Plerixafor 24mg/1.2ml Inj, 1.2ml

Manufacturer MEITHEAL PHARMACEUTICALS Active Ingredient Plerixafor(pler IX a fore) Pronunciation pler IX a fore
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 Antagonist
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Pregnancy Category
Category D
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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?

Plerixafor is an injection given under the skin to help release your own blood stem cells from your bone marrow into your bloodstream. These stem cells can then be collected and used later for a stem cell transplant, which is a treatment for certain blood cancers like lymphoma or multiple myeloma.
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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 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 procedure.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Follow all instructions from your healthcare team regarding G-CSF injections and apheresis appointments.
  • Report any new or worsening symptoms immediately, especially severe abdominal pain (could indicate splenic issues) or signs of an allergic reaction.
  • Maintain good hydration as advised by your doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 0.24 mg/kg subcutaneously once daily for up to 4 consecutive days, administered approximately 11 hours prior to initiation of apheresis.
Dose Range: 0.24 - 0.24 mg

Condition-Specific Dosing:

Non-Hodgkin's Lymphoma (NHL) and Multiple Myeloma (MM) for Autologous Stem Cell Transplantation (ASCT): 0.24 mg/kg subcutaneously once daily for up to 4 consecutive days, administered approximately 11 hours prior to initiation of apheresis. Continue daily until the target number of CD34+ cells is collected or for up to 4 consecutive days.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established in pediatric patients. Limited data suggest similar pharmacokinetics to adults, but specific dosing recommendations are not available.)
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment required (CrCl > 50 mL/min)
Moderate: Reduce dose to 0.16 mg/kg (CrCl 30-50 mL/min)
Severe: Reduce dose to 0.16 mg/kg (CrCl < 30 mL/min)
Dialysis: Administer 0.16 mg/kg. Administer dose approximately 11 hours prior to apheresis, and do not administer on the day of apheresis if the patient is undergoing hemodialysis on that day. Administer after hemodialysis is complete.

Hepatic Impairment:

Mild: No dose adjustment required
Moderate: No dose adjustment required
Severe: No dose adjustment required (Plerixafor is primarily renally eliminated; hepatic impairment is not expected to significantly alter exposure.)

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 blockade leads to the rapid mobilization of hematopoietic stem cells (HSCs) from the bone marrow into the peripheral blood, where they can be collected by apheresis.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (administered subcutaneously)
Tmax: 0.3-0.5 hours (subcutaneous)
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: 0.3 L/kg
ProteinBinding: < 10%
CnssPenetration: Limited (not expected to cross the blood-brain barrier significantly)

Elimination:

HalfLife: 4.4 hours
Clearance: 7.4 L/hr (renal clearance is the primary route)
ExcretionRoute: Renal (urine)
Unchanged: > 70% (excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Rapid (mobilization of CD34+ cells observed within 6-10 hours post-dose)
PeakEffect: 6-10 hours post-dose (peak peripheral CD34+ cell count)
DurationOfAction: Approximately 24 hours (effect on CD34+ cell mobilization)

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:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Unexplained bruising or bleeding
Left upper stomach pain or shoulder pain, which may indicate an enlarged spleen that could potentially rupture

Other Possible Side Effects

As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Dizziness, fatigue, or weakness
Headache
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Gas
Joint pain
Irritation at the injection site
Trouble sleeping

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice on managing side effects.
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Seek Immediate Medical Attention If You Experience:

  • Severe abdominal pain (especially left upper quadrant or shoulder pain)
  • Lightheadedness or fainting
  • Hives, rash, swelling of face/lips/tongue, difficulty breathing (signs of allergic reaction)
  • Unusual bleeding or bruising
  • Signs of infection (fever, chills, sore throat)
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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 and its symptoms.
If you have been diagnosed with leukemia.
If you are breastfeeding. Note that 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 existing health problems

Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
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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, stand up slowly when getting up 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 can cause harm to an unborn baby. Therefore, a pregnancy test will be performed before initiating treatment to confirm that you are not pregnant. If you or your partner are of childbearing potential, it is crucial to use effective birth control methods during treatment and for a specified period after the last dose. Consult your doctor to determine the recommended duration of birth control use. If you or your partner becomes pregnant, notify your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Hypotension (low blood pressure)
  • Bradycardia (slow heart rate)
  • Gastrointestinal disturbances (nausea, vomiting, diarrhea)
  • Headache
  • Dizziness

What to Do:

There is no specific antidote. Treatment should be supportive and symptomatic. Monitor vital signs and provide general supportive care. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Moderate Interactions

  • Myelosuppressive agents (e.g., chemotherapy, radiation therapy): Plerixafor is used in conjunction with G-CSF, which can cause myelosuppression. Concurrent use with other myelosuppressive agents should be carefully considered due to additive effects.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with differential

Rationale: To assess baseline hematologic status and ensure adequate neutrophil and platelet counts before mobilization.

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

Renal function (CrCl)

Rationale: To determine appropriate dosing, as Plerixafor is primarily renally eliminated.

Timing: Prior to first dose.

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Routine Monitoring

Peripheral blood CD34+ cell count

Frequency: Daily, starting on the morning of the first apheresis (approximately 10-11 hours after the first dose of Plerixafor).

Target: Typically >20 CD34+ cells/ยตL to proceed with apheresis; target collection varies by transplant center and patient.

Action Threshold: If CD34+ count is insufficient, continue daily dosing and apheresis for up to 4 days or until target is met.

Complete Blood Count (CBC) with differential

Frequency: Daily during mobilization and apheresis.

Target: Maintain adequate neutrophil and platelet counts.

Action Threshold: Monitor for leukocytosis (WBC > 100,000/ยตL) or thrombocytopenia. Consider holding Plerixafor if WBC > 100,000/ยตL.

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Symptom Monitoring

  • Injection site reactions (erythema, swelling, pain)
  • Gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal pain)
  • Fatigue
  • Headache
  • Dizziness
  • Arthralgia
  • Pericardial effusion (rare, serious)
  • Splenomegaly/splenic rupture (rare, serious, especially with G-CSF)

Special Patient Groups

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Pregnancy

Plerixafor is Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for one week after the final dose.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, including skeletal abnormalities, based on animal studies.
Second Trimester: Potential for fetal harm.
Third Trimester: Potential for fetal harm.
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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, advise women not to breastfeed during treatment with Plerixafor and for one week after the final dose.

Infant Risk: Risk unknown, but potential for serious adverse effects. Advise against breastfeeding.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Limited data suggest similar pharmacokinetics to adults, but specific dosing recommendations are not available. Use in pediatric patients should be considered only in clinical trials or compassionate use programs.

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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 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 typically used in combination with G-CSF for stem cell mobilization.
  • The timing of Plerixafor administration (approximately 11 hours prior to apheresis) is crucial for optimal stem cell collection.
  • Monitor CD34+ cell counts closely to determine the optimal day(s) for apheresis and the duration of Plerixafor treatment.
  • Patients should be well-hydrated before and during mobilization.
  • Educate patients on the importance of reporting any severe abdominal pain, as splenic rupture is a rare but serious complication, especially when used with G-CSF.
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Alternative Therapies

  • Alternative mobilization strategies for poor mobilizers may include higher doses of G-CSF, or alternative chemotherapy regimens followed by G-CSF.
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Cost & Coverage

Average Cost: Approximately $7,000 - $10,000 per 24mg/1.2ml vial per vial
Insurance Coverage: Specialty Tier (requires prior authorization, often covered for approved indications)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.