Baxter Announces Continued Growth of Pharmaceuticals Portfolio With Five Injectable Product Launches in the U.S.

Rhea-AI Summary

Baxter International (NYSE:BAX) announced five new injectable pharmaceutical product launches in the U.S., bringing their total launches to 10 in 2024. The new products include: Micafungin for Candida infections, Cyclophosphamide Injection for malignant diseases, Pantoprazole Sodium for GERD treatment, Cefazolin in a new 3g/150mL strength for various infections, and Levetiracetam for seizure treatment.

These ready-to-use formats utilize Baxter's proprietary container technology and are designed to improve operational efficiencies, simplify medication preparation, and enhance patient safety by reducing contamination risks and potential compounding errors.

Positive

• Expansion of product portfolio with 10 total injectable launches in 2024
• Ready-to-use formats potentially reduce operational costs and medication errors
• Proprietary container technology demonstrates technological advantage
• Strategic diversification across multiple therapeutic areas (critical care, anti-infectives, pain, oncology)

Negative

• None.

Insights

Pharmaceutical Industry Analyst

The launch of five new injectable products significantly strengthens Baxter's pharmaceutical portfolio, bringing their total 2024 launches to 10 products. This expansion focuses on high-value specialty injectables across critical therapeutic areas including anti-infectives, oncology and critical care. The ready-to-use format of these products offers a compelling competitive advantage, potentially driving market share gains and operational efficiencies for healthcare providers.

The introduction of Cyclophosphamide Injection is particularly noteworthy for the oncology segment, while Micafungin addresses the growing need for antifungal treatments in immunocompromised patients. These launches leverage Baxter's proprietary container technology, which could provide sustained competitive advantages and higher margins. The diverse therapeutic coverage of these products should help buffer against individual product risks while creating multiple revenue streams.

Healthcare Operations Analyst

From an operational perspective, these ready-to-use formulations address critical healthcare efficiency needs. The elimination of manual compounding processes can generate significant cost savings for healthcare facilities through reduced labor requirements and decreased medication preparation time. More importantly, these formulations enhance patient safety by minimizing the risk of contamination and dosing errors inherent in manual compounding.

The standardized concentrations align with healthcare facilities' push toward operational optimization and risk reduction. The diverse range of container sizes and dosage strengths demonstrates Baxter's understanding of varying clinical needs. This portfolio expansion strengthens Baxter's position as a key supplier to healthcare institutions, potentially leading to increased market penetration and customer retention.

• New launches reinforce Baxter’s leadership in bringing high-value, specialty injectable products to market to help address critical patient needs
• Products help support patient safety, simplify medication preparation and increase efficiencies for healthcare professionals
• Marks total of 10 launches¹ for Baxter’s U.S. Pharmaceuticals portfolio in 2024

DEERFIELD, Ill.--(BUSINESS WIRE)-- Baxter International Inc. (NYSE:BAX), a global leader in injectables, anesthesia and drug compounding, today announced five new injectable pharmaceutical product launches in the U.S., joining the previous five launches announced in April of this year and marking a total of 10 U.S. injectable product launches in 2024.

“Our Pharmaceuticals teams are relentlessly focused on bringing differentiated products to market that support our customers in helping to address vital patient needs,” said Alok Sonig, executive vice president and group president, Pharmaceuticals, at Baxter. “We look forward to further accelerating our impact with a robust innovation pipeline across our key therapeutic areas, including critical care, anti-infectives, pain and oncology.”

The five recent product launches within Baxter’s Pharmaceuticals portfolio in the U.S. include the following. For all products, please see full Indications, including Limitations of Use, Important Risk Information and links to full Prescribing Information below.

• Micafungin in 0.9% Sodium Chloride Injection single-dose container is indicated for use in adult and pediatric patients to treat Candida infections and for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved. Micafungin uses Baxter’s proprietary container technology. Baxter offers Micafungin in 50 mg/50 mL, 100 mg/100 mL and 150 mg/150 mL strengths.
• Cyclophosphamide Injection is an alkylating drug indicated for treatment of adults and pediatric patients with various malignant diseases and is frequently used in combination with other oncology medications. This liquid cyclophosphamide product requires further dilution before use. Baxter offers Cyclophosphamide Injection in 500 mg/2.5 mL and 1000 mg/5 mL strengths in Multiple-Dose Vials.
• Pantoprazole Sodium in 0.9% Sodium Chloride Injection is a proton pump inhibitor indicated in adults for the short-term treatment (seven to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE) and pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. Pantoprazole uses Baxter’s proprietary container technology. Baxter offers Pantoprazole in 40 mg/50 mL, 40 mg/100 mL and 80 mg/100 mL strengths.
• Cefazolin in Dextrose Injection, USP now available in a new 3 g/150 mL strength, is a single-dose, first generation cephalosporin antibacterial indicated for adults and pediatric patients to treat various infections caused by susceptible organisms and for perioperative prophylaxis. Cefazolin uses Baxter’s proprietary container technology. Baxter offers Cefazolin in 1 g/50 mL, 2 g/100 mL and 3 g/150 mL strengths.
• Levetiracetam in Sodium Chloride Injection is an anti-epileptic drug indicated for adjunct therapy in adult patients for partial onset seizures, myoclonic seizures, and tonic-clonic seizures. Levetiracetam uses Baxter’s proprietary container technology and is now offered in 500 mg/100 mL, 1000 mg/100 mL and 1500 mg/100 mL strengths.

Ready-to-use formats of standard concentrations of commonly prescribed drugs may offer operational efficiencies for healthcare providers. Compounding a drug for patient use is a multi-step, manual process that requires oversight by pharmacy staff. A ready-to-use product can simplify the preparation process and support patient safety by reducing the chance of contamination² and avoiding potential errors that may occur when medications are compounded.³

These five newly launched products are now available for use in the U.S.

About Baxter Pharmaceuticals

Baxter is a global leader in specialty injectables, drug compounding and anesthesia that addresses unmet patient needs in the therapeutic areas of pain, critical care, anti-infectives and oncology. Baxter’s comprehensive pharmaceuticals portfolio contains injectables (including ready-to-use products), inhaled gases and compounded medications, and is designed to expand access to products that simplify medication preparation and support patient safety. Pharmaceuticals employees across the globe are focused on driving customer-centered innovation, bringing new and differentiated products and delivery platforms to market, and helping patients receive the medications they need.

About Baxter

Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on X, LinkedIn and Facebook.

Micafungin in 0.9% Sodium Chloride Injection

Indications

• Micafungin in Sodium Chloride Injection is an echinocandin indicated in adult and pediatric patients for:
  • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved.
  • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved.
  • Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved.
  • Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT) for whom appropriate dosing with this formulation can be achieved.
• Limitations of Use:
  • The safety and effectiveness of Micafungin in Sodium Chloride Injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed.
  • Micafungin in Sodium Chloride Injection has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida.
  • The efficacy of Micafungin in Sodium Chloride Injection against infections caused by fungi other than Candida has not been established.

Important Risk Information

• Contraindications: Micafungin in Sodium Chloride Injection is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of Micafungin in Sodium Chloride Injection, or other echinocandins.
• Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue Micafungin in Sodium Chloride Injection and administer appropriate treatment.
• Hematological Effects: Acute intravascular hemolysis and hemoglobinuria was seen in a healthy volunteer during infusion of Micafungin for Injection (200 mg) and oral prednisolone (20 mg). Cases of significant hemolysis and hemolytic anemia have also been reported in patients treated with Micafungin for Injection. Patients who develop clinical or laboratory evidence of hemolysis or hemolytic anemia during therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing therapy.
• Hepatic Effects: Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with Micafungin. In some patients with serious underlying conditions who were receiving Micafungin along with multiple concomitant medications, clinical hepatic abnormalities have occurred, and isolated cases of significant hepatic impairment, hepatitis, and hepatic failure have been reported. Monitor hepatic function. Discontinue if severe dysfunction occurs.
• Renal Effects: Elevations in BUN and creatinine; isolated cases of renal impairment or acute renal failure have been reported. Monitor renal function.
• Infusion and Injection Site Reactions: Possible histamine-mediated symptoms have been reported with Micafungin for Injection, including rash, pruritus, facial swelling, and vasodilatation. Slow the infusion rate if infusion reaction occurs. Injection site reactions, including phlebitis and thrombophlebitis have been reported, at Micafungin for Injection doses of 50 to 150 mg/day. These reactions tended to occur more often in patients receiving Micafungin for Injection via peripheral intravenous administration.
• High Sodium Load: Each 50, 100, and 150 mL Galaxy container contains 200, 400, and 600 mg of sodium, respectively. Avoid use in patients with congestive heart failure, elderly patients, and patients requiring restricted sodium intake.
• Adverse Reactions:
  • Most common adverse reactions across adult and pediatric clinical trials for all indications include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache.
  • In pediatric patients younger than 4 months of age, the following additional common adverse reactions were reported at an incidence rate of ≥15%: hypokalemia, acidosis, sepsis, anemia, and oxygen saturation decreased.
• Drug Interactions:
  • Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary.
• Pregnancy: Based on animal data, Micafungin in Sodium Chloride Injection may cause fetal harm. Advise pregnant women of the risk to the fetus.

Please see accompanying full Prescribing Information for Micafungin in 0.9% Sodium Chloride Injection.

Cyclophosphamide Injection

Indications

• Cyclophosphamide Injection is an alkylating drug indicated for treatment of adult and pediatric patients with:
  • Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma.

Important Risk Information

• Contraindications
  • Hypersensitivity: Cyclophosphamide is contraindicated in patients who have a history of severe hypersensitivity reactions to it, any of its metabolites, or to other components of the product. Anaphylactic reactions including death have been reported. Possible cross-sensitivity with other alkylating agents can occur.
  • Urinary outflow obstruction
• Myelosuppression, Immunosuppression, Bone Marrow Failure and Infections: Cyclophosphamide can cause myelosuppression, bone marrow failure, and severe immunosuppression which may lead to serious and sometimes fatal infections, including sepsis and septic shock. Latent infections can be reactivated. Monitoring of complete blood counts is essential during cyclophosphamide treatment so that the dose can be adjusted, if needed.
• Urinary Tract and Renal Toxicity: Hemorrhagic cystitis, pyelitis, ureteritis, and hematuria have been reported with cyclophosphamide. Discontinue cyclophosphamide therapy in case of severe hemorrhagic cystitis. Urotoxicity may require interruption of cyclophosphamide treatment or cystectomy. Urotoxicity can be fatal. Before starting treatment, exclude or correct any urinary tract obstructions. Urinary sediment should be checked regularly for the presence of erythrocytes and other signs of urotoxicity and/or nephrotoxicity. Cyclophosphamide Injection should be used with caution, if at all, in patients with active urinary tract infections. Aggressive hydration with forced diuresis and frequent bladder emptying can reduce the frequency and severity of bladder toxicity. Mesna has been used to prevent severe bladder toxicity.
• Cardiotoxicity: Myocarditis, myopericarditis, pericardial effusion including cardiac tamponade, and congestive heart failure, which may be fatal, have been reported with cyclophosphamide therapy. Supraventricular arrhythmias and ventricular arrhythmias have been reported after treatment with regimens that included cyclophosphamide. The risk of cardiotoxicity may be increased with high doses of cyclophosphamide, in patients with advanced age, and in patients with previous radiation treatment to the cardiac region and/or previous or concomitant treatment with other cardiotoxic agents. Monitor patients, especially those with risk factors for cardio toxicity or pre-existing cardiac disease.
• Pulmonary Toxicity: Pneumonitis, pulmonary fibrosis, pulmonary veno-occlusive disease and other forms of pulmonary toxicity leading to respiratory failure have been reported during and following treatment with cyclophosphamide. Late onset pneumonitis appears to be associated with increased mortality. Monitor patients for signs and symptoms of pulmonary toxicity.
• Secondary Malignancies: Cyclophosphamide is genotoxic. Secondary malignancies have been reported in patients treated with cyclophosphamide-containing regimens. The risk of bladder cancer may be reduced by prevention of hemorrhagic cystitis.
• Veno-occlusive Liver Disease (VOD): VOD including fatal outcome has been reported in patients receiving cyclophosphamide-containing regimens. A cytoreductive regimen in preparation for bone marrow transplantation that consists of cyclophosphamide in combination with whole-body irradiation, busulfan, or other agents has been identified as a major risk factor. VOD has also been reported to develop gradually in patients receiving long-term low-dose immunosuppressive doses of cyclophosphamide.
• Alcohol Content: The alcohol content in a dose of Cyclophosphamide Injection may affect the central nervous system. Consideration should be given to the alcohol content on the ability to drive or use machines immediately after the infusion.
• Embryo-Fetal Toxicity: Cyclophosphamide Injection can cause fetal harm when administered to a pregnant woman. Exposure to cyclophosphamide during pregnancy may cause birth defects, miscarriage, fetal growth retardation, and fetotoxic effects in the newborn. Advise females of reproductive potential to use effective contraception during treatment and for up to 1 year after completion of therapy. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after completion of therapy.
• Infertility: Male and female reproductive function and fertility may be impaired in patients being treated with Cyclophosphamide Injection. Cyclophosphamide interferes with oogenesis and spermatogenesis. It may cause sterility in both sexes. Cyclophosphamide-induced sterility may be irreversible in some patients.
• Adverse Reactions: Most common adverse reactions reported are neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea.
• Lactation: Advise not to breastfeed.
• Renal Patients: Monitor for toxicity in patients with moderate and severe renal impairment.

Please see accompanying full Prescribing Information for Cyclophosphamide Injection.

Pantoprazole Sodium in 0.9% Sodium Chloride Injection

Indications

• Pantoprazole Sodium in 0.9% Sodium Chloride Injection is a proton pump inhibitor (PPI) indicated in adults for the following:
  • Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE).
  • Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome.

Important Risk Information

• Contraindications
  • Patients with a known hypersensitivity to any component of the formulation or to substituted benzimidazoles. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria.
  • Patients receiving rilpivirine-containing products.
• Presence of Gastric Malignancy: In adults, symptomatic response to therapy does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
• Injection Site Reactions: Thrombophlebitis was reported in association with the administration of another intravenous pantoprazole sodium product.
• Potential for Exacerbation of Zinc Deficiency: Pantoprazole Sodium in 0.9% Sodium Chloride Injection contains edetate disodium (the salt form of EDTA), a chelator of metal ions including zinc. Therefore, zinc supplementation should be considered in patients who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously.
• Acute Tubulointerstitial Nephritis (TIN): Has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function. Discontinue Pantoprazole Sodium in 0.9% Sodium Chloride Injection and evaluate patients with suspected acute TIN.
• Clostridioides difficile-associated diarrhea: Published observational studies suggest that PPI therapy may be associated with an increased risk of Clostridioides difficile-associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
• Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
• Severe Cutaneous Adverse Reactions: Including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs. Discontinue Pantoprazole Sodium in 0.9% Sodium Chloride Injection at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
• Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE): Have been reported in patients taking PPIs, including pantoprazole sodium. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematous cases were CLE. Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks.
• Hepatic Effects: Mild, transient transaminase elevations have been observed in clinical studies with another intravenous pantoprazole sodium product. The clinical significance of this finding in a large population of subjects is unknown.
• Hypomagnesemia and Mineral Metabolism: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
• Fundic Gland Polyps: PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic. Use the shortest duration of PPI therapy appropriate to the condition being treated.
• Adverse Reactions: Most common adverse reactions (incidence > 2%) are headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.
• Drug Interactions: See the full prescribing information for a list of clinically important drug interactions.
• Pregnancy: Based on animal data, may cause fetal harm.

Please see accompanying full Prescribing Information for Pantoprazole Sodium in 0.9% Sodium Chloride Injection.

Cefazolin in Dextrose Injection, USP

Indications

• Cefazolin in Dextrose Injection is a cephalosporin antibacterial indicated for:
  • Treatment of respiratory tract infections in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved.
    Limitations of Use: Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.
  • Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: Urinary tract infections; Skin and skin structure infections; Biliary tract infections; Bone and joint infections; Genital infections; Septicemia; Endocarditis.
  • Perioperative prophylaxis in adults and pediatric patients aged 10 – 17 years old for whom appropriate dosing with this formulation can be achieved.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin in Dextrose Injection and other antibacterial drugs, Cefazolin in Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Important Risk Information

• Contraindications: Hypersensitivity to Cefazolin or other cephalosporin class antibacterial drugs, penicillins, or other beta-lactams.
• Hypersensitivity Reactions to Cefazolin, Cephalosporins, Penicillins, or Other Beta-lactams: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with Cefazolin in Dextrose Injection, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefazolin, cephalosporins, penicillins, or carbapenems. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among betalactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue the drug.
• Seizures in Patients with Renal Impairment: Seizures may occur particularly in patients with renal impairment when the dosage is not reduced appropriately. Discontinue Cefazolin in Dextrose Injection if seizures occur or make appropriate dosage adjustments in patients with renal impairment. Anticonvulsant therapy should be continued in patients with known seizure disorders
• Clostridioides difficile-associated Diarrhea (CDAD): May range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• Prothrombin Activity: Cefazolin in Dextrose Injection may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
• Adverse Reactions: Adult and Pediatric Patients: Most common adverse reactions: gastrointestinal (nausea, vomiting, diarrhea), and allergic reactions (anaphylaxis, urticaria, skin rash). Pediatric Patients with Perioperative Prophylaxis: The most frequently reported adverse reactions (incidence ≥ 5%) were nausea, infusion site pain, and headache.
• Drug Interactions:
  • Probenecid: The renal excretion of cefazolin is inhibited by probenecid. Co-administration of probenecid with Cefazolin in Dextrose Injection is not recommended.

Please see accompanying full Prescribing Information for Cefazolin in Dextrose Injection, USP.

Levetiracetam in Sodium Chloride Injection

Indications

• Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible:
  • Partial-onset seizures
  • Myoclonic seizures in patients with juvenile myoclonic epilepsy
  • Primary generalized tonic-clonic seizures

Important Risk Information

• Contraindications: Levetiracetam in Sodium Chloride Injection is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema.
• Psychiatric Reactions: Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed. Monitor patients for psychiatric signs and symptoms.
• Somnolence and Fatigue: Monitor patients for these symptoms and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam.
• Anaphylaxis and Angioedema: Levetiracetam can cause anaphylaxis or angioedema. In some reported cases, reactions were life-threatening and required emergency treatment. If a patient develops signs or symptoms of anaphylaxis or angioedema, levetiracetam should be discontinued and the patient should seek immediate medical attention.
• Serious Dermatological Reactions: Serious reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with levetiracetam. Recurrence of the serious skin reactions following rechallenge has also been reported. Levetiracetam should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed, and alternative therapy should be considered.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: This has been reported in patients taking antiepileptic drugs, including levetiracetam. These events can be fatal or life-threatening, particularly if diagnosis and treatment do not occur as early as possible. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, sometimes resembling an acute viral infection. If such signs or symptoms are present, the patient should be evaluated immediately. Levetiracetam should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
• Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on levetiracetam.
• Withdrawal Seizures: Levetiracetam must be gradually withdrawn. But if withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered.
• Hematologic Abnormalities: Hematologic abnormalities occurred in clinical trials and included decreases in white blood cell, neutrophil, and red blood cells counts; decreases in hemoglobin and hematocrit; and increases in eosinophil counts. Cases of agranulocytosis, pancytopenia, and thrombocytopenia have been reported in the post-marketing setting. A complete blood count is recommended in patients experiencing significant weakness, pyrexia, recurrent infections, or coagulation disorders.
• Adverse Reactions: Most common adverse reactions (incidence in levetiracetam-treated patients is ≥5% more than in placebo-treated patients) include: somnolence, asthenia, infection, and dizziness.
• Pregnancy: Plasma levels of levetiracetam may be decreased; monitor closely during pregnancy. Based on animal data, may cause fetal harm. Encourage women who are taking levetiracetam injection during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry.
• Renal Impairment: Dosage adjustment is recommended for patients with impaired renal function and supplemental doses should be given to patients after dialysis.

Please see accompanying full Prescribing Information for Levetiracetam in Sodium Chloride Injection.

This release includes forward-looking statements concerning Micafungin in 0.9% Sodium Chloride Injection, Cyclophosphamide Injection, Pantoprazole Sodium in 0.9% Sodium Chloride Injection, Cefazolin in Dextrose Injection, USP and Levetiracetam in Sodium Chloride Injection, including potential benefits associated with the use of these products. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and Form 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

Baxter is a registered trademark of Baxter International Inc.

¹ Includes line extensions.

² Mercaldi CJ, Lanes S, Bradt J. Comparative risk of bloodstream infection in hospitalized patients receiving intravenous medication by open, point-of-care, or closed delivery systems. Am J Health-Syst Pharm. 2013;70:957-965.

³ Billstein-Leber M, Carrillo CJD, Cassano AT, Moline K, Robertson JJ. ASHP Guidelines on Preventing Medication Errors in Hospitals. Am J Health Syst Pharm. 2018;75(19):1493-1517.

US-PH121-240011 (v3.0) 12/2024

View source version on businesswire.com: https://www.businesswire.com/news/home/20241211980642/en/

Media Contact

Tara Reardon, (224) 948-5353

media@baxter.com

Investor Contact

Clare Trachtman, (224) 948-3020

Source: Baxter International Inc.

FAQ

What are the 5 new injectable products launched by BAX in 2024?

The five new products are Micafungin for Candida infections, Cyclophosphamide Injection for malignant diseases, Pantoprazole Sodium for GERD treatment, Cefazolin in 3g/150mL strength for various infections, and Levetiracetam for seizure treatment.

How many total injectable products has BAX launched in 2024?

Baxter International has launched a total of 10 injectable products in 2024, with five launches announced earlier in April and five new launches just announced.

What are the benefits of BAX's ready-to-use injectable formats?

The ready-to-use formats offer operational efficiencies, simplify medication preparation, reduce contamination risks, and help avoid potential errors that may occur during manual compounding processes.

What therapeutic areas does BAX's pharmaceutical portfolio focus on?

Baxter's pharmaceutical portfolio focuses on key therapeutic areas including critical care, anti-infectives, pain, and oncology.