Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
5 WARNINGS AND PRECAUTIONS Anaphylactic Shock and Hypersensitivity Reactions: Premedicate all patients with a combination of an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor prior to each APHEXDA dose.
Administer APHEXDA in a setting where personnel and therapies are available for immediate treatment.
Observe for signs and symptoms and manage promptly.
( 2.1 , 2.3 , 5.1 ) Injection Site Reactions: The addition of analgesic premedication (e.g., acetaminophen) is recommended.
( 5.2 ) Tumor Cell Mobilization in Patients with Leukemia: APHEXDA may mobilize leukemic cells and should not be used in leukemia patients.
Like all medications, Aphexda can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: