aprocitentan
Tryvio
Pharmaceutical company: Idorsia Pharmaceuticals
Pharmacologic classification: Endothelin receptor antagonist
Therapeutic classification: Antihypertensive
AVAILABLE FORMS
Tablets (enteric-coated): 12.5 mg
INDICATIONS AND DOSAGES
Hypertension in combination with other antihypertensive drugs in patients who are not adequately controlled on other agents
Adults: 12.5 mg PO once daily.
CONTRAINDICATIONS AND CAUTIONS
- Boxed Warning: This drug is only available through the Tryvio REMS Program.
- Contraindicated in those hypersensitive to aprocitentan or any of its components, and patients who are pregnant.
- This drug may increase the risk of fluid retention. Use cautiously in older adults and in patients with heart failure or kidney impairment. Use is not recommended in patients with New Your Heart Association heart failure stage III to IV, unstable cardiac function, with N-terminal pro b-type natriuretic peptide greater than or equal to 500 pg/mL, eGFR less than 15 mL/minute, or in patients on dialysis.
- This drug may increase the risk of liver toxicity. Use is not recommended in patients with Child-Pugh class B or C liver impairment.
- This drug may increase the risk of anemia. Use is not recommended in patients with severe anemia.
- Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
- Safety and effectiveness in children have not been established.
- Dialyzable drug: Unlikely.
PREGNANCY-LACTATION-REPRODUCTION
- Boxed Warning: Tryvio can cause major birth defects if used during pregnancy. In patients who can become pregnant, a negative pregnancy test must be obtained prior to initiation of treatment, monthly during treatment, and for one month after stopping aprocitentan. Discontinue the drug if pregnancy is detected.
- Boxed Warning: Patients who can become pregnant must use acceptable methods of contraception prior to initiation of treatment, during treatment, and for one month after discontinuation.
- This drug may be present in human milk and may cause serious adverse effects to the breastfed infant. Breastfeeding is not recommended during treatment.
- This drug may adversely affect spermatogenesis and male fertility. It's unknown if the effects on fertility are reversible.
INTERACTIONS
Drug-drug. Antihypertensive drugs: May increase hypotensive effects. Monitor the patient.
ADVERSE REACTIONS
CV: edema, fluid retention.
Hematologic: anemia.
Reactions in bold italics are life-threatening.
Released: August 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
cefepime and enmetazobactam
Exblifep
Pharmaceutical company: Allecra Therapeutics
Pharmacologic classification: Combination cephalosporin and beta-lactamase inhibitor
Therapeutic classification: Antibiotic
AVAILABLE FORMS
Powder for injection: 2.5 g in a single-dose vial (2 g cefepime and 0.5 g enmetazobactam)
INDICATIONS AND DOSAGES
Complicated UTI, including pyelonephritis, caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex
Adults: 2.5-g IV infusion every 8 hours for 7 days and up to 14 days for patients with concurrent bacteremia.
Adjust-a-dose: If eGFR is 130 mL/minute or more, infuse 2.5 g IV every 8 hours over 4 hours. If eGFR is 30 to 59 mL/minute, infuse 1.25 g IV every 8 hours; if eGFR is 15 to 29 mL/minute, infuse 1.25 g IV every 12 hours; if eGFR is less than 15 mL/minute or the patient is receiving intermittent hemodialysis, give a loading dose of 1.25 g IV on the first day of treatment, followed by 0.625 g IV every 24 hours.
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in patients with a history of serious hypersensitivity reactions to cefepime, enmetazobactam, or other beta-lactam antibacterial drugs.
- Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs.
- Use cautiously in patients with altered kidney function.
- Neurotoxicity has been reported during treatment with cefepime, including life-threatening or fatal episodes of encephalopathy, aphasia, myoclonus, seizures, and nonconvulsive status epilepticus, especially in patients with kidney impairment who didn't receive an appropriate dosage adjustment.
- Positive direct Coombs tests with or without hemolysis have been reported during treatment with cefepime. If hemolytic anemia develops, discontinue the drug and institute appropriate therapy.
- To reduce development of drug-resistant bacteria and maintain effectiveness of antibacterial drugs, use the drug only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
- Safety and efficacy haven't been established in children.
- Use cautiously in older adults.
- Dialyzable drug: Yes.
- Overdose S&S: encephalopathy, myoclonus, seizures, neuromuscular excitability, nonconvulsive status epilepticus.
PREGNANCY-LACTATION-REPRODUCTION
- There are no available data with use in pregnancy.
- Positive Coombs test may be observed in newborns whose mothers have received cephalosporin antibacterial drugs during pregnancy.
- This drug appears in human milk; use cautiously during breastfeeding.
INTERACTIONS
Drug-drug. Aminoglycosides (gentamicin, tobramycin): May increase risk of kidney toxicity and ototoxicity. Monitor kidney function and hearing.
Diuretics (furosemide): May increase risk of kidney toxicity. Monitor kidney function.
ADVERSE REACTIONS
CNS: headache.
GI: diarrhea, vomiting, nausea.
Hematologic: anemia.
Hepatic: increased transaminase levels, bilirubinemia.
Skin: infusion site reactions.
Other: hypersensitivity reactions.
Reactions in bold italics are life-threatening.
Released: August 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer