Idarubicin. Injection

Idarubicin Vial is an anthracycline that is administered with other agents to treat acute myeloid leukemia.

Idamycin

Idarubicin

Zavedos

1

P. Upjohn, Pfizer

VIal

5 mg

India

Idarubicin. Injection

Introduction to Idarubicin Injection

Overview of Idarubicin

Idarubicin is a medication used to target cancers with precision by interfering with DNA intercalation to hinder cancer cell growth and replication process efficiently through injection delivery, quick absorption, and widespread impact.

Classification as an Anthracycline Antibiotic

Classified as an anthracycline antibiotic, idarubicin belongs to a group of chemotherapeutic agents known for their dual role in DNA intercalation and topoisomerase inhibition. These compounds, although originally isolated from Streptomyces, are primarily used for their cytotoxic properties rather than antibacterial effects.

FDA Approval Status and Global Availability

Idarubicin has been approved by the FDA for treating acute myeloid leukemia in the US. It is considered essential in countries worldwide due to its significant impact on healthcare systems and regulatory approvals that differ by region.

General Indications in Oncology

Idarubicin is primarily indicated for:

It remains a cornerstone in oncologic protocols, particularly in hematologic cancers.

Idarubicin mechanism of action

Cellular Target and DNA Intercalation

Idarubicin works by fitting in between the building blocks of DNA, hindering the production of acids in the process. This disruption impacts the stability of DNA and RNA strands and eventually halts the growth of cells.


Inhibition of Topoisomerase II

It hinders the action of the topoisomerase II enzyme, which is crucial for the DNA replication process by stabilizing the complex between DNA and the enzyme, thus preventing the rejoining of DNA strands, leading to stranded breaks.

Impact on Cell Cycle and Apoptosis

Idarubicin causes a pause in the cell cycle during the S phase. Then, it leads to apoptosis starting up. The substance activates caspases and makes the mitochondrial membrane more permeable, which helps in causing cell death in a way.

Selectivity for Rapidly Dividing Cancer Cells

Idarubicin demonstrates a preference, for dividing cells due to its mechanism of action. This targets blood cell precursors while minimizing harm to dormant cells

Idarubicin uses

Treatment of Acute Myeloid Leukemia (AML)

Idarubicin is mainly used in the treatment of acute myeloid leukemia (AML), providing remission rates when administered during induction therapy and often combined with cytarabine in a 7-day regimen.


Use in Combination Chemotherapy Protocols

The medication plays a role in combined treatments with cytarabine, etoposide, and fludarabine to improve effectiveness and lower resistance levels.


Role in Induction and Consolidation Therapy

Throughout the treatment phase for leukemia patients, known as induction therapy,  Idarubicin plays a role in reducing the cancerous load within the body's system. As treatment progresses to consolidation therapy following induction phase completion, idarubicin continues its function by aiding in eradicating any remaining disease cells and acting as a measure against potential relapses.

Treatment of Relapsed or Refractory Leukemia

Idarubicin is often used in follow-up treatment for individuals dealing with resistant AML, where adjustments in dosage and pairing with medications are frequently practiced.

Off-Label Uses of Idarubicin Injection

Use in Acute Lymphoblastic Leukemia (ALL)

Even though it's not formally authorized for that purpose yet, idarubicin is utilized off-label in high-risk or relapsed cases of acute lymphoblastic leukemia (ALL), especially within pediatric treatment plans.


Off-label Application in Non-Hodgkin Lymphoma

Certain types of Hodgkin's lymphoma that are aggressive have been treated with idarubicin, specifically when sensitivity to anthracycline is observed.

Investigational Use in Breast Cancer

In stages of testing, Idarubicin's effectiveness in treating resistant breast cancer has been studied further with a focus on patients who have received prior treatment with different anthracycline medications.

Experimental Role in Sarcomas and Other Solid Tumors

Data from the stages of testing shows that it is effective in fighting types of soft tissue cancers, while ongoing studies are looking into how well it works against solid tumors that grow rapidly.

Composition and Formulation of Idarubicin Injection

Active Ingredient and Its Concentration

Each vial usually contains idarubicin hydrochloride at concentrations of 5 mg/mL or 10 mg/mL with an active ingredient that improves tissue penetration.

Inactive Ingredients and Their Functions

Common excipients include:

  • Lactose monohydrate: stabilizer
  • Water for injection: solvent

Available Dosage Forms and Packaging

Idarubicin is available in single-use glass vials, sealed under sterile conditions. Dosage presentations include 5 mg, 10 mg, and 20 mg vials.

Dosage and Administration Guidelines

Standard Dosage for Adults with AML

Recommended dosing: 12 mg/m2 IV daily for 3 days, often in combination with 100 mg/m2 of cytarabine for 7 days.

Dosage Adjustments for Renal or Hepatic Impairment

Adjustments may include:

  • 50% dose reduction in moderate hepatic dysfunction
  • Use contraindicated in severe renal impairment

Idarubicin administration

Given through an injection or brief infusion lasting 10 to 15 minutes, preferably using a central line to prevent leakage into surrounding tissues.

Monitoring During and After Administration

Includes:

  • Complete blood counts
  • Cardiac function tests (e.g., LVEF via echocardiogram)
  • Liver and renal panels

Dosage in Combination with Other Chemotherapy Agents

It's important to coordinate dosing schedules to avoid many toxicities overlapping each other as the dose intensity and intervals vary depending upon the specific protocol in use.

Storage and Handling of Idarubicin Injection

Keep the item in a place between 2°C and 8°C, away from light exposure, and make sure not to freeze it.

Shelf Life and Stability Considerations

Unused vials can be kept intact for 24 months when stored correctly, while reconstituted solutions should be utilized within a day of preparation. 

Proper Handling Procedures for Healthcare Providers

Remember to use biological safety cabinets when working with chemicals and always wear equipment (PPE). Follow the protocols for handling materials and be sure to prevent aerosol generation when mixing substances.

Disposal of Unused Medication and Contaminated Materials

Please ensure disposal through authorized waste management facilities instead of throwing it in regular trash bins or sewage systems.

Idarubicin side effects

Frequently Reported Adverse Effects

Serious and Life-Threatening Side Effects

Late-Onset Side Effects and Long-Term Risks

Side Effect Management and Supportive Care

Drug Interactions and Incompatibilities

Interactions with Other Chemotherapeutic Agents

Interaction with CYP450 Enzyme Modulators

Contraindicated Drug Combinations

Impact on Laboratory and Diagnostic Tests

Warnings and Precautions for Idarubicin Injection

Idarubicin cardiotoxicity and Monitoring Requirements

Risk of Myelosuppression and Neutropenia

Secondary Malignancy Risk

Extravasation Risk and Tissue Damage

Immunosuppression and Infection Risk

Contraindications to Idarubicin Injection Use

Known Hypersensitivity to Idarubicin or Anthracyclines

Pre-existing Cardiac Conditions

Severe Hepatic or Renal Impairment

Concomitant Live Vaccination

Special Considerations in Specific Populations

Administration to Elderly Patients

Use During Pregnancy and Lactation

Pediatric Use and Dosing Adjustments

Genetic and Ethnic Considerations in Pharmacokinetics

Careful Administration and Monitoring Parameters

Baseline Assessments Before Initiation

Ongoing Hematologic and Cardiac Monitoring

Managing Cumulative Dose Limits

Important Precautions When Using Idarubicin Injection

Avoiding Exposure to Infections

Lifestyle Adjustments During Treatment

Recognizing Early Signs of Complications

Use of Protective Measures by Healthcare Workers

Overdose Management and Emergency Intervention

Signs and Symptoms of Idarubicin Overdose

Emergency Response and Supportive Measures

Role of Hematopoietic Support in Overdose

Reporting and Documentation of Overdose Cases

Safe Handling Precautions for Healthcare Providers

Use of Personal Protective Equipment (PPE)

Prevention of Drug Exposure Through Skin or Inhalation

Procedures for Spillage or Accidental Contact

Training Requirements for Handling Cytotoxic Agents

Idarubicin. Injection FAQ

What is idarubicin used for?

Idarubicin is a type of medication from the anthracene group that is commonly prescribed to adult patients with acute myeloid leukemia (AML). It is taken orally. It has been found to be effective in treating breast cancer and various types of lymphomas and leukemias while also having the advantage of causing less harm to the heart.

How do you give idarubicin?

Idarubicin is typically administered via infusion or injection directly into a vein.

Is idarubicin a chemo drug?

Idarubicin belongs to a category of chemotherapy used to treat acute myeloid leukemia (AML) as acute lymphoblastic leukemia (ALL).

What are the long term effects of idarubicin?

Serious heart conditions such as heart failure due to fluid buildup and irregular heartbeats like atrial fibrillation have been observed in individuals receiving initial treatment for acute myeloid leukemia (AML) along with chest discomfort and asymptomatic decreases in left ventricular ejection fraction (EF).

What is the difference between doxorubicin and idarubicin?

Idarubicin is typically preferred as the anthracycline treatment for AML patients. On the other hand, doxorubicin is commonly utilized for treating other forms of cancer.

What is the use of idarubicin injection?

Idarubicin injection is typically prescribed alongside medications for the treatment of acute myeloid leukemia (AML).

What is Idarubicin Injection used for?

It's used to treat acute myeloid leukemia (AML) in adults.

How does Idarubicin work?

It functions by decelerating or halting the proliferation of cells.

How is Idarubicin administered?

It is given through an IV by a professional.

What are the common side effects of Idarubicin?

Typical symptoms may consist of queasiness or stomach upset along with hair thinning or loss and ulcers in the mouth area as lower levels of blood cells.

Can Idarubicin cause heart problems?

It has the potential to result in cardiotoxicity. It may lead to heart failure when administered at cumulative doses.

Can Idarubicin cause low blood cell counts?

It often results in myelosuppression which can lead to decreased blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia).

How often is Idarubicin administered?

The amount and timing of the medication vary based on the treatment plan and how the patient reacts to it.

Can Idarubicin be used during pregnancy?

No, It can harm the fetus.

Can Idarubicin be used during breastfeeding?

It is advised to avoid it while breastfeeding because of the harm it could pose to the baby.

What precautions should be taken before receiving Idarubicin?

Before commencing the treatment regimen, patients should undergo cardiac function assessments and blood work, as well as other essential evaluations.

What should patients report to their doctor while on Idarubicin?

Patients need to inform the healthcare provider if they experience any signs of infection, like chest pain or shortness of breath, and any unusual bleeding, bruising or other worrying symptoms.

Can Idarubicin cause hair loss?

It's quite common for people to experience hair loss as a side effect.

How is cardiac function monitored during Idarubicin treatment?

Doctors keep track of how the heart is working by using echocardiograms or other types of heart imaging tests.

Can Idarubicin cause mucositis (mouth sores)?

Yes

Can Idarubicin cause nausea and vomiting?

Yes

What are the long-term risks associated with Idarubicin?

Potential long-term dangers consist of heart-related issues and the possibility of developing cancers.

How is Idarubicin dosage determined?

The prescribed amount is meticulously calculated according to the patient's body surface area and other relevant considerations.

What blood tests are monitored during Idarubicin treatment?

Monitoring blood counts (CBCs helps evaluate bone marrow function and the likelihood of infection or bleeding complications.

Can Idarubicin cause changes in liver or kidney function?

It has the potential to impact the functioning of the liver and kidneys, thus necessitating monitoring.

Is Idarubicin always used alone?

It's commonly paired with chemotherapy medications to address AML.

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