Mozobil Inj, 1.2ml

Manufacturer SANOFI PHARMACEUTICALS Active Ingredient Plerixafor(pler IX a fore) Pronunciation ple-rix-a-for (Plerixafor)
It is used to raise the number of stem cells.
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Drug Class
Hematopoietic Stem Cell Mobilizer
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Pharmacologic Class
CXCR4 Chemokine Receptor Antagonist
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Pregnancy Category
Not available
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FDA Approved
Dec 2008
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Mozobil is an injection used in combination with another medicine called G-CSF to help release your own blood-forming stem cells from your bone marrow into your bloodstream. These stem cells are then collected and later given back to you after high-dose chemotherapy or radiation, to help your body recover and make new blood cells.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the dosage instructions carefully. This medication is administered via injection into the fatty tissue under the skin.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on the best course of action.
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Lifestyle & Tips

  • Avoid driving or operating machinery if you experience dizziness or fatigue after the injection.
  • Report any new or worsening abdominal pain, especially in the upper left side, or shoulder pain, as this could be a sign of a serious spleen problem.
  • Stay well-hydrated as advised by your healthcare team.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 0.24 mg/kg subcutaneously (SC) once daily for 2 to 4 days (or up to 6 days) prior to apheresis, given 6 to 11 hours before apheresis.
Dose Range: 0.24 - 0.24 mg

Condition-Specific Dosing:

Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM): Used in combination with granulocyte-colony stimulating factor (G-CSF) for mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 0.24 mg/kg SC once daily for 2 to 4 days (or up to 6 days) prior to apheresis, given 6 to 11 hours before apheresis. Approved for pediatric patients with NHL and acute lymphoblastic leukemia (ALL) for stem cell mobilization.
Adolescent: 0.24 mg/kg SC once daily for 2 to 4 days (or up to 6 days) prior to apheresis, given 6 to 11 hours before apheresis. Approved for pediatric patients with NHL and acute lymphoblastic leukemia (ALL) for stem cell mobilization.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl โ‰ฅ 50 mL/min).
Moderate: Reduce dose to 0.16 mg/kg SC (CrCl 30 to < 50 mL/min).
Severe: Reduce dose to 0.16 mg/kg SC (CrCl < 30 mL/min).
Dialysis: Administer 0.16 mg/kg SC in patients on hemodialysis after hemodialysis is complete. No data for peritoneal dialysis.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended. Use with caution due to limited data.

Pharmacology

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Mechanism of Action

Plerixafor is a CXCR4 chemokine receptor antagonist. It blocks the binding of stromal cell-derived factor-1 alpha (SDF-1ฮฑ) to the CXCR4 receptor. This interaction is crucial for the homing and retention of hematopoietic stem cells (HSCs) in the bone marrow. By blocking CXCR4, plerixafor disrupts the SDF-1ฮฑ/CXCR4 axis, leading to the rapid mobilization of CD34+ hematopoietic stem cells from the bone marrow into the peripheral blood.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 100% (subcutaneous)
Tmax: 0.3 to 1 hour
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: Approximately 0.3 L/kg
ProteinBinding: Low (less than 10%)
CnssPenetration: Limited

Elimination:

HalfLife: 4 to 5 hours
Clearance: Approximately 7 L/hr (renal clearance is primary route)
ExcretionRoute: Renal (primarily unchanged drug)
Unchanged: Approximately 70% of administered dose excreted unchanged in urine within 24 hours.
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Pharmacodynamics

OnsetOfAction: Rapid (within 6-11 hours of administration, leading to peak mobilization)
PeakEffect: Approximately 10-14 hours post-dose (peak CD34+ cell count in peripheral blood)
DurationOfAction: Mobilization effect typically lasts for 12-18 hours after a single dose.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:

Rash, hives, itching, or red, swollen, blistered, or peeling skin, with or without fever
Wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking
Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat

Some allergic reactions can be life-threatening. Additionally, seek medical help right away if you experience:

Severe dizziness or fainting
Unexplained bruising or bleeding
Left upper stomach pain or shoulder pain, as this may indicate an enlarged spleen, which can lead to rupture

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:

Dizziness, tiredness, or weakness
Headache
Diarrhea, stomach pain, upset stomach, or vomiting
Gas
Joint pain
Irritation at the injection site
* Trouble sleeping

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Unusual bleeding or bruising
  • Signs of infection (fever, chills, sore throat)
  • Severe allergic reaction (difficulty breathing, swelling of face/lips/tongue, rash, hives)
  • Severe abdominal pain, especially in the upper left side, or pain in the left shoulder (possible splenic rupture)
  • Numbness or tingling in hands or feet (peripheral neuropathy, rare)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with leukemia.
If you are breastfeeding. You should not breastfeed while taking this medication and for 1 week after your last dose.

This medication may interact with other medications or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems you have

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution when climbing stairs.

Regular blood tests and other laboratory assessments should be conducted as directed by your doctor to monitor your condition.

This medication may pose a risk to an unborn baby. Therefore, a pregnancy test will be administered before initiating treatment to confirm that you are not pregnant. If you or your partner could become pregnant, it is crucial to use effective birth control methods during treatment and for a specified period after the final dose. Consult your doctor to determine the recommended duration of birth control use. If pregnancy occurs, notify your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Exaggerated side effects (e.g., severe gastrointestinal upset, dizziness, fatigue)
  • Profound leukocytosis or thrombocytopenia

What to Do:

There is no specific antidote for plerixafor overdose. Treatment should be supportive and aimed at managing symptoms. Monitor blood counts closely. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Moderate Interactions

  • Myelosuppressive agents (concurrent use may exacerbate myelosuppression, though plerixafor is used in this context)
  • Drugs that affect renal function (may alter plerixafor clearance)

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with differential

Rationale: To assess baseline white blood cell (WBC) and platelet counts, and to monitor for leukocytosis or thrombocytopenia during mobilization.

Timing: Prior to initiation of G-CSF and plerixafor.

Renal function (Serum Creatinine, CrCl)

Rationale: Plerixafor is primarily renally excreted; dose adjustment is required for renal impairment.

Timing: Prior to first dose of plerixafor.

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Routine Monitoring

Peripheral blood CD34+ cell count

Frequency: Daily, starting the morning after the first dose of plerixafor and G-CSF.

Target: Target varies by transplant center and patient, typically aiming for >20 CD34+ cells/ยตL to proceed with apheresis.

Action Threshold: If CD34+ count is insufficient, consider additional doses of plerixafor or alternative mobilization strategies.

Complete Blood Count (CBC) with differential

Frequency: Daily during mobilization and apheresis.

Target: Monitor for significant leukocytosis (>100,000/ยตL) or thrombocytopenia (<50,000/ยตL).

Action Threshold: Consider dose modification of G-CSF or plerixafor, or delay apheresis if counts are outside acceptable ranges.

Signs/symptoms of splenic enlargement/rupture

Frequency: Daily clinical assessment.

Target: Not applicable

Action Threshold: Discontinue plerixafor and G-CSF immediately if splenic rupture is suspected.

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Symptom Monitoring

  • Injection site reactions (redness, swelling, pain)
  • Gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal pain)
  • Fatigue
  • Dizziness
  • Headache
  • Musculoskeletal pain
  • Signs of hypersensitivity reaction (rash, urticaria, dyspnea, facial swelling)
  • Signs of splenic enlargement or rupture (left upper quadrant abdominal pain, shoulder pain, rapid breathing, pallor)

Special Patient Groups

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Pregnancy

Plerixafor may cause fetal harm when administered to a pregnant woman. Animal studies have shown adverse effects on embryo-fetal development. Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for embryo-fetal toxicity based on animal data.
Second Trimester: Potential for embryo-fetal toxicity based on animal data.
Third Trimester: Potential for embryo-fetal toxicity based on animal data.
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Lactation

It is not known whether plerixafor is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Unknown, but potential for serious adverse effects. Advise caution or interruption of breastfeeding.
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Pediatric Use

Approved for pediatric patients with Non-Hodgkin Lymphoma (NHL) and acute lymphoblastic leukemia (ALL) for stem cell mobilization. Dosing is weight-based (0.24 mg/kg) and similar to adults, with renal dose adjustments as needed. Safety and efficacy in children <1 year of age have not been established.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly patients (โ‰ฅ65 years) and younger patients. No specific dose adjustment is required based on age alone, but renal function should be assessed as elderly patients are more likely to have decreased renal function.

Clinical Information

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Clinical Pearls

  • Plerixafor is always used in combination with G-CSF for stem cell mobilization, not as monotherapy.
  • Timing is crucial: Plerixafor should be administered 6-11 hours prior to the start of apheresis.
  • Monitor CD34+ cell counts closely to determine the optimal timing and number of apheresis sessions.
  • Patients should be monitored for signs and symptoms of splenic enlargement or rupture, especially those with pre-existing splenic conditions or those receiving high doses of G-CSF.
  • There is a theoretical risk of tumor cell mobilization in patients with leukemia; however, clinical studies have not shown an increased risk of relapse in patients with NHL or MM.
  • Patients with a history of cardiac risk factors should be monitored for cardiac events, though these are rare.
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Alternative Therapies

  • Granulocyte-colony stimulating factor (G-CSF) alone (e.g., filgrastim, pegfilgrastim)
  • Chemotherapy-based mobilization regimens (e.g., cyclophosphamide with G-CSF)
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Cost & Coverage

Average Cost: Extremely high (e.g., $25,000 - $35,000+ per vial) per 1.2 mL vial (24 mg/1.2 mL)
Insurance Coverage: Specialty Tier (requires prior authorization, often limited to specific indications and transplant centers)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred, as this will aid in providing appropriate treatment.