Doxorubicin 50mg Inj, 1 Vial

Doxorubicin is an anthracycline cytotoxic antibiotic. Its primary mechanisms of action include: 1. DNA intercalation: It inserts between base pairs of DNA, leading to unwinding of the DNA helix and inhibition of DNA and RNA synthesis. 2. Topoisomerase II inhibition: It stabilizes the topoisomerase II-DNA complex, preventing DNA re-ligation and leading to DNA strand breaks. 3. Free radical formation: It generates highly reactive oxygen free radicals (superoxide, hydroxyl radicals) that damage DNA, proteins, and cell membranes, contributing to its cytotoxic and cardiotoxic effects.

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
+ 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: This medication may increase the risk of a severe condition called tumor lysis syndrome (TLS), which can be life-threatening. Seek medical help immediately if you experience:
+ Fast or abnormal heartbeat
+ Fainting
+ Trouble urinating
+ Muscle weakness or cramps
+ Upset stomach, vomiting, diarrhea, or loss of appetite
+ Feeling sluggish

Other Possible Side Effects

Most people taking this medication will not experience severe side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

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 not mentioned here. 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, 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 certain medications, such as daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone. Discuss your history with your doctor.
Other medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Some medications, such as those used for 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 consult your doctor about the need to avoid breastfeeding after your last dose.

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 start, stop, or change the dose 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 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.

You may experience an increased risk of bleeding. To reduce this risk, be cautious and avoid injuries. Use a soft-bristled toothbrush and an electric razor for shaving. If you experience gastrointestinal side effects such as stomach upset, vomiting, diarrhea, or a decrease in 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 immediately.

To prevent exposure to body fluids, take precautions to avoid contact with family members or caregivers. 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 certain 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 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 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.

• Live or live-attenuated vaccines (due to immunosuppression)

• Trastuzumab (increased risk of cardiotoxicity)
• Cyclophosphamide (increased risk of cardiotoxicity)
• Paclitaxel (altered doxorubicin pharmacokinetics, administer doxorubicin first)
• Verapamil (increased doxorubicin exposure and toxicity)
• Phenytoin (decreased doxorubicin exposure)
• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - increased doxorubicin exposure
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John's Wort) - decreased doxorubicin exposure
• Cardiotoxic agents (e.g., other anthracyclines, cyclophosphamide, 5-fluorouracil, mitomycin C, trastuzumab, radiation to mediastinum) - increased risk of cardiotoxicity
• Myelosuppressive agents (e.g., other chemotherapy, radiation) - increased risk of myelosuppression

• Cimetidine (increased doxorubicin exposure)
• Phenobarbital (decreased doxorubicin exposure)
• Warfarin (potential for increased anticoagulant effect due to myelosuppression and altered platelet function)
• Dexrazoxane (cardioprotectant, but may interfere with doxorubicin's antitumor efficacy if given concurrently for initial cycles)
• Sorafenib (increased doxorubicin exposure)

• Acetaminophen (potential for increased hepatotoxicity with high doses/prolonged use)
• NSAIDs (increased risk of GI bleeding in myelosuppressed patients)

• Signs of heart failure (shortness of breath, swelling, fatigue, rapid heartbeat)
• Signs of infection (fever, chills, sore throat)
• Unusual bleeding or bruising
• Severe nausea, vomiting, or diarrhea
• Mouth sores or pain (mucositis)
• Pain, redness, or swelling at injection site (extravasation)
• Reddish discoloration of urine (expected, but inform patient)

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

Doxorubicin is excreted in human milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is contraindicated during doxorubicin therapy and for a period after the last dose (e.g., at least 10 days).

Children are at increased risk for cardiotoxicity, especially at younger ages and with higher cumulative doses. Long-term follow-up for cardiac function is crucial. Growth and development should be monitored. Secondary malignancies are a concern.

Elderly patients may have reduced hepatic, renal, or cardiac function, which can increase the risk of toxicity. Careful monitoring of organ function and dose adjustments may be necessary. Cardiotoxicity risk may be higher in patients with pre-existing cardiac disease.

• Always administer doxorubicin via a free-flowing IV infusion, preferably through a central venous catheter, to minimize the risk of extravasation.
• Dexrazoxane (Totect) is an antidote for doxorubicin extravasation. Dexrazoxane (Zinecard) can be used as a cardioprotectant to reduce the incidence and severity of doxorubicin-induced cardiotoxicity in patients who have received a cumulative doxorubicin dose of 300 mg/m² and who require continued doxorubicin therapy.
• The urine may turn reddish-orange for 1-2 days after administration; this is a harmless effect of the drug and not blood.
• Strictly adhere to cumulative lifetime dose limits to prevent irreversible cardiotoxicity. These limits vary based on patient factors and prior mediastinal radiation.
• Prophylactic antiemetics are essential to manage severe nausea and vomiting.
• Monitor for 'radiation recall' phenomenon in patients who have previously received radiation therapy, where doxorubicin can reactivate skin reactions in irradiated areas.

• Other anthracyclines (e.g., Epirubicin, Idarubicin, Daunorubicin)
• Liposomal doxorubicin (e.g., Doxil, Myocet) - designed to reduce cardiotoxicity and extravasation risk, different pharmacokinetic profile.
• Other cytotoxic agents depending on cancer type (e.g., taxanes, platinum compounds, antimetabolites, vinca alkaloids)
• Targeted therapies or immunotherapies (depending on specific cancer and molecular profile)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and 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. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities have drug take-back programs; your pharmacist can provide information on these programs. Some medications may have additional patient information leaflets; consult with your pharmacist if you have questions. If you have concerns or questions 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 occurred to ensure prompt and effective treatment.