Doxorubicin 2mg/ml Inj, 100ml

Doxorubicin is an anthracycline cytotoxic antibiotic. Its primary mechanisms of action include: 1) DNA intercalation, 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 effects and cardiotoxicity.

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 medical attention immediately:

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
+ 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

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 help immediately if you experience:

Rapid or abnormal 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. Many people may not experience any side effects or may only have mild ones. If you notice 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 is not a comprehensive list of all possible 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Anemia (low red blood cell count)
+ Heart problems
+ Liver disease
+ Low platelet count (thrombocytopenia)
+ Low white blood cell count (leukopenia)
If you have had a recent heart attack
If you have previously received daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone, as these medications may interact with this drug
Any medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some medications may interact with this drug. Specifically, certain drugs used to treat HIV, infections, seizures, and other conditions may be contraindicated with this medication.
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 or plan to breastfeed. You should not breastfeed while taking this medication, and you may need to avoid breastfeeding for a period after your last dose. Consult your doctor to determine the necessary duration of breastfeeding avoidance 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.

Be cautious of bleeding easily, and take steps to prevent injury. 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 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 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 medication, 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 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 (risk of severe infection in immunosuppressed patients)

• Trastuzumab (increased risk of cardiotoxicity)
• Cyclophosphamide (increased risk of cardiotoxicity)
• Paclitaxel (altered doxorubicin pharmacokinetics, increased myelosuppression)
• Verapamil (increased doxorubicin exposure, increased toxicity)
• Phenobarbital, Phenytoin (CYP3A4 inducers, may decrease doxorubicin levels)
• Cimetidine (CYP3A4 inhibitor, may increase doxorubicin levels)
• Other myelosuppressive agents (additive myelosuppression)
• Other cardiotoxic agents (additive cardiotoxicity, e.g., anthracyclines, cyclophosphamide, 5-FU, taxanes, trastuzumab)

• Warfarin (potential for altered INR, monitor closely)
• Digoxin (decreased digoxin absorption)
• St. John's Wort (CYP3A4 inducer, may decrease doxorubicin levels)
• Grapefruit juice (CYP3A4 inhibitor, may increase doxorubicin levels)
• Sorafenib (increased doxorubicin exposure)

• Not available

• Signs of infection (fever, chills, sore throat)
• Bleeding or bruising (petechiae, epistaxis)
• Fatigue, weakness
• Nausea, vomiting, diarrhea, mucositis
• Hair loss
• Red-orange discoloration of urine
• Signs of cardiotoxicity (shortness of breath, swelling of ankles/feet, palpitations, chest pain)
• Signs of extravasation (pain, swelling, redness, blistering 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. 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 is crucial. Secondary malignancies are also a concern.

Elderly patients may have reduced hepatic function, pre-existing cardiac conditions, or decreased bone marrow reserve, which may increase the risk of doxorubicin-related toxicities (e.g., cardiotoxicity, myelosuppression). Careful monitoring and potential dose adjustments are warranted.

• Always verify cumulative lifetime doxorubicin dose before administration to prevent irreversible cardiotoxicity.
• Administer doxorubicin via a free-flowing intravenous infusion over 3-5 minutes or longer to minimize extravasation risk. Avoid rapid IV push.
• Ensure patency of the IV line and monitor for signs of extravasation throughout infusion. If extravasation occurs, stop infusion immediately, aspirate residual drug, and consider local cooling and dexrazoxane (Totect) if indicated.
• Red-orange discoloration of urine is a common and harmless side effect; inform patients to prevent alarm.
• Prophylactic antiemetics are essential due to the high emetogenic potential of doxorubicin.
• Consider cardioprotective agents like dexrazoxane (Zinecard) for patients receiving high cumulative doses or those at increased risk of cardiotoxicity.
• Patients should be educated on signs of myelosuppression (fever, bleeding) and cardiotoxicity (SOB, swelling) and instructed to report them immediately.

• Epirubicin (another anthracycline with potentially lower cardiotoxicity)
• Liposomal Doxorubicin (e.g., Doxil, Myocet - reduced cardiotoxicity and extravasation risk, different PK profile)
• Other cytotoxic agents depending on cancer type (e.g., taxanes, platinum compounds, antimetabolites)
• Targeted therapies or immunotherapies (for specific cancer types where applicable)

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 or take someone else's medication. 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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. 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 have additional patient information leaflets, so it is a good idea to check with your pharmacist. If you have any questions or concerns about this medication, 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it happened to ensure timely and effective treatment.