APHEXDA

APHEXDA is an FDA-registered drug product whose active ingredient is MOTIXAFORTIDE. It is labelled by Gamida Cell Inc. taken by subcutaneous and marketed as a human prescription drug product. Identifiers on file: NDC 73441-062, application NDA217159, label effective 20260604. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing MOTIXAFORTIDE are most often described in connection with: hematopoietic stem, indicated combination, filgrastim g-csf, peripheral blood, subsequent autologous, transplantation patients, multiple myeloma, usage aphexda. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

2 DOSAGE AND ADMINISTRATION Initiate APHEXDA treatment after filgrastim has been administered daily for 4 days. ( 2.1 ) Recommended dosage is 1.25 mg/kg actual body weight by subcutaneous injection 10 to 14 hours prior to initiation of apheresis. ( 2.2 ) A second dose of APHEXDA can be administered 10 to 14 hours prior to a third apheresis. ( 2.2 ) See Full Prescribing Information for instructions on preparation and administration. 2.1 Important Dosing Information Premedicate all patients before each dose of APHEXDA to reduce the risk of hypersensitivity and injection site reactions: Administer diphenhydramine (12.5 mg intravenously or 25 mg to 50 mg orally, or another H1-antihistamine), an H2 blocker (e.g., famotidine), and a leukotriene inhibitor (e.g., montelukast) approximately 30 to 60 minutes before injection of APHEXDA. The addition of an analgesic medication (e.g., acetaminophen) to the premedication regimen is recommended. Administer filgrastim 10 mcg/kg subcutaneously once daily for 4 days prior to the first dose of APHEXDA and on each day prior to each apheresis. 2.2 Recommended Dosage The recommended dosage of APHEXDA is 1.25 mg/kg administered via slow (approximately 2 minutes) subcutaneous injection 10 to 14 hours prior to the initiation of the first apheresis. Dosing is based on actual body weight. A second dose of APHEXDA can be administered 10 to 14 hours before a third apheresis, if necessary. 2.3 Preparation and Administration Use aseptic technique to prepare and administer APHEXDA: More than one vial may be needed for a full dose. Calculate the dose, the total volume of reconstituted APHEXDA solution required, and number of APHEXDA vials required based on patient's actual body weight. Remove the APHEXDA vial(s) from the refrigerator and allow to reach room temperature at 20°C to 25°C (68°F to 77°F) for at least 30 minutes. Reconstitute each vial with 2 mL of 0.45% Sodium Chloride Injection, USP at room temperature (20°C to 25°C (68°F to 77°F)) resulting in a concentration of 36.5 mg/mL of APHEXDA and permitting withdrawal of up to 1.7 mL (62 mg). Alternatively, you can reconstitute each vial with 1 mL of Sterile Water for Injection, USP and 1 mL of 0.9% Sodium Chloride Injection, USP. Gently swirl and invert for up to 3 minutes slowly until completely dissolved. Inspect the reconstituted solution for discoloration and particulate matter. The reconstituted solution should appear clear and colorless. Do not use if the reconstituted solution is discolored, is cloudy, or contains visible particulates. If needed, store the reconstituted APHEXDA solution refrigerated at 2°C to 8°C (36°F to 46°F) or at room temperature at 20°C to 25°C (68°F to 77°F) for up to 24 hours protected from light. Withdraw the required injection volume of APHEXDA from the vial(s) into an appropriately sized syringe. Each injection volume should not exceed 2 mL. Divide doses requiring greater than 2 mL into multiple syringes to allow different injection sites. Administration Administer subcutaneous injection into the abdomen, the back or side of the upper arms, or the thighs. Rotate injection sites. An injection should never be given into scar tissue or areas that are reddened, inflamed, or swollen. If injecting into the abdomen, avoid a 5 cm diameter circle around the navel. If more than one injection is needed for a single dose of APHEXDA, the injection sites should be at least 2 cm apart from previous injection locations. Discard unused portion of the drug. Monitor patients for one hour after administration [see Warnings and Precautions (5.1) ].

4 CONTRAINDICATIONS APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide [see Warnings and Precautions (5.1) ] . History of serious hypersensitivity reaction to APHEXDA. ( 4 )

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.

What is APHEXDA used for?
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 …

Who makes APHEXDA?
Gamida Cell Inc. is the labeler of record for APHEXDA.

What form does APHEXDA come in?
administered by subcutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is APHEXDA prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has APHEXDA been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.