Mozobil Inj, 1.2ml
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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)
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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
Baseline Monitoring
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.
Rationale: Plerixafor is primarily renally excreted; dose adjustment is required for renal impairment.
Timing: Prior to first dose of plerixafor.
Routine Monitoring
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.
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.
Frequency: Daily clinical assessment.
Target: Not applicable
Action Threshold: Discontinue plerixafor and G-CSF immediately if splenic rupture is suspected.
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
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:
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.
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.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (โฅ65 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
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.
Alternative Therapies
- Granulocyte-colony stimulating factor (G-CSF) alone (e.g., filgrastim, pegfilgrastim)
- Chemotherapy-based mobilization regimens (e.g., cyclophosphamide with G-CSF)
Cost & Coverage
General Drug Facts
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.