Pemetrexed Disodium

Pemetrexed Injection Vial is administered for the treatment of certain types of non-small cell lung cancer. It is also administered along with Cisplatin to help treat malignant pleural mesothelioma.

ALIMTA

Pemetrexed Disodium

Pemnat, Pexitaz

1

Natco Pharma

Vial

500 mg, 100 mg

India

Pemetrexed Disodium

1. Introduction to Pemetrexed Disodium

Overview of Pemetrexed Disodium

The use of Pemetrexed Disodium is crucial in treating cancer types. It acts as a chemotherapy drug, targeting specific enzymes necessary for DNA synthesis in malignant cells and rapid growth control—a valuable asset in today's oncology practices.

History and Development of Pemetrexed Disodium

Developed in the 1990s after research on antifolates for inhibiting tumor growth, Pemetrexed Disodium represented a breakthrough in cancer treatment by providing a more precise method than conventional chemotherapy agents.

FDA Approval and Regulatory Status

In 2004, the FDA approved Pemetrexed Disodium for treating mesothelioma and non-small cell lung cancer (NSCLC). Since then it has been extensively used in cancer treatment with support, from clinical studies and real life proof of its effectiveness.

Chemical Structure and Mechanism of Action

Pemetrexed Disodium is considered an analog in terms of its structure and function within the body processes that depend upon levels to operate efficiently. It is particularly effective in impeded the activity of enzymes like thymidylate synthase and dihydrofolate reductase, which are crucial for DNA replication and cell division processes essential for the growth of cancer cells.

2. Uses of Pemetrexed Disodium

Approved Uses of Pemetrexed Disodium

Pemetrexed Disodium has been clinically approved for the treatment of two primary cancer types:

Its approval in these domains stems from its demonstrated ability to effectively inhibit malignant cell proliferation.

Treatment of Non-Small Cell Lung Cancer (NSCLC)

Patients with small cell lung cancer often receive a combination of chemotherapy drugs, and one such medication is known as pemetrexed disodium, which can also be used alone when necessary, especially for those with a nonsquamous type of cancer cells.

Treatment of Malignant Pleural Mesothelioma

When dealing with pleural mesothelioma that cannot be surgically removed, Pemetrexed Disodium paired with cisplatin stands out as a primary treatment choice. This duo has been shown to significantly enhance patient survival rates.

Off-Label Uses of Pemetrexed Disodium

Potential Uses in Colorectal Cancer

There is an increasing focus on the use of Pemetrexed Disodium in treating colorectal cancer for patients who do not respond well to treatments. Early research indicates outcomes in this regard.

Use in Bladder Cancer

Patients with bladder cancer could find advantages in using the drug known as disodium off-label. This is particularly helpful for those, in stages of the disease or facing recurring issues.

Investigational Uses in Pancreatic Cancer

Studies on treating cancer are looking into the effectiveness of Pemetrexel Disodium for its potential to interfere with the metabolism of cancer cells in this type of cancer.

Other Off-Label Applications

Clinical studies are currently investigating the effectiveness of Pemetrexed Disodium in types of cancer, such as cancer and specific lymphomas, as it demonstrates usefulness beyond its originally approved uses.

3. Pemetrexed mechanism of action

Mechanism of Action: Inhibition of Folate Metabolism

The drug Pemetrexed Disodium blocks a few enzymes that rely on folate for their function, such as thymidylate synthase and dihydrofolate Reductase. These enzymes are crucial for creating DNA and RNA in cells, essentially stopping cell growth in its tracks.

Role of Pemetrexed in Cancer Cell Growth Inhibition

By disrupting the metabolic processes essential for the expansion of cancer cells, Pemetrexed Disodium effectively diminishes tumor size and hinders further advancement.

Effect on DNA Synthesis and Tumor Growth

Hindering the process of DNA synthesis impedes the growth and multiplication of cancer cells, ultimately resulting in either shrinking or stabilizing tumors.

4. Dosage and Administration of Pemetrexed Disodium

Standard Dosage Guidelines for NSCLC and Mesothelioma

The usual amount of Pemetrexed Disodium is given through an IV every 21 days. The dosage depends on the body's surface area. An adjustment is needed if used in combination with cisplatin for NSCL and mesothelioma treatment.

Adjustments Based on Renal and Hepatic Function

Patients who have issues with their kidneys or liver might need to adjust their medication dosage to prevent any effects. It should be closely monitored.


Administration in Combination with Other Chemotherapies

In the treatment of NSCL and mesothelioma cancer types, Pemetrexed Disodium is often used in combination with cisplatin or carboplatin to improve its effectiveness.

Monitoring and Assessment During Treatment

Regularly checking blood tests and organ health is important to catch any side effects, especially issues like reduced blood cell production and kidney damage.

Importance of Vitamin B12 and Folic Acid Supplementation

Patients receiving treatment with Pemetrexed Disodium should consider taking vitamin B12 and folic acid supplements to lower the chances of experiencing side effects like myelosuppression.

Frequency of Treatment and Duration

Patients typically undergo treatment cycles every three weeks, which can vary in length based upon how they respond to the treatment and their ability to tolerate it.

5. Composition of Pemetrexed Disodium

Active Ingredients in Pemetrexed Disodium

The main ingredient in this medication is Pemetrexed. It functions as an antifolate agent by interfering with processes that are dependent on folate.

Inactive Ingredients and Excipients

The formulation, for administration, is stabilized by inactive ingredients such as mannitol and hydrochloric acid.

Available Formulations and Strengths

The medication is available in vials of 100 mg or 500 mg, so the dosage can be adjusted according to each patient's requirements.

Pemetrexed chemotherapy

Pemetrexed belongs to a category of medications called antimetabolites, which work by inhibiting the production and repair of DNA in cancer cells, preventing their growth and reproduction.

Pemetrexed and carboplatin

Pemetrexed and carboplatin are commonly prescribed for mesothelioma and non-small cell lung cancer (NSCL). In some cases, they may also be employed in the treatment of forms of cancer, so it's advisable to refer to our guides on chemotherapy and your specific cancer type.

Pemetrexed and cisplatin

A common treatment for small-cell lung cancer and pleural mesothelioma involves using a combination of drugs. Like for instance, a mix of medications such as pemetrexed and cisplatin is often prescribed, sometimes along with carboplatin or even pembrolizumab, an immunotherapy drug.

Pemetrexed folic acid

Supplementing with Vitamin B12 and folic acid (FA), known as B12 FAS, helps decrease side effects when undergoing pemetrexed-based chemotherapy (PEM).

6. Storage of Pemetrexed Disodium

Proper Storage Conditions

To preserve its effectiveness, keep Pemetrexed Disodium in a place where the temperature is controlled within the range of 20°C to 25°C (68°F to 77°F).

Stability and Shelf Life

After mixing Pemetrexed Disodium, it needs to be used within a timeframe since the solution's stability is not long-lasting.

Precautions for Handling and Disposal

Special care must be taken when dealing with the properties of Pemetrexed Disodium. Proper disposal of any leftover medication or materials is crucial to prevent contamination.

7. Side Effects of Pemetrexed Disodium

Overview of Potential Side Effects

Side effects resulting from the use of Pemetrexed Disodium may vary in intensity and type based on patient characteristics and prescribed dosage levels.

Frequency and Severity of Adverse Reactions

Typical responses are usually mild; however, some individuals might encounter issues that require careful observation.

7.1. Common Side Effects of Pemetrexed Disodium

  • Fatigue and Weakness
  • Nausea and Vomiting
  • Diarrhea and Constipation
  • Anemia and Blood Count Abnormalities
  • Rash and Skin Reactions

7.2. Serious Side Effects of Pemetrexed Disodium

  • Kidney Toxicity and Renal Failure
  • Liver Toxicity and Hepatic Dysfunction
  • Pulmonary Toxicity and Breathing Issues
  • Allergic Reactions and Hypersensitivity

8. Drug Interactions with Pemetrexed Disodium

Interaction with NSAIDs and Pain Relievers

Taking nonsteroidal inflammatory drugs (NSAIDs) such as ibuprofen or naproxen sodium alongside Pemetrexed Disodium may impact how the body eliminates the medication and raise the chance of harmful effects—especially for individuals with kidney issues.

Interaction with Other Chemotherapeutic Agents

Close collaboration, with chemotherapy medications is essential to prevent harmful effects when using drugs that impact kidney or liver function.

Potential Interaction with Anticoagulants

During treatment, with Pemetrexed Disodium, anticoagulants may not work well, and you'll need to keep an eye on your blood clotting times.

Effect of Vaccinations on Pemetrexed Efficacy

Avoid using vaccines while undergoing treatment with Pemetrexed Disodium, because it can increase the chances of developing infections.

9. Warnings and Precautions for Pemetrexed Disodium

Important Safety Information Before Starting Treatment

Prior to starting treatment with Pemetrexed Disodium (brand name Alintha), it's essential to assess the patient's health condition and any existing medical issues or medications they may be taking concurrently. Thorough screening before beginning treatment helps determine if the patient is a candidate and minimizes the risk of side effects. Moreover, it's important to perform tests to evaluate kidney function, liver enzyme levels, and blood cell counts to customize the treatment plan according to the patient's requirements.

Risks Associated with Renal Impairment

The kidneys are crucial in removing Pemetrexed Disodium from the body efficiently. Individuals with kidney issues may accumulate the drug in their system, which can boost toxicity levels. In cases of kidney function, it is essential to adjust the dosage and maintain regular monitoring of creatinine levels and other kidney markers while undergoing treatment to avoid kidney damage.

Monitoring Blood Counts and Organ Function

It's crucial to check blood counts (CBC) to spot any possible blood-related issues, like low white blood cell count (neutropenia), low platelet count (thrombocytopenia), or reduced red blood cell count (anemia). Additionally, keeping an eye on liver and kidney function is important to make sure the patient's organs can handle the treatment they're receiving. Detecting organ issues can lead to taking actions such as adjusting the dosage or temporarily stopping the medication.

Precautions to Prevent Dehydration

Lack of hydration can worsen the impacts of Pemetrexed Disodium and increase the risk of kidney issues in patients undergoing treatment with this medication. It is recommended for patients to stay well hydrated both before and throughout the treatment process. Healthcare professionals should educate patients about identifying symptoms of dehydration, like feeling headed reduced urine production and a dry mouth. This helps in minimizing risks and achieving the treatment results.

9.1. Administration to Elderly Patients

Special Considerations for Elderly Populations

As older patients undergo treatment, Pemetrexed Disodium medication should be closely monitored due to aging-related changes. Older individuals may experience changes in kidney and liver function which can impact how the medication is processed in their bodies. Moreover, elderly patients often have conditions like high blood pressure or diabetes, which can make treatment more complex and require careful evaluation of risks and benefits.

Dosage Adjustments and Increased Monitoring

Elderly individuals may require dosage modifications due to decreased organ function levels, which need monitoring along with blood counts for detection of any adverse effects to ensure effective treatment while considering potential side effects in this vulnerable group carefully.

9.2. Administration to Pregnant Women and Nursing Mothers

Risks of Pemetrexed Disodium During Pregnancy

The drug Pemetrexed Disodium falls under pregnancy category D, which indicates risks to the development of the fetus based on animal studies and limited human data findings that suggest harm to fetuses if used by pregnant women. The general recommendation is to avoid using it during pregnancy unless there are no options and the benefits outweigh the risks.

Breastfeeding Considerations

It is not recommended for mothers who are nursing to breastfeed during Pemetrexed Disodium treatment as it could have effects on the baby's health due to the drug being passed through breast milk.

Use of Contraception During Treatment

Women who can have children and are taking Pemetrexed Disodium should use birth control while undergoing treatment and for a period after the final dose to avoid pregnancy risks. Healthcare providers need to offer advice on birth control choices. 

9.3. Administration to Children

Pediatric Use and Efficacy

Pemetrexed Disodiums usage in children has not been extensively studied yet; although there have been some instances of its administration in trials involving patients,safety and effectiveness in this population are not firmly established.Pediatric dosages should be used cautiously, determined based upon each child's clinical situation.

Research on Safety and Dosage in Pediatric Patients

Research is still ongoing to investigate how effective using Pemetrexed Disodium may be for treating types of cancer in children. However, comprehensive data is needed to figure out the dosages and completely grasp the safety aspects for pediatric patients. Until solid evidence is gathered, administering this medication to children should only take place in a clinical trial setting or under oncology supervision.

10. Contraindications of Pemetrexed Disodium

Absolute Contraindications

Patients who have a known allergy to the drug or its ingredients should not take disodium under any circumstances. It is also advised that individuals, with kidney problems (creatinine clearance than 45 mL/min) as they face a higher risk of harmful effects from the medication, in these instances.


Relative Contraindications and Risk-Benefit Analysis

Some situations, like kidney issues or ongoing infections, can make using disodium treatment a bad idea. Clinicians need to weigh the risks and benefits to decide if the treatment's advantages are worth any potential downsides.

Conditions Where Pemetrexed Should Be Avoided

It's best to steer off using pemetrexed in patients who have liver problems at the start or those getting live vaccines because the immune system weakening impact of chemotherapy could up the chances of getting serious infections. Moreover, it's essential to be careful with folks who already have blood disorders or significant bone marrow suppression.

11. Careful Administration of Pemetrexed Disodium

Importance of Pre-treatment Health Assessment

Before starting Pemetrexed Disodium treatment procedures, it is crucial to conduct a health assessment that involves examining the patient's history in detail and evaluating any existing health conditions, along with comprehensive laboratory tests to determine the baseline functioning of the organs involved in the process of treatment initiation and its aftereffects. Recognition of any existing health issues that could potentially complicate the treatment is vital to ensuring effective management during the therapeutic regimen.

Considerations for Patients with Co-morbidities

Patients with health issues like heart problems or diabetes need personalized attention in their treatment plans due to how these conditions can impact medications' work and safety profiles.Collaboration among experts is crucial to achieving the best results and reducing any potential risks for these patients.

Monitoring During and After Treatment for Adverse Effects

It's crucial to monitor patients after giving them the medication pemetrexed disodium to catch any negative effects early on and take quick action, like adjusting the dosage or providing extra care, to prevent serious problems that could arise.

12. Overdosage of Pemetrexed Disodium

Symptoms of Overdose

Excessive use of the medication known as Pemetrexed Disodium may result in health issues such as suppression of the bone marrow function and kidney failure along with mucositis problems that can be severe for patients to handle, including extreme tiredness or fatigue and symptoms, like bleeding or infection indicators manifesting in the body system which ultimately necessitates urgent medical intervention if an overdose is suspected by anyone.

Emergency Treatment for Pemetrexed Overdose

In cases of Pemetrexed Disodium overdose, emergency situations require providing support such as blood transfusions, renal assistance, dialysis when needed, and giving folic acid and vitamin B12 to counteract any harm. Patients often need hospitalization for stabilization.

Long-term Consequences of Overdosage

The prolonged effects of an intake of pemetrexed may lead to lasting harm to organs, such as the kidneys and bone marrow. While some individuals may fully recover after weeks or months of treatment some may face enduring impairments.

13. Handling Precautions for Pemetrexed Disodium

Safe Handling in Clinical and Home Settings

Handling Pemetrexed Disodium requires caution due to its properties. To prevent exposure incidents, Healthcare providers should wear protective gear such as gloves and gowns while preparing and giving the medication. Patients and caregivers should receive guidance on safe handling procedures if the treatment is given at home.

Guidelines for Healthcare Professionals Administering Pemetrexed

Healthcare professionals need to follow protocols when giving Pemetrexed Disodium to patients. A careful approach should be taken to avoid any contamination risks associated with it during administration procedures.

Disposal of Unused or Expired Medication

When you no longer need it or if the expiration date has passed, make sure to get rid of any leftover or expired doses of Pemetrexed Disodium following your rules for disposing of materials responsibly. Never throw it away with your household trash. Flush it down the toilet, as this can harm the environment and put public health at risk due to exposure to harmful substances.

Pemetrexed Disodium FAQ

What is pemetrexed?

Pemetrexed belongs to a category of medication called a metabolite which works by halting the ability of cancer cells to produce and mend DNA thereby preventing their proliferation and growth.

What is pemetrexed and carboplatin used for?

Using pemetrexed and carboplatin is a treatment for mesothelioma and non-small cell lung cancer (NSCL). Occasionally it is also prescribed for types of cancer well so its advisable to review this information along with our general details, on chemotherapy and the specific type of cancer you are dealing with.

What does pemetrexed do?

Antifolate antineoplastic agents, like Pemetrexed, belong to a group of medications that function by inhibiting a substance in the body that could potentially promote the proliferation of cancer cells.

What is pemetrexed and carboplatin?

To treat mesothelioma and nonsmall cell lung cancer (NSCL), doctors often prescribe a combination of pemetrexed and carboplatin, which are sometimes utilized for types of cancer as well. It is advisable to review this guidance along with our overall details on chemotherapy and your specific cancer type.

What is pemetrexed chemotherapy?

Pemetrexed is an antimetabolite drug. It stops cancer cells from making and repairing DNA so they can't grow and multiply.

What is pemetrexed used for?

The injection of pemetrexed is administered alongside pembrolizumab and platinum-based cancer medications for therapy in cases of non-squamous non-small cell lung cancer that has metastasized without mutations in EGFR or ALk genes.

Pemetrexed what class?

The drug Pemetrexed belongs to a group of medicines known as antifolate agents, which function by inhibiting the activity of a substance, in the body that could support the proliferation of cancer cells.

Pemetrexed how does it work?

The drug Pemetrexed falls under the category of antimetabolites. It hinders cancer cells from producing and repairing DNA, thereby inhibiting their ability to proliferate and expand.

How pemetrexed is given?

Doctors or nurses typically administer the injections, which can be in the form or as a powder mixed with liquid for intravenous injection, over a 10-minute period, usually occurring every 21 days in a medical office or infusion center.

How pemetrexed works?

Antifolate antineoplastic agents such as Pemetrexed belong to a category of medications that function by inhibiting a substance in the body, potentially limiting the ability of cancer cells to proliferate.

How long can you take pemetrexed?

Each treatment phase typically spans three weeks or 21 days. Depending on your specific cancer diagnosis, it could involve undergoing approximately four to six cycles over a period of around four months. During one part of your treatment, pemetrexed is administered intravenously into your bloodstream within a timeframe of 10 minutes, while another component, carboplatin, is introduced into your system through an IV infusion lasting between 15 and 60 minutes.

Can pemetrexed be given iv?

You will receive a Pemetrexed Injection through an IV infusion into your vein, administered over a 10-minute period every 21 days (every 3 weeks).

Can pemetrexed cause renal failure?

Even though pemetrexed is commonly used in conjunction with cisplatin or carboplatin for treatment purposes, sole administration of pemetrexed can lead to kidney failure. There is an understanding about how pemetrexed triggers damage; however, histopathological analysis in various case studies has outlined unique patterns of tubular toxicity.

Can pemetrexed cause pneumonitis?

Pemetrexed, a type of chemotherapy known as an antifolate, shows effectiveness against mesothelioma and nonsmall cell lung cancer (NSCL). It's worth noting that pneumonitis is a possible side effect associated with the use of Pemetrexed.

Can pemetrexed be given peripherally?

Chemotherapy can be given through a (PIV ) line or through central venous access devices (CVADs), depending on the treatment plan.

Can pemetrexed cure lung cancer?

Pemetrexed shows efficacy in treating small cell lung cancer (NSCLC) in individuals with nonsquamous types of cancer.

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