Simplist^® Fentanyl ready-to-administer prefilled syringes come in Fresenius Kabi’s proprietary MicroVault^® packaging system that also supports secure dispensing of narcotics and reduces the opportunity for diversion. Because the syringes require no assembly, they streamline point-of-care preparation. The presentation reduces the potential for product waste and makes it easier for health care professionals to dispense the prescribed dose.

Fresenius Kabi is a leader in injectable medicines with a growing U.S. portfolio of prefilled syringes.

“The introduction of an exclusive smaller-dose fentanyl injection is an important expansion of our Simplist^® ready-to-administer prefilled syringe portfolio in line with our commitment to the secure dispensing of controlled substances for the safe delivery of drugs to patients,” said John Ducker, president and CEO of Fresenius Kabi USA. “We are proud to design, develop and introduce products and labeling that support the safe dispensing of controlled substances, and all products.”

About Simplist^® Fentanyl MicroVault^® Prefilled Syringe

Fresenius Kabi’s Simplist^® prefilled syringes were associated with an error rate that was four times lower when compared to traditional medication administration practice, according to a study published in the Journal of Patient Safety in 2018. The Simplist Fentanyl prefilled syringe is manufacturer prepared in the United States, with a 24-month shelf life, and is a single-unit dose, supporting best practices for medication administration.

Fentanyl Citrate Injection, for intravenous or intramuscular use, is indicated for:

• Analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance and in the immediate postoperative period (recovery room) as the need arises.
• Use as an opioid analgesic supplement in general or regional anesthesia.
• Administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
• Use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

Fentanyl Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available.

PLUSS Advanced Technologies (PLUSS), a Delhi based company, in collaboration with Apollo Supply Chain, part of the Apollo International Group, has set up a 20,000 sqft facility in Hyderabad, for packaging boxes for temperature sensitive vaccines, pharmaceuticals and biologics.

The boxes maintain inside temperature without electricity at desired levels for over 4 days, using ‘phase change materials’ technology. The facility has the capacity to condition boxes for transporting the equivalent of 3 to 5 million vaccine doses per month and will cater to the various vaccine and pharma manufacturers in and around Hyderabad.

Samit Jain, CEO, PLUSS, said, “With the installation of this facility, the burden of creating a cold chain logistics infrastructure for pharmaceutical companies can be reduced. Shared resources always make a lot of sense, in the long run, it reduces costs and expenses for everyone in the endeavour to increase access to temperature-sensitive healthcare products. The boxes come pre-fitted with temperature sensors and monitoring of temperature is seamless.”

Raaja Kanwar, VC & MD, Apollo LogiSolutions, said, “This facility addresses the obligation on pharmaceutical companies to create a cold-chain supply infrastructure for the vaccines.”

The temperature-sensitive boxes, called Celsure boxes, are customizable and can maintain temperature from -70 to +30 degree Celsius, in 35 different ranges. The boxes are also used to transport Covid-19 vaccines, which require temperatures in the range +15 to +25, -15 to -25, and +2 to +8 degree Celsius. The Celsure box serves as a better and safer alternative to dry ice and conventional ice-packs, and brings about operational and cost efficiency in transporting temperature-sensitive cargo, including pharmaceutical products, vaccines and foodstuff.

PLUSS has partnered with pharmaceutical companies across India for transporting their products using Celsure boxes and also exports Celsure boxes and its ‘phase change materials’ to pharma packaging suppliers in Europe and the USA. PLUSS has received a patent for the Celsure box from the United States Patent and Trademark Office and the European Patent Office in Germany and has applied for a patent in India, Singapore and Brazil.

The boxes maintain inside temperature without electricity at desired levels for over 4 days, using ‘phase change materials’ technology. The facility has the capacity to condition boxes for transporting the equivalent of 3 to 5 million vaccine doses per month and will cater to the various vaccine and pharma manufacturers in and around Hyderabad.

Samit Jain, CEO, PLUSS, said, “With the installation of this facility, the burden of creating a cold chain logistics infrastructure for pharmaceutical companies can be reduced. Shared resources always make a lot of sense, in the long run, it reduces costs and expenses for everyone in the endeavour to increase access to temperature-sensitive healthcare products. The boxes come pre-fitted with temperature sensors and monitoring of temperature is seamless.”

Raaja Kanwar, VC & MD, Apollo LogiSolutions, said, “This facility addresses the obligation on pharmaceutical companies to create a cold-chain supply infrastructure for the vaccines.”

The temperature-sensitive boxes, called Celsure boxes, are customizable and can maintain temperature from -70 to +30 degree Celsius, in 35 different ranges. The boxes are also used to transport Covid-19 vaccines, which require temperatures in the range +15 to +25, -15 to -25, and +2 to +8 degree Celsius. The Celsure box serves as a better and safer alternative to dry ice and conventional ice-packs, and brings about operational and cost efficiency in transporting temperature-sensitive cargo, including pharmaceutical products, vaccines and foodstuff.

PLUSS has partnered with pharmaceutical companies across India for transporting their products using Celsure boxes and also exports Celsure boxes and its ‘phase change materials’ to pharma packaging suppliers in Europe and the USA. PLUSS has received a patent for the Celsure box from the United States Patent and Trademark Office and the European Patent Office in Germany and has applied for a patent in India, Singapore and Brazil.

Nerlynx is a kinase inhibitor indicated as a single agent for the extended adjuvant treatment of adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant trastuzumab based therapy. It is also indicated in combination with capecitabine for the treatment of adults with advanced or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2 based regimens in the metastatic setting.

The approval for the use of Nerlynx dose escalation was based on data from the multicenter, open-label, multi-cohort phase 2 CONTROL trial (ClinicalTrials.gov Identifier: NCT02400476) that included adults with early stage HER2-positive breast cancer. Patients received either Nerlynx 240mg daily for up to 1 year, along with loperamide prophylaxis with additional anti-diarrheal treatment as needed, or Nerlynx dose escalation with loperamide as needed. In the dose escalation cohort, patients received Nerlynx 120mg daily for week 1, then 160mg daily for week 2, then 240mg daily for week 3 and thereafter.

Findings showed that dose escalation therapy was associated with improved management and prevention of grade 3 diarrhea, including a 60% reduction in the percentage of patients with grade 3 diarrhea (40% vs 13%), a 50% reduction in median cumulative days of grade 3 diarrhea (5 days vs 2.5 days), and an approximately 80% reduction in discontinuation rates (17% vs 3%), when compared with data from the phase 3 ExteNET trial (ClinicalTrials.gov Identifier: NCT00878709), which did not include dose escalation or antidiarrheal prophylaxis.

“We believe that utilizing dose escalation has the potential to improve the overall tolerability of Nerlynx and increase the average length of therapy, with the end result benefiting more patients battling breast cancer,” said Alan H. Auerbach, Chief Executive Officer and President of Puma.

Nerlynx will also be made available in a new 133-count bottle containing a 4-week supply of 40mg tablets for use in dose escalation.