Doxorubicin 2mg/ml Inj, 5ml

Doxorubicin is an anthracycline cytotoxic agent. 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, leading to DNA strand breaks. 3) Generation of free radicals (e.g., superoxide radicals, hydroxyl radicals) through redox cycling, which can damage DNA, proteins, and cell membranes, contributing to its cytotoxic and cardiotoxic effects.

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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
+ 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

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. Seek medical attention immediately if you experience:

Rapid or irregular heartbeat
Fainting
Difficulty urinating
Muscle weakness or cramps
Nausea, 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 minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for guidance:

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 list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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.

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. Describe the allergic reaction and its symptoms.
Existing health conditions, including:
+ Anemia
+ Heart problems
+ Liver disease
+ Low platelet count (thrombocytopenia)
+ Low white blood cell count (leukopenia)
Recent heart attack
Previous treatment with daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone; discuss the details with your doctor
Concurrent use of other medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, that may interact with this medication. Certain medications, such as those used to treat HIV, infections, or seizures, 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 potentially for a period after the last dose, as advised by your doctor

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, health conditions, and concerns to ensure safe use of this medication. Do not initiate, discontinue, or modify the dosage of any medication without 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 drug, 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 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 taken 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 drug 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 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 with this drug, which may or may not resume after treatment. Additionally, treatment with this medication may lead to premature menopause. If you have questions or concerns, consult your doctor.

This drug 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 during treatment and for a specified period after the final dose, as advised by your doctor. If pregnancy occurs, notify your doctor immediately.

• Trastuzumab (concurrent use increases cardiotoxicity risk, avoid for 7 months post-trastuzumab)
• Live vaccines (due to immunosuppression)

• Cyclophosphamide (increased cardiotoxicity)
• Paclitaxel (altered doxorubicin pharmacokinetics, administer doxorubicin first)
• Verapamil (increased doxorubicin levels)
• Phenobarbital, Phenytoin (decreased doxorubicin levels)
• Cimetidine (increased doxorubicin levels)
• Other cardiotoxic agents (e.g., other anthracyclines, cyclophosphamide, 5-FU, mitomycin C, trastuzumab, radiation to mediastinum) - increased cardiotoxicity risk
• Myelosuppressive agents (additive myelosuppression)

• CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice) - potential increase in doxorubicin levels
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) - potential decrease in doxorubicin levels
• Warfarin (potential increase in INR/bleeding risk)
• Digoxin (decreased digoxin absorption)

• Not available

• Signs of myelosuppression (fever, chills, unusual bleeding/bruising, fatigue)
• Signs of cardiotoxicity (shortness of breath, swelling of ankles/feet, rapid weight gain, palpitations, chest pain)
• Signs of extravasation (pain, burning, swelling, redness at injection site)
• Nausea, vomiting, diarrhea, mucositis/stomatitis
• Alopecia (hair loss)
• Red-orange discoloration of urine (expected, harmless)

Doxorubicin is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. It is embryotoxic, fetotoxic, and teratogenic in animals. Women of childbearing potential should be advised to avoid becoming pregnant during therapy and to use effective contraception.

Doxorubicin is contraindicated during breastfeeding. It is unknown if doxorubicin is excreted in human milk, but due to the potential for serious adverse reactions in breastfed infants, women should discontinue breastfeeding 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 is crucial. Growth and development should also be monitored.

Elderly patients may be more susceptible to the cardiotoxic effects of doxorubicin, especially those with pre-existing cardiac disease. Renal and hepatic function should be carefully assessed, and dose adjustments may be necessary based on hepatic impairment. Close monitoring for myelosuppression and other toxicities is essential.

• Always administer doxorubicin via a free-flowing intravenous infusion, preferably into a large vein, to minimize the risk of extravasation.
• Extravasation is a medical emergency. Stop infusion immediately, disconnect syringe (leave needle in place), aspirate residual drug, remove needle, elevate limb, and apply cold packs. Consider dexrazoxane for doxorubicin extravasation.
• Cumulative lifetime dose limits for doxorubicin are critical due to irreversible cardiotoxicity (typically 450-550 mg/m² for conventional doxorubicin). Dexrazoxane can be used to reduce cardiotoxicity risk in certain settings.
• Red-orange discoloration of urine is a common and harmless side effect, but patients should be informed to avoid unnecessary alarm.
• Severe nausea and vomiting are common; aggressive antiemetic prophylaxis is essential.
• Mucositis/stomatitis can be severe; encourage good oral hygiene and consider cryotherapy (ice chips) during infusion for prevention.
• Doxorubicin is a vesicant; proper administration technique and patient education on extravasation symptoms are paramount.

• Other anthracyclines (e.g., Idarubicin, Daunorubicin)
• Alkylating agents (e.g., Cyclophosphamide, Ifosfamide)
• Antimetabolites (e.g., 5-Fluorouracil, Methotrexate)
• Taxanes (e.g., Paclitaxel, Docetaxel)
• Platinum compounds (e.g., Cisplatin, Carboplatin)
• Targeted therapies (e.g., Trastuzumab, Pertuzumab for HER2+ breast cancer)
• Immunotherapy (e.g., Pembrolizumab, Nivolumab)

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 for 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 pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate. 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, 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 amount, and the time it was taken to ensure prompt and effective treatment.