Updates from FDA
APhA Staff
New molecular entities
SOTYKTU
(Deucravacitinib—Bristol-Myers Squibb)
Drug class: Deucravacitinib is a tyrosine kinase 2 inhibitor (TYK2).
Indication: Sotyktu is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Recommended dosage and administration: The recommended dosage is 6 mg orally once daily with or without food.
Common adverse effects: The most common adverse reactions in patients taking Sotyktu are upper respiratory infections, increased blood creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis, and acne.
Warnings and precautions: Sotyktu may cause a hypersensitivity reaction such as angioedema. It may increase the risk of infection and should be avoided in patients with an active infection. If a serious infection develops, discontinue Sotyktu use until the infection resolves. Patients should be evaluated for tuberculosis prior to initiating treatment. Malignancies such as lymphomas may occur. Elevated creatine phosphokinase (CPK) and rhabdomyolysis may also occur. Serum triglycerides liver enzymes should be evaluated at baseline and thereafter. Avoid use of Sotyktu with live vaccines. It is not known whether TYK2 inhibition may be associated with the observed or potential adverse reactions of Janus kinase inhibitor (JAK) inhibition. Sotyktu is not approved for use in rheumatoid arthritis. Use is not recommended in patients with severe hepatic impairment and is contraindicated in known hypersensitivity to deucravacitinib or any of the excipients in Sotyktu.
TERLIVAZ
(Terlipressin—Mallinckrodt Ireland)
Drug class: Terlipressin is a vasopressin receptor agonist.
Indication: Terlivaz is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Patients with a serum creatine of > 5 mg/dL are unlikely to experience benefit.
Recommended dosage and administration: The recommended dosage regimen is as follows. On days 1–3, administer Terlivaz 0.85 mg (1 vial) intravenously every 6 hours. On day 4, assess serum creatinine versus baseline. If serum creatinine has decreased by at least 30% from baseline, continue Terlivaz 0.85 mg intravenously every 6 hours. If serum creatinine has decreased by less than 30% from baseline, dose may be increased to Terlivaz 1.7 mg (2 vials) intravenously every 6 hours. If serum creatinine is at or above baseline value, discontinue Terlivaz. Continue Terlivaz until 24 hours after 2 consecutive serum creatinine evaluations less than or equal to 1.5 mg/dL values at least 2 hours apart or a maximum of 14 days.
Common adverse effects: The most common adverse reactions in patients taking Terlivaz are abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.
Black box warning: Terlivaz may cause serious or fatal respiratory failure. Patients with volume overload or acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygen saturation before initiating Terlivaz. Do not initiate in patients experiencing hypoxia until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue Terlivaz if SpO2 decreases below 90%.
Other warnings and precautions: Actively manage intravascular volume overload during treatment with Terlivaz and adjust therapy as appropriate. Adverse reactions related to Terlivaz may make a patient ineligible for liver transplantation. Terlivaz is a vasoconstrictor and can cause ischemic events that may require dose interruption or discontinuation. Terlivaz may cause fetal harm when used during pregnancy. Use is contraindicated in patients experiencing hypoxia or worsening respiratory symptoms and in patients with ongoing coronary, peripheral, or mesenteric ischemia.
OMLONTI
(Omidenepag isopropyl ophthalmic solution—Santen)
Drug class: Omidenepag isopropyl is a relatively selective prostaglandin E2 receptor agonist.
Indication: Omlonti is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Recommended dosage and administration: The recommended dosage is one drop in the affected eye(s) once daily in the evening.
Common adverse effects: The most common adverse reactions are conjunctival hyperemia, photophobia, blurred vision, dry eye, instillation site pain, eye pain, ocular hyperemia, punctate keratitis, headache, eye irritation, and visual impairment.
Warnings and precautions: Omlonti may cause pigmentation, eyelash changes, ocular inflammation, and macular edema.
ELUCIREM
(Gadopiclenol—Guerbet)
Drug class: Elucirem is a gadolinium-based contrast agent.
Indication: Elucirem is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging to detect and visualize lesions with abnormal vascularity in the brain, spine, head, neck, thorax, abdomen, pelvis, and musculoskeletal system.
Recommended dosage and administration: The recommended dosage is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec.
Common adverse effects: The most common adverse reactions in patients who received Elucirem are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, and localized swelling.
Other warnings and precautions: Elucirem should be avoided in patients with history of hypersensitivity reactions to gadopiclenol. Nephrogenic systemic fibrosis may occur in patients with impaired elimination of gadolinium-based contrast agents and there appears to be an increased risk in those who received higher than recommended dosing or repeat doses. Serious hypersensitivity reactions may occur and patients should be closely monitored for need of emergency cardiorespiratory support. Gadolinium is retained for months or years in brain, bone, and other organs. Elucirem should only be used during pregnancy if imaging is essential and cannot be delayed.
New indication
APONVIE
(Aprepitant—Heron Theraps Inc)
Drug class: Aprepitant is a substance P/neurokinin-1 (NK1) receptor antagonist.
Indication: Aponvie is indicated for the prevention of postoperative nausea and vomiting in adults.
Recommended dosage and administration: The recommended dose is 32 mg administered as a 30-second I.V. injection prior to induction of anesthesia.
Common adverse effects: The most common adverse effects are constipation, fatigue, headache, constipation, and hypotension.
Warnings and precautions: Hypersensitivity may occur during or soon after administration. If symptoms occur, administer appropriate medical therapy. Aponvie is a substrate, weak to moderate inhibitor, and inducer of CYP3A4. Following administration of Aponvie, there is a risk of decreased international normalized ratio (INR) of prothrombin time. Efficacy of contraceptives may be reduced for 28 days following administration of aprepitant. Use of Aponvie is contraindicated in known hypersensitivity to any component of this product or concurrent use with pimozide.
New dosage form
IHEEZO
(Chloroprocaine hydrochloride ophthalmic gel—Sintetica SA)
Drug class: Chloroprocaine hydrochloride is an ester anesthetic.
Indication: Iheezo is indicated for ocular surface anesthesia.
Recommended dosage and administration: The recommended dose
of Iheezo is 3 drops applied topically to the ocular surface in the area of
the planned procedure. It may be reapplied as needed to maintain
anesthetic effect.
Common adverse effects: The most common adverse effect is mydriasis.
Other warnings and precautions: Iheezo is contraindicated in patients with a history of hypersensitivity to any component of this preparation. Corneal injury due to insensitivity or corneal opacification may occur. ■