aphexda
Aphexda (Motixafortide Acetate) is a medication supplied as an injection, powder, lyophilized, for solution.
Motixafortide Acetate · by Ayrmid Pharma
Key facts
- Active ingredient
- Motixafortide Acetate
- Form
- Injectable
- Strength
- Motixafortide Acetate EQ 62MG BASE/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Ayrmid Pharma
- FDA application
- NDA217159
What is Aphexda?
From the FDA label: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 5 -L-citrullinyl-L-lysyl-D-lysyl-L-prolyl-L-tyrosyl 10 -L-arginyl-L-citrullinyl-L-cysteinyl-L-arginineamide, cyclic (4-13)-disulfide, acetate salt. Motixafortide acetate is a synthetic, cyclic peptide composed of a sequence of amino acids with the following structure: Sequence: Cit: Citrulline Nal: Naphthylalanine Fba: 4-Florobenzoic acid Counter Ion: Acetate Molecular weight: 2159.6 g/mol (as the free base) 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. Chemical Structure Chemical Structure Chemical Structure…
How to use
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…
Side effects
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…
Warnings
Important safety information
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. ( 5.3 ) Leukocytosis: Increased circulating leukocytes have been observed. Monitor white blood cell counts during APHEXDA use. ( 5.4 ) Potential for Tumor Cell Mobilization: Tumor cells may be released from marrow during HSC mobilization with APHEXDA and filgrastim. Effect of reinfusion of tumor cells is unknown. ( 5.5 ) Embryo-fetal Toxicity: Can cause fetal harm. Advise women of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 ) 5.1 Anaphylactic Shock and Hypersensitivity Reactions Anaphylactic shock occurred in 0.7% of APHEXDA-treated patients in clinical studies (n=407). The time to anaphylactic shock was between 5 minutes and 30 minutes after drug administration. Hypersensitivity reactions occurred in 7.6% of APHEXDA-treated patients in the GENESIS study. In addition, pruritus, flushing, urticaria, rash, erythema, vomiting, nausea and chills have been reported. Premedicate all patients prior to each dose of APHEXDA 30-60 minutes prior to administration with a triple-drug premedication regimen that includes an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor [see Dosage and Administration (2.1) ] . Patients receiving concomitant negative chronotropic drugs (e.g., beta blockers) may be more at risk for hypotension in case of hypersensitivity reaction. When appropriate, beta blockers should be replaced with non-chronotropic drugs. Administer APHEXDA only in a setting where personnel and therapies are immediately available for the treatment of anaphylaxis and other systemic reactions. Monitor patients for signs or symptoms of hypersensitivity reactions for one hour following administration of APHEXDA and manage reactions promptly. 5.2 Injection Site Reactions Injection site reactions were reported in 73% of patients receiving APHEXDA in the GENESIS trial. Symptoms of injection site reactions included pain, erythema, pruritus, bruising, discomfort, induration, mass, nodule, rash, swelling, and urticaria. Among 92 patients treated with APHEXDA, the highest severity of the reactions was severe in 9%. Premedicate with an analgesic medication (e.g., acetaminophen) prior to each APHEXDA dose. Use analgesic medication and local treatments postdose, as needed. 5.3 Tumor Cell Mobilization in Patients with Leukemia For the purpose of hematopoietic stem cell (HSC) mobilization, APHEXDA may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, APHEXDA is not intended for HSC mobilization and harvest in patients with leukemia. 5.4 Leukocytosis Administration of APHEXDA in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during APHEXDA use. 5.5 Potential for Tumor Cell Mobilization When APHEXDA is used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied. 5.6 Embryo-fetal Toxicity Based on its mechanism of action, APHEXDA can cause fetal harm when administered to a pregnant woman. Animal models link dysfunction in CXCR4/SDF-1 signaling to adverse outcomes in mammalian embryo-fetal development and suggest risks to normal placental development. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with APHEXDA and for 8 days after the final dose [see Use in Specific Populations (8.1 , 8.3) ] .
Who should not take Aphexda
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 )
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- Is there a coupon or discount for Aphexda?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Aphexda. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Aphexda?
- Aphexda is marketed by Ayrmid Pharma. You can see Ayrmid Pharma's full profile, rating, and other products on pharmaranks.
- Is Aphexda a brand-name or generic drug?
- Aphexda is a brand-name product with the active ingredient Motixafortide Acetate.
- Is Aphexda available over the counter?
- No. Aphexda is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Aphexda come in?
- Aphexda is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Aphexda FDA-registered?
- Aphexda is on record with the U.S. FDA under application number NDA217159. You can verify this on its official FDA label.
- Is Aphexda safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Aphexda. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Aphexda?
- Aphexda's side effects are taken directly from its FDA label. From the label: 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 Pati… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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