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New and Approved
Kate Setzler 352

New and Approved

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Updates from FDA

New drugs

IPTACOPAN

(Fabhalta—Novartis)

Drug class: Fabhalta is a complement factor B inhibitor.

Indication: Fabhalta is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria.

Recommended dosage and administration: The recommended dosage is 200 mg orally twice daily with or without food.

Common adverse effects: The most common adverse reactions in adults were headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea, and rash.

Boxed warning: Fabhalta increases the risk of serious and life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of Fabhalta unless the risks of delaying Fabhalta outweigh the risk of developing a serious infection. Comply with the most current ACIP recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. Patients receiving Fabhalta are at increased risk for invasive disease caused by encapsulated bacteria even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Fabhalta is available only through a restricted program under a REMS called Fabhalta REMS.

Other warnings and precautions: Fabhalta is contraindicated against serious hypersensitivity to iptacopan or any of the excipients and in patients with an unresolved serious infection caused by encapsulated bacteria. Monitor patients for signs of paroxysmal nocturnal hemoglobinuria after discontinuation of Fabhalta. Monitor serum lipid parameters periodically during treatment and initiate cholesterol-lowering medication if indicated as hyperlipidemia may occur. Coadministration with CYP2C8 inducers may decrease iptacopan exposure. Monitor for loss of efficacy. Coadministration with strong CYP2C8 inhibitors may increase iptacopan exposure and is not recommended. Use of Fabhalta is not recommended in people with severe renal or hepatic impairment.

EPLONTERSEN

(Wainua—Ionis Pharmaceuticals)

Drug class: Wainua is a transthyretin-directed antisense oligonucleotide.

Indication: Wainua is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Recommended dosage and administration: The recommended dosage of Wainua is 45 mg administered via S.C. injection once monthly. It should be administered into the abdomen or upper thigh region. The back of the upper arm can be used if a health care provider or caregiver administers the injection.

Common adverse effects: The most common adverse reactions were decreased vitamin A and vomiting.

Warnings and precautions: Supplement with the recommended daily allowance of vitamin A. Refer to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur.

New dosage forms

TRAVOPROST INTRACAMERAL IMPLANT

(iDose TR—Glaukos)

Drug class: iDose TR is a prostaglandin analog.

Indication: iDose TR is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Recommended dosage and administration: iDose TR is an intracameral implant containing 75 μg travoprost preloaded in a single-dose inserter. The intracameral administration should be carried out under standard aseptic conditions.

Common adverse effects: The most common adverse reactions were increases in intraocular pressure, iritis, dry eye, and visual field defects.

Warnings and precautions: iDose TR is contraindicated in ocular or periocular infections, corneal endothelial dystrophy, prior corneal transplantation, and hypersensitivity. iDose TR should be used with caution in patients with narrow angles and other angle abnormalities. Monitor patients routinely to confirm the location of the implant at the site of administration. Increased pigmentation of the iris can occur. Iris pigmentation is likely to be permanent.

ROFLUMILAST

(Zorvye—Arcutis Biotherapeutics)

Drug class: Zorvye is a phosphodiesterase 4 inhibitor.

Indication: Zorvye is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years and older.

Recommended dosage and administration: Zorvye is a topical foam that should be applied once daily to affected areas. It is not for ophthalmic, oral, or intravaginal use.

Common adverse effects: The most common adverse reactions are nasopharyngitis, nausea, and headache.

Warnings and precautions: Zorvye is contraindicated in people with moderate to severe liver impairment. The propellants in Zorvye foam are flammable. Avoid fire, flame, and smoking during and immediately following application. Coadministration of Zorvye with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are coadministered with Zorvye, weigh the potential for increased adverse reactions against benefit.

New indications

BELZUTIFAN

(Welireg—Merck Sharp Dohme)

Drug class: Welireg is a hypoxia-inducible factor inhibitor.

Indication: Welireg is indicated for treatment of adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors not requiring immediate surgery. Welireg is also now indicated for treatment of adult patients with advanced RCC following a programmed death receptor-1 or programmed death-ligand 1 inhibitor and a vascular endothelial growth
factor tyrosine kinase inhibitor.

Recommended dosage and administration: The recommended dosage of Welireg is 120 mg administered orally once daily with or without food.

Common adverse effects: The most common adverse reactions were decreased hemoglobin, fatigue, increased creatinine, headache, dizziness, increased glucose, nausea, musculoskeletal pain, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium, and increased aspartate aminotransferase.

Boxed warning: Exposure to Welireg during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of Welireg. Advise patients of these risks and the need for effective nonhormonal contraception. Welireg can render some hormonal contraceptives ineffective.

Warnings and precautions: Monitor for anemia before initiation of and periodically throughout treatment with Welireg. Withhold Welireg until hemoglobin is ≥8g/dL, then resume at the same or reduced dose or discontinue. For life-threatening anemia, or for anemia requiring urgent intervention, withhold Welireg until hemoglobin is ≥8 g/dL and resume at a reduced dose or permanently discontinue Welireg. Monitor oxygen saturation before initiation of and periodically throughout treatment with Welireg. For hypoxia at rest, withhold until resolved, resume at reduced dose, or discontinue permanently depending on severity. For life-threatening hypoxia, permanently discontinue Welireg. If used concomitantly with UGT2B17 or CYP2C19 inhibitors, monitor for signs and symptoms of anemia and hypoxia and reduce the dosage of Welireg as recommended in the package insert. Advise patients not to breastfeed during treatment with Welireg. Additionally, Welireg may impair fertility in males and females.

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