Succinylcholine Chloride

ZUNVEYL ® net product revenue increased approximately 71% quarter-over-quarter to $6.0 million in the second quarter of 2026. Bottles dispensed increased approximately 37% quarter-over-quarter to 8,294, with monthly demand reaching 2,997 in June. Quarterly prescribers increased approximately 26% to 1,347 and repeat prescribers increased approximately 29% to 1,024, with approximately 76% prescribing in multiple months. Cash and cash equivalents totaled $41.4 million as of June 30, 2026, supporting the Company’s continued target of operating profitability in 2027 Company to host conference call and webcast today, August 13, at 4:30 p.m. ET. VANCOUVER, British Columbia & DALLAS--(BUSINESS WIRE)-- Alpha Cognition Inc. (NASDAQ: ACOG) (“Alpha Cognition”, “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. “We are pleased with the continued commercial adoption of ZUNVEYL during the second quarter,” said Michael McFadden, Chief Executive Officer of Alpha Cognition. “Our commercial team continues to execute effectively, expanding the prescriber base while driving deeper utilization within existing accounts. We are particularly encouraged by the growth in repeat prescribers, long-term care facility adoption and monthly prescription demand, which we believe reflects increasing clinical confidence in ZUNVEYL. Its differentiated pro growing real-world utilization provide a strong foundation for continued growth.” Mr. McFadden continued, “As we move through the second half of 2026 and into 2027, we will remain focused on further strengthening commercial execution, supporting appropriate patient access and maintaining disciplined capital allocation.” ZUNVEYL Commercial Performance Net ZUNVEYL Revenue: Revenue increased to approximately $6.0 million in the second quarter of 2026, representing approximately 71% growth compared to first quarter 2026 revenue of $3.5 million. Bottles Dispensed: Dispensed 8,294 bottles during Q2 2026, compared with 6,054 in Q1 2026, representing approximately 37% quarter-over-quarter growth. Monthly prescription demand grew throughout the quarter to 2,997 in June, reflecting consistent commercial momentum. Expanding Prescriber Base: Q2 2026 prescribing healthcare professionals increased to 1,347, compared with 1,060 in Q1 2026, representing approximately 26% sequential growth. Cumulative prescribing healthcare professionals reached 1,908 launch-to-date, compared with 1,484 at March 31, 2026, reflecting continued expansion of the Company’s prescriber base. Repeat Prescribers: Repeat prescribers increased to 1,024, compared with 795 in Q1 2026, representing 29% sequential growth. Approximately 76% of all Q2 prescribers generated prescriptions in multiple months during the quarter, demonstrating growing prescribing consistency and continued utilization across the prescriber base. Commercial Reach: Long-term care facility penetration continued to expand, with 1,095 facilities generating prescriptions during Q2 2026. Recent and Upcoming Business, Clinical, and Operational Highlights Reported positive topline results from BEACON, a real-world effectiveness study evaluating provider-reported cognitive, behavioral, functional, and tolerability outcomes among long-term care residents with mild to moderate Alzheimer’s disease (“AD”) who were receiving ZUNVEYL. Initiated CONVERGE, a 400-patient retrospective data analysis evaluating tolerability, dosing, polypharmacy, and adverse events in long-term care, in April 2026 as planned. This study is designed to provide insights into real-world use in complex patient populations, including polypharmacy, which is a key consideration for both prescribers and payers. The Company continues to expect topline data for CONVERGE in Q3 2026. Initiated RESOLVE, a Phase 4 interventional trial in AD patients with behaviors that will evaluate ZUNVEYL’s effect on tolerability, cognitive and behavioral outcomes, and caregiver burden, with sites selected, activated, and initial patient enrollment underway. The study is expected to be completed in Q2 2027 and expands the Company’s evidence base into the outpatient setting, representing a significant long-term commercial opportunity. Continued to advance the sublingual development program toward the clinic in 2027. The Company believes this formulation, if approved, would provide a disruptive treatment option for AD patients with dysphagia or severe swallowing difficulties who currently have limited treatment options for medication treatment Second Quarter 2026 Financial Results Revenues: Revenue for the second quarter of 2026 was approximately $6.0 million, compared to $3.5 million for the first quarter of 2026 primarily due to an increase in sales volume. Cost of Product Sales: Cost of ZUNVEYL Product Sales, including amortization of intangible assets, for the second quarter of 2026 was approximately $352 thousand, compared to $111 thousand for the same period last year. Gross margin increased slightly to 94% for the second quarter of 2026 compared to 93% in the same quarter last year. Research and Development (R&D): R&D expenses for the second quarter were approximately $2.0 million compared to $406 thousand in the comparable period in 2025, reflecting continued advancement of the BEACON study, and RESOLVE clinical trial, which initiated during the first quarter and is actively enrolling. Sales, General & Administrative (SG&A) : SG&A expenses for the three months ended June 30, 2026 were approximately $11.5 million compared to $9.5 million for the same period in 2025, primarily driven by commercial activities supporting the launch and expansion of ZUNVEYL, partially offset by cost-containment initiatives and operational efficiencies. Operating Loss: Total operating expenses for Q2 2026 were approximately $13.5 million, resulting in an operating loss of approximately $7.8 million. This was compared to total operating expenses of $9.9 million and a net loss of $8.4 million for the same period last year. The increase in operating expenses reflects deliberate investment in commercial infrastructure, payer engagement, and clinical programs. These investments are aligned with driving long-term revenue growth and market expansion. The Company is reducing it’s full-year 2026 R&D and SG&A expense guidance to $50–$54 million. Net Loss: Net loss for the second quarter of 2026 was approximately $8.8 million, or $(0.40) per share, compared with $13.2 million, or $(0.82) per share, in the comparable prior-year period. Cash Position: Cash, cash equivalents and short-term investments totaled approximately $41.4 million as of June 30, 2026. The Company continues to manage expenditures prudently and believes its current resources support execution of its strategic commercial and development priorities. Conference Call Information Alpha Cognition will host a conference call and webcast today, August 13 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-407-9039 or 201-689-8470. The live audio webcast will be accessible at . A replay of the call will be available three hours following the call via the Events section of the Alpha Cognition website. About Alpha Cognition Inc. Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options. ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. INDICATION AND USAGE ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. WARNINGS AND PRECAUTIONS Serious Skin Reactions: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered. Anesthesia: See Drug Interactions Section Cardiovascular Conditions: Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction. Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Gastrointestinal Conditions: Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL Genitourinary Conditions: Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Neurological Conditions: Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL. Pulmonary Conditions: Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions. ADVERSE REACTIONS The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. DRUG INTERACTIONS Use with Anticholinergics: Galantamine has the potential to interfere with the activity of anticholinergic medications. Use with Cholinomimetics and Other Cholinesterase Inhibitors: A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data may cause fetal harm. Hepatic Impairment : In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended. Renal Impairment: In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended. These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Forward-looking Statements This news release contains forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the commercial performance, growth prospects and market adoption of ZUNVEYL ® ; prescription demand, bottles dispensed, prescriber adoption and repeat prescribing trends; long-term care facility penetration; payer access and reimbursement; implementation and expansion of Medicare Part D and pharmacy benefit manager ("PBM") contracts; the Company's expectations regarding future revenues, operating expenses, capital allocation, liquidity, cash runway and potential operating profitability; the timing, conduct, completion and results of the Company's clinical, observational and real-world evidence studies, including CONVERGE, RESOLVE and BEACON; advancement of the Company's sublingual development program and other product candidates; and the potential benefits, characteristics, commercial opportunity and future development of ZUNVEYL and the Company's development programs. Forward-looking statements are often identified by words such as "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "continue," "ongoing," and similar expressions, or the negative of such terms, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on management's current expectations, assumptions and beliefs and are subject to a number of known and unknown risks, uncertainties and other factors that could cause actual results, performance or achievements to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others: risks related to the commercial adoption and market acceptance of ZUNVEYL; prescription demand; prescriber behavior and repeat prescribing patterns; long-term care facility adoption; patient access; payer coverage; formulary positioning; reimbursement levels; PBM and Medicare Part D implementation; utilization management restrictions; pricing pressure; gross-to-net deductions, including rebates, chargebacks, discounts, returns and patient assistance programs; the accuracy, completeness, timing and potential revision of third-party prescription and commercial data; the Company's ability to achieve revenue growth, manage operating expenses, maintain adequate liquidity, obtain additional financing if needed, and achieve its expected financial and operational objectives, including any target of future operating profitability; risks related to commercial manufacturing, supply chain operations, inventory management, distribution, marketing and sales execution; risks related to the safety, efficacy, tolerability and real-world clinical performance of ZUNVEYL; ongoing regulatory oversight, pharmacovigilance obligations and product labeling requirements; risks related to the initiation, enrollment, conduct, timing, completion, results and interpretation of clinical trials, chart review studies and real-world evidence programs; risks relating to the development, regulatory review and potential approval of new formulations and product candidates; intellectual property protection and enforcement; and other risks described from time to time in the Company's filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. Additional information regarding these and other risks and uncertainties is contained in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K filed with the SEC on March 31, 2026, and in the Company's subsequent filings with the SEC, as well as the Company's filings available under its pro SEDAR+. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Note regarding Key Performance Indicators As the company began commercial sales of ZUNVEYL in 2025, management has identified several key performance indicators that it utilizes to assess the progress of commercialization and sale of ZUNVEYL and the success of its operations period over period. These key performance indicators include bottles dispensed, number of prescribers, homes and unique facilities engaged. These indicators are defined below along with management’s reasons for focusing on these indicators. “Bottles dispensed” refers to the number of 30-day prescriptions of ZUNVEYL filled during a given period. This data is sourced from third-party providers. Reported figures reflect the bottles recorded as dispensed within that period based on management’s review of the data. Because the data may be updated over time, actual totals may vary slightly. Management considers bottles dispensed a key performance metric because it closely reflects real-world product usage and is a meaningful indicator of ZUNVEYL’s commercial performance and the Company’s operational progress. “Prescribers” refers to the number of healthcare providers actively writing prescriptions for ZUNVEYL at the end of a reported period. This data is sourced from third-party providers and is evaluated on a weekly basis. The reported number reflects prescriber activity at a specific point in time and may not represent the total number of prescribers throughout the entire period. Management considers prescribers a key metric because it indicates the level of commercial adoption of ZUNVEYL among healthcare providers and helps assess the potential for future growth in bottles dispensed. “Homes” refers to the number of long-term care facilities where medical staff have prescribed ZUNVEYL to patients residing in those facilities. “Unique facilities engaged” refers to the number of long-term care facilities with which the Company’s sales team has had discussions regarding prescribing ZUNVEYL. This data is sourced from third-party providers. Reported figures may vary from actual totals as data is updated over time. Management considers homes and unique facilities engaged to be key performance metrics, as they reflect the effectiveness of the Company’s sales efforts in reaching potential prescribers and expanding coverage within the long-term care market. ALPHA COGNITION INC. CONDENSED CONSOLIDATED BALANCE SHEETS June 30, December 31, 2026 2025 (unaudited) ASSETS Current assets Cash and cash equivalents $ 41,384,287 $ 66,046,789 Restricted cash 58,400 58,400 Accounts receivable, net 5,474,956 4,236,136 Inventory 6,394,817 5,123,496 Prepaid expenses and other current assets 4,614,222 3,545,451 Total current assets 57,926,682 79,010,272 Equipment, net 374,692 328,540 Intangible assets, net 6,218,509 391,423 Total assets $ 64,519,883 $ 79,730,235 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable and accrued liabilities $ 6,237,986 $ 8,976,904 Current deferred income 103,192 153,171 Other current liabilities 71,540 - Total current liabilities 6,412,718 9,130,075 Deferred income 30,170 35,944 Option liability - 3,174,662 Warrant liabilities 5,080,530 4,812,198 Other long-term liabilities 34,716 47,181 Total liabilities 11,558,134 17,200,060 Stockholders’ equity Common stock, no par value, unlimited shares authorized, 21,774,104 and 21,742,104 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively 133,952,684 133,891,673 Class B preferred stock, no par value, unlimited shares authorized, 316,655 shares issued and outstanding as of June 30, 2026, and December 31, 2025, respectively 62 62 Additional paid-in capital 31,487,837 25,849,516 Accumulated other comprehensive loss (104,301 ) (104,301 ) Accumulated deficit (112,374,533 ) (97,106,775 ) Total stockholders’ equity 52,961,749 62,530,175 Total liabilities and stockholders’ equity $ 64,519,883 $ 79,730,235 ALPHA COGNITION INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) For the Three Months Ended June 30, For the Six Months Ended June 30, 2026 2025 2026 2025 Revenue Product, net $ 6,041,506 $ 1,576,411 $ 9,545,327 $ 1,923,340 Licensing 51,468 81,276 81,445 2,663,001 Total revenue 6,092,974 1,657,687 9,626,772 4,586,341 Cost of Revenues Cost of product sales, excluding amortization of intangible assets 277,466 105,354 526,319 131,895 Cost of licensing revenue 39,362 93,118 62,285 903,118 Amortization of intangible assets 74,229 5,386 79,616 10,773 Total cost of revenues 391,057 203,858 668,220 1,045,786 Gross Profit 5,701,917 1,453,829 8,958,552 3,540,555 Operating Expenses Research and development 2,008,870 406,140 3,105,175 806,556 Selling, general and administrative expenses 11,449,054 9,494,966 21,705,611 14,586,238 Total operating expenses 13,457,924 9,901,106 24,810,786 15,392,794 Loss from operations (7,756,007 ) (8,447,277 ) (15,852,234 ) (11,852,239 ) Other income (expenses) Interest income, net 380,735 425,670 886,791 887,539 Grant income - - - 71,095 Loss on change in fair value of warrant liabilities (1,414,267 ) (5,172,091 ) (290,195 ) (4,024,209 ) Loss on foreign currency contracts (42,251 ) - (42,251 ) - Other income (expenses) 42,050 (5,530 ) 30,131 (6,487 ) Total other income (expenses) (1,033,733 ) (4,751,951 ) 584,476 (3,072,062 ) Net loss and comprehensive loss (8,789,740 ) (13,199,228 ) (15,267,758 ) (14,924,301 ) Weighted average shares outstanding, basic 21,774,104 16,020,702 21,768,115 16,020,015 Net loss per share, basic $ (0.40 ) $ (0.82 ) $ (0.70 ) $ (0.93 ) Adjusted net loss, diluted $ (8,789,740 ) $ (13,199,228 ) $ (15,629,682 ) $ (14,924,301 ) Weighted average outstanding stock, diluted 21,774,104 16,020,702 21,879,362 16,020,015 Net loss per share, diluted $ (0.40 ) $ (0.82 ) $ (0.71 ) $ (0.93 ) Contacts For further information: Investor Relations LifeSci Advisors, PJ Kelleher pkelleher@lifesciadvisors.com Read full story here

Hikma launches Sugammadex Injection in a prefilled syringe in the US London, UK, 29 July 2026 – Hikma Pharmaceuticals PLC (Hikma, Group), a multinational pharmaceutical company, today announced the launch of Sugammadex Injection in the US, at patent expiry. “We are pleased to be among the first to bring Sugammadex Injection to patients in the US,” said Jon Kafer, Vice President of Commercial for US Injectables. "The launch of our prefilled syringes expands the options available to hospitals, pharmacists, doctors and nurses and reflects our commitment to delivering high-quality medicines in formulations that support clinical practice. This launch is another example of how Hikma is using its capabilities as a leading sterile injectable manufacturer to introduce differentiated dosage forms and serve the evolving needs of US medical professionals and their patients.” The product has been launched in a prefilled syringe form in a 200 mg/2 mL (100 mg/mL) dose, and is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Please see the full package insert for important safety information. According to IQVIA, US sales for Sugammadex Injection were approximately $1.6 billion for the 12 months ended May 2026. Sugammadex Injection is comparable to BRIDION® (sugammadex) injection, marketed by Merck Sharp & Dohme B.V. Hikma’s generic version is indicated for fewer than all approved indications of the Reference Listed Drug. – ENDS – This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States. BRIDION® is a registered trademark of Merck Sharp & Dohme B.V. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (LEI:549300BNS685UXH4JI75) (rated BBB/stable S&P and BBB/stable Fitch) Download full press release Enquiries Hikma Pharmaceuticals PLC Susan Ringdal EVP, Strategic Planning and Global Affairs +44 (0)20 7399 2760/+44 7776 477050 Steven Weiss US Communications +1 732 788 8279 Important Safety Information for Sugammadex Injection CONTRAINDICATIONS Sugammadex injection is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex. WARNINGS & PRECAUTIONS Anaphylaxis and Hypersensitivity – Clinicians should be prepared for the possibility of drug hypersensitivity reactions (including anaphylactic reactions) and take the necessary precautions. Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with sugammadex injection. Marked Bradycardia – Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after the administration of sugammadex injection. Respiratory Function Monitoring During Recovery – Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured. Even if recovery from neuromuscular blockade is complete, other drugs used in the peri- and post-operative period could depress respiratory function and therefore ventilatory support might still be required. Risk of Prolonged Neuromuscular Blockade – In clinical trials, a small number of patients experienced a delayed or minimal response to the administration of sugammadex injection. Thus, it is important to monitor ventilation until recovery occurs. Waiting Times for Re-Administration of Neuromuscular Blocking Agents for Intubation Following Reversal with Sugammadex Injection – A minimum waiting time is necessary before administration of a steroidal neuromuscular blocking agent after administration of sugammadex injection. If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocking agent. Interactions Potentially Affecting the Efficacy of Other Drugs – Due to the administration of sugammadex injection, certain drugs, including hormonal contraceptives, could become less effective due to a lowering of the (free) plasma concentrations. Risk of Recurrence of Neuromuscular Blockade Due to Displacement Interactions – Recurrence of neuromuscular blockade may occur due to displacement of rocuronium or vecuronium from sugammadex injection by other drugs. In this situation the patient may require mechanical ventilation. Administration of the drug which caused displacement should be stopped in case of an infusion. Risk of Recurrence of Neuromuscular Blockade with Lower Than Recommended Dosing – The use of lower than recommended doses of sugammadex injection may lead to an increased risk of recurrence of neuromuscular blockade after initial reversal and is not recommended. Risk of Recurrence of Neuromuscular Blockade Due to the Administration of Drugs that Potentiate Neuromuscular Blockade – When drugs which potentiate neuromuscular blockade are used in the post-operative phase, special attention should be paid to the possibility of recurrence of neuromuscular blockade. Refer to the package insert for rocuronium or vecuronium for a list of the specific drugs which potentiate neuromuscular blockade. In case recurrence of neuromuscular blockade is observed, the patient may require mechanical ventilation. Risk of Coagulopathy and Bleeding – Since bleeding risk has been studied systematically with only heparin and low molecular weight heparin thromboprophylaxis and 4 mg/kg doses of sugammadex, coagulation parameters should be carefully monitored in patients with known coagulopathies, being treated with therapeutic anticoagulation, receiving thromboprophylaxis drugs other than heparin and low molecular weight heparin, or receiving thromboprophylaxis drugs and who then receive a dose of 16 mg/kg sugammadex. Renal Impairment – Sugammadex injection is not recommended for use in patients with severe renal impairment, including those requiring dialysis. Light Anesthesia – When neuromuscular blockade was reversed intentionally in the middle of anesthesia in clinical trials, e.g., when investigating urgent reversal, signs of light anesthesia were noted occasionally. Reversal after Rocuronium or Vecuronium Administration in the ICU – Sugammadex injection has not been studied for reversal following rocuronium or vecuronium administration in the ICU. Reversal of Neuromuscular Blocking Agents Other Than Rocuronium or Vecuronium – Do not use sugammadex injection to reverse blockade induced by nonsteroidal neuromuscular blocking agents such as succinylcholine or benzylisoquinolinium compounds. Do not use sugammadex injection to reverse neuromuscular blockade induced by steroidal neuromuscular blocking agents other than rocuronium or vecuronium. ADVERSE REACTIONS Most common adverse reactions (reported in ≥10% of adult patients at a 2, 4, or 16 mg/kg sugammadex injection dose and higher than the placebo rate): vomiting, pain, nausea, hypotension, and headache. Most common adverse reactions (reported in ≥10% of pediatric patients 2 to <17 years of age at sugammadex injection doses of 2 or 4 mg/kg): pain, vomiting, and nausea. DRUG INTERACTIONS Interactions Potentially Affecting the Efficacy of Sugammadex Injection For toremifene, which has a relatively high binding affinity for sugammadex and for which relatively high plasma concentrations might be present, some displacement of vecuronium or rocuronium from the complex with sugammadex injection could occur. The recovery to TOF ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of surgery. Interaction Potentially Affecting the Efficacy of Hormonal Contraceptives In vitro binding studies indicate that sugammadex injection may bind to progestogen, thereby decreasing progestogen exposure. Therefore, the administration of a bolus dose of sugammadex injection is considered to be equivalent to missing dose(s) of oral contraceptives containing an estrogen or progestogen. If an oral contraceptive is taken on the same day that sugammadex injection is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days. In the case of non-oral hormonal contraceptives, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days. Interference with Laboratory Tests Sugammadex injection may interfere with the serum progesterone assay. Interference with this test was observed at sugammadex plasma concentrations of 100 mcg/mL, which may be observed for up to 30 minutes after a 16 mg/kg dose. USE IN SPECIFIC POPULATIONS Geriatric Use This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Hepatic Impairment Exercise caution when administering sugammadex injection to patients with hepatic impairment accompanied by coagulopathy or severe edema. OVERDOSAGE In premarketing clinical trials, one case of accidental overdose with 40 mg/kg sugammadex injection was reported without significant effects. Sugammadex injection can be removed using hemodialysis with a high-flux filter, but not with a low-flux filter. Based upon clinical studies, sugammadex injection concentrations in plasma are reduced with a high-flux filter by about 70% after a 3- to 6-hour dialysis session. INDICATIONS AND USAGE Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information. ENDING INFORMATION Patient Counseling Information should be shared with the patient prior to administration. For additional information, please refer to the Package Insert for full prescribing information, available on www.hikma.com. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 USA BRIDION is a registered trademark of Merck Sharp & Dohme B.V. © 2026. Hikma Pharmaceuticals USA Inc. All rights reserved. HK-3578-v1