Doxorubicin 10mg Inj, 1vial

Doxorubicin is an anthracycline cytotoxic antibiotic. Its primary mechanisms of action include: 1) Intercalation into DNA, leading to inhibition of macromolecular biosynthesis (DNA and RNA synthesis). 2) Inhibition of topoisomerase II, an enzyme critical for DNA replication and repair, resulting in DNA strand breaks. 3) Generation of free radicals (e.g., superoxide radicals, hydroxyl radicals) that damage DNA, cell membranes, and proteins, contributing to its cytotoxic and cardiotoxic effects.

Serious 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
+ 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 discolored sputum
+ 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
Patients with cancer taking this medication may be at a higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition. If you experience any of the following symptoms, contact your doctor immediately:
+ Rapid or abnormal heartbeat
+ Fainting
+ Difficulty urinating
+ Muscle weakness or cramps
+ Nausea, vomiting, diarrhea, or loss of appetite
+ Feeling sluggish

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 mouth sores
Changes in nail color or texture
* Orange or red urine for 1 to 2 days after receiving this medication

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.

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, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Anemia
+ Heart problems
+ Liver disease
+ Low platelet count
+ Low white blood cell count
+ Recent heart attack
If you have previously taken daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone, discuss this with your doctor.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, inform your doctor about medications used to treat HIV, infections, seizures, and other conditions, as these may be contraindicated with this drug.
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 breast-feeding or plan to breast-feed. You should not breast-feed while taking this medication, and you may need to avoid breast-feeding for a period after your last dose. Consult your doctor to determine the necessary duration of breast-feeding avoidance after completing treatment.

This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist to ensure safe treatment. Do not initiate, discontinue, or modify 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.

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 aware that this medication can increase your risk of bleeding easily. Take precautions to avoid injury, and consider using a soft 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 mitigate 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 promptly.

To prevent the transmission of body fluids to family members or caregivers, exercise caution and take necessary precautions. Wash any soiled clothing immediately, 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 to monitor your condition, as directed by your doctor. If you have a history of radiation treatment or are scheduled to undergo radiation therapy, 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 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 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 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.

• Live or live-attenuated vaccines (due to immunosuppression)
• Trastuzumab (concurrent or sequential use within 7 months due to increased cardiotoxicity risk)

• Cyclophosphamide (increased cardiotoxicity)
• Paclitaxel (altered doxorubicin pharmacokinetics, increased myelosuppression)
• Verapamil (increased doxorubicin levels)
• Phenytoin (decreased phenytoin levels)
• Cimetidine (increased doxorubicin levels)
• Cyclosporine (increased doxorubicin levels)
• Other myelosuppressive agents (additive myelosuppression)
• Cardiotoxic agents (e.g., other anthracyclines, high-dose cyclophosphamide, mediastinal radiation) - increased risk of cardiotoxicity

• CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) - potential for increased doxorubicin levels (minor pathway)
• CYP3A4 inducers (e.g., rifampin, carbamazepine) - potential for decreased doxorubicin levels (minor pathway)
• Warfarin (potential for altered INR, monitor closely)

• Not available

• Signs of congestive heart failure (e.g., dyspnea, edema, fatigue, cough)
• Signs of infection (e.g., fever, chills, sore throat)
• Signs of bleeding (e.g., bruising, petechiae, unusual bleeding)
• Oral mucositis/stomatitis (pain, redness, ulcers in mouth/throat)
• Nausea and vomiting
• Alopecia (hair loss)
• Extravasation at injection site (pain, swelling, redness, blistering)
• Red discoloration of urine (expected, harmless)

Doxorubicin is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. Avoid use during pregnancy.

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., 10 days).

Doxorubicin is used in pediatric oncology. Children are at increased risk for cardiotoxicity, especially at younger ages and with higher cumulative doses. Long-term monitoring for cardiac function and secondary malignancies is crucial. Dosing is based on BSA and specific protocols.

Elderly patients (≥65 years) may have an increased risk of cardiotoxicity and myelosuppression. Careful monitoring of cardiac function, blood counts, and renal/hepatic function is essential. Dose adjustments may be necessary based on individual tolerance and comorbidities.

• Doxorubicin causes red discoloration of urine for 1-2 days after administration, which is harmless and not indicative of hematuria. Inform patients to prevent alarm.
• Lifetime cumulative dose limits (e.g., 450-550 mg/m² for conventional doxorubicin) are critical to minimize the risk of irreversible cardiotoxicity. These limits may be lower in patients with prior cardiac disease, mediastinal radiation, or concurrent cardiotoxic agents.
• Doxorubicin is a vesicant; extravasation can cause severe tissue necrosis. Administer via a free-flowing IV line, preferably a central venous catheter. If extravasation occurs, stop infusion immediately, aspirate residual drug, and consider applying cold packs and topical dexrazoxane (Totect) if available and indicated.
• Prophylactic antiemetics are recommended due to the moderate to high emetogenic potential of doxorubicin.
• Mucositis is a common and painful side effect; encourage good oral hygiene and consider prophylactic measures like cryotherapy (ice chips) during infusion for head and neck cancers.

• Liposomal doxorubicin (Doxil, Myocet) - designed to reduce cardiotoxicity and extravasation risk, used in specific indications like Kaposi's sarcoma, ovarian cancer, multiple myeloma.
• Other cytotoxic agents (e.g., cyclophosphamide, paclitaxel, 5-fluorouracil) depending on the specific cancer type and treatment regimen.
• Targeted therapies or immunotherapies, depending on the cancer's molecular profile.

If your symptoms or health problems do not improve or worsen over time, 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.

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 advice. 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, the amount taken, and the time it was ingested, to ensure prompt and effective treatment.