal and connective tissue disorders: arthralgia, muscle spasms
- Nervous system disorders: headache, paresthesia
- Metabolism and nutrition disorders: hypocalcemia, hyperglycemia
- Respiratory, thoracic and mediastinal disorders: dyspnea, pulmonary edema
- Cardiac disorders: atrial fibrillation
Table 11 summarizes the laboratory abnormalities in patients who received DARZALEX FASPRO in PLEIADES.
Relapsed/Refractory Multiple Myeloma
In Combination with Lenalidomide and Dexamethasone
The safety of DARZALEX FASPRO with lenalidomide and dexamethasone was evaluated in a single-arm cohort of PLEIADES
Serious adverse reactions occurred in 48% of patients who received DARZALEX FASPRO. Serious adverse reactions in >5% of patients included pneumonia, influenza and diarrhea. Fatal adverse reactions occurred in 3.1% of patients.
Permanent discontinuation of DARZALEX FASPRO due to an adverse reaction occurred in 11% of patients who received DARZALEX FASPRO. Adverse reactions resulting in permanent discontinuation of DARZALEX FASPRO in more than 1 patient were pneumonia and anemia.
Dosage interruptions due to an adverse reaction occurred in 63% of patients who received DARZALEX FASPRO. Adverse reactions requiring dosage interruptions in >5% of patients included neutropenia, pneumonia, upper respiratory tract infection, influenza, dyspnea, and blood creatinine increased.
The most common adverse reactions (≥20%) were fatigue, diarrhea, upper respiratory tract infection, muscle spasms, constipation, pyrexia, pneumonia, and dyspnea.
Table 12 summarizes the adverse reactions in patients who received DARZALEX FASPRO in PLEIADES.
Clinically relevant adverse reactions in <10% of patients who received DARZALEX FASPRO with lenalidomide and dexamethasone included:
- Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal chest pain
- Nervous system disorders: dizziness, headache, paresthesia
- Skin and subcutaneous tissue disorders: rash, pruritus
- Gastrointestinal disorders: abdominal pain
- Infections: influenza, sepsis, herpes zoster
- Metabolism and nutrition disorders: decreased appetite
- Cardiac disorders: atrial fibrillation
- General disorders and administration site conditions: chills, infusion reaction, injection site reaction
- Vascular disorders: hypotension, hypertension
Table 13 summarizes the laboratory abnormalities in patients who received DARZALEX FASPRO in PLEIADES.
In Combination with Pomalidomide and Dexamethasone
The safety of DARZALEX FASPRO with pomalidomide and dexamethasone compared to pomalidomide and dexamethasone (Pd) in patients who had received at least one prior line of therapy with lenalidomide and a proteasome inhibitor (PI) was evaluated in APOLLO
Serious adverse reactions occurred in 50% of patients who received DARZALEX FASPRO-Pd. The most frequent serious adverse reactions in >5% of patients who received DARZALEX FASPRO-Pd were pneumonia (15%) and lower respiratory tract infection (12%). Fatal adverse reactions occurred in 7% of patients who received DARZALEX FASPRO-Pd.
Permanent treatment discontinuation due to an adverse reaction occurred in 2% of patients who received DARZALEX FASPRO-Pd.
The most common adverse reactions (≥20%) were fatigue, pneumonia, upper respiratory tract infection, and diarrhea.
Table 14 summarizes the adverse reactions in patients who received DARZALEX FASPRO in APOLLO.
Clinically relevant adverse reactions in <10% of patients who received DARZALEX FASPRO with pomalidomide and dexamethasone include:
- Metabolism and nutrition disorders: hypocalcemia, hypokalemia, decreased appetite, dehydration
- Nervous system disorders: peripheral sensory neuropathy, syncope, headache, paresthesia, dizziness
- Musculoskeletal and connective tissue disorders: muscle spasms, musculoskeletal chest pain, arthralgia
- Psychiatric disorders: insomnia
- Gastrointestinal disorders: nausea, abdominal pain, vomiting
- Skin and subcutaneous tissue disorders: rash, pruritus
- Cardiac disorders: atrial fibrillation
- General disorders and administration site conditions: infusion reactions, chills, injection site reaction
- Infections: urinary tract infection, influenza, hepatitis B reactivation, herpes zoster, sepsis
- Vascular disorders: hypertension, hypotension
Table 15 summarizes the laboratory abnormalities in patients who received DARZALEX FASPRO in APOLLO.
In Combination with Carfilzomib and Dexamethasone
The safety of DARZALEX FASPRO with carfilzomib and dexamethasone was evaluated in a single-arm cohort of PLEIADES
Serious adverse reactions occurred in 27% of patients who received DARZALEX FASPRO in combination with carfilzomib and dexamethasone. Fatal adverse reactions occurred in 3% of patients who received DARZALEX FASPRO in combination with carfilzomib and dexamethasone.
Permanent discontinuation of DARZALEX FASPRO due to an adverse reaction occurred in 6% of patients who received DARZALEX FASPRO.
Dosage interruptions due to an adverse reaction occurred in 46% of patients who received DARZALEX FASPRO.
The most common adverse reactions (≥20%) were upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.
Table 16 summarizes the adverse reactions in patients who received DARZALEX FASPRO with carfilzomib and dexamethasone (DARZALEX FASPRO-Kd) in PLEIADES.
Clinically relevant adverse reactions in <10% of patients who received DARZALEX FASPRO with carfilzomib and dexamethasone include:
- Gastrointestinal disorders: abdominal pain, constipation, pancreatitis
- Infection and infestations: pneumonia, influenza, urinary tract infection, herpes zoster, sepsis
- Metabolism and nutrition disorders: hyperglycemia, decreased appetite, hypocalcemia
- Musculoskeletal and connective tissue disorders: muscle spasms, arthralgia
- Nervous system disorders: paresthesia, dizziness, syncope
- General disorders and administration site conditions: injection site reaction, infusion reactions, chills
- Skin and subcutaneous tissue disorders: rash, pruritus
- Cardiac disorders: cardiac failure
- Vascular disorders: hypotension
Table 17 summarizes the laboratory abnormalities in patients who received DARZALEX FASPRO with carfilzomib and dexamethasone in PLEIADES.
Monotherapy
The safety of DARZALEX FASPRO as monotherapy was evaluated in COLUMBA
Serious adverse reactions occurred in 26% of patients who received DARZALEX FASPRO. Fatal adverse reactions occurred in 5% of patients. Fatal adverse reactions occurring in more than 1 patient were general physical health deterioration, septic shock, and respiratory failure.
Permanent discontinuation due to an adverse reaction occurred in 10% of patients who received DARZALEX FASPRO. Adverse reactions resulting in permanent discontinuation of DARZALEX FASPRO in more than 2 patients were thrombocytopenia and hypercalcemia.
Dosage interruptions due to an adverse reaction occurred in 26% of patients who received DARZALEX FASPRO. Adverse reactions requiring dosage interruption in >5% of patients included thrombocytopenia.
The most common adverse reaction (≥20%) was upper respiratory tract infection.
Table 18 summarizes the adverse reactions in COLUMBA.
Clinically relevant adverse reactions in <10% of patients who received DARZALEX FASPRO included:
- General disorders and administration site conditions: injection site reaction, peripheral edema
- Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal chest pain, muscle spasms
- Gastrointestinal disorders: constipation, vomiting, abdominal pain
- Metabolism and nutrition disorders: decreased appetite, hyperglycemia, hypocalcemia, dehydration
- Psychiatric disorders: insomnia
- Vascular disorders: hypertension, hypotension
- Nervous system disorders: dizziness, peripheral sensory neuropathy, paresthesia
- Infections: bronchitis, influenza, urinary tract infection, herpes zoster, sepsis, hepatitis B virus reactivation
- Skin and subcutaneous tissue disorders: pruritus, rash
- Cardiac disorders: atrial fibrillation
- Respiratory, thoracic and mediastinal disorders: pulmonary edema
Table 19 summarizes the laboratory abnormalities in COLUMBA.
High-Risk Smoldering Multiple Myeloma
The safety of DARZALEX FASPRO as monotherapy in patients with high-risk smoldering multiple myeloma was evaluated in AQUILA
The median duration of treatment for patients receiving DARZALEX FASPRO was 35 months (0 to 36 months).
Serious adverse reactions occurred in 29% of patients who received DARZALEX FASPRO. The most frequent serious adverse reactions in ≥2% of patients who received DARZALEX FASPRO were pneumonia (7%), fracture (3%), sepsis (2%), and upper respiratory tract infection (2%). Fatal adverse reactions occurred in 1% of patients who received DARZALEX FASPRO, including COVID-19 (0.5%) and pneumonia (0.5%).
Permanent treatment discontinuation due to an adverse reaction occurred in 6% of patients who received DARZALEX FASPRO. Adverse reactions which resulted in permanent discontinuation of DARZALEX FASPRO in more than 1 patient included fatigue, anxiety, and dyspnea.
Dosage interruptions of DARZALEX FASPRO due to an adverse reaction occurred in 47% of patients. Adverse reactions which required dosage interruption in ≥5% of patients included upper respiratory infection, pneumonia, and COVID-19.
The most common adverse reactions (≥20%) were upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy, and injection site reactions.
Table 20 summarizes the adverse reactions in patients who received DARZALEX FASPRO in AQUILA.
Clinically relevant adverse reactions in <10% of patients who received DARZALEX FASPRO included:
- Gastrointestinal disorders: constipation, vomiting
- Skin and subcutaneous tissue disorders: pruritus
- Infections: bronchitis, urinary tract infection, herpes zoster, sepsis
- General disorders and administration site conditions: chills
- Metabolism and nutrition disorders: decreased appetite, hyperglycemia, dehydration
- Nervous system disorders: syncope
- Vascular disorders: hypotension
Table 21 summarizes the laboratory abnormalities in patients who received DARZALEX FASPRO in AQUILA.
Light Chain Amyloidosis
In Combination with Bortezomib, Cyclophosphamide and Dexamethasone
The safety of DARZALEX FASPRO with bortezomib, cyclophosphamide and dexamethasone (DARZALEX FASPRO-VCd) was evaluated in ANDROMEDA
Serious adverse reactions occurred in 43% of patients who received DARZALEX FASPRO in combination with VCd. Serious adverse reactions that occurred in at least 5% of patients in the DARZALEX FASPRO-VCd arm were pneumonia (9%), cardiac failure (8%), and sepsis (5%). Fatal adverse reactions occurred in 11% of patients. Fatal adverse reactions that occurred in more than one patient included cardiac arrest (4%), sudden death (3%), cardiac failure (3%), and sepsis (1%).
Permanent discontinuation of DARZALEX FASPRO due to an adverse reaction occurred in 5% of patients. Adverse reactions resulting in permanent discontinuation of DARZALEX FASPRO in more than one patient were pneumonia, sepsis, and cardiac failure.
Dosage interruptions (defined as dose delays or skipped doses) due to an adverse reaction occurred in 36% of patients who received DARZALEX FASPRO. Adverse reactions which required a dosage interruption in ≥3% of patients included upper respiratory tract infection (9%), pneumonia (6%), cardiac failure (4%), fatigue (3%), herpes zoster (3%), dyspnea (3%), and neutropenia (3%).
The most common adverse reactions (≥20%) were upper respiratory tract infection, diarrhea, peripheral edema, constipation, fatigue, peripheral sensory neuropathy, nausea, insomnia, dyspnea, and cough.
Table 22 below summarizes the adverse reactions in patients who received DARZALEX FASPRO in ANDROMEDA.
Clinically relevant adverse reactions not included in Table 22 and occurred in patients who received DARZALEX FASPRO with bortezomib, cyclophosphamide and dexamethasone included:
- Skin and subcutaneous tissue disorders: rash, pruritus
- Nervous system disorders: paresthesia
- General disorders and administration site conditions: infusion reaction, chills
- Cardiac disorders: cardiac failure
Cardiac failure includes cardiac dysfunction, cardiac failure, cardiac failure congestive, cardiovascular insufficiency, diastolic dysfunction, pulmonary edema, and left ventricular dysfunction occurred in 11% of patients. , cardiac arrest - Metabolism and nutrition disorders: hyperglycemia, hypocalcemia, dehydration
- Infections: bronchitis, herpes zoster, sepsis, urinary tract infection, influenza
- Vascular disorders: hypertension
- Musculoskeletal and connective tissue disorders: musculoskeletal chest pain
- Gastrointestinal disorders: pancreatitis
- Respiratory, thoracic and mediastinal disorders: pulmonary edema
Table 23 summarizes the laboratory abnormalities in patients who received DARZALEX FASPRO in ANDROMEDA.
Cardiac Adverse Reactions in Light Chain (AL) Amyloidosis
Among patients who received DARZALEX FASPRO in combination with VCd, 72% of patients had baseline cardiac involvement with Mayo Cardiac Stage I (3%), Stage II (46%) and Stage III (51%). Serious cardiac disorders occurred in 16% of patients (8% of patients with Mayo Cardiac Stage I and II and 28% of patients with Stage III). Serious cardiac disorders in >2% of patients included cardiac failure (8%), cardiac arrest (4%) and arrhythmia (4%). Fatal cardiac disorders occurred in 10% of patients (5% of patients with Mayo Cardiac Stage I and II and 19% of patients with Stage III) who received DARZALEX FASPRO in combination with VCd. Fatal cardiac disorders that occurred in more than one patient in the DARZALEX FASPRO-VCd arm included cardiac arrest (4%), sudden death (3%), and cardiac failure (3%).
3.2Postmarketing Experience
The following adverse reactions have been identified with post-approval use of daratumumab. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System: Anaphylactic reaction, Systemic administration reactions (including death)
Gastrointestinal: Pancreatitis
Infections: Cytomegalovirus, Listeriosis
4DESCRIPTION
Daratumumab is an immunoglobulin G1 kappa (IgG1κ) human monoclonal antibody that binds to the CD38 antigen. Daratumumab is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. The molecular weight of daratumumab is approximately 148 kDa.
Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by Chinese Hamster Ovary cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa.
DARZALEX FASPRO
Each DARZALEX FASPRO 15 mL single-dose vial contains 1,800 mg of daratumumab and 30,000 units of hyaluronidase, L-histidine (4.9 mg), L-histidine hydrochloride monohydrate (18.4 mg), L-methionine (13.5 mg), polysorbate 20 (6 mg), sorbitol (735.1 mg), and Water for Injection, USP.
5REFERENCES
- Chapuy, CI, RT Nicholson, MD Aguad, et al., 2015, Resolving the daratumumab interference with blood compatibility testing, Transfusion, 55:1545–1554 (accessible at http://onlinelibrary.wiley.com/doi/10.1111/trf.13069/epdf).
6HOW SUPPLIED/STORAGE AND HANDLING
DARZALEX FASPRO
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hypersensitivity and Other Administration Reactions
Advise patients to seek immediate medical attention for any of the following signs and symptoms of systemic administration-related reactions: itchy, runny or blocked nose; chills, nausea, throat irritation, cough, headache, shortness of breath or difficulty breathing, and blurred vision
Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis
Advise patients to immediately contact their healthcare provider if they have signs or symptoms of cardiac adverse reactions
Infections
Inform patients about the risk of developing infections during DARZALEX FASPRO treatment, and to report immediately any fever or symptoms of infection to their healthcare provider
Neutropenia
Advise patients to contact their healthcare provider if they have a fever
Thrombocytopenia
Advise patients to contact their healthcare provider if they have bruising or bleeding
Embryo-Fetal Toxicity
Advise pregnant women of the potential hazard to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy
Advise females of reproductive potential to use effective contraception during treatment with DARZALEX FASPRO and for 3 months after the last dose
Advise patients that lenalidomide, thalidomide and pomalidomide have the potential to cause fetal harm and have specific requirements regarding contraception, pregnancy testing, blood and sperm donation, and transmission in sperm. Lenalidomide, thalidomide and pomalidomide are only available through a REMS program
Interference with Laboratory Tests
Advise patients to inform their healthcare provider, including personnel at blood transfusion centers, that they are taking DARZALEX FASPRO, in the event of a planned transfusion
Advise patients that DARZALEX FASPRO can affect the results of some tests used to determine complete response in some patients and additional tests may be needed to evaluate response
Hepatitis B Virus (HBV) Reactivation
Advise patients to inform healthcare providers if they have ever had or might have a hepatitis B infection and that DARZALEX FASPRO could cause hepatitis B virus to become active again
8PRINCIPAL DISPLAY PANEL - 15 mL Vial Box
NDC 57894-503-01
DARZALEX Faspro
1,800 mg and
For Subcutaneous Use Only
Administer subcutaneous
Rx only
One 15 mL Vial
Single-dose vial.
janssen
