Updates from FDA
APhA Staff
New drugs
ELINZANETANT
(Lynkuet—Bayer Healthcare Pharmaceuticals)
Drug class: Lynkuet is a neurokinin 1 and neurokinin 3 receptor antagonist.
Indication: Lynkuet is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Recommended dosage and administration: The recommended dosage is 120 mg (two 60 mg capsules) orally once daily at bedtime, with or without food.
Common adverse effects: The most common adverse reactions are headache, fatigue, dizziness, and somnolence.
Warnings and precautions: Lynkuet is contraindicated in pregnancy. Advise patients about the potential for somnolence and other nervous system effects. Advise patients who experience these effects to refrain from driving or engaging in hazardous occupations or activities until the effects have resolved. Perform bloodwork prior to initiation of Lynkuet to evaluate for hepatic function and injury. Do not start therapy if serum transaminase concentration is equal to or exceeds two times the upper limit of normal or if the total bilirubin is equal to or exceeds two times the upper limit of normal. Perform follow-up evaluations of hepatic transaminase concentration 3 months after initiation. Advise patients to discontinue Lynkuet immediately if signs or symptoms suggesting liver injury occur. There is a risk of seizure in patients with a history of seizures taking Lynkuet. Avoid concomitant use with strong CYP3A4 inhibitors and grapefruit. Reduce the Lynkuet dose to 60 mg once daily if taken concomitantly with moderate CYP3A4 inhibitors. Avoid concomitant use with strong or moderate CYP3A4 inducers. Lynkuet is not recommended in patients with end stage renal disease with or without hemodialysis or in those with moderate to severe hepatic impairment.
NERANDOMILAST
(Jascayd—Boehringer Ingelheim)
Drug class: Jascayd is a phosphodiesterase 4 inhibitor.
Indication: Jascayd is indicated for the treatment of idiopathic pulmonary fibrosis in adult patients.
Recommended dosage and administration: The recommended dosage is 18 mg orally twice daily approximately 12 hours apart, with or without food. Reduce the Jascayd dose to 9 mg twice daily for patients who are unable to tolerate 18 mg twice daily, except in patients taking concomitant pirfenidone. Swallow tablets whole or dispersed in water.
Common adverse effects: The most common adverse reactions are diarrhea, COVID-19, upper respiratory tract infection, depression, decreased weight, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.
Warnings and precautions: If taken concomitantly with strong CYP3A inhibitors, reduce the Jascayd dose to 9 mg twice daily. Avoid concomitant use with moderate or strong CYP3A inducers.
New indications
FERUMOXYTOL
(Ferabright—Covis)
Drug class: Ferabright is an iron-based contrast agent.
Indication: Ferabright is indicated for MRI of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood brain barrier.
Recommended dosage and administration: The recommended dosage of Ferabright is based on patient weight. In patients weighing 50 kg or less, 300 mg of elemental iron should be administered as a single I.V. infusion over at least 15 minutes. In patients weighing 51 kg or more, 510 mg of elemental iron should be administered as a single I.V. infusion over at least 15 minutes. Ferabright must be diluted before administration in either 0.9% sodium chloride injection or 5% dextrose injection to achieve concentrations of 2 mg/mL to 8 mg/mL of elemental iron. Obtain post-contrast T1-weighted images approximately 24 hours after administration.
Common adverse effects: The most common adverse reactions are nausea, pruritus, constipation, headache, diarrhea, increased BP, bleeding, hyperpigmentation, vein injury, taste alteration, burning/tingling sensation with injection, allergic rhinitis, red sclera, back pain, vomiting, and increased ALT.
Boxed warning: Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol products that contain the same active ingredient as Ferabright. Initial signs may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest. Hypersensitivty reactions have occurred even in patients who previously tolerated ferumoxytol. Only administer Ferabright as an I.V. infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Ferabright infusion including monitoring of BP and pulse during and after Ferabright administration.
Other warnings and precautions: Ferabright is contraindicated in known hypersensitivity to ferumoxytol, any of Ferabright’s components, or any other I.V. iron products. Monitor for signs and symptoms of hypotension following administration. Avoid use of Ferabright in patients with iron overload. Conduct other anticipated MRI studies prior to the administration of Ferabright or use T1 or proton density weighted pulse sequences if MRI is required within 3 months after administration. Be aware of the potentially limited interpretability of changes in lesion contrast appearance if prior images were not obtained with Ferabright.
RISPERIDONE EXTENDED-RELEASE INJECTABLE SUSPENSION
(Uzedy—Teva)
Drug class: Uzedy is an atypical antipsychotic.
Indication: Uzedy is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.
Recommended dosage and administration: Establish tolerability with oral risperidone prior to initiating Uzedy. Administer Uzedy monthly by S.C. injection in the abdomen or upper arm by a health care professional. Do not administer by any other route. Recommended dosing is based on the comparable daily oral risperidone therapy.
Common adverse effects: The most common adverse reactions are parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, pruritus, and pharyngolaryngeal pain.
Boxed warning: Older adult patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Uzedy is not approved for use in patients with dementia-related psychosis.
Other warnings and precautions: Uzedy is contraindicated in patients with known hypersensitivity to risperidone, paliperidone, or to any of the components in Uzedy. Manage neuroleptic malignant syndrome with immediate discontinuation and close monitoring. Tardive dyskinesia, metabolic changes, hyperprolactinemia, orthostatic hypotension, leukopenia, cognitive and motor impairment, seizures, and priapism may occur with use of Uzedy. Strong CYP2D6 inhibitors increase risperidone plasma concentration and strong CYP3A4 inducers decrease plasma concentrations of risperidone. Use during pregnancy may cause extrapyramidal or withdrawal symptoms in neonates with third trimester exposure.
New dosage forms
CLONIDINE HYDROCHLORIDE ORAL SOLUTION
(Javadin—Azurity)
Drug class: Javadin is a central a-2 adrenergic agonist.
Indication: Javadin is indicated for the treatment of hypertension in adult patients to lower BP.
Recommended dosage and administration: The initial dosage is 0.1 mg orally twice daily with or without food. Titrate in increments of 0.1 mg per day at weekly intervals if necessary until the desired response is achieved. The therapeutic doses most commonly used range from 0.2 mg to 0.6 mg per day, given in divided doses. The maximum recommended daily dose is 2.4 mg.
Common adverse effects: The most common adverse reactions are dry mouth, drowsiness, dizziness, constipation, and sedation.
Warnings and precautions: Javadin is contraindicated in patients with known hypersensitivity to clonidine. Clonidine may cause bradycardia, conduction abnormalities, and hypotension. Titrate slowly in patients with syncope, heart block, or vascular disease. Monitor BP and heart rate. Avoid drugs affecting sinus or AV node function. Abrupt discontinuation of Javadin may cause rebound hypertension. Taper gradually over 2 to 4 days. Continue administration up to 4 hours before surgery and resume promptly postoperatively. Clonidine may cause sedation.Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates, or other sedating drugs. Tricyclic antidepressants may reduce the hypotensive effect of clonidine. Neuroleptics may induce or exacerbate orthostatic regulation disturbances. Caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction due to a potential for additive effects such as bradycardia and AV block. Patients with renal impairment may require a lower initial dose.
FUROSEMIDE S.C. INJECTION
(Lasix ONYU—SQ Innovation)
Drug class: Lasix ONYU is a loop diuretic.
Indication: Lasix ONYU is indicated for the treatment of edema in adult patients with chronic heart failure.
Recommended dosage and administration: The infusor is pre-programmed to deliver 30 mg of Lasix ONYU over the first hour, then 12.5 mg per hour for the subsequent 4 hours. Lasix ONYU is not for chronic use and should be replaced with oral diuretics as soon as practical.
Common adverse effects: The most common adverse reactions are administration site and skin reactions, such as erythema, bruising, edema, and infusion site pain.
Warnings and precautions: Lasix ONYU is contraindicated in anuria and hypersensitivity to furosemide or medical adhesives. Monitor serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid. Monitor for dehydration and azotemia.Avoid higher than recommended doses to avoid ototoxicity. Monitor patients with symptoms of urinary retention. Avoid combination use of Lasix ONYU and aminoglycoside antibiotics or ethacrynic acid.If used concomitantly with salicylates, there is a risk for salicylate toxicity. When taken concomitantly with cisplatin and nephrotoxic drugs, there is a risk for ototoxicity and nephrotoxicity. If taken with lithium, there is a risk for lithium toxicity. There is an increased risk of hypotension and renal failure when Lasix ONYU is used concomitantly with renin-angiotensin inhibitors. There is a risk of potentiation if used concomitantly with adrenergic-blocking drugs and a risk of toxicity potentiation if used concomitantly with drugs undergoing renal tubular secretion. ■