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New FDA Drug Approvals - October 2024


imetelstat

Rytelo

Pharmaceutical company: Geron Corporation

Pharmacologic classification: Oligonucleotide telomerase inhibitor

Therapeutic classification: Antineoplastic

AVAILABLE FORMS

Powder for injection (preservative-free): 47-mg, 188-mg single-dose vials

INDICATIONS AND DOSAGES

Low- to intermediate-risk myelodysplastic syndromes in patients with transfusion-dependent anemia requiring 4 or more RBC units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents

Adults: 7.1-mg/kg IV infusion every 4 weeks. Discontinue if the need for RBC transfusions doesn't decrease after 24 weeks of treatment (six doses) or for unacceptable toxicity.

Adjust-a-dose:  Grade 3 or 4 adverse reactions may require temporary dose delay, dose reductions, or treatment discontinuation. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.

CONTRAINDICATIONS AND CAUTIONS

  • Use of this drug hasn't been established in patients with creatinine clearance of less than 30 mL/minute or Child-Pugh class C liver impairment.
  • Safety and effectiveness in children haven't been established.
  • Dialyzable drug: Unknown.

PREGNANCY-LACTATION-REPRODUCTION

  • This drug may cause embryo-fetal harm. Avoid use during pregnancy. Patients of childbearing potential should use effective contraception during treatment and for 1 week after the last dose.
  • Because of the risk to breastfed children, breastfeeding isn't recommended during treatment and for 1 week after the last dose.
  • This drug may cause reversible fertility impairment in patients of childbearing potential.

INTERACTIONS

None reported by the manufacturer.

ADVERSE REACTIONS

CNS: fatigue, headache, syncope.
CV: HF, hemorrhage, atrial arrhythmia.
EENT: epistaxis.
Hematologic: neutropenia, leukopenia, thrombocytopenia, prolonged PTT, hematoma.
Hepatic: increased liver function studies.
Musculoskeletal: arthralgia, myalgia, fracture.
Other: sepsis, infection, COVID-19, infusion-related reactions.

Reactions in bold italics are life-threatening.
 

Released: October 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


ceftobiprole medocaril

Zevtera

Pharmaceutical company: Basilea Pharmaceutica International

Pharmacologic classification: Cephalosporin

Therapeutic classification: Antibiotic

AVAILABLE FORMS

Powder for injection: 667-mg single-dose vials

INDICATIONS AND DOSAGES

Staphylococcus aureus bloodstream infections, including right-sided infective endocarditis

Adults: 667 mg IV every 6 hours on days 1 to 8, then every 8 hours on day 9 and thereafter. May treat for up to 42 days.

Acute bacterial skin and skin structure infections (ABSSSI) caused by strains of Staphylococcus aureus, Streptococcus pyogenes, and Klebsiella pneumoniae

Adults: 667 mg IV every 8 hours for 5 to 14 days.

Community-acquired bacterial pneumonia (CABP) caused by strains of Staphylococcus aureus, Streptococcus pneumoniae (methicillin-susceptible isolates), Haemophilus influenzae, H. parainfluenzae, Escherichia coli, and K. pneumoniae

Adults: 667 mg IV every 8 hours for 5 to 14 days.
Children ages 12 to less than 18 years: 13.3 mg/kg (up to 667 mg/dose) every 8 hours for 7 to 14 days.
Children ages 3 months to less than 12 years: 20 mg/kg (up to 667 mg/dose) every 8 hours for 7 to 14 days.

Adjust-a-dose (for CABP): Refer to the manufacturer's instructions for dosage adjustments for children ages 2 to less than 18 years old with kidney impairment. Dosage adjustments for children less than 2 years of age with any degree of kidney impairment haven't been established.

Adjust-a-dose(for all indications): For adults with creatinine clearance (CrCl) greater than 150 mL/minute, increase dosage to 667 mg every 6 hours. For adults with CrCl less than 15 mL/minute including patients on hemodialysis, decrease dosage to 333 mg every 24 hours. For adults with CrCl of 15 to less than 50 mL/minute, refer to the manufacturer's instructions for dosage adjustments based on indication and CrCl.

CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated for use in patients with known history of severe hypersensitivity to this drug or other cephalosporins.
  • This drug isn't indicated for treatment of ventilator-associated bacterial pneumonia. Increased mortality has been reported.
  • Serious and sometimes fatal hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving beta-lactam antibacterial drugs.
  • Seizures and other CNS reactions have been reported especially in patients with a history of epilepsy or lack of dose adjustment for kidney impairment. Ensure patients with known seizure disorders continue anticonvulsant therapy.
  • Don't use this drug in the absence of proven or strongly suspected bacterial infection as the risk of drug-resistant bacteria increases and the patient is unlikely to benefit from treatment.
  • Safety and effectiveness for the treatment of Staphylococcus aureus blood stream infections and ABSSSI in children haven't been established.
  • Dialyzable drug: Yes.

PREGNANCY-LACTATION-REPRODUCTION

  • There are no adequate studies during pregnancy. Use during pregnancy only if the benefit outweighs fetal risk.
  • It isn't known if this drug appears in human milk, or how the drug affects milk production or infants who are breastfed. Weigh the benefit to the patient against the risk to the infant before use.

INTERACTIONS

Drug-drug. OATP1B1 and OATP1B3 substrates (statins, repaglinide, olmesartan, enalapril, some chemotherapeutic agents): May increase substrate level. Use together is not recommended.

ADVERSE REACTIONS

CNS: fever, headache, dizziness, altered sense of taste, seizures, insomnia.
CV: hypertension, phlebitis.
GI: nausea, vomiting, diarrhea, abdominal pain.
GU: increased creatinine levels.
Hematologic: anemia, leukopenia.
Hepatic: increased liver enzymes, hyperbilirubinemia.
Metabolic: hypokalemia, hyponatremia.
Respiratory: dyspnea, pleuritis, aggravated pneumonia.
Skin: injection site reactions, rash, pruritus, urticaria.
Other: fungal infection, hypersensitivity reactions including angioedema and anaphylaxis, death.

Reactions in bold italics are life-threatening.
 

Released: October 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

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