Brand Name
Aphexda
Generic Name
Motixafortide
View Brand Information FDA approval date: September 08, 2023
Form: Injection
What is Aphexda (Motixafortide)?
APHEXDA is indicated in combination with filgrastim 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 to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
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A Phase Ⅲ, Randomized, Double-Blinded Study Evaluating the Safety and Efficacy of Combination Treatment of Motixafortide and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma
Summary: This is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in Chinese patients with multiple myeloma.
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Brand Information
APHEXDA (MOTIXAFORTIDE)
1INDICATIONS 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.
2DOSAGE FORMS AND STRENGTHS
For injection: 62 mg as a white to off-white lyophilized powder in a single-dose vial for reconstitution.
3CONTRAINDICATIONS
APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in other sections of the labeling:
- Anaphylactic Shock and Hypersensitivity Reactions
- Injection Site Reactions
- Potential for Tumor Cell Mobilization in Patients in Leukemia
- Leukocytosis
- Potential for Tumor Cell Mobilization
4.1Clinical 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.
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
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
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.
5DESCRIPTION
APHEXDA for injection contains motixafortide, which is a hematopoietic stem cell mobilizer. The chemical name of the synthetic motixafortide acetate, the active pharmaceutical ingredient, is N-(4-Fluoro-benzoyl)-L-arginyl-L-arginyl-[L-3-naphthyl)alanyl]-L-cysteinyl-L-tyrosyl
APHEXDA is supplied as a sterile white to off-white, preservative-free lyophilized powder in single-dose vials. Each vial contains 73 mg of motixafortide (provided as motixafortide acetate) for reconstitution with 2 mL 0.45% saline, delivering 62 mg motixafortide per 1.7 mL. Motixafortide is present as a salt with 4 to 8.5 molar equivalents of acetate. The inactive ingredients include 26 mg of mannitol and hydrochloric acid for pH adjustment.
Reconstitution with 2 mL of 0.45% sodium chloride for injection (or 1 mL water for injection + 1 mL 0.9% sodium chloride for injection) yields a clear solution of 36.5 mg/mL motixafortide, pH 5.8 to 7.5.
6CLINICAL STUDIES
The efficacy of APHEXDA in combination with filgrastim was evaluated in the GENESIS study (NCT 03246529). In this randomized, double-blind, placebo-controlled study, 122 patients with multiple myeloma were randomized in a 2:1 ratio to receive APHEXDA 1.25 mg/kg subcutaneously (N=80) or placebo (N=42). Prior to receiving APHEXDA or placebo, patients received daily morning doses of filgrastim 10-15 mcg/kg for 4 days. On the evening of Day 4, patients received APHEXDA or placebo. On Day 5, patients received a fifth morning dose of filgrastim within 1 hour prior to their first apheresis (12 hours ± 2 hours from the APHEXDA/placebo administration). The apheresis cell collection goal for the study was ≥ 6 × 10
In the event that the cell collection goal was not achieved with the first apheresis on Day 5, patients received another morning dose of filgrastim on Day 6 within 1 hour prior to their second apheresis. In the event that the cell collection goal was still not achieved, patients received a second administration of APHEXDA or placebo on the evening of Day 6 and a seventh dose of filgrastim in the morning of Day 7 within 1 hour prior to a third apheresis. If the collection goal was not achieved, patients received an eighth dose of filgrastim in the morning of Day 8 within 1 hour prior to a fourth apheresis.
The median age of the study population was 63 years (range 34-75); 65% were males; 86% Caucasian, 8% African American, 2% Asian and 10% were of Hispanic or Latino ethnicity. Seventy percent of patients were previously treated with lenalidomide.
The efficacy of APHEXDA was based upon the proportion of patients who achieved a cell collection goal of ≥ 6 × 10
Efficacy results showed that 67.5% of patients in the APHEXDA treatment arm versus 9.5% in the placebo arm achieved the cell collection goal of ≥ 6 × 10
Multiple factors can influence time to engraftment and graft durability following stem cell transplantation. In the GENESIS study, time to neutrophil and platelet engraftment and graft durability following transplantation were similar across treatment groups.
7HOW SUPPLIED/STORAGE AND HANDLING
APHEXDA (motixafortide) for injection is supplied as a white to off-white lyophilized powder in a single-dose vial for reconstitution. Each vial delivers 62 mg motixafortide free base.
NDC 73441-062-01 (Carton containing one vial)
8PATIENT COUNSELING INFORMATION
- Advise patients of the risk of anaphylactic and hypersensitivity reactions (such as pruritus, flushing, urticaria, rash, vomiting, nausea and chills) during and after APHEXDA injection and to immediately report such signs and symptoms to healthcare professionals
- Advise patients that APHEXDA may cause injection site reactions, such as pain, redness, and swelling
- Advise females of reproductive potential to use effective contraceptive methods during APHEXDA treatment and for 8 days after the administration of APHEXDA
- Advise females of reproductive potential of the potential risk to a fetus. Advise females to contact their healthcare provider if they become pregnant or if pregnancy is suspected during treatment with APHEXDA
- Advise women that breastfeeding is not recommended during treatment with APHEXDA and for 8 days following the last dose
9PRINCIPAL DISPLAY PANEL - 62 mg Vial Carton
NDC 73441-062-01
APHEXDA
For Subcutaneous Injection by
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