Doxorubicin 2mg/ml Inj, 25ml
Overview
What is this medicine?
How to Use This Medicine
For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
Lifestyle & Tips
- Report any signs of infection (fever, chills) immediately.
- Avoid contact with people who are sick or have infections.
- Practice good hand hygiene.
- Avoid activities that could cause cuts or bruises.
- Use a soft toothbrush and gentle mouthwash to prevent mouth sores.
- Stay well-hydrated.
- Avoid live vaccines during treatment.
- Be aware that hair loss (alopecia) is common and usually reversible after treatment.
Available Forms & Alternatives
Available Strengths:
- Doxorubicin 2mg/ml Inj, 5ml
- Doxorubicin 2mg/ml Inj, 10ml
- Doxorubicin 2mg/ml Inj, 25ml
- Doxorubicin 2mg/ml Inj, 100ml
- Doxorubicin Lipo 2mg/ml Inj, 25ml
- Doxorubicin 20/10ml Inj, 10ml
- Doxorubicin 10mg Inj, 1vial
- Doxorubicin Lipo 2mg/ml Inj, 10ml
- Doxorubicin 50mg Inj, 1 Vial
- Doxorubicin 10mg/5ml Inj, 5ml
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
BLACK BOX WARNING
Side Effects
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 immediate medical attention:
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
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Feeling extremely tired or weak
Patients with cancer taking this medication may be at increased risk of developing a severe condition called tumor lysis syndrome (TLS), which can be life-threatening. Seek immediate medical attention if you experience:
+ Rapid or irregular heartbeat
+ Fainting
+ Difficulty urinating
+ Muscle weakness or cramps
+ Nausea, vomiting, diarrhea, or loss of appetite
+ Feeling lethargic
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you're concerned about any of the following side effects or if they persist, contact your doctor:
Hair loss
Diarrhea
Upset stomach or vomiting
Mouth irritation or sores
Changes in nail color or texture
* Urine that turns orange or red for 1-2 days after receiving this medication
This is not an exhaustive list of potential side effects. If you have questions or concerns, 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:
- Chest pain, shortness of breath, swelling in ankles/feet (signs of heart problems)
- Fever (100.4°F or 38°C or higher), chills, sore throat (signs of infection)
- Unusual bleeding or bruising (e.g., nosebleeds, blood in urine/stools)
- Severe nausea, vomiting, or diarrhea that doesn't improve
- Pain, redness, or swelling at the injection site
- Severe mouth sores that make eating difficult
- Extreme fatigue or weakness
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 and its symptoms.
Existing health conditions, such as anemia, heart problems, liver disease, low platelet count, or low white blood cell count.
A recent heart attack.
Previous treatment with daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone. Discuss your medical history with your doctor.
Any medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins, as some may interact with this medication. Certain medications used to treat HIV, infections, seizures, and other conditions should not be taken with this drug.
Pregnancy or potential pregnancy. Do not take this medication during the first trimester of pregnancy.
* Breastfeeding. Avoid breastfeeding while taking this medication, and consult your doctor to determine if you need to avoid breastfeeding for a period after your last dose.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or modify the dosage of any medication without consulting your doctor.
Precautions & Cautions
While on this medication, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Be cautious, as this medication may increase your risk of bleeding easily. To reduce this risk, avoid injuries, use a soft toothbrush, and consider using an electric razor. If you experience gastrointestinal side effects such as stomach upset, vomiting, diarrhea, or decreased appetite, consult your doctor, as there may be ways to mitigate these effects.
If side effects like stomach upset, vomiting, diarrhea, or mouth sores interfere with your ability to eat or drink normally, contact your doctor promptly.
To prevent exposure to body fluids, take precautions to avoid contact with family members or caregivers. Immediately wash any soiled clothing and wear gloves when handling body fluids for at least 5 days following each treatment.
Before receiving any vaccinations, consult your doctor, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication.
Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions with your doctor.
If you have a history of or are scheduled to undergo radiation treatment, inform your doctor, as this medication may exacerbate the side effects of radiation.
When administering this medication to children, exercise caution, as they may be at a higher risk of developing low blood sugar.
This medication may affect fertility, potentially leading to difficulties in becoming pregnant 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 concludes. Additionally, treatment with this medication may lead to premature menopause. If you have questions or concerns, consult your doctor.
This medication can cause harm to an unborn baby. A pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you or your partner may become pregnant, it is crucial to use birth control during treatment and for a specified period after the final dose, as advised by your doctor. If pregnancy occurs, notify your doctor immediately.
Overdose Information
Overdose Symptoms:
- Severe myelosuppression (very low blood counts)
- Severe mucositis
- Acute cardiac toxicity
What to Do:
There is no specific antidote for doxorubicin overdose. Management is supportive, including hospitalization, aggressive treatment of myelosuppression (e.g., transfusions, G-CSF), and management of cardiac complications. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Trastuzumab (increased cardiotoxicity)
- Cyclophosphamide (increased cardiotoxicity)
- Paclitaxel (altered doxorubicin pharmacokinetics, increased myelosuppression)
- Live vaccines (risk of severe infection in immunosuppressed patients)
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - may increase doxorubicin levels
- Strong CYP3A4 inducers (e.g., rifampin, phenytoin, St. John's Wort) - may decrease doxorubicin levels
Moderate Interactions
- Other cardiotoxic agents (e.g., 5-fluorouracil, epirubicin, mitomycin C) - additive cardiotoxicity risk
- Myelosuppressive agents (e.g., other chemotherapy, radiation therapy) - additive myelosuppression
- Warfarin (potential for increased INR/bleeding)
- Phenobarbital (may increase doxorubicin clearance)
- Verapamil (may increase doxorubicin levels and toxicity)
Minor Interactions
- Not specifically documented for minor interactions with significant clinical impact.
Monitoring
Baseline Monitoring
Rationale: To establish baseline cardiac function due to dose-dependent cardiotoxicity.
Timing: Prior to initiation of therapy.
Rationale: To assess baseline bone marrow function due to myelosuppression.
Timing: Prior to initiation of therapy.
Rationale: Doxorubicin is primarily metabolized and excreted by the liver; hepatic impairment requires dose adjustment.
Timing: Prior to initiation of therapy.
Rationale: To assess baseline renal function, though renal excretion is minor.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Prior to each cycle and periodically during therapy.
Target: WBC > 3,000-4,000/mm³, ANC > 1,500/mm³, Platelets > 100,000/mm³
Action Threshold: Hold or reduce dose if counts are below threshold; administer G-CSF as appropriate.
Frequency: Prior to each cycle.
Target: Within normal limits or acceptable for patient's condition.
Action Threshold: Adjust dose based on bilirubin levels as per guidelines.
Frequency: Periodically during therapy (e.g., every 2-3 cycles or after cumulative dose thresholds are reached, such as 300 mg/m²), and at cumulative lifetime dose limits.
Target: Maintain LVEF > 50% or within acceptable limits.
Action Threshold: Discontinue doxorubicin if LVEF drops significantly (e.g., >10-15% from baseline or below 50%) or if signs of congestive heart failure develop.
Frequency: Calculated and tracked with each dose.
Target: < 450-550 mg/m² (conventional doxorubicin); lower for patients with prior mediastinal radiation, pre-existing heart disease, or concurrent cardiotoxic agents.
Action Threshold: Discontinue doxorubicin upon reaching cumulative dose limit to minimize cardiotoxicity risk.
Symptom Monitoring
- Signs/symptoms of congestive heart failure (e.g., dyspnea, edema, fatigue, cough)
- Signs/symptoms of infection (e.g., fever, chills, sore throat)
- Unusual bleeding or bruising
- Severe nausea, vomiting, or diarrhea
- Oral mucositis/stomatitis
- Pain, redness, or swelling at injection site (extravasation)
- Hair loss
- Reddish discoloration of urine (expected for 1-2 days after dose)
Special Patient Groups
Pregnancy
Doxorubicin is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. It is embryotoxic and teratogenic in animals. Women of childbearing potential should be advised to avoid becoming pregnant during doxorubicin therapy.
Trimester-Specific Risks:
Lactation
Doxorubicin is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during doxorubicin therapy and for a period after the last dose (e.g., at least 10 days).
Pediatric Use
Children are at increased risk of cardiotoxicity, especially at younger ages and with higher cumulative doses. Long-term monitoring for cardiac function is crucial. Growth and development should also be monitored. Dosing is typically based on body surface area, with careful attention to cumulative lifetime dose limits.
Geriatric Use
Elderly patients may have reduced hepatic, renal, or cardiac function, which could increase the risk of toxicity. Careful monitoring of cardiac function, blood counts, and liver function is essential. Dose adjustments may be necessary based on individual patient status and comorbidities.
Clinical Information
Clinical Pearls
- Always verify cumulative lifetime doxorubicin dose before administration to prevent irreversible cardiotoxicity.
- Administer doxorubicin via a free-flowing IV infusion into a large vein to minimize extravasation risk. Have extravasation kits readily available.
- Red urine is an expected, harmless side effect for 1-2 days post-infusion due to drug excretion.
- Consider prophylactic antiemetics due to high emetogenic potential.
- Dexrazoxane can be used as a cardioprotectant in patients receiving high cumulative doses or those at high risk of cardiotoxicity.
- Monitor for 'radiation recall' phenomenon in patients who have previously received radiation therapy.
Alternative Therapies
- Other cytotoxic agents (e.g., taxanes, cyclophosphamide, platinum compounds, vinca alkaloids) depending on cancer type and stage.
- Targeted therapies (e.g., trastuzumab for HER2+ breast cancer)
- Immunotherapy (e.g., checkpoint inhibitors)
- Radiation therapy
- Surgery
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 flush medications down the toilet or pour them down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs that provide a safe and environmentally friendly way to dispose of unwanted medications.
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 critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.