Updates from FDA
APhA Staff
New drugs
ZONGERTINIB
(Hernexeos—Boehringer Ingelheim)
Drug class: Hernexeos is a kinase inhibitor.
Indication: Hernexeos is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
Recommended dosage and administration: Select patients for treatment with Hernexeos based on the presence of HER2 (ERBB2) tyrosine kinase domain activating mutations. The recommended dosage of Hernexeos is based on body weight. For patients weighing less than 90 kg, the recommended dose is 120 mg once daily. For patients weighing 90 kg or more, the recommended dose is 180 mg once daily. Hernexeos can be taken once daily with or without food until disease progression or unacceptable toxicity occurs.
Common adverse effects: The most common adverse effects include diarrhea, hepatoxicity, rash, fatigue, nausea, decreased lymphocytes, increased alanine aminotransferase, increased aspartate aminotransferase, decreased potassium, and increased γ-glutamyl transferase.
Warnings and precautions: Monitor liver function tests at baseline prior to administration, every 2 weeks during the first 12 weeks, and then monthly thereafter as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Interrupt, reduce the dose, or permanently discontinue Hernexeos based on severity. Before initiating, evaluate left ventricular ejection fraction and monitor at regular intervals during treatment and as clinically indicated. Interrupt, reduce the dose, or permanently discontinue Hernexeos based on severity. Monitor for new or worsening symptoms indicative of interstitial lung disease or pneumonitis. Interrupt, reduce the dose, or permanently discontinue Hernexeos based on severity. Hernexeos can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. Advise patients not to breastfeed during treatment. Avoid concomitant use with strong CYP3A inducers. If concomitant use cannot be avoided, increase the Hernexeos dose. Avoid concomitant use with certain BCRP substrates where minimal concentration increase may lead to serious adverse reactions and consider alternative therapies. If concomitant use cannot be avoided, monitor patients closely for adverse reactions and follow recommendations provided in the BCRP substrate approved product labeling. For other BCRP substrates, monitor for increased adverse reactions and adjust the dosages of those substrates as clinically appropriate.
BRENSOCATIB
(Brinsupri—Insmed Inc)
Drug class: Brinsupri is a dipeptidyl peptidase 1 (DPP1) inhibitor.
Indication: Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years and older.
Recommended dosage and administration: The recommended dosage is 10 mg or 25 mg orally once daily with or without food.
Common adverse effects: The most common adverse reactions include upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension.
Warnings and precautions: Monitor for new rash or skin conditions and refer to dermatology for evaluation. Gingival and periodontal adverse reactions can occur with Brinsupri use. Refer to dental care services for regular dental checkups and advise patients to perform routine dental hygiene. It is unknown whether administration of live attenuated vaccines during Brinsupri treatment will affect the safety or effectiveness of the vaccines. Avoid use of live attenuated vaccines.
DONIDALORSEN INJECTION
(Dawnzera—Ionis Pharmaceuticals)
Drug class: Dawnzera is a prekallikrein-directed antisense oligonucleotide.
Indication: Dawnzera is indicated for prophylaxis to prevent attacks of hereditary angioedema in adult and pediatric patients 12 years and older.
Recommended dosage and administration: The recommended dosage of Dawnzera is 80 mg administered subcutaneously every 4 weeks. A dosage of 80 mg every 8 weeks may also be considered.
Common adverse effects: The most common adverse reactions are injection site reactions, upper respiratory tract infections, UTIs, and abdominal discomfort.
Warnings and precautions: Dawnzera is contraindicated in patients with a history of serious hypersensitivity reactions, including anaphylaxis, to donidalorsen or any of the excipients in Dawnzera. Hypersensitivity reactions including anaphylaxis have been reported following use of Dawnzera. Advise patients to discontinue Dawnzera and seek immediate medical attention if serious hypersensitivity reactions occur. Use in patients with moderate and severe hepatic impairment is not recommended.
RILZABRUTINIB
(Wayrilz—Genzyme)
Drug class: Wayrilz is a kinase inhibitor.
Indication: Wayrilz is indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
Recommended dosage and administration: The recommended dosage is 400 mg orally twice daily. Wayrilz tablets should be swallowed whole with water and with or without food. Do not cut, crush, or chew the tablets.
Common adverse effects: The most common adverse reactions include diarrhea, nausea, headache, abdominal pain, and COVID-19.
Warnings and precautions: Monitor patients for signs and symptoms of infection, evaluate promptly, and treat. Evaluate bilirubin and transaminases at baseline and as clinically indicated during treatment, as hepatotoxicity may occur. Wayrilz may cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. Advise patients not to breastfeed during treatment. Avoid coadministration with moderate or strong CYP3A inhibitors and inducers. Avoid coadministration with PPIs. Wayrilz should be administered at least 2 hours before taking an antacid or H2 receptor antagonist.
New dosage forms
ESCITALOPRAM CAPSULES
(Escitalopram—Almatica)
Drug class: Escitalopram is an SSRI.
Indication: Escitalopram is indicated for the treatment of major depressive disorder in adults younger than 65 years and pediatric patients 12 years and older and for the treatment of generalized anxiety disorder in adults younger than 65 years.
Recommended dosage and administration: Escitalopram capsules are only available in a 15 mg strength. Use another escitalopram product for dosage initiation, titration, dosages other than 15 mg once daily, and for discontinuation. Escitalopram capsules are not indicated in geriatric patients and not recommended in patients with hepatic impairment. The recommended starting dose is 10 mg orally once daily of another escitalopram product. Based on response and tolerability, the dose may increase to the maximum recommended dosage of 20 mg once daily of another escitalopram product. Escitalopram capsules may be initiated in patients experiencing unfavorable tolerability to a 20 mg dose. Administer orally once daily with or without food. Swallow capsules whole. When discontinuing, reduce the dosage gradually using another escitalopram product.
Common adverse effects: The most common adverse reactions include insomnia, ejaculation disorder, nausea, increased sweating, fatigue and somnolence, decreased libido, and anorgasmia.
Boxed warning: There is an increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors.
Other warnings and precautions: Use of escitalopram is contraindicated in concomitant use of an MAOI or within 14 days of stopping an MAOI, in concomitant use of pimozide, and in patients with a known hypersensitivity to escitalopram or citalopram or any inactive ingredient in escitalopram capsules. There is an increased risk for serotonin syndrome when escitalopram is coadministered with other serotonergic agents but also when taken alone. If it occurs, discontinue treatment and initiate supportive therapies. When discontinuing escitalopram, reduce the dose gradually whenever possible, and monitor for discontinuation syndrome. Use with caution in patients with a history of seizures. Screen patients for bipolar disorder, as activation of mania or hypomania can occur. Hyponatremia can occur in association with syndrome of inappropriate antidiuretic hormone secretion. Concomitant use of NSAIDs, aspirin, other antiplatelet drugs, warfarin, and other anticoagulants may increase the risk of bleeding. Use caution when operating machinery as escitalopram may interfere with cognitive and motor performance. Avoid use of antidepressants, including escitalopram, in patients with untreated anatomically narrow angles. Use caution in patients with disease or conditions that produce altered metabolism or hemodynamic responses. Escitalopram may cause symptoms of sexual dysfunction. SSRI use, particularly in late pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation in the neonate.
ARTICAINE OPHTHALMIC SOLUTION
(Cyklx—AM Genomics)
Drug class: Cyklx is an amide local anesthetic.
Indication: Cyklx is indicated for ocular surface anesthesia prior to ocular procedures and intraocular injections in adults and pediatric patients.
Recommended dosage and administration: The recommended dosage is two drops applied 30 seconds apart to the ocular surface.
Common adverse effects: The most common adverse reaction is instillation site pain.
Warnings and precautions: Cyklx is contraindicated in patients with a hypersensitivity to any component of this preparation. Cyklx is not for injection or intraocular administration. Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. Prolonged use of topical ocular anesthetics may produce permanent corneal opacification and ulceration with accompanying visual loss. Do not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution. Cyklx should be administered by a health care provider and is not intended for patient self-administration. ■