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Plerixafor: Drug information

Plerixafor: Drug information
(For additional information see "Plerixafor: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Mozobil
Brand Names: Canada
  • Mozobil
Pharmacologic Category
  • Hematopoietic Agent;
  • Hematopoietic Stem Cell Mobilizer
Dosing: Adult

Note: Dosing is based on actual body weight. Begin plerixafor after patient has received filgrastim for 4 days (refer to Filgrastim monograph for filgrastim dose).

Hematopoietic cell mobilization

Hematopoietic cell mobilization (for autologous transplantation in non-Hodgkin lymphoma and multiple myeloma): Note: Administer ~11 hours prior to apheresis. Plerixafor, filgrastim, and apheresis should be continued daily until sufficient cell collection up to a maximum of 4 days.

Patients ≤83 kg: SUBQ: 20 mg fixed dose or 0.24 mg/kg once daily for up to 4 consecutive days.

Patients >83 kg: SUBQ: 0.24 mg/kg once daily for up to 4 consecutive days; maximum dose: 40 mg daily.

Hematopoietic cell mobilization prior to betibeglogene autotemcel in beta thalassemia

Hematopoietic cell mobilization prior to betibeglogene autotemcel in beta thalassemia (off-label use): SUBQ: 0.24 mg/kg once daily in the evening on mobilization days 4 and 5 (and day 6 if needed), followed by apheresis, which usually begins on mobilization day 5 (Ref). Refer to protocol for further mobilization and apheresis details.

Dosing: Kidney Impairment: Adult

Note: Creatinine clearance estimate based on Cockcroft-Gault formula:

CrCl >50 mL/minute: No dosage adjustment necessary.

CrCl ≤50 mL/minute:

Patients ≤83 kg: 13 mg fixed dose or 0.16 mg/kg once daily

Patients >83 kg and <160 kg: 0.16 mg/kg once daily; maximum dose: 27 mg daily

Hemodialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Obesity: Adult

The manufacturer recommends calculating the dose based on actual weight for patients weighing up to 175% of ideal body weight (maximum dose: 40 mg daily). Dosing in patients >175% of ideal body weight has not been studied.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported with filgrastim combination therapy.

>10%:

Central nervous system: Fatigue (27%), headache (22%), dizziness (11%)

Gastrointestinal: Diarrhea (37%), nausea (34%)

Local: Injection site reaction (34%, including edema, erythema, hematoma, hemorrhage, induration, inflammation, irritation, pain, paresthesia, pruritus, skin rash, urticaria)

Neuromuscular & skeletal: Arthralgia (13%)

1% to 10%:

Central nervous system: Insomnia (7%), malaise (<5%)

Dermatologic: Erythema (<5%), hyperhidrosis (<5%)

Gastrointestinal: Vomiting (10%), flatulence (7%), abdominal distension (<5%), abdominal distress (<5%), abdominal pain (<5%), constipation (<5%), dyspepsia (<5%), oral hypoesthesia (<5%), xerostomia (<5%)

Hematologic & oncologic: Hyperleukocytosis (7%)

Neuromuscular & skeletal: Musculoskeletal pain (<5%)

<1%, postmarketing, and/or case reports: Abnormal dreams, anaphylaxis, diaphoresis, dyspnea, hypersensitivity reaction, hypoxia, leukocytosis, nightmares, orthostatic hypotension, periorbital swelling, syncope, thrombocytopenia

Contraindications

History of hypersensitivity to plerixafor or any component of the formulation (anaphylactic shock has occurred).

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactic shock/hypersensitivity: Serious hypersensitivity reactions, including anaphylactic-type reactions (may be life-threatening with serious hypotension and shock) have been reported. Observe patients for hypersensitivity symptoms during, for 30 minutes after administration, and until clinically stable. Medication, personnel, and equipment for hypersensitivity management should be immediately available. Mild-to-moderate allergic reactions may also occur, usually within 30 minutes of administration.

• Hematologic effects: Increases circulating leukocytes when used in conjunction with filgrastim. Thrombocytopenia has been observed.

• Splenic enlargement/rupture: Cases of splenomegaly and/or splenic rupture have been reported with plerixafor when used in conjunction with filgrastim; instruct patients to report left upper quadrant pain or scapular/shoulder tip pain; promptly evaluate in any patient who report these symptoms.

Disease-related concerns:

• Leukemia: Not intended for mobilization in patients with leukemia; may contaminate apheresis product by mobilizing leukemic cells.

Concurrent drug therapy issues:

• Nephrotoxic drugs: Medications that may reduce renal function or compete for active tubular secretion may increase serum concentrations of plerixafor.

Special populations:

• Obese patients: Plerixafor has not been studied in patients weighing >175% of ideal body weight.

Other warnings/precautions:

• Tumor cell mobilization: When used in combination with filgrastim, tumor cells released from marrow could be collected in leukapheresis product; potential effect of tumor cell reinfusion is unknown.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous [preservative free]:

Mozobil: 24 mg/1.2 mL (1.2 mL)

Generic: 24 mg/1.2 mL (1.2 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Mozobil Subcutaneous)

24 mg/1.2 mL (per mL): $9,968.07

Solution (Plerixafor Subcutaneous)

24 mg/1.2 mL (per mL): $500.00 - $3,987.23

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.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

Mozobil: 24 mg/1.2 mL (1.2 mL)

Generic: 24 mg/1.2 mL (1.2 mL)

Administration: Adult

SUBQ: Administer subcutaneously, ~11 hours prior to initiation of apheresis. In some clinical trials, plerixafor administration began in the evening prior to apheresis; filgrastim was begun on day 1, plerixafor initiated in the evening on day 4 and apheresis in the morning on day 5; with filgrastim, plerixafor, and apheresis then continued daily until sufficient cell collection for autologous transplant (Ref).

Observe patients for signs/symptoms of hypersensitivity reactions during, for 30 minutes after administration, and until clinically stable.

There are reports of shifting the plerixafor administration time to late afternoon (eg, 4 PM or 5 PM) followed by apheresis ~15 to 17 hours later instead if administering plerixafor in the late evening (Ref).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 3]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020). Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Use: Labeled Indications

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 non-Hodgkin lymphoma and multiple myeloma.

Use: Off-Label: Adult

Hematopoietic cell mobilization prior to betibeglogene autotemcel in beta thalassemia

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Evaluate pregnancy status prior to use in patients who could become pregnant. Pregnancy should be avoided during therapy. Patents who could become pregnant and males treated with plerixafor should use effective contraception during treatment and for 1 week after the final plerixafor dose.

Pregnancy Considerations

Based on data from animal reproduction studies, in utero exposure to plerixafor may cause fetal harm.

Breastfeeding Considerations

It is not known if plerixafor is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer does not recommend breastfeeding during therapy or for 1 week after the final plerixafor dose.

Monitoring Parameters

CBC with differential and platelets. Evaluate pregnancy status prior to use in patients who could become pregnant. Monitor for signs/symptoms of hypersensitivity (during, for 30 minutes after administration, and until clinically stable) and for signs/symptoms of splenomegaly (promptly evaluate reports of left upper quadrant pain or scapular/shoulder tip pain).

Mechanism of Action

Plerixafor reversibly inhibits binding of stromal cell-derived factor-1-alpha (SDF-1α), expressed on bone marrow stromal cells, to the CXC chemokine receptor 4 (CXCR4), resulting in mobilization of hematopoietic stem and progenitor cells from bone marrow into peripheral blood. Plerixafor used in combination with filgrastim results in synergistic increase in CD34+ cell mobilization. Mobilized CD34+ cells are capable of engrafting with extended repopulating capacity.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Peak CD34+ mobilization (healthy volunteers): Plerixafor monotherapy: 6 to 9 hours after administration; Plerixafor + filgrastim: 10 to 14 hours

Duration: Sustained elevation in CD34+ cells (healthy volunteers): 4 to 18 hours after administration

Absorption: SUBQ: Rapid; exposure using the mg/kg dosing increases with increasing body weight; the fixed dosing (20 mg) results in higher exposure than the mg/kg dose, but the median time to reach the target cell count is the same for both dosing regimens

Distribution: 0.3 L/kg; primarily to extravascular fluid space

Protein binding: ≤58%

Metabolism: Not metabolized

Half-life elimination: Terminal: 3 to 5 hours

Time to peak, plasma: SUBQ: 30 to 60 minutes

Excretion: Urine (~70%; as parent drug)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Clearance is reduced in patients with renal impairment. When compared to patients with normal renal function, the mean AUC was increased 7% in patients with mild renal impairment (CrCl 51 to 80 mL/minute), 32% for moderate renal impairment (CrCl 31 to 50 mL/minute), and 39% with severe renal impairment (CrCl <31 mL/minute).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Celixafor | Mozobil | Revixil 20;
  • (AU) Australia: Mozobil;
  • (BE) Belgium: Mozobil;
  • (BG) Bulgaria: Mozobil;
  • (BR) Brazil: Mozobil;
  • (CH) Switzerland: Mozobil;
  • (CL) Chile: Mozobil | Revixil 20;
  • (CO) Colombia: Mozobil;
  • (CZ) Czech Republic: Mozobil;
  • (DE) Germany: Mozobil;
  • (DK) Denmark: Mozobil;
  • (EE) Estonia: Mozobil;
  • (EG) Egypt: Mozobil;
  • (ES) Spain: Mozobil;
  • (FI) Finland: Mozobil;
  • (FR) France: Mozobil;
  • (GB) United Kingdom: Mozobil;
  • (GR) Greece: Mozobil;
  • (HK) Hong Kong: Mozobil;
  • (HU) Hungary: Mozobil;
  • (IE) Ireland: Mozobil;
  • (IN) India: Mozifor;
  • (IT) Italy: Mozobil;
  • (JO) Jordan: Mozobil;
  • (JP) Japan: Mozobil;
  • (KR) Korea, Republic of: Mozobil;
  • (KW) Kuwait: Mozobil;
  • (LB) Lebanon: Mozobil;
  • (LT) Lithuania: Mozobil | Plerixafor;
  • (LU) Luxembourg: Mozobil;
  • (LV) Latvia: Mozobil;
  • (MT) Malta: Mozobil;
  • (MY) Malaysia: Mozobil;
  • (NL) Netherlands: Mozobil;
  • (NO) Norway: Mozobil;
  • (NZ) New Zealand: Mozobil;
  • (PE) Peru: Revixil 20;
  • (PL) Poland: Mozobil;
  • (PR) Puerto Rico: Mozobil;
  • (PT) Portugal: Mozobil;
  • (PY) Paraguay: Revixil 20;
  • (RO) Romania: Mozobil;
  • (RU) Russian Federation: Mozobil | Plerifor;
  • (SA) Saudi Arabia: Mozobil;
  • (SE) Sweden: Mozobil;
  • (SI) Slovenia: Mozobil;
  • (SK) Slovakia: Mozobil;
  • (TH) Thailand: Mozobil;
  • (TN) Tunisia: Mozobil;
  • (TR) Turkey: Mozobil | Mozosent | Pleksor;
  • (TW) Taiwan: Mozobil;
  • (ZA) South Africa: Mozobil
  1. <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Cooper DL, Pratt K, Baker J, et al. Late afternoon dosing of plerixafor for stem cell mobilization: a practical solution. Clin Lymphoma Myeloma Leuk. 2011;11(3):267-272. doi:10.1016/j.clml.2011.03.014 [PubMed 21658654]
  3. DiPersio JF, Micallef I, Stiff PJ, et al. Phase III Prospective Randomized Double-Blinded Placebo-Controlled Trial of Plerixafor Plus Granulocyte Colony-Stimulating Factor Compared With Placebo Plus Granulocyte Stimulating Factor for Autologous Stem-Cell Mobilization and Transplantation for Patients With Non-Hodgkin’s Lymphoma. J Clin Oncol. 2009a;27(28):4767-4773. [PubMed 19720922]
  4. DiPersio JF, Stadtmauer EA, Nadamanee NP, et al. Plerixafor and G-CSF Versus Placebo and G-CSF to Mobilize Hematopoietic Stem Cells for Autologous Stem Cell Transplantation in Patients With Multiple Myeloma. Blood. 2009b;113(23):5720-5726. [PubMed 19363221]
  5. El Rahi C, Cox JE, May R, et al. Efficacy of afternoon plerixafor administration for stem cell mobilization. Clin Med Insights Blood Disord. 2018;11:1179545X18792253. doi:10.1177/1179545X18792253 [PubMed 30186032]
  6. Locatelli F, Thompson AA, Kwiatkowski JL, et al. Betibeglogene autotemcel gene therapy for non-β00 genotype β-thalassemia. N Engl J Med. 2022;386(5):415-427. doi:10.1056/NEJMoa2113206 [PubMed 34891223]
  7. Mozobil (plerixafor) [prescribing information]. Cambridge, MA: Genzyme Corporation; September 2023.
  8. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 2016. Accessed October 5, 2016.
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