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New FDA Drug Approvals - September 2023


fezolinetant

Veozah

Pharmaceutical company: Astellas Pharma

Pharmacologic classification: Neurokinin 3 receptor antagonist

Therapeutic classification: Menopause drug
 

AVAILABLE FORMS

Tablets: 45 mg
 

INDICATIONS AND DOSAGES

Moderate to severe vasomotor symptoms due to menopause

Adults: 45 mg PO once daily.
 

CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in patients with known cirrhosis, severe kidney impairment or kidney failure.
  • Safety and efficacy in children haven't been established.
  • Dialyzable drug: Unknown.
 

PREGNANCY-LACTATION-REPRODUCTION

  • There are no data on the risks associated with the use of this drug during pregnancy.
  • It's unknown if this drug appears in human milk.
 

INTERACTIONS

Drug-drug. 
CYP1A2 inhibitors (cimetidine, ciprofloxacin, fluvoxamine): May increase fezolinetant level. Use together is contraindicated.
 

ADVERSE REACTIONS

CNS: insomnia.
GI: abdominal pain, diarrhea.
Hepatic: transaminase elevation.
Musculoskeletal: back pain.
Other: hot flash.

Reactions in bold italics are life-threatening.
 

Released: September 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


perfluorohexyloctane

Miebo

Pharmaceutical company: Bausch and Lomb

Pharmacologic classification: Semifluorinated alkane

Therapeutic classification: Miscellaneous ophthalmic drug
 

AVAILABLE FORMS

Ophthalmic solution:  100% multi-dose bottles
 

INDICATIONS AND DOSAGES

Dry eye disease

Adults:  Instill one drop q.i.d. into affected eye(s).
 

CONTRAINDICATIONS AND CAUTIONS

  • Safety and effectiveness in patients younger than age 18 have not been established.
  • Dialyzable drug: Unknown.
 

PREGNANCY-LACTATION-REPRODUCTION

  • There are no adequate studies during pregnancy. Use cautiously during pregnancy.
  • There are no data on the presence of this drug in human milk, its effects on breastfed infants, or on milk production. Use cautiously during breastfeeding.
 

INTERACTIONS

None reported by the manufacturer.
 

ADVERSE REACTIONS
EENT: blurred vision, conjunctival redness.

Reactions in bold italics are life-threatening.
 

Released: September 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer
 

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