20 Clinical
Pharmacy Practice News • May 2021
Oncology
Spotting Risk Factors Helps In CAR T-Cell Toxicity Fight
C
himeric antigen receptor (CAR) T-cell therapy is a rapidly expanding, promising treatment for a variety of adult and pediatric cancers, but it brings with it a number of significant toxicities, speakers said during the 2021 Critical Care Congress Virtual Event. The good news is that researchers and clinicians—including pharmacists—are starting to find characteristics that predict the risk for some severe toxicities, and several therapies are under investigation that may eventually decrease their rate and severity, said Julie Fitzgerald, MD, MACP, the co-director of the pediatric sepsis program at Children’s Hospital of Philadelphia. There are about six major toxicities associated with CAR T-cell therapy, said Stephen M. Pastores, MD, the program director of critical care medicine and vice chair of education at Memorial Sloan Kettering
4, as established by the American Society for Transplantation and Cellular Therapy (ASTCT), and includes antipyretics, IV fluids and oxygen (Crit Care Med 2020;48[1]:10-21). Additional treatments include the anti–interleukin-6 (IL-6) receptor antibody tocilizumab (Actemra, Genentech) for grade 2 or greater CRS, and corticosteroids for those with grade 3 to 4 CRS. Siltuximab (Sylvant, EUSA Pharma), a monoclonal antibody to IL-6, and anakinra (Kineret, Sobi), an IL-1 receptor antagonist, may be used in refractory cases. Clinicians also should consider infection and treat sepsis accordingly.
Best Practices Overall best practices include close observation of patients with regular, frequent assessments; having a process for rapid p treatment escalation and communication among ICU, oncology, nursing
Q & A The following advertorial is provided by Medi-Dose. It is designed to support the adjacent advertisement.
MPB - Multi-Purpose Blisters Q: For over 45 years your MediDose solid oral blisters have been instrumental to the adoption of unit dose and bedside bar coding. How has a product that seems so simple adapted to the constant evolution in the practice of pharmacy over the years? A: From the start, this company was built on our close relationships with pharmacists and pharmacy staff. Our products are the results of conversations with these professionals about the challenges they face when balancing their goal to provide safe, effective treatments for their patients with the always-present pressure to control costs. When new innovations, such as bedside bar coding, or new standards, such as USP <800>, require sweeping changes to the way medications are packaged and handled, their input has been essential in helping us quickly refine and improve our products to navigate and meet these new requirements. There are so many moving parts in a modern pharmacy setting. The expectations and challenges are constantly shifting, making an economical, easy to use, adaptable system such as Medi-Dose so important to the smooth operation of your practice.
Q: What changes has Medi-Dose made in response to the new USP <800> recommendations? A: As a manual system requiring no machinery, thereby reducing the risk of cross-contamination, Medi-Dose is well positioned to mitigate many of the issues that standards like USP <800> address regarding the safe handling of hazardous medications. In addition, free updates to our MILT software bring awareness of these issues to the attention of pharmacy staff. So now, we have been focused on extending the ability of our industry leading packaging solutions to secure even more sizes and types of medications by introducing a dramatically larger blister.
Q: How does a larger blister help? Chimeric antigen receptor (CAR) T-cell therapy uses T-cells gathered from the patient’s own blood. The T-cells are engineered and then infused back into the patient to target and attack cancer cells.
Cancer Center in New York City. The most common are cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS). The incidence of grade 3 to 4 CRS is about 16%, and that of ICANS is about 35% (Cancers [Basel] 2020;12[11]:3445). CRS is a hyperinflammatory syndrome most commonly seen in patients with a high disease burden or after high CAR T-cell doses. Symptoms typically start two to three days after infusion. Toxicities from CRS can affect every system of the body, Pastores said, including fever, malaise and fatigue (Blood 2016;127[26]:33213330). Fever, which is always present at onset, can be accompanied by anything from fatigue or diarrhea in mild cases to hypotension and systemic inflammation in more severe cases. Management is guided by the grade of CRS, with severity ranging from 1 to
and pharmacy staff; having guidelines for management of complications; and conducting an infectious disease workup and empirical broad antimicrobial coverage in cases of concomitant infection, he said. ICANS typically occurs four to five days after infusion; previous severe CRS is the primary risk factor. Symptoms include encephalopathy, headache, tremor or seizures. The condition is marked by elevated levels of cytokines such as IL-6, interferon gamma and tumor necrosis factor-alpha, as well as elevated C-reactive protein. ICANS grading also is on a scale of 1 to 4, standardized by the ASTCT (Crit Care Med 2020;48[1]: 10-21). In addition, ICANS has an immune effector cell–associated encephalopathy score, ranging from 0 to 10. To calculate this, clinicians give patients cognitive tasks such as naming objects or writing a sentence. see CAR T-CELL, page 22
A: In addition to traditional unit dose packaging, there are numerous medication forms and types of packaging required of pharmacy. We designed the MPB™ (Multi-Purpose Blister) to accommodate these special items and situations, such as oversized tablets, unit-of-use packaging, suppositories, compounded medications and even items already packaged in unit dose but not bar coded or labeled correctly for your practice.
Q: So, the MPB is like your current blisters, only larger? A: We used the same materials for the blisters and labels because they have been shown to be stable and trustworthy through many years of field experience in countless environments. These materials create a package that is resilient, tamper evident, moisture resistant and UV light inhibitant without the need for machinery or heat sealers. The two new sizes, 5/8” deep and 1-1/4” deep, both have a well that is 1-1/2” square and a printing area that is 2” square. This balances the room needed for clear labeling of the blister’s contents against the space required to store it in most dispensing cabinets. As always, comments and suggestions from customers were incorporated into the design of the MPB to improve the user experience with the product.
Q: Is it expensive or difficult to introduce the MPB into my practice? A: Not at all. If you are already using our MILT 4 software, there is a free update on our web site that adds the new label format. You would only need a Fil-Form template, the blisters and labels. If you are new to Medi-Dose, a free demo of MILT 4 can be downloaded from our web site. New customers can be ready to package their medication for under a thousand dollars, with no capital expense required.
Support for the MILT software is always free and unlimited. We are happy to send samples and to work with you to configure the system for your needs. Simply call us at 800-523-8966 or visit MediDose.com for more information.
