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New FDA Drug Approvals - November 2023


avacincaptad pegol

Izervay

Pharmaceutical company: Iveric Bio, Inc.

Pharmacologic classification: Complement C5 inhibitor

Therapeutic classification: Ophthalmic agent
 

AVAILABLE FORMS

Intravitreal solution: 20 mg/mL single-dose vial
 

INDICATIONS AND DOSAGES

Geographic atrophy secondary to age-related macular degeneration (AMD)

Adults: 2 mg (0.1 mL) by intravitreal injection to each affected eye once per month (approximately 28 days, plus or minus 7 days) for up to 12 months.
 

CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in those with ocular or periocular infections, or active intraocular inflammation.
  • Intravitreal injections may be associated with endophthalmitis and retinal detachment. Aseptic injection technique must be used to minimize the risk of endophthalmitis.
  • Use of this drug was associated with increased incidence of neovascular (wet) AMD.
  • Transient increased intraocular pressure (IOP) has been observed following intravitreal injection.
  • Dialyzable drug: Unknown.
 

PREGNANCY-LACTATION-REPRODUCTION

  • There are no adequate studies during pregnancy. Use cautiously during pregnancy.
  • It isn't known if this drug appears in human milk. Use cautiously during breastfeeding.
 

INTERACTIONS

None reported.
   

ADVERSE REACTIONS

EENT: conjunctival hemorrhage, increased IOP, blurred vision, choroidal neovascularization, neovascular AMD, eye pain, vitreous floaters, blepharitis.

Reactions in bold italics are life-threatening.
 

Released: November 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


lotilaner

Xdemvy

Pharmaceutical company: Tarsus Pharmaceuticals

Pharmacologic classification: Ectoparasiticide

Therapeutic classification: Antiparasitic
 

AVAILABLE FORMS

Ophthalmic solution: 0.25%
 

INDICATIONS AND DOSAGES

Demodex blepharitis

Adults: Instill one drop in each eye b.i.d. (approximately 12 hours apart) for 6 weeks.
 

CONTRAINDICATIONS AND CAUTIONS

  • Safety and effectiveness in children haven't been established.
  • Dialyzable drug: Unknown.
 

PREGNANCY-LACTATION-REPRODUCTION

  • There are no adequate studies on use during pregnancy or breastfeeding. Systemic exposure by ophthalmic route is limited. Use cautiously during pregnancy or breastfeeding.
 

INTERACTIONS

None reported.

 

ADVERSE REACTIONS
EENT: stinging and burning at instillation site, eyelid cyst, bacterial eyelid infection, corneal inflammation.

Reactions in bold italics are life-threatening.
 

Released: November 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer
 

ritlecitinib

Litfulo

Pharmaceutical company: Pfizer

Pharmacologic classification: Kinase inhibitor

Therapeutic classification: Immunosuppressant
 

AVAILABLE FORMS

Capsule: 50 mg
 

INDICATIONS AND DOSAGES

Severe alopecia areata

Adults and children age 12 and older: 50 mg PO once daily.
 

Adjust-a-dose: Discontinue this drug if platelet count is less than 50,000/mm3 or if absolute lymphocyte count (ALC) is less than 500/mm3. May restart once ALC returns above this value.

 

CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in patients with known hypersensitivity to ritlecitinib or its components. Hypersensitivity reactions, such as anaphylaxis, urticaria, and rash have been reported.
  • Boxed Warning: This drug increases the risk of serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death. Interrupt treatment if serious infection occurs until the infection is controlled.
  • Boxed Warning: This drug shouldn't be given to patients with active tuberculosis (TB). Avoid use in patients with active, serious infections.
  • Use cautiously in patients with chronic or recurrent infection, who have been exposed to TB, have a history of serious infection or opportunistic infection, who have resided or traveled in areas of endemic TB or mycoses, or with underlying conditions that may predispose them to infection.
  • Viral reactivation, including cases of herpes zoster, has occurred.
  • Boxed Warning: A higher rate of all-cause mortality, including sudden CV death, and major adverse CV events (MI, stroke) occurred with another janus kinase (JAK) inhibitor versus tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis (RA). This drug isn't approved for use in patients with RA.
  • Use cautiously in patients who are current or former smokers and with other CV risk factors.
  • Boxed Warning: Malignancies have occurred in patients treated with this drug. A higher rate of lymphomas and lung cancers have occurred with another JAK inhibitor versus TNF blockers in patients with RA.
  • Nonmelanoma skin cancer has been observed. Use cautiously in patients with a known malignancy other than successfully treated nonmelanoma skin cancer or cervical cancer. Patients who currently smoke or previously smoked may have an increased risk of malignancy.
  • Boxed Warning: Thrombosis has occurred in patients treated with this drug. An increased incidence of pulmonary embolism, and venous and arterial thrombosis occurred with another JAK inhibitor versus TNF blockers. Avoid this drug in patients who may be at increased risk for thrombosis.
  • This drug isn't recommended in patients with Child-Pugh class C liver impairment, hepatitis B or hepatitis C.
  • Safety and effectiveness in children younger than age 12 haven't been established.
  • Use cautiously in older adults who generally have a higher incidence of infections.
  • Dialyzable drug: Unknown.
 

PREGNANCY-LACTATION-REPRODUCTION

  • Studies during pregnancy are inadequate. It's unknown if this drug causes harm to a fetus. Report pregnancies to the pregnancy exposure registry at 1-877-390-2940.
  • There is no data on the appearance of this drug in human milk, but the drug is present in animal milk. Because of potential adverse effects, breastfeeding isn't recommended during treatment and for 14 hours after the last dose.
 

INTERACTIONS

Drug–drug. CYP3A inducers (rifampin): May decrease ritlecitinib level. Use together isn't recommended.
CYP3A substrates (midazolam), CYP1A2 substrates (clozapine, theophylline, zolpidem): Increases substrate level and risk of adverse reactions. Monitor patient closely and adjust substrate dosage as needed.
JAK inhibitors, biologic immunomodulators, potent immunosuppressants (cyclosporine): May enhance adverse reactions of immunosuppressants. Avoid use together.
Live vaccines: May increase risk of vaccine-associated infection and diminish therapeutic effect of vaccine. Avoid live vaccines just prior to and during treatment.
Drug–food. Caffeine: May increase risk of adverse reactions of caffeine. Use together cautiously.

ADVERSE REACTIONS

CNS: dizziness, headache, fever.
GI: diarrhea, stomatitis.
Hematologic: decreased RBC count.
Metabolic: increased CK level.
Skin: acne, rash, urticaria, folliculitis, atopic dermatitis.
Other: herpes zoster, infection.

Reactions in bold italics are life-threatening.
 

Released: November 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer

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