Doxorubicin Lipo 2mg/ml Inj, 10ml

Doxorubicin is an anthracycline antibiotic that exerts its cytotoxic effects through several mechanisms: 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) which cause oxidative damage to DNA, proteins, and cell membranes. The liposomal formulation encapsulates doxorubicin in pegylated liposomes, which prolongs its circulation time, alters its tissue distribution (preferential accumulation in tumor tissues with leaky vasculature), and reduces uptake by the heart, thereby decreasing cardiotoxicity compared to conventional doxorubicin.

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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased or discolored sputum
+ Painful urination or mouth sores
+ Wounds that do not heal
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Coffee ground-like vomit
+ Blood in the urine or black, red, or tarry stools
+ Bleeding gums or abnormal vaginal bleeding
+ Unexplained bruises or bleeding that will not stop
Abnormal sensations, such as:
+ Burning, numbness, or tingling
+ Redness or irritation on the palms of hands or soles of feet
Blood clots in the lungs, which can be life-threatening. Seek immediate medical attention if you experience:
+ Chest pain or pressure
+ Coughing up blood
+ Rapid breathing or heartbeat
+ Shortness of breath
Irritation at the injection site, including:
+ Redness, burning, pain, swelling, or fluid leakage

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, contact your doctor or seek medical attention if they bother you or persist:

Fatigue or weakness
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Back pain or headache
Hair loss or throat irritation
Weight loss
Urine and other body fluids may turn orange or red, which is a normal effect of this medication
* Mouth irritation, including:
+ Redness, swelling, or pain
+ Mouth sores or dry mouth, lips, or tongue
+ Painful swallowing

Reporting 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. Be sure to describe the allergic reaction and its symptoms.
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 breastfeeding. You should not breastfeed while taking this medication.

Additionally, this medication may interact with other medications or health conditions. To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your health problems, including any medical conditions or concerns

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the medication is used effectively and safely.

Important Warnings and Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests and heart function checks will be necessary, as directed by your doctor.

Blood-Related Risks

This medication may affect the bone marrow's ability to produce essential blood cells, leading to potential bleeding problems, infections, or anemia. If you have concerns, discuss them with your doctor. You may be more susceptible to infections, so it is crucial to:

Wash your hands frequently
Avoid close contact with people who have infections, colds, or flu

Additionally, you may experience easier bleeding. To minimize this risk:

Be cautious and avoid injuries
Use a soft toothbrush and an electric razor

Managing Side Effects

If you experience stomach upset, vomiting, diarrhea, or decreased appetite, consult your doctor, as there may be ways to alleviate these side effects. To help manage mouth sores:

Use a soft toothbrush or cotton swabs
Rinse your mouth regularly
* Avoid using mouthwashes that contain alcohol

Previous Medication Use

If you have previously taken daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone, inform your doctor.

Long-Term Risks

Prolonged use of this medication (more than 1 year) may increase the risk of mouth cancer, which can occur during treatment or up to 6 years after the last dose. Your doctor will regularly examine your mouth. If you experience mouth pain, sores, or ulcers, contact your doctor immediately.

Vaccinations

Before receiving any vaccines, consult your doctor, as some vaccines may not be effective or may increase the risk of infection when used with this medication.

Fertility and Pregnancy

This medication may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. This effect may be reversible, but in some cases, it may be permanent. If you have concerns, discuss them with your doctor.

Women may experience cessation of menstrual periods during treatment, which may not resume after treatment completion. This medication may also lead to premature menopause. If you have questions, consult your doctor.

Pregnancy and Birth Control

This medication can harm an unborn baby. A pregnancy test will be conducted before starting treatment to confirm you are not pregnant. If you may become pregnant, use birth control during treatment and for 6 months after the last dose, unless otherwise advised by your doctor. If you become pregnant, contact your doctor immediately.

If your partner may become pregnant, use birth control during treatment and for 6 months after the last dose. If your partner becomes pregnant, contact the doctor immediately.

• Live or attenuated vaccines (risk of severe or fatal infection)
• Trastuzumab (increased risk of cardiotoxicity)
• Cyclosporine, Tacrolimus, Verapamil (may increase doxorubicin levels/toxicity)
• Paclitaxel (sequential administration may alter doxorubicin PK, increased myelosuppression)

• Other myelosuppressive agents (additive myelosuppression)
• Cardiotoxic agents (e.g., cyclophosphamide, 5-fluorouracil, radiation to mediastinum; increased risk of cardiotoxicity)
• Hepatotoxic agents (potential for increased doxorubicin toxicity)
• Phenytoin (decreased phenytoin levels)

• Signs of infection (fever, chills, sore throat)
• Unusual bleeding or bruising
• Fatigue, weakness
• Shortness of breath, swelling of ankles/feet (signs of heart failure)
• Redness, swelling, pain, blistering on palms of hands or soles of feet (PPE)
• Nausea, vomiting, diarrhea, mucositis/stomatitis
• Infusion reactions (flushing, shortness of breath, chest pain, back pain, chills, fever, tachycardia, hypotension)

Doxorubicin liposomal can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 6 months after the last dose.

It is not known whether doxorubicin liposomal is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 10 days after the last dose.

Safety and effectiveness have not been established in pediatric patients. Use in pediatric patients is generally not recommended.

No overall differences in safety or effectiveness were observed between elderly patients and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Close monitoring for adverse effects is recommended.

• The liposomal formulation significantly reduces the risk of cardiotoxicity compared to conventional doxorubicin, but cardiac monitoring is still essential, especially with higher cumulative doses.
• Palmar-plantar erythrodysesthesia (PPE), or hand-foot syndrome, is a common and dose-limiting toxicity unique to the liposomal formulation. Management includes dose reduction/interruption, cooling, emollients, and sometimes pyridoxine.
• Infusion-related reactions are common and can be severe. Administer slowly (over at least 60 minutes) and consider premedication (antihistamines, corticosteroids) for patients with prior reactions.
• Extravasation is less likely to cause severe local tissue damage than conventional doxorubicin, but the infusion site should still be monitored closely.
• Cumulative lifetime dose limits for doxorubicin liposomal are higher than for conventional doxorubicin due to reduced cardiotoxicity, but individual patient risk factors (prior anthracycline exposure, pre-existing cardiac disease) must be considered.

• Paclitaxel (for ovarian/breast cancer)
• Carboplatin (for ovarian cancer)
• Bortezomib (for multiple myeloma)
• Pomalidomide (for multiple myeloma)
• Lenalidomide (for multiple myeloma)
• Other cytotoxic agents depending on specific cancer type and stage.

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 and effective treatment, never share your medication with others or take someone else's medication.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure. 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 that provide a safe and convenient way to dispose of unwanted medications.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance and support.

In the event of a suspected overdose, immediately contact 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 taken, to ensure prompt and effective treatment.