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New FDA Drug Approvals - December 2022


deucravacitinib

Sotyktu

Pharmaceutical company: Bristol-Myers Squibb

Pharmacologic classification:Janus kinase inhibitor

Therapeutic classification:Antipsoriatic

AVAILABLE FORMS

Tablets: 6 mg

INDICATIONS AND DOSAGES

Moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy

Adults:6 mg PO once daily.

CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in patients hypersensitive to the drug or its components. Hypersensitivity reactions, including angioedema, have been reported.
  • Use cautiously in patients with known or suspected liver disease. This drug isn’t recommended in patients with severe hepatic impairment (Child-Pugh C).
  • This drug isn’t recommended for use in patients with active hepatitis B or hepatitis C.
  • This drug may increase risk of infection. Avoid use in patients with active or serious infection.
  • Use cautiously in patients with chronic or recurrent infection, exposure to tuberculosis (TB), history of serious or opportunistic infection, with underlying conditions that predispose them to infection.
  • Evaluate for active or latent TB prior to initiating treatment. Don’t administer to patients with active TB. This drug may reactivate latent TB. Initiate treatment of latent TB prior to administering the drug. Consider anti-TB therapy in patients with a history of latent or active TB when an adequate course of treatment can’t be confirmed.
  • Malignancies, including lymphomas, were observed in clinical trials. Use cautiously in patients with known malignancy and patients who develop malignancy during treatment.
  • Higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding nonmelanoma skin cancer) were observed in patients treated with a JAK inhibitor compared to those treated with TNF blockers in rheumatoid arthritis patients; this drug isn’t approved for use in rheumatoid arthritis.
  • Safety and effectiveness in children haven’t been established.
  • Use cautiously in older adults as the incidence of adverse reactions may be higher in this population.
  • Dialyzable drug: 5.4%.

PREGNANCY-LACTATION-REPRODUCTION

  • It’s unknown if this drug causes harm to a fetus. Report pregnancies to Bristol-Myers Squibb’s Adverse Event reporting line (1-800-721-5072).
  • There is no data on the appearance of this drug in human milk, its effects on the breastfed infant, or on milk production. This drug is excreted in rat milk. Weigh the risk to the infant versus the benefit to the patient.

INTERACTIONS

Drug-drug. Live vaccines: May increase risk of infection. Avoid use during deucravacitinib therapy.

Potent immunosuppressants: May increase immunosuppression. Use together isn’t recommended.

ADVERSE REACTIONS

EENT: mouth ulcers.

Hepatic: increased liver enzymes.

Metabolic: increased CK level.

Musculoskeletal: rhabdomyolysis.

Respiratory: upper respiratory infection.

Skin: folliculitis, acne.

Other: infection (bacterial and viral), malignancy.

Reactions in bold italics are life-threatening.

Released: December 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


omidenepag isopropyl

Omlonti

Pharmaceutical company: Santen Pharmaceutical and UBE Corporation

Pharmacologic classification:Selective prostaglandin E2 receptor agonist

Therapeutic classification:Antiglaucoma drug–antihypertensive

AVAILABLE FORMS

Ophthalmic solution: 0.002% (0.02 mg/mL)

INDICATIONS AND DOSAGES

Reduction of elevated intraocular pressure in patient with open-angle glaucoma or ocular hypertension

Adults:Instill one drop in the affected eye(s) once daily in the evening.

CONTRAINDICATIONS AND CAUTIONS

  • Irreversible increase in brown pigmentation of the iris may occur and may not be noticeable for months to years.
  • This drug may gradually increase pigment of the periorbital tissues and increase length, thickness, and number of lashes or hairs of the treated eye. These are usually reversible upon discontinuation.
  • Ocular inflammation has been reported. Use caution in patients with active ocular inflammation, including iritis or uveitis.
  • Macular edema has been reported. Use caution in patients with aphakic or pseudophakic glaucoma, or in patients with risk factors for macular edema.
  • Dialyzable drug: Not likely.

PREGNANCY-LACTATION-REPRODUCTION

  • There are no data on the use of this drug in pregnant women. Use cautiously during pregnancy.
  • There are no data on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to omidenepag following topical ocular administration is low.

INTERACTIONS

None reported.

ADVERSE REACTIONS

CNS: headache.

EENT: conjunctival hyperemia, photophobia, blurred vision, dry eye, instillation site pain, eye pain, ocular hyperemia, punctate keratitis, eye irritation, visual impairment.

Reactions in bold italics are life-threatening.

Released: December 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


terlipressin

Terlivaz

Pharmaceutical company: Mallinckrodt Pharmaceuticals

Pharmacologic classification:Posterior pituitary hormone

Therapeutic classification:Vasoconstrictor

AVAILABLE FORMS

Powder for injection: 0.85-mg single-dose vial

INDICATIONS AND DOSAGES

To improve kidney function in patients with hepatorenal syndrome with rapid reduction in kidney function

Adults: 0.85 mg (1 vial) IV bolus over 2 minutes every 6 hours on days 1 to 3.

On day 4, compare serum creatinine (SCr) to baseline. If SCr has decreased by 30% or more, continue 0.85 mg IV bolus every 6 hours. If SCr has decreased by less than 30%, increase dose to 1.7 mg (2 vials) IV bolus every 6 hours. If SCr is at or above baseline, discontinue the drug. Continue for 24 hours after two consecutive SCr values at least 2 hours apart of less than 1.5 mg/dL have been achieved or for a maximum of 14 days. 

CONTRAINDICATIONS AND CAUTIONS

  • Black Box Warning: This drug may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) grade 3 are at increased risk.
  • Use is contraindicated in patients experiencing hypoxia or worsening respiratory symptoms and in patients with ongoing coronary, peripheral, or mesenteric ischemia.
  • Avoid use in ACLF grade 3.
  • Terlipressin-related adverse reactions may make a patient ineligible for liver transplantation. The benefits of the drug in patients with high priority for liver transplantation may not outweigh its risks.
  • This drug is a vasoconstrictor and can cause ischemic events (cardiac, cerebrovascular, peripheral, or mesenteric). Avoid use in patients with a history of severe CV conditions, cerebrovascular, and ischemic disease. Discontinue in patients who experience signs or symptoms suggestive of ischemia.
  • Patients with SCr greater than 5 mg/dL are unlikely to benefit from this drug.
  • Safety and effectiveness in children haven’t been established.
  • Use cautiously in older adults who may be more sensitive to the drug’s effects.
  • Dialyzable drug: Unknown.

PREGNANCY-LACTATION-REPRODUCTION

  • This drug may cause fetal harm as it induces uterine contractions and endometrial ischemia. Advise patients of the risk to the fetus.
  • There are no data on the presence of this drug in human or animal milk or on its effects on the breastfed infant or milk production. Evaluate the risk to the infant versus the benefit to the patient.

INTERACTIONS

None reported.

ADVERSE REACTIONS

CV: bradycardia.

GI: abdominal pain, nausea, diarrhea.

Metabolic: fluid overload.

Respiratory: respiratory failure, dyspnea, pleural effusion.

Other: sepsis, ischemia-related events.

Reactions in bold italics are life-threatening.

Released: December 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

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