Motixafortide
Generic Name: motixafortide
Brand Names:
Aphexda
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
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 )
Dosage
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.
Side Effects
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.
Warnings
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. ( 5.3 ) Leukocytosis: Increased circulating leukocytes have been observed. Monitor white blood cell counts during APHEXDA use. 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 )
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action, APHEXDA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data with APHEXDA use in pregnant women informing the risk of embryo-fetal toxicity. Animal models link dysfunction in CXCR4/SDF-1 signaling to adverse outcomes in mammalian embryo-fetal development and suggest risks to normal placental development (see Data ) . No animal studies have been conducted to evaluate the effect of motixafortide on reproduction and fetal development.
Storage
Store at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Discard prepared reconstituted solution after 24 hours storage under refrigeration 2°C to 8°C (36°F to 46°F) or at room temperature 20°C to 25°C (68°F to 77°F) protected from light.
Frequently Asked Questions
What is Motixafortide 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 for collection and subsequent autologous transplantation in patients with multiple myeloma. ( 1 )
What are the side effects of Motixafortide?▼
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.
Can I take Motixafortide during pregnancy?▼
8.1 Pregnancy Risk Summary Based on its mechanism of action, APHEXDA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data with APHEXDA use in pregnant women informing the risk of embryo-fetal toxicity. Animal models link dysfunction in CXCR4/SDF-1 signaling to adverse outcomes in mammalian embryo-fetal development and suggest risks to normal placental development (see Data ) . No animal studies have been conducted to evaluate the effect of motixafortide on reproduction and fetal development.
What are the important warnings for Motixafortide?▼
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. ( 5.3 ) Leukocytosis: Increased circulating leukocytes have been observed. Monitor white blood cell counts during APHEXDA use. 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.