Doxorubicin 10mg/5ml Inj, 5ml

Doxorubicin is an anthracycline cytotoxic antibiotic. Its primary mechanisms of action include: 1) Intercalation into DNA, leading to inhibition of DNA and RNA synthesis. 2) Inhibition of topoisomerase II, which is crucial for DNA replication and repair, causing DNA strand breaks. 3) Generation of free radicals (e.g., superoxide radicals, hydroxyl radicals) that damage cellular components, including DNA, proteins, and lipids, 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
+ Pain while urinating
+ 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 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 health condition called tumor lysis syndrome (TLS), which can be life-threatening. Seek medical help 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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or don't go away, 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

Reporting Side Effects

This list is not exhaustive, and you may experience other 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, such as foods or drugs. Be sure to 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 certain medications, such as daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone. Discuss your history with these medications with your doctor.
Current medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Some medications, such as those used to treat HIV, infections, or seizures, may interact with this medication and should be avoided.
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 first.

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. To reduce this risk, exercise caution to avoid injuries, use a soft-bristled toothbrush, and consider using an electric razor.

If you experience gastrointestinal side effects such as stomach upset, vomiting, diarrhea, or a decrease in appetite, consult your doctor. They may be able to suggest ways to alleviate these symptoms.

If side effects like stomach upset, vomiting, diarrhea, or mouth sores interfere with your ability to eat or drink normally, contact your doctor promptly.

To prevent exposure to body fluids, take precautions to avoid contact with family members or caregivers. Immediately wash any soiled clothing and wear gloves when handling body fluids for at least 5 days following each treatment.

Before receiving any vaccinations, consult your doctor. The use of certain vaccines in conjunction with this medication may increase the risk of infection or reduce the vaccine's effectiveness.

Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions you have with your doctor.

If you have a history of or are scheduled to undergo radiation treatment, inform your doctor. This medication may exacerbate the side effects of radiation treatment.

When administering this medication to children, exercise caution due to the increased risk of hypoglycemia (low blood sugar).

This medication may affect fertility, potentially leading to difficulty conceiving or fathering a child. Although fertility may return to normal after treatment, in some cases, it may not. If you have concerns, discuss them with your doctor.

Women may experience cessation of menstrual periods during treatment with this medication, 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 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 pregnancy occurs, notify your doctor immediately.

• Live vaccines (due to immunosuppression)
• St. John's Wort (may decrease doxorubicin levels)

• Trastuzumab (increased risk of cardiotoxicity)
• Cyclophosphamide (increased risk of cardiotoxicity)
• Paclitaxel (altered doxorubicin pharmacokinetics, administer doxorubicin first)
• Verapamil (increased doxorubicin levels and toxicity)
• Phenobarbital, Phenytoin (may decrease doxorubicin levels)
• Cimetidine (may increase doxorubicin levels)
• Other myelosuppressive agents (additive myelosuppression)
• Cardiotoxic agents (e.g., other anthracyclines, cyclophosphamide, high-dose radiation to mediastinum) (additive cardiotoxicity)

• CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice) (may increase doxorubicin levels)
• CYP3A4 inducers (e.g., rifampin, carbamazepine) (may decrease doxorubicin levels)
• Warfarin (potential for altered INR, monitor closely)
• Digoxin (may decrease digoxin absorption)

• Not available

• Signs of infection (fever, chills, sore throat)
• Unusual bleeding or bruising
• Fatigue, weakness
• Nausea, vomiting, diarrhea, mucositis
• Hair loss
• Red or dark urine (expected due to drug color, but differentiate from hematuria)
• Signs of cardiotoxicity (shortness of breath, swelling of ankles/feet, rapid weight gain, palpitations, chest pain)
• Signs of extravasation (pain, swelling, redness at injection site)

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 reproductive potential should be advised to use effective contraception during treatment and for 6 months after the last dose. Men with female partners of reproductive potential should use effective contraception during treatment and for 3 months after the last dose.

Doxorubicin is contraindicated during breastfeeding. It is unknown if doxorubicin or its metabolites are excreted in human milk, but due to the potential for serious adverse reactions in the breastfed infant, women should not breastfeed during treatment and for at least 10 days after the last dose.

Doxorubicin is used in pediatric oncology. Children are at increased risk for delayed cardiotoxicity, which can manifest years after treatment. Long-term cardiac monitoring is crucial for pediatric survivors. They may also be at higher risk for secondary malignancies and growth impairment.

Elderly patients may be more susceptible to the cardiotoxic and myelosuppressive effects of doxorubicin. Careful monitoring of cardiac function, bone marrow function, and renal/hepatic function is essential. Dose adjustments may be necessary based on individual patient tolerance and comorbidities.

• 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 dexrazoxane (Totect) if available and indicated.
• The red color of doxorubicin can cause urine to turn reddish-orange for 1-2 days after administration; this is normal and not hematuria.
• Cumulative lifetime dose limits are critical to minimize the risk of irreversible cardiotoxicity. These limits vary based on formulation (conventional vs. liposomal) and patient risk factors.
• Dexrazoxane can be used as a cardioprotectant in patients receiving doxorubicin for metastatic breast cancer who have received a cumulative dose of 300 mg/m² and are expected to benefit from continued doxorubicin therapy.
• Administer doxorubicin slowly, typically over 3-5 minutes for bolus or 30-60 minutes for infusion, to minimize acute infusion reactions and extravasation risk.

• Other cytotoxic agents (e.g., cyclophosphamide, paclitaxel, fluorouracil, cisplatin, etoposide) depending on cancer type and stage.
• Targeted therapies (e.g., trastuzumab, pertuzumab for HER2+ breast cancer)
• Immunotherapy (e.g., checkpoint inhibitors)
• Hormonal therapies (e.g., tamoxifen, aromatase inhibitors for hormone-sensitive cancers)
• Liposomal doxorubicin (e.g., Doxil, Myocet) - a different formulation with altered pharmacokinetic and toxicity profiles, particularly reduced cardiotoxicity and myelosuppression but increased hand-foot syndrome.

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. 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 otherwise, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, as they can provide guidance or inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. 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, as this will aid in receiving appropriate care.