New & Approved
New drugs
FEZOLINETANT
(Veozah—Astellas Pharma)
Drug class: Veozah is a neurokinin 3 (NK3) receptor antagonist.
Indication: Veozah is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Recommended dosage and administration: Baseline bloodwork should be performed to evaluate for hepatic function and injury before beginning treatment with Veozah. While using Veozah, follow-up bloodwork should be performed at 3 months, 6 months, and 9 months after initiation of therapy and when symptoms suggest liver injury. The recommended daily dosage is 45 mg (1 tablet) once daily with or without food.
Common adverse effects: The most common adverse reactions with Veozah are abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation.
Warnings and precautions: Veozah is contraindicated in known cirrhosis, severe renal impairment or end-stage renal disease, and concomitant use with CYP1A2 inhibitors. Do not start therapy with Veozah if serum transaminase concentration is equal to or exceeds two times the upper limit of normal. Elevations in serum transaminase concentrations greater than three times the upper limit of normal occurred in the clinical trials.
FLOTULFOLASTAT F 18
(Posluma—Blue Earth Diagnostics)
Drug class: Posluma is a radioactive diagnostic agent.
Indication: Posluma is indicated for positron emission tomography (PET) of prostate-specific membrane antigen positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level.
Recommended dosage and administration: The recommended amount of radioactivity of Posluma is 296 MBq (8 mCi) administered as an intravenous bolus injection. Initiate imaging approximately 60 minutes after administration. Scanning should start from mid-thigh and proceed to the base of skull.
Common adverse effects: The most common adverse reactions are diarrhea, BP increase, and injection site pain.
Warnings and precautions: Image interpretation errors can occur with Posluma imaging. Interpretation of Posluma PET may differ depending on imaging readers in patients with suspected recurrence of prostate cancer. Consider multidisciplinary consultation and histopathological confirmation. Posluma contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
SOTAGLIFLOZIN
(Inpefa—Lexicon Pharmaceuticals)
Drug class: Inpefa is a sodium glucose cotransporter 2 (SGLT-2) inhibitor.
Indication: Inpefa is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent care visits in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.
Recommended dosage and administration: Correct volume status before starting Inpefa at 200 mg daily and titrate to 400 mg as tolerated. In patients with decompensated heart failure, begin dosing when patients are hemodynamically stable. Withhold Inpefa for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting.
Common adverse effects: The most common adverse reactions are UTI, volume depletion, diarrhea, and hypoglycemia.
Warnings and precautions: Inpefa is contraindicated in patients with a history of serious hypersensitivity reaction to Inpefa. Monitor digoxin levels if used concomitantly. Sotagliflozin exposure is reduced if taken concomitantly with uridine 5’-diphospho-glucuronosyltransferase inducers. Monitor serum lithium concentrations if used concomitantly. Advise patients of reproductive potential of the potential risk to a fetus especially during the second and third trimesters. Inpefa is not recommended while breastfeeding. Higher incidence of adverse reactions related to volume depletion have occurred in geriatrics and renal impairment. Consider ketone monitoring in patients with type 1 diabetes and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue Inpefa if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. Before initiating therapy with Inpefa, correct volume status. Monitor for signs and symptoms of hypotension during therapy. Monitor for signs and symptoms of urosepsis and pyelonephritis during therapy and treat promptly. A lower dose of insulin or insulin secretagogue may be required if used concomitantly with Inpefa. Monitor for pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise as necrotizing fasciitis of the perineum may occur. Discontinue Inpefa and treat urgently. Monitor and treat genital mycotic infections as appropriate.
SULBACTAM AND DURLOBACTAM
(Xacduro—Entasis Therapeutics)
Drug class: Xacduro is a copackaged product containing sulbactam, a beta-lactam antibacterial and beta lactamase inhibitor, and durlobactam, which is a beta lactamase inhibitor.
Indication: Xacduro is indicated in patients 18 years and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Xacduro is not indicated for the treatment of HABP/VABP caused by other pathogens. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Xacduro and other antibacterial drugs, Xacduro should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Recommended dosage and administration: Admister Xacduro (1 g of sulbactam, 1 g of durlobactam) every 6 hours by intravenous infusion over 3 hours in patients with creatine clearance of 45–129 mL/min. Dosing regimen adjustments are recommended for creatine clearance <45 mL/min or ≥130 mL/min. Administer all doses of Xacduro by intravenous infusion over 3 hours.
Common adverse effects: The most common adverse reactions with Xacduro are liver test abnormalities, diarrhea, anemia, and hypokalemia.
Warnings and precautions: Xacduro is contraindicated in patients with a known history of severe hypersensitivity to the components of Xacduro or other beta-lactam antibacterial drugs. Serious and occasionally fatal hypersensitivity reactions have been reported with beta-lactam antibacterial drugs. Hypersensitivity was observed in patients treated with Xacduro. If an allergic reaction occurs, discontinue therapy.
Clostridioides difficile–associated diarrhea has been reported with nearly all systemic antibacterial agents, including Xacduro. Evaluate if diarrhea occurs. Concomitant administration with OAT1 inhibitors may increase plasma concentrations of Xacduro. Concomitant administration is not recommended.
New indications
BREXIPIPRAZOLE
(Rexulti—Otsuka Pharmaceutical)
Drug class: Rexulti is an atypical antipsychotic.
Indication: Rexulti is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults, treatment of schizophrenia in adults and pediatric patients ages 13 years and older, and treatment of agitation associated with dementia due to Alzheimer disease. Though indicated for daily treatment, Rexulti is not indicated as an as-needed treatment for agitation associated with dementia due to Alzheimer disease.
Recommended dosage and administration: Adminster Rexulti once daily with or without food. For treatment of major depressive disorder in adults, the starting dosage is 0.5 mg/day or 1 mg/day, with a recommended target dosage of 2 mg/day and maximum dosage of 3 mg/day. For treatment of schizophrenia in adults, the starting dosage is 1 mg/day with a recommended target dosage of 2 mg/day to 4 mg/day and a maximum dosage of 4 mg/day. For treatment of schizophrenia in pediatric patients, the starting dosage is 0.5 mg/day with a recommended target dosage of 2 mg/day to 4 mg/day and a maximum dosage of 4 mg/day. For treatment of agitation associated with dementia due to Alzheimer disease, the starting dosage is 0.5 mg/day with a recommended target dosage of 2 mg/day and a maximum dosage of 3 mg/day. In moderate to severe hepatic impairment or a creatine clearance of <60 mL/min, the maximum recommended dosage is 2 mg once daily for patients with major depressive disorder or agitation associated with dementia due to Alzheimer disease and 3 mg once daily for patients with schizophrenia.
Common adverse effects: The most common adverse reactions with Rexulti in adults were increased weight, somnolence, akathisia, nasopharyngitis, and dizziness.
Warnings and precautions: Rexulti is contraindicated in known hypersensitivity to Rexulti or any of its components. Extrapyramidal and withdrawal symptoms may be seen in neonates with third trimester exposure. If taken with strong CYP2D6 or CYP3A4 inhibitors, administer half of the recommended dosage. If taken with strong/moderate CYP2D6 with strong/moderate CYP3A4 inhibitors, administer a quarter of the recommended dosage. In known CYP2D6 poor metabolizers taking strong/moderate CYP3A4 inhibitors, administer a quarter of the recommended dosage. If taken with strong CYP3A4 inducers, double the recommended dosage and further adjust based on clinical response. There is an increased incidence of cerebrovascular adverse reactions in older patients with dementia-related psychosis. Manage neuroleptic malignant syndrome with immediate discontinuation and close monitoring. If tardive dyskinesia occurs, discontinue if clinically appropriate. Monitor for hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. If pathological gambling or other compulsive behaviors occur, consider dose reduction or discontinuation. Perform complete blood counts in patients with pre-existing low white blood cells count or history of leukopenia or neutropenia. Consider discontinuing Rexulti if a clinically significant decline in white blood cell count occurs in absence of other causative factors. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope of the risk for orthostatic hypotension and syncope. Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. ■