plerixafor (Rx)

Brand and Other Names:Mozobil
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

single use injection

  • 20mg/mL (24mg vial)

Stem Cell Transplantation

Mobilization of Hematopoietic Stem Cells to Peripheral Blood for Collection and Subsequent Autoloqous Transplantation in Patients with Non-Hodgkin's Lymphoma (NHL) & Multiple Myeloma

Initiate treatment after patient has received granulocyte-colony stimulating factor (G-CSF) qDay for 4 days

Recommended dose: 0.24 mg/kg SC qDay; repeat up to 4 consecutive days; not to exceed 40 mg/day  

Start treatment approximately 11 hr prior to apheresis initiation

Acute Myeloid Leukemia (Orphan)

Orphan indication sponsor

  • Genzyme Corporation; 500 Kendall Street, Cambridge, MA 02142

Renal Impairment

CrCl >50 mL: Dose adjustment not necessary

CrCl <50 mL/min: Reduce Dose by 1/3 to 0.16 mg/kg; not to exceed 27 mg/day

Safety and efficacy not established

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Adverse Effects

>10%

Diarrhea (37%)

Injection site reaction (34%)

Nausea (34%)

Fatigue (27%)

Headache (22%)

Arthralgia (13%)

Dizziness (11%)

Vomiting (10%)

1-10%

Insomnia (7%)

Flatulence (7%)

Vomiting (10%)

Postmarketing Reports

Immune System Disorders: Anaphylactic reactions, including anaphylactic shock

Abnormal dreams and nightmares

Blood and lymphatic system: Splenomegaly and splenic rupture

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Warnings

Contraindications

None listed in the manufacturer's labeling

History of hypersensitivity; anaphylaxis reported

Cautions

Not intended for HSC mobilization and harvest in patients with leukemia

When used in combination with filgrastim tumor cells may be released from the bond marrow and subsequently collected in the leukapheresis product. Effects of potential reinfusion of tumor cells not studied

Dose reduction recommended in patients with moderate-severe renal impairment

Leukocytosis; use in conjunction with G-CSF increases circulating leukocytes as well as HSC populations

Risk of thrombocytopenia; monitor platelet counts in all patients receiving treatment and then undergo apheresis

Risk of splenic enlargement and rupture

Optimal effective dose in patients wighing >175% of ideal body weight not studied

Cases of splenic enlargement and/or rupture reported following administration in conjunction with growth factor G-CSF

Medications that reduce renal function or compete for active tubular secretion may increase serum concentrations of plerixafor

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Pregnancy & Lactation

Pregnancy

Limited available data in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes

Advise pregnant women of potential risk to fetus

Advise women of reproductive potential to avoid becoming pregnant while receiving treatment

Verify pregnancy status in females of reproductive potential prior to initiating therapy

Therapy can cause embryo-fetal harm when administered to pregnant women; advise females of reproductive potential to use effective contraception during treatment and for one week after final dose

Animal data

  • In animal reproduction studies, subcutaneous administration of plerixafor to pregnant rats during organogenesis at doses ten times maximum recommended human doses resulted in embryo-fetal mortality, structural abnormalities, and alterations to growth

Lactation

There are no data on presence of plerixafor in human milk, effect on breastfed child, or the effect on milk production; because of potential serious adverse reactions in breastfed child, advise females that breastfeeding is not recommended during treatment and for one week after final dose

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

A hematopoeitic stem cell mobilizer. Blocks binding of stromal cell-derived factor-1-alpha, found on bone marrow stromal cells, to the CXC chemokine receptor 4 (CXCR4). The inhibition results in the mobilization of progenitor and hematopoietic stem cells from the bone marrow into peripheral blood.

Absorption

Peak Plasma Time: 30-60 min (SC)

Distribution

Protein Bound: 58%

Vd: 0.3 L/kg

Metabolism

None

Elimination

Half-Life: 3-6 hr

Excretion: Urine 70%

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Images

No images available for this drug.
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Patient Handout

Patient Education
plerixafor subcutaneous

PLERIXAFOR - INJECTION

(pler-IX-a-for)

COMMON BRAND NAME(S): Mozobil

USES: Plerixafor is used by patients with certain types of cancer (non-Hodgkin's lymphoma-NHL, multiple myeloma-MM) to prepare them for stem cell transplant. Stem cells, which are found mainly in the bone marrow, turn into red blood cells, white blood cells, and platelets. Plerixafor is used to help stem cells move from the bone marrow to the bloodstream so that the cells can be collected and stored. The stem cells are then infused back into the patient after chemotherapy or radiation.

HOW TO USE: Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.Inject this medication under the skin as directed by your doctor, usually about 11 hours before the blood filtering procedure. The dosage is based on your medical condition and weight. Your doctor will also direct you to use another medication (G-CSF) to prepare for the procedure. Carefully follow your doctor's instructions on how to use both medications correctly.

SIDE EFFECTS: Diarrhea, nausea, vomiting, gas, dizziness, or pain/redness/swelling at injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: left upper abdominal pain, left shoulder pain, fainting, easy bleeding/bruising.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using plerixafor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, leukemia.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using plerixafor. Plerixafor may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for one week after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for one week after stopping treatment. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fainting, severe dizziness.

NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count) should be done while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised November 2019. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.