Doxorubicin Lipo 2mg/ml Inj, 25ml

Manufacturer SUN Active Ingredient Doxorubicin (Liposomal)(doks oh ROO bi sin lye po SO mal) Pronunciation doks oh ROO bi sin lye po SO mal
WARNING: This drug may cause severe heart problems like heart failure. This can happen during treatment or years after your last dose. Sometimes, these problems will not go away or may be deadly. The chance may be higher if you have ever had heart problems or chest area radiation, or are using other drugs that may cause heart problems. The chance may be higher if you have ever had this drug or other drugs like this one. Ask your doctor if you are not sure if any of your drugs may cause heart problems. The chance of heart problems depends on the dose of this drug and your health problem. In children, the chance of heart problems later in life is higher. Heart problems may happen even without any risk factors. Call your doctor right away if you have cough; chest pain; fast, slow, or abnormal heartbeat; swelling in the arms or legs, shortness of breath, or sudden weight gain; or feeling very tired or weak.Side effects like flushing, shortness of breath, wheezing, swelling of the face, headache, chills, back pain, chest pain, chest or throat tightness, fever, fast heartbeat, itching, blue or gray skin, very bad dizziness, or passing out have happened with this drug during the infusion. Most of the time, these side effects happen with the first infusion and go away within a few hours to a day after the infusion is stopped. Sometimes, these reactions have been very bad and even life-threatening or deadly. Tell your doctor right away if you have any of these signs. @ COMMON USES: It is used to treat cancer.
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Drug Class
Antineoplastic agent
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Pharmacologic Class
Anthracycline antibiotic; DNA intercalator; Topoisomerase II inhibitor
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Pregnancy Category
Category D
FDA Approved
Nov 1995
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Doxorubicin liposomal is a chemotherapy drug used to treat certain types of cancer. It works by stopping cancer cells from growing and multiplying. The drug is enclosed in tiny fat particles (liposomes) which helps it stay in the body longer and target cancer cells more effectively, potentially reducing some side effects compared to regular doxorubicin.
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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. This medication is administered as an infusion into a vein over a period of time. Unless your doctor advises you to limit your fluid intake, be sure to drink plenty of non-caffeinated liquids.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.

Missing a Dose

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

  • Report any signs of infection (fever, chills, sore throat) immediately.
  • Avoid contact with people who are sick or have infections.
  • Practice good hand hygiene.
  • Avoid activities that may cause cuts or bruises.
  • Use a soft toothbrush and be gentle when flossing to prevent mouth sores.
  • Stay well-hydrated.
  • Report any new or worsening shortness of breath, swelling, or fatigue.
  • Protect hands and feet from friction and heat to help prevent Hand-Foot Syndrome (e.g., wear loose-fitting shoes, avoid hot water, use moisturizing creams).

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. Examples: Ovarian Cancer: 50 mg/m² IV every 4 weeks; AIDS-Related Kaposi's Sarcoma: 20 mg/m² IV every 2-3 weeks; Multiple Myeloma: 30 mg/m² IV on Day 4 of a 21-day cycle (in combination with bortezomib)
Dose Range: 20 - 50 mg

Condition-Specific Dosing:

Ovarian Cancer: 50 mg/m² IV over 1 hour, every 4 weeks, for 6 cycles or until disease progression/unacceptable toxicity.
AIDS-Related Kaposi's Sarcoma (AIDS-KS): 20 mg/m² IV over 30 minutes, every 2-3 weeks. Continue treatment as long as patient responds and tolerates therapy.
Multiple Myeloma (in combination with bortezomib): 30 mg/m² IV over 1 hour on Day 4 of a 21-day cycle, after bortezomib administration. For up to 8 cycles.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.
Dialysis: Not dialyzable. No specific dose adjustment recommended, but caution is advised due to limited data.

Hepatic Impairment:

Mild: Bilirubin 1.2-3.0 mg/dL: Reduce dose by 25%.
Moderate: Bilirubin >3.0 mg/dL: Reduce dose by 50%.
Severe: Not recommended for use in patients with severe hepatic impairment (bilirubin >5.0 mg/dL or AST >4x ULN).

Pharmacology

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Mechanism of Action

Doxorubicin liposomal is an anthracycline topoisomerase II inhibitor. It intercalates into DNA, inhibiting topoisomerase II, which is essential for DNA replication and repair. This leads to DNA strand breaks and inhibition of nucleic acid synthesis. The liposomal encapsulation alters the pharmacokinetics of doxorubicin, allowing for prolonged circulation time and preferential accumulation in tumor tissues due to enhanced permeability and retention (EPR) effect, while reducing exposure to healthy tissues like the heart.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IV administration)
Tmax: Not applicable (IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: 4.1 L/m² (low, indicating limited distribution outside of plasma)
ProteinBinding: Not extensively protein bound (primarily associated with plasma proteins)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 55 hours (terminal half-life)
Clearance: 0.041 L/hr/m²
ExcretionRoute: Primarily biliary/fecal; minor renal excretion
Unchanged: Less than 5% renally excreted as unchanged drug
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Pharmacodynamics

OnsetOfAction: Immediate (cytotoxic effect)
PeakEffect: Not directly applicable (cytotoxic agent, effect is cumulative)
DurationOfAction: Dependent on cell cycle and cumulative exposure

Safety & Warnings

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BLACK BOX WARNING

Myocardial Damage: Doxorubicin liposomal can cause myocardial damage, including congestive heart failure. The risk increases with increasing cumulative doses. Assess left ventricular ejection fraction (LVEF) prior to initiation of treatment and periodically during treatment. Myelosuppression: Severe myelosuppression, including neutropenia, thrombocytopenia, and anemia, can occur. Monitor complete blood counts frequently. Secondary Malignancies: Secondary acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) have been reported. Infusion-Related Reactions: Serious, life-threatening, and fatal infusion-related reactions can occur. Administer slowly and monitor patients closely.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever or chills
+ Severe sore throat
+ Ear or sinus pain
+ Coughing or increased sputum production (with a change in color)
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Coffee ground-like vomit
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Abnormal sensations, such as:
+ Burning or numbness
+ Tingling that is not typical
Redness or irritation on the palms of the hands or soles of the feet
Blood clots in the lungs, which can be severe or life-threatening. Seek immediate medical attention if you experience:
+ Chest pain or pressure
+ Coughing up blood
+ Rapid breathing or heartbeat
+ Shortness of breath

Vein Irritation

This medication may cause vein irritation. If the medication leaks from the vein, it can also cause irritation around the affected area. Inform your nurse if you notice any redness, burning, pain, swelling, or fluid leakage at the injection site.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor or seek medical attention:

Fatigue or weakness
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Back pain
Headache
Hair loss
Throat irritation
Weight loss
Urine and other body fluids may turn orange or red, which is a normal effect of this medication
* Mouth irritation is common with this drug. Contact your doctor if you experience:
+ Mouth redness, swelling, or pain
+ Mouth sores
+ Dry mouth, lips, or tongue
+ Difficulty swallowing

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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.
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Seek Immediate Medical Attention If You Experience:

  • Fever (especially >100.4°F or 38°C)
  • Chills
  • Sore throat or other signs of infection
  • Unusual bleeding or bruising
  • Severe fatigue or weakness
  • Shortness of breath, cough, or chest pain
  • Swelling in ankles or legs
  • Severe redness, pain, or blistering on palms or soles of feet
  • Severe mouth sores or difficulty eating/drinking
  • Severe nausea, vomiting, or diarrhea
  • Allergic reaction symptoms during infusion (flushing, rash, difficulty breathing, chest tightness)
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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 are pregnant or think you may be pregnant. Note that this medication should not be taken during the first trimester of pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication.

Additionally, this medication may interact with other medications or health conditions. To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your health problems, both current and past

It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never 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. Regular blood tests and heart function checks will be necessary, as directed by your doctor, to monitor your condition.

This medication can affect the bone marrow's ability to produce blood cells, which may lead to bleeding problems, infections, or anemia if blood cell counts become too low. If you have concerns, discuss them with your doctor. You may be more susceptible to infections, so it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with people who have infections, colds, or flu.

Be cautious, as you may experience easier bleeding. To minimize the risk of injury, use a soft toothbrush and an electric razor. If you encounter stomach upset, vomiting, diarrhea, or decreased appetite, consult your doctor, as there may be ways to alleviate these side effects.

To manage mouth sores, use a soft toothbrush or cotton swabs and rinse your mouth with a non-alcoholic mouthwash. If you have previously received daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone, inform your doctor.

Long-term use of this medication (more than 1 year) has been associated with an increased risk of mouth cancer, which may occur during treatment or up to 6 years after the last dose. Your doctor will regularly examine your mouth while you are taking this medication. If you experience mouth pain, sores, or ulcers, contact your doctor immediately.

Before receiving any vaccinations, consult your doctor, as some vaccines may not be effective or may increase the risk of infection when used with this medication.

This medication may affect fertility, potentially leading to difficulty conceiving or fathering a child. Although fertility may return to normal, it is essential to discuss any concerns with your doctor.

Women may experience cessation of menstrual periods during treatment, which may or may not resume after treatment completion. Additionally, women treated with this medication may enter menopause at a younger age than usual. If you have questions or concerns, discuss them with your doctor.

This medication can harm an unborn baby. A pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you may become pregnant, use birth control while taking this medication and for 6 months after the last dose, unless otherwise instructed by your doctor. If you become pregnant, notify your doctor immediately.

If your partner may become pregnant, use birth control while taking this medication and for 6 months after the last dose. If your partner becomes pregnant, contact the doctor right away.
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Overdose Information

Overdose Symptoms:

  • Severe myelosuppression (very low white blood cell, red blood cell, and platelet counts)
  • Severe mucositis
  • Acute cardiac toxicity

What to Do:

There is no specific antidote for doxorubicin overdose. Management is supportive, including hospitalization, antibiotics for infection, platelet transfusions for bleeding, and symptomatic treatment for mucositis and cardiac toxicity. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Major Interactions

  • Live vaccines (risk of severe infection)
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - may increase doxorubicin levels
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - may decrease doxorubicin levels
  • Other myelosuppressive agents (additive myelosuppression)
  • Cardiotoxic agents (e.g., trastuzumab, cyclophosphamide, 5-FU) - increased risk of cardiotoxicity
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Moderate Interactions

  • Warfarin (potential for increased INR/bleeding)
  • Phenytoin (potential for decreased phenytoin levels)
  • Cimetidine (may increase doxorubicin levels)
  • Paclitaxel (may increase doxorubicin levels when given before doxorubicin)

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with differential

Rationale: To assess baseline bone marrow function and identify pre-existing cytopenias.

Timing: Prior to initiation of therapy.

Liver Function Tests (LFTs) - Bilirubin, AST, ALT

Rationale: To assess hepatic function for dose adjustment.

Timing: Prior to initiation of therapy.

Renal Function Tests (RFTs) - Creatinine, BUN

Rationale: To assess renal function.

Timing: Prior to initiation of therapy.

Cardiac Function Assessment (Echocardiogram or MUGA scan)

Rationale: To establish baseline cardiac ejection fraction due to risk of cardiotoxicity.

Timing: Prior to initiation of therapy.

Oral cavity examination

Rationale: To assess for mucositis risk.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Complete Blood Count (CBC) with differential

Frequency: Prior to each dose and as clinically indicated.

Target: ANC ≥ 1,000-1,500 cells/mm³, Platelets ≥ 75,000-100,000 cells/mm³ (varies by protocol)

Action Threshold: Hold or reduce dose for significant myelosuppression (e.g., ANC < 1,000 cells/mm³ or platelets < 50,000 cells/mm³).

Liver Function Tests (LFTs)

Frequency: Prior to each dose.

Target: Bilirubin < 1.2 mg/dL, AST/ALT within normal limits.

Action Threshold: Adjust dose for elevated bilirubin (>1.2 mg/dL) or AST (>2x ULN).

Cardiac Function Assessment (Echocardiogram or MUGA scan)

Frequency: Periodically, especially with cumulative doses exceeding 400 mg/m² or if cardiac symptoms develop.

Target: LVEF within normal limits or no significant decline from baseline.

Action Threshold: Discontinue if LVEF declines significantly (e.g., >10-20% absolute drop) or falls below lower limit of normal.

Skin assessment (especially palms and soles)

Frequency: Prior to each dose and throughout treatment.

Target: No signs of Hand-Foot Syndrome (Palmar-Plantar Erythrodysesthesia - PPE).

Action Threshold: Hold or reduce dose for Grade 2 or higher PPE.

Oral cavity assessment

Frequency: Prior to each dose and throughout treatment.

Target: No signs of mucositis.

Action Threshold: Hold or reduce dose for Grade 2 or higher mucositis.

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Symptom Monitoring

  • Fever, chills, signs of infection (due to myelosuppression)
  • Unusual bleeding or bruising
  • Fatigue, shortness of breath, swelling in ankles/legs (signs of cardiotoxicity)
  • Redness, swelling, pain, blistering on palms of hands or soles of feet (Hand-Foot Syndrome)
  • Sore mouth, mouth sores, difficulty swallowing (mucositis)
  • Nausea, vomiting, diarrhea
  • Hair loss
  • Infusion-related reactions (flushing, shortness of breath, chest pain, back pain, fever, chills, hypotension, tachycardia)

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy. Doxorubicin liposomal can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 6 months after the last dose.

Trimester-Specific Risks:

First Trimester: High risk of major birth defects and fetal death.
Second Trimester: High risk of fetal growth restriction, organ toxicity, and fetal death.
Third Trimester: High risk of fetal growth restriction, organ toxicity, and neonatal complications.
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Lactation

Breastfeeding is contraindicated during treatment and for 10 days after the last dose. It is unknown if doxorubicin liposomal is excreted in human milk, but due to the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed.

Infant Risk: L5 (Contraindicated - significant risk to infant)
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly patients and younger adult patients. However, greater sensitivity of some older individuals cannot be ruled out. Close monitoring for adverse effects is recommended.

Clinical Information

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Clinical Pearls

  • Always administer doxorubicin liposomal slowly (over 30-60 minutes) to minimize infusion-related reactions. Pre-medication (antihistamines, corticosteroids) may be considered for patients with prior infusion reactions.
  • The liposomal formulation has a different toxicity profile than conventional doxorubicin, with reduced cardiotoxicity and myelosuppression but increased incidence of Hand-Foot Syndrome (PPE) and mucositis.
  • Cumulative lifetime dose of doxorubicin liposomal should be carefully monitored, especially in patients with pre-existing cardiac conditions or prior anthracycline exposure, due to the risk of cardiotoxicity.
  • Manage Hand-Foot Syndrome proactively with moisturizers, avoiding hot water, and wearing comfortable shoes. Dose modifications may be necessary for severe PPE.
  • Oral cryotherapy (ice chips) during infusion may help reduce the incidence and severity of mucositis.
  • Extravasation is rare with the liposomal formulation due to its encapsulation, but still requires careful administration. If extravasation occurs, follow institutional guidelines; cold compresses are generally recommended.
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Alternative Therapies

  • Paclitaxel (for ovarian cancer)
  • Topotecan (for ovarian cancer)
  • Bortezomib (for multiple myeloma)
  • Lenalidomide (for multiple myeloma)
  • Pomalidomide (for multiple myeloma)
  • Other cytotoxic agents depending on specific cancer type and stage.
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Cost & Coverage

Average Cost: Check current pricing (highly variable) per 2mg/ml, 25ml vial
Generic Available: Yes
Insurance Coverage: Specialty Tier (often requires prior authorization)
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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, never share your prescription medications with others, and do not take medications that have been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Unless instructed otherwise by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. Instead, consult with your pharmacist to determine the best disposal method, as some communities may have designated drug take-back programs.

Some medications may come with an additional patient information leaflet; if you have questions, consult with your pharmacist. If you have any concerns or questions about your medication, it is best to 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 emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time it was taken, as this will aid in providing appropriate treatment.