Premixed chemotherapy mitigates risks of drug exposure for healthcare workers

(BPT) - Medication is essential for cancer patients in treating their disease. However, there are inherent risks associated with compounding and administering chemotherapies for intravenous infusion. Risk mitigation is important for the well-being of healthcare workers who may be exposed to hazardous materials.

"Cancer patients receive a treatment plan that typically includes multiple medications, often with chemotherapy as the foundation," says Jeffrey Lombardo, PharmD BCOP. "Taking proper precautions with compounding is essential to protect the pharmacists, nurses and other healthcare workers who handle these materials, as well as the patient. It’s very important that the patient receives a high-quality chemotherapy preparation at the right dose.”

Smart practices for cancer medication safety

Dr. Lombardo says patients, caregivers and healthcare team members must remain vigilant and follow industry standards and guidelines that are designed to mitigate risk. These include taking the following basic steps:

• Check the spelling of the medication and the patient’s name every time a dose is administered.
• Verify the correct doses of each medication every time it is administered. Use a zero in front of any decimals to avoid number confusion.
• Cross-reference all information to ensure consistency. For example, make sure electronic records match paper records in treatment centers.
• Document every dose of medication and other treatments in the patient’s medical record.

"Chemotherapy continues to be an essential part of cancer treatment. Based on the size of a clinical practice and resources available, intravenous solutions are typically compounded by a pharmacist or nurse," explains Dr. Lombardo. "Premixed options introduce more engineering controls to further protect against unintended exposure.”

INFUGEM™ (gemcitabine in sodium chloride injection)

One option uses engineering controls to mitigate safety risk with the compounding process. INFUGEM is the first and only ready-to-use, premixed formulation of gemcitabine, a commonly used chemotherapy agent.

INFUGEM uses advanced technology that allows the medication to be premixed in a sterile environment and supplied to prescribers in ready-to-infuse final dosage bags. This eliminates accidental exposure to toxic substances that may happen through mixing. INFUGEM, which is made by Sun Pharma, is the first in a portfolio of premixed chemotherapies.

Dr. Lombardo notes that INFUGEM is stable at room-temperature storage conditions for two years, even without the use of alcohol and other preservatives in the bag. By contrast, other gemcitabine products require compounding for patient use, and remain stable at room temperature for only 24 hours.

For more information on INFUGEM, visit www.infugem.com.

Important Safety Information

INDICATIONS AND USAGE

INFUGEM (gemcitabine in sodium chloride injection) is a nucleoside metabolic inhibitor indicated:

• in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy
• in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated
• in combination with cisplatin, for the treatment of non-small cell lung cancer.
• as a single agent for the treatment of pancreatic cancer

CONTRAINDICATIONS

Patients with a known hypersensitivity to gemcitabine.

WARNINGS AND PRECAUTIONS

• Schedule-Dependent Toxicity: Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly
• Myelosuppression: Monitor for myelosuppression prior to each cycle and reduce or withhold dose for severe myelosuppression
• Pulmonary Toxicity and Respiratory Failure: Discontinue INFUGEM for unexplained dyspnea or other evidence of severe pulmonary toxicity
• Hemolytic Uremic Syndrome (HUS): Monitor renal function prior to initiation and during treatment. Discontinue INFUGEM for HUS or severe renal impairment.
• Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment. Discontinue INFUGEM for severe hepatic toxicity
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females and males of reproductive potential to use effective contraception
• Exacerbation of Radiation Therapy Toxicity: May cause severe and life-threatening toxicity when administered during or within 7 days of radiation therapy.
• Capillary Leak Syndrome: Discontinue INFUGEM
• Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue INFUGEM

ADVERSE REACTIONS

The most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed

Please see Full Prescribing Information by clicking here