
Here's why school nurses need Texas law change to give new epi nasal spray to students
Children who have an allergy that could cause anaphylaxis symptoms such throat swelling and other severe reactions have long had to carry an epinephrine injectable pen with them or have one stored at school.
Those pens, known under the brand name EpiPen, can become unusable if subjected to heat like in a hot car in a Texas summer. They also have a one-year shelf life, which means families have to fill a new prescription each school year for hundreds of dollars and then supply it to the school nurse's office.
Last year, the U.S. Food and Drug Administration approved Neffy, a nasal spray form of epinephrine for people who weigh 66 pounds or more, and this month it approved a lower dose spray for children ages 4 and older who are between 33 pounds and 66 pounds.
This is great news, but families can't just hand over the nasal spray form to their school nurse. The Texas law allowing school nurses to give epinephrine uses the phrase "auto-injectors" when referring to delivering the drug to students who have a prescription for it. That means only the pen form.
Senate Bill 1619 and House Bill 2283 both aim to rectify that by simply taking out the phrase "auto-injector" and changing it to "delivery devices."
Allergy treatment takes girl from fear of cashews to no-worry birthday cake
"This is a happy bill," said Dr. Allen Lieberman of Austin Family Allergy and Asthma. "There is no downside to it."
This new nasal spray delivers medicine the same way as a nasal allergy spray like Flonase or the same way as Narcan for people experiencing an opioid overdose. You put the nozzle into one nostril and push down on the plunger to spray the medicine into the nose. It's easy to use, and people are less intimidated by it than by the idea of giving someone a shot.
The nasal spray offers the same medical results as the auto-injectors, but it has some other advantages, Lieberman said. If you want to buy the nasal spray without insurance, a two-pack is about $200, Lieberman said, compared with $600 for one auto-injector. Neffy comes in a two-pack because if a first dose doesn't improve the symptoms, you can give a second dose. With the traditional pen, it's just one dose.
The sprays also remain effective for two years instead of one, and they don't have heat restrictions like the injectables do.
Lieberman is now prescribing the nasal sprays and getting it approved by insurance about 50% of the time, and "the more we write for it, the more insurance sees it, and will approve it," he said.
He encourages people, especially in Texas, who have a prescription for an EpiPen to consider the Neffy instead. He has had many patients with auto-injectors accidentally leave them in a bag in the trunk of a car for days or weeks in the Texas heat and then have to throw the auto-injector away and get a new one. With the nasal spray, that spray would still be effective.
It's going to be "a game-changer," Lieberman said.
This article originally appeared on Austin American-Statesman: Texas law keeps school nurses from using new epi nasal spray
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38 minutes ago
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About BRUKINSA ® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton's tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is also the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets in at least one indication, and more than 200,000 patients have been treated globally. U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib) INDICATIONS BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Waldenström's macroglobulinemia (WM). Mantle cell lymphoma (MCL) who have received at least one prior therapy. Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hemorrhage Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding. Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. 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Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients. Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment. Hepatotoxicity, Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA. Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA. 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Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding physicians and patients trust in BRUKINSA; whether the new tablet formulation for BRUKINSA will result in better patient experience; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our News & Media site.
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