Doxorubicin 20/10ml Inj, 10ml

Doxorubicin is an anthracycline topoisomerase II inhibitor. It exerts its cytotoxic effect by several mechanisms: 1) Intercalation into DNA, leading to inhibition of macromolecular biosynthesis. 2) Inhibition of topoisomerase II, which is essential for DNA replication and repair, causing DNA strand breaks. 3) Generation of free radicals, which damage DNA, cell membranes, and proteins. The liposomal formulation encapsulates doxorubicin in pegylated liposomes, which prolongs its circulation time, allows for preferential accumulation in tumor tissues (due to enhanced permeability and retention effect), and alters its toxicity profile, particularly reducing cardiotoxicity and myelosuppression compared to conventional doxorubicin, while increasing the incidence of hand-foot syndrome.

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 immediate medical attention:

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, or cough
+ Increased or discolored sputum
+ Painful urination or 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 or black, red, or tarry stools
+ Gum bleeding or abnormal vaginal bleeding
+ Unexplained bruises or bleeding that won't stop
Abnormal sensations, such as:
+ Burning, numbness, or tingling
+ Redness or irritation on the palms of hands or soles of feet
Blood clots in the lungs, which can be life-threatening. Seek immediate medical attention if you experience:
+ Chest pain or pressure
+ Coughing up blood
+ Rapid breathing or heartbeat
+ Shortness of breath
Irritation at the injection site, including:
+ Redness, burning, pain, swelling, or fluid leakage

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Feeling tired or weak
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Back pain or headache
Hair loss or throat irritation
Weight loss
Urine and other body fluids may turn orange or red, which is a normal effect of this medication
* Mouth irritation, including:
+ Redness, swelling, or pain
+ Mouth sores
+ Dry mouth, lips, or tongue
+ Painful swallowing

Reporting 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.

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. Do not take this medication 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 your safety, tell your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Any health problems you have

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.

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 may suppress the bone marrow's ability to produce essential blood cells, which can increase the risk of bleeding problems, infections, or anemia if blood cell counts become severely low. If you have concerns, discuss them with your doctor. You may also 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.

To minimize the risk of bleeding, be cautious and avoid injuries. Use a soft toothbrush and an electric razor to reduce the risk of bleeding gums or other bleeding complications. If you experience stomach upset, vomiting, diarrhea, or loss of appetite, consult your doctor, as there may be ways to alleviate these side effects.

For 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, as this may affect your treatment.

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 for any abnormalities. 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, 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. Additionally, treatment with this medication may lead to premature menopause. If you have questions or concerns, discuss them with your doctor.

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

If your partner may become pregnant, use birth control during treatment and for 6 months after the last dose. If your partner becomes pregnant, contact the doctor right away.

• Live or attenuated vaccines (risk of severe infection)
• Other myelosuppressive agents (additive myelosuppression)
• Other cardiotoxic agents (e.g., trastuzumab, cyclophosphamide, 5-FU, paclitaxel) (additive cardiotoxicity)
• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) (potential increase in doxorubicin exposure, though less significant for liposomal form)
• Strong CYP3A4 inducers (e.g., rifampin, phenytoin) (potential decrease in doxorubicin exposure)

• P-glycoprotein inhibitors (e.g., verapamil, cyclosporine) (potential increase in doxorubicin exposure)
• Radiation therapy (may enhance skin reactions, especially hand-foot syndrome)

• Fever (sign of infection/neutropenia)
• Unusual bleeding or bruising (thrombocytopenia)
• Extreme fatigue or shortness of breath (anemia, cardiac dysfunction)
• Chest pain, palpitations, swelling in ankles/feet (cardiotoxicity)
• Redness, swelling, pain, or blistering on palms of hands or soles of feet (hand-foot syndrome)
• Sore mouth or throat, difficulty swallowing (mucositis)
• Nausea, vomiting, diarrhea
• Hair loss

Doxorubicin liposomal is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment and for at least 6 months after the last dose.

It is not known whether doxorubicin liposomal is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during treatment and for at least 10 days after the last dose.

Safety and effectiveness have not been established in pediatric patients. However, doxorubicin (including liposomal formulations) is used off-label in some pediatric cancer regimens. Dosing and monitoring require specialized expertise.

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, elderly patients may be more susceptible to cardiotoxicity and myelosuppression, and careful monitoring is warranted.

• Administer via IV infusion over 60-90 minutes; do not administer as a bolus injection or undiluted. Rapid infusion can increase the risk of infusion-related reactions.
• Always dilute in 5% Dextrose Injection, USP. Do not mix with saline or other IV fluids.
• Cumulative lifetime dose of doxorubicin (including liposomal and conventional forms) should be carefully monitored due to the risk of cardiotoxicity. While liposomal doxorubicin has a lower risk of cardiotoxicity than conventional doxorubicin, the risk is still present, especially with higher cumulative doses.
• Hand-foot syndrome (Palmar-Plantar Erythrodysesthesia) is a common and dose-limiting toxicity. Management includes dose reduction/interruption, cooling hands/feet, and topical emollients. Pyridoxine has been explored but its efficacy is not consistently proven.
• Infusion-related reactions (e.g., flushing, shortness of breath, chest pain, back pain, fever, chills) can occur, usually within minutes of starting the infusion. These are typically managed by slowing or temporarily stopping the infusion. Premedication (antihistamines, corticosteroids) may be considered for patients with prior reactions.
• Extravasation is less common with the liposomal formulation compared to conventional doxorubicin due to its encapsulated nature, but it can still occur. If extravasation occurs, stop the infusion immediately and manage according to institutional guidelines (e.g., cold compress, elevation).
• Monitor for secondary malignancies, particularly acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), which can occur years after treatment.

• Other anthracyclines (e.g., conventional doxorubicin, epirubicin, daunorubicin, idarubicin)
• Other topoisomerase inhibitors (e.g., etoposide, irinotecan)
• Platinum-based chemotherapy (e.g., carboplatin, cisplatin)
• Taxanes (e.g., paclitaxel, docetaxel)
• Alkylating agents (e.g., cyclophosphamide)
• Targeted therapies or immunotherapies depending on the specific cancer type.

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to 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. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. 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.