Version May 2024
Note: Dosing is based on actual body weight. Begin motixafortide after patient has received filgrastim for 4 days and on each day prior to apheresis.
Premedication: Premedicate all patients ~30 to 60 minutes prior to motixafortide injection to reduce the risk of hypersensitivity and injection-site reactions. Premedication includes diphenhydramine (IV 12.5 mg or 25 to 50 mg oral, or an alternate histamine H1 antagonist), a histamine H2 antagonist (eg, famotidine), and a leukotriene-receptor antagonist (eg, montelukast). The addition of an analgesic (eg, acetaminophen) for injection-site reactions is also recommended.
Hematopoietic cell mobilization: Note: Dosing is based on actual body weight. Begin motixafortide after patient has received filgrastim for 4 days and on each day prior to apheresis. SUBQ: 1.25 mg/kg once as a single dose 10 to 14 hours prior to the first apheresis. A second dose (1.25 mg/kg) may be administered 10 to 14 hours prior to a third apheresis, if needed (Ref).
Mild to moderate kidney impairment: There are no dosage adjustments provided in the manufacturer’s labeling; however, no clinically significant difference in motixafortide pharmacokinetics were observed.
Severe kidney impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Hepatic impairment prior to treatment initiation:
Mild hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling; however, no clinically significant difference in motixafortide pharmacokinetics was observed.
Moderate to severe hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in combination with filgrastim in adults.
>10%:
Cardiovascular: Flushing (33%)
Dermatologic: Erythema of skin (12%), pruritus (38%), skin rash (16%), urticaria (14%)
Endocrine & metabolic: Hypokalemia (15%)
Gastrointestinal: Nausea (14%)
Local: Injection-site reaction (73%; including bruising at injection site, cellulitis at injection site, discomfort at injection site, erythema at injection site [27%], induration at injection site, injection-site nodule, injection-site pruritus [24%], pain at injection site [53%], rash at injection site, residual mass at injection site, swelling at injection site, urticaria at injection site)
Nervous system: Paresthesia (19%)
Neuromuscular & skeletal: Back pain (21%)
1% to 10%:
Cardiovascular: Hypertension (<10%)
Dermatologic: Exfoliative dermatitis (<10%)
Hypersensitivity: Hypersensitivity reaction (8%)
Nervous system: Chills (<10%), dizziness (<10%), tremor (<10%)
Otic: Swelling of the ear (<10%)
Miscellaneous: Fever (<10%)
<1%: Hypersensitivity: Anaphylactic shock
Frequency not defined:
Gastrointestinal: Vomiting
Hematologic & oncologic: Leukocytosis
Respiratory: Hypoxia
Serious hypersensitivity reactions to motixafortide or any component of the formulation.
Concerns related to adverse effects:
• Anaphylactic shock/hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylactic shock, have been reported in patients treated with motixafortide; time to anaphylactic shock was 5 to 30 minutes following administration. Symptoms of hypersensitivity reactions may include pruritus, flushing, urticaria, rash, erythema, vomiting, nausea, and chills. Patients receiving negative chronotropic drugs (eg, beta-blockers) may be at higher risk of hypotension with hypersensitivity reactions; replace with nonchronotropic drugs if appropriate. Manage promptly as clinically indicated. Administer in a facility where adequate personnel and treatments are immediately available for the treatment of hypersensitivity reactions, including anaphylaxis.
• Injection-site reactions: Injection-site reactions were observed in approximately three-quarters of patients treated with motixafortide. Symptoms of injection-site reactions may include pain, erythema, pruritus, bruising, discomfort, induration, mass, nodule, rash, swelling, and urticaria. Analgesics and local treatments may be administered after the motixafortide dose as needed to manage local reactions.
• Leukocytosis: Use of motixafortide with filgrastim increases leukocyte counts, including hematopoietic stem cell populations, in peripheral circulation.
Disease-related concerns:
• Leukemia: Not intended for mobilization in patients with leukemia; may cause contamination of apheresis product through mobilization of leukemic cells.
Other warnings/precautions:
• Tumor cell mobilization: When used in combination with filgrastim, tumor cells released from marrow could be collected in apheresis product; potential effect of tumor cell reinfusion is unknown.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Subcutaneous, as acetate [preservative free]:
Aphexda: 62 mg (1 ea)
No
Solution (reconstituted) (Aphexda Subcutaneous)
62 mg (per each): $7,080.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
SUBQ: Administer SUBQ as a slow (~2 minutes) injection into the abdomen, the back or side of upper arm, or the thigh; avoid a 5 cm diameter around the navel for doses administered in the abdomen. Doses requiring >2 mL total volume should be divided into multiple syringes. If multiple injection sites are required, injections should be at least 2 cm apart. Do not inject into scar tissue or areas where the skin is red, inflamed, or swollen.
Administer in a facility with adequate personnel and treatments are immediately available for the treatment of hypersensitivity reactions, including anaphylaxis. Monitor patient for 1 hour after administration of motixafortide.
Hematopoietic cell mobilization: Mobilization of hematopoietic stem cells to the peripheral blood (in combination with granulocyte colony–stimulating factor [filgrastim]) for collection and subsequent autologous transplantation in patients with multiple myeloma.
None known.
There are no known significant interactions.
Verify pregnancy status prior to treatment initiation in patients who could become pregnant. Patients who could become pregnant should use effective contraception during therapy and for 8 days after the last dose of motixafortide.
Animal reproduction studies have not been conducted. Based on the mechanism of action, in utero exposure to motixafortide may cause fetal harm.
It is not known if motixafortide is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment and for 8 days after the last dose of motixafortide.
CBC with differential. Evaluate pregnancy status prior to treatment initiation (in patients who could become pregnant). Monitor patients for signs/symptoms of hypersensitivity (eg, pruritus, flushing, urticaria, rash, erythema, vomiting, nausea, chills, hypotension), including anaphylaxis for 1 hour after administration of motixafortide. Monitor injection site for local reactions.
Motixafortide selectively inhibits C-X-C motif chemokine receptor 4 (CXCR4) binding to stromal cell–derived factor-1-alpha (SDF-1α)/C-X-C motif chemokine ligand 12 (CXCL 12), expressed by bone marrow stromal cells, resulting in mobilization of hematopoietic stem and progenitor cells from bone marrow into peripheral blood. Motixafortide binds CXCR4 with high affinity and prolonged receptor occupancy, resulting in extended clinical activity (Crees 2023). In animal models, mobilized CD34+ cells are capable of engrafting with extended repopulating capacity.
Onset: Peak CD34+ mobilization (healthy volunteers): Motixafortide monotherapy: 16 hours after administration.
Duration: CXCR4 receptor occupancy maintained for >72 hours.
Distribution: Vd: 27 L.
Protein binding: >99% (human plasma proteins).
Metabolism: Nonspecific degradation via catabolic pathways in blood and liver into small peptides and individual amino acids.
Half-life elimination: ~2 hours.
Time to peak: SUBQ: ~0.25 to 1.17 hours.
Excretion: Clearance: 46.5 L/hour.
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