APHEXDA
Generic: MOTIXAFORTIDE
Basic Information
Manufacturer
Gamida Cell Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
SUBCUTANEOUS
FDA Set ID
e704b2db-f119-40ba-9346-9229e3281c9e
Indications & Usage
1 INDICATIONS AND USAGE APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
APHEXDA, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
( 1 )
APHEXDA, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in other sections of the labeling: Anaphylactic Shock and Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Injection Site Reactions [see Warnings and Precautions (5.2) ] Potential for Tumor Cell Mobilization in Patients in Leukemia [see Warnings and Precautions (5.3) ] Leukocytosis [see Warnings and Precautions (5.4) ] Potential for Tumor Cell Mobilization [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence >20%) are injection site reactions, injection site pain, injection site erythema, injection site pruritus, pruritus, flushing, and back pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gamida Cell at (844) 477-7478 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical 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.
The safety of APHEXDA was evaluated in the GENESIS study based on data from 92 patients with multiple myeloma who received at least one dose of APHEXDA 1.25 mg/kg subcutaneously and filgrastim and 42 patients who received placebo and filgrastim for mobilization of hematopoietic stem cells for collection and apheresis [see Clinical Studies (14) ] .
The premedication regimen changed during the conduct of the trial as evidence of hypersensitivity reactions was noted.
Of the 92 patients who received at least one dose of APHEXDA, 14 patients received the triple-drug premedication regimen and 78 did not receive the triple-drug premedication regimen (either received no premedication or another premedication regimen).
Serious adverse reactions occurred in 5.4% of patients receiving APHEXDA in combination with filgrastim.
Serious adverse reactions included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia and hypoxia.
One patient did not receive the 5 th dose of filgrastim due to an elevated white blood cell count following administration of APHEXDA.
The most common adverse reactions occurring in GENESIS (>20% and at least 2% higher than the filgrastim + placebo arm) were injection site reactions (pain, erythema and pruritus), pruritus, flushing, and back pain.
Table 1 summarizes the common adverse reactions in GENESIS.
Table 1: Common Adverse Reactions in Patients with Multiple Myeloma During Hematopoietic Stem Cell Mobilization and Apheresis in GENESIS Adverse reactions that occurred in ≥10% in APHEXDA-treated patients and ≥2% more than placebo-treated patients.
APHEXDA and Filgrastim n=92 % Placebo and Filgrastim n=42 % All Grades Grade ≥3 All reactions were grade 3.
All Grades Grade ≥3 Injection site reactions Injection site reactions includes: injection site bruising, injection site discomfort, injection site erythema, injection site induration, injection site mass, injection site nodule, injection site pain, injection site pruritus, injection site rash, injection site swelling, injection site urticaria, injection site cellulitis and injection related reaction.
73 8 5 0 Injection site pain 53 7 5 0 Injection site erythema 27 0 0 0 Injection site pruritus 24 0 0 0 Pruritus 38 11 0 0 Flushing Flushing includes hot flush.
33 7 0 0 Rash Rash includes: rash erythematous, rash maculo-papular, rash papular and rash pruritic.
16 0 5 0 Urticaria 14 1.1 0 0 Erythema 12 0 0 0 Back pain Back pain includes spinal pain and sacral pain.
21 0 17 0 Paresthesia (g) Paresthesia includes: paresthesia oral, hypoesthesia, hypoesthesia oral and burning sensation.
19 0 17 0 Hypokalemia 15 4.3 12 0 Nausea 14 0 12 0 Clinically relevant adverse reactions that occurred in the APHEXDA arm only in <10% of patients include dermatitis exfoliative generalized, ear swelling, pyrexia, chills, dizziness, tremor and hypertension.
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of APHEXDA.
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: General Disorders and Administration Site Conditions – injection site necrosis, injection site ulcer.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gamida Cell at (844) 477-7478 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical 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.
The safety of APHEXDA was evaluated in the GENESIS study based on data from 92 patients with multiple myeloma who received at least one dose of APHEXDA 1.25 mg/kg subcutaneously and filgrastim and 42 patients who received placebo and filgrastim for mobilization of hematopoietic stem cells for collection and apheresis [see Clinical Studies (14) ] .
The premedication regimen changed during the conduct of the trial as evidence of hypersensitivity reactions was noted.
Of the 92 patients who received at least one dose of APHEXDA, 14 patients received the triple-drug premedication regimen and 78 did not receive the triple-drug premedication regimen (either received no premedication or another premedication regimen).
Serious adverse reactions occurred in 5.4% of patients receiving APHEXDA in combination with filgrastim.
Serious adverse reactions included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia and hypoxia.
One patient did not receive the 5 th dose of filgrastim due to an elevated white blood cell count following administration of APHEXDA.
The most common adverse reactions occurring in GENESIS (>20% and at least 2% higher than the filgrastim + placebo arm) were injection site reactions (pain, erythema and pruritus), pruritus, flushing, and back pain.
Table 1 summarizes the common adverse reactions in GENESIS.
Table 1: Common Adverse Reactions in Patients with Multiple Myeloma During Hematopoietic Stem Cell Mobilization and Apheresis in GENESIS Adverse reactions that occurred in ≥10% in APHEXDA-treated patients and ≥2% more than placebo-treated patients.
APHEXDA and Filgrastim n=92 % Placebo and Filgrastim n=42 % All Grades Grade ≥3 All reactions were grade 3.
All Grades Grade ≥3 Injection site reactions Injection site reactions includes: injection site bruising, injection site discomfort, injection site erythema, injection site induration, injection site mass, injection site nodule, injection site pain, injection site pruritus, injection site rash, injection site swelling, injection site urticaria, injection site cellulitis and injection related reaction.
73 8 5 0 Injection site pain 53 7 5 0 Injection site erythema 27 0 0 0 Injection site pruritus 24 0 0 0 Pruritus 38 11 0 0 Flushing Flushing includes hot flush.
33 7 0 0 Rash Rash includes: rash erythematous, rash maculo-papular, rash papular and rash pruritic.
16 0 5 0 Urticaria 14 1.1 0 0 Erythema 12 0 0 0 Back pain Back pain includes spinal pain and sacral pain.
21 0 17 0 Paresthesia (g) Paresthesia includes: paresthesia oral, hypoesthesia, hypoesthesia oral and burning sensation.
19 0 17 0 Hypokalemia 15 4.3 12 0 Nausea 14 0 12 0 Clinically relevant adverse reactions that occurred in the APHEXDA arm only in <10% of patients include dermatitis exfoliative generalized, ear swelling, pyrexia, chills, dizziness, tremor and hypertension.
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of APHEXDA.
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: General Disorders and Administration Site Conditions – injection site necrosis, injection site ulcer.