Doxorubicin 2mg/ml Inj, 10ml
Overview
What is this medicine?
How to Use This Medicine
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor immediately to receive guidance on what to do next.
Lifestyle & Tips
- Report any signs of infection (fever, chills, sore throat) immediately, as your immune system will be weakened.
- Avoid contact with people who are sick or have infections.
- Practice good hand hygiene.
- Avoid live vaccines during treatment and for a period after, as your immune system is suppressed.
- Use effective birth control during treatment and for a period after, as this medication can harm a fetus.
- Do not breastfeed during treatment and for a period after.
- You may experience hair loss (alopecia), which is usually temporary.
- Your urine may turn reddish-orange for 1-2 days after treatment; this is normal and harmless.
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 medical attention immediately:
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
+ 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 get bigger
+ Uncontrollable bleeding
Feeling extremely tired or weak
Special Consideration for Cancer Patients
If you have cancer and are taking this medication, you may be at a higher risk of developing a severe condition called tumor lysis syndrome (TLS), which can be life-threatening. Contact your doctor immediately if you experience:
Fast or abnormal heartbeat
Fainting
Difficulty urinating
Muscle weakness or cramps
Upset stomach, vomiting, diarrhea, or loss of appetite
Feeling sluggish
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any 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:
Hair loss
Diarrhea
Upset stomach or vomiting
Mouth irritation or mouth sores
Changes in nail color or texture
Orange or red urine for 1 to 2 days after receiving this medication
Reporting Side Effects
This is not an exhaustive list of possible 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.
Seek Immediate Medical Attention If You Experience:
- Shortness of breath, swelling of ankles/feet, rapid weight gain, or unusual tiredness (signs of heart problems)
- Fever (100.4°F or 38°C or higher), chills, sore throat, or any signs of infection
- Unusual bleeding or bruising
- Severe mouth sores or difficulty swallowing
- Severe nausea, vomiting, or diarrhea that doesn't improve
- Pain, redness, swelling, or blistering at the injection site (signs of extravasation)
- Yellowing of skin or eyes (jaundice)
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, such as foods or drugs. Describe the allergic reaction and its symptoms.
Existing health conditions, including:
+ Anemia
+ Heart problems
+ Liver disease
+ Low platelet count
+ Low white blood cell count
Recent heart attack
Previous treatment with daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone
Current medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, certain drugs used to treat HIV, infections, seizures, and other conditions should not be taken with this medication.
Pregnancy or potential pregnancy. Do not take this medication during the first trimester of pregnancy.
* Breastfeeding. Avoid breastfeeding while taking this medication, and discuss with your doctor whether you need to avoid breastfeeding for a period after your last dose.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, health problems, and concerns to ensure safe treatment. Do not start, stop, or change the dose 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 the flu.
Be cautious of bleeding easily, and take steps to prevent injuries. Use a soft-bristled toothbrush and an electric razor to reduce the risk of bleeding. If you experience stomach upset, vomiting, diarrhea, or a decrease in appetite, consult your doctor, as there may be ways to alleviate these side effects.
If side effects such as stomach upset, vomiting, diarrhea, or mouth sores interfere with your ability to eat or drink normally, contact your doctor immediately.
To prevent the transmission of body fluids to family members or caregivers, exercise caution and take necessary precautions. Wash any soiled clothing promptly and wear gloves when handling body fluids for at least 5 days following each treatment.
Before receiving any vaccinations, consult your doctor, as some vaccines may increase the risk of infection or reduce their effectiveness when used in conjunction with this medication.
Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions you may have 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 therapy.
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 with this medication, which may or may not resume after treatment. Additionally, women treated with this medication may enter menopause at a younger age than expected. If you have questions or concerns, consult your doctor.
This medication may 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 while taking this medication and for a specified period after the final dose. Consult your doctor to determine the duration of birth control use. If you or your partner becomes pregnant, 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, growth factors), and management of cardiac and gastrointestinal toxicities. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Contraindicated Interactions
- Live or attenuated vaccines (due to immunosuppression)
Major Interactions
- Trastuzumab (increased risk of cardiotoxicity)
- Cyclophosphamide (increased risk of cardiotoxicity)
- Paclitaxel (may increase doxorubicin levels if given before doxorubicin)
- Cyclosporine (may increase doxorubicin levels and toxicity)
- Verapamil (may increase doxorubicin levels and toxicity)
- Phenobarbital, Phenytoin (may decrease doxorubicin levels)
- St. John's Wort (may decrease doxorubicin levels)
- Other myelosuppressive agents (additive myelosuppression)
- Other cardiotoxic agents (additive cardiotoxicity)
Moderate Interactions
- Cimetidine (may increase doxorubicin levels)
- Diltiazem (may increase doxorubicin levels)
- Ritonavir (may increase doxorubicin levels)
- Warfarin (potential for altered INR, monitor closely)
- Radiation therapy (may enhance doxorubicin toxicity in irradiated fields)
Minor Interactions
- Not specifically categorized as minor for doxorubicin; most interactions are significant due to narrow therapeutic index.
Monitoring
Baseline Monitoring
Rationale: To assess baseline hematopoietic function before initiating myelosuppressive therapy.
Timing: Prior to first dose
Rationale: Doxorubicin is primarily metabolized and excreted by the liver; hepatic impairment necessitates dose adjustment.
Timing: Prior to first dose
Rationale: To assess baseline renal function, though renal excretion is minor, severe impairment may warrant caution.
Timing: Prior to first dose
Rationale: Doxorubicin is highly cardiotoxic; baseline LVEF is crucial to assess cardiac reserve and establish a reference point.
Timing: Prior to first dose
Routine Monitoring
Frequency: Prior to each dose and periodically during treatment
Target: WBC >3,000-4,000/mm³, ANC >1,500/mm³, Platelets >100,000/mm³ (may vary by protocol)
Action Threshold: Hold dose if ANC <1,500/mm³ or platelets <75,000-100,000/mm³; consider dose reduction or delay.
Frequency: Prior to each dose
Target: Bilirubin <1.2 mg/dL
Action Threshold: Dose reduction or hold if bilirubin elevated (see hepatic impairment dosing).
Frequency: Periodically during treatment (e.g., every 2-3 cycles or after cumulative dose thresholds are reached, such as 300 mg/m²), and at signs of cardiac dysfunction.
Target: LVEF within normal limits or no significant decline from baseline.
Action Threshold: Hold doxorubicin if LVEF declines significantly (e.g., >10-15% absolute drop from baseline or below 50%) or if signs/symptoms of congestive heart failure develop. Cumulative lifetime dose limit (e.g., 450-550 mg/m²) should be strictly observed.
Symptom Monitoring
- Signs and symptoms of myelosuppression (fever, chills, sore throat, unusual bleeding or bruising, fatigue)
- Signs and symptoms of cardiotoxicity (shortness of breath, swelling of ankles/feet, rapid weight gain, palpitations, chest pain)
- Signs and symptoms of extravasation (pain, burning, swelling, redness at injection site during or after infusion)
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, mucositis/stomatitis)
- Alopecia (hair loss)
- Red-orange discoloration of urine (expected, harmless)
- Fatigue
Special Patient Groups
Pregnancy
Doxorubicin can cause fetal harm when administered to a pregnant woman. It is contraindicated in pregnancy. Women of childbearing potential should be advised to use effective contraception during treatment and for 6 months after the last dose. Men with female partners of childbearing potential should use effective contraception during treatment and for 10 weeks after the last dose.
Trimester-Specific Risks:
Lactation
Doxorubicin is excreted in human milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is contraindicated during doxorubicin treatment and for at least 10 days after the last dose.
Pediatric Use
Doxorubicin is used in pediatric oncology. Children are at increased risk for delayed cardiotoxicity, especially at younger ages and higher cumulative doses. Long-term monitoring of cardiac function is essential. Secondary malignancies are also a concern.
Geriatric Use
Elderly patients (≥65 years) may be at increased risk for cardiotoxicity and myelosuppression. Careful monitoring of cardiac function and blood counts is crucial. Dose adjustments may be necessary based on individual tolerance and comorbidities.
Clinical Information
Clinical Pearls
- Doxorubicin is a vesicant; ensure proper IV access and monitor closely for extravasation. If extravasation occurs, stop infusion immediately, aspirate residual drug, and consider applying cold packs and administering dexrazoxane (Totect) as an antidote.
- The cumulative lifetime dose of doxorubicin is critical due to dose-dependent cardiotoxicity (typically limited to 450-550 mg/m²). This limit may be lower in patients with pre-existing cardiac disease, prior mediastinal radiation, or concomitant cardiotoxic agents.
- Patients should be informed that their urine may turn red-orange for 1-2 days after administration, which is a harmless effect of the drug's color.
- Severe nausea and vomiting are common; aggressive antiemetic prophylaxis is essential.
- Mucositis/stomatitis can be severe and painful; oral hygiene and supportive care are important.
- Doxorubicin is highly myelosuppressive, with nadir typically occurring 10-14 days after administration. Monitor CBC closely and manage neutropenic fever promptly.
Alternative Therapies
- Other anthracyclines (e.g., Daunorubicin, Idarubicin)
- Other cytotoxic agents used in similar indications (e.g., cyclophosphamide, paclitaxel, cisplatin, etoposide, vincristine)
- Targeted therapies or immunotherapies, depending on the specific cancer type and molecular profile.