Updates from FDA
APhA staff
New drugs
LANDIOLOL
(Rapiblyk—AOP Orphan Pharmaceuticals)
Drug class: Rapiblyk is a b-adrenergic blocker.
Indication: Rapiblyk is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including AFib and atrial flutter.
Recommended dosage and administration: Administer as an I.V. infusion in a monitored setting. Titrate the dose according to ventricular rate. If the patient has normal cardiac function, start at 9 µg/kg/min and adjust the dose in 10-minute intervals as needed in increments of 9 µg/kg/min to a maximum of 36 µg/kg/min. If the patient has impaired cardiac function, start at 1 µg/kg/min and adjust the dose in 15-minute intervals as needed in increments of 1 µg/kg/min to a maximum of 36 µg/kg/min.
Common adverse effects: The most common adverse reaction is hypotension.
Warnings and precautions: Rapiblyk is contraindicated in severe sinus bradycardia, sick sinus syndrome, heart block greater than first degree, decompensated heart failure, cardiogenic shock, pulmonary hypertension, and known hypersensitivity to landiolol. There is a risk of hypotension, bradycardia, and cardiac failure, so patients should be monitored for signs and symptoms of cardiovascular adverse effects. Reduce or discontinue use if any occur. There is also a risk of exacerbating reactive airway disease. Rapiblyk may mask symptoms of hypoglycemia and alter glucose levels. Monitor for signs of myocardial ischemia when abruptly discontinuing in patients with coronary artery disease.
Avoid concomitant use with negative inotropes and chronotropes, sympathomimetics, positive inotropes, and vasoconstrictors. If used concomitantly with catecholamine depleting drugs, monitor BP and heart rate.
REVUMENIB
(Revuforj—Syndax)
Drug class: Revuforj is a menin inhibitor.
Indication: Revuforj is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients aged 1 year and older.
Recommended dosage and administration: Select patients for treatment with Revuforj based on the presence of a KMT2A translocation. Administer Revuforj orally twice daily fasted or with a low-fat meal at approximately the same time each day. For patients weighing 40 kg or more and also taking a strong CYP3A4 inhibitor, the recommended dosage is 160 mg orally twice daily. For patients weighing 40 kg or more and not taking a strong CYP3A4 inhibitor, the recommended dosage is 270 mg orally twice daily. For patients weighing less than 40 kg and also taking a strong CYP3A4 inhibitor, the recommended dosage is 95 mg/m2 orally twice daily. For patients weighing less than 40 kg and not taking a strong CYP3A4 inhibitor, the recommended dosage is 160 mg/m2 twice daily. If needed, attain the desired dose by combining different strengths of Revuforj tablets. If a strong CYP3A4 inhibitor is discontinued, increase the Revuforj dose after at least 5 half-lives of the strong CYP3A4 inhibitor to the recommended dosage without strong CYP3A4 inhibitors. Concurrent use of standard intrathecal chemotherapy prophylaxis is recommended for patients with risk of central nervous system relapse.
Common adverse effects: The most common adverse reactions are hemorrhage, nausea, increased or decreased phosphate, musculoskeletal pain, infection, increased AST and ALT, febrile neutropenia, increased parathyroid hormone, diarrhea, differentiation syndrome, prolonged QT interval, increased triglycerides, decreased potassium, decreased appetite, constipation, edema, fatigue, and increased alkaline phosphatase.
Boxed warning: Differentiation syndrome, which can be fatal, has occurred with Revuforj. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
Other warnings and precautions: Monitor ECGs and electrolytes as QTc interval prolongation could occur. Correct hypokalemia and hypomagnesemia prior to and during treatment. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue Revuforj. Fetal harm may occur. Advise patients of reproductive potential and patients who are partners of individuals with reproductive potential of the risk to a fetus and to use effective contraception. Avoid concomitant use with strong or moderate CYP3A4 inducers and QTc interval prolonging drugs. Advise patients not to breastfeed.
IOMEPROL
(Iomervu—Bracco Diagnostics)
Drug class: Iomervu is a radiographic contrast agent.
Indication: Iomervu is indicated for cerebral arteriography in adults and pediatric patients, visceral and peripheral arteriography and aortography in adults and pediatric patients, coronary arteriography and cardiac ventriculography in adults, radiographic evaluation of cardiac chambers and related arteries in pediatric patients, CT of the head and body in adults and pediatric patients, CT angiography of intracranial, visceral, and lower extremity arteries in adults and pediatric patients, coronary CT angiography in adults and pediatric patients, and CT urography in adults and pediatric patients.
Recommended dosage and administration: Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, vessel size, rate of blood flow within the vessel, and structures or areas to be examined. These dosing tables can be found in the full prescribing information for Iomervu.
Common adverse effects: The most common adverse reactions are feeling hot, headache, nausea, chest pain, back pain, and vomiting.
Boxed warning: Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Iomervu is for intra-arterial or I.V. use only.
Other warnings and precautions: Life-threatening or fatal hypersensitivity reactions may occur. Always have emergency resuscitation equipment and trained personnel available. Acute injury including renal failure can occur. Minimize the dose and maintain adequate hydration to minimize risk. Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. Thyroid dysfunction in pediatric patients ages 0 years to 3 years may occur. Individualize thyroid function monitoring based on risk factors such as prematurity. A lactating patient may pump and discard breast milk for 10 hours after Iomervu administration.
New dosage forms
TRAZODONE HYDROCHLORIDE
(Raldesy—Kamat Pharmatech)
Drug class: Rapiblyk is an SSRI.
Indication: Rapiblyk is indicated for the treatment of major depressive disorder in adults.
Recommended dosage and administration: The starting dosage is 150 mg orally in divided doses daily. This may be increased by 50 mg per day every 3 to 4 days.
The maximum dose is 400 mg per day in divided doses. Administer Raldesy shortly after a meal or light snack. When discontinuing, gradually reduce the dose.
Common adverse effects: The most common adverse reactions are edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, and weight loss.
Boxed warning: Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors. Raldesy is not approved for use in pediatric patients.
Other warnings and precautions: Raldesy is contraindicated in concomitant use of MAOIs or use within 14 days of stopping MAOIs. There is a risk of serotonin syndrome when co-administered with other serotonergic agents. QT interval prolongation may occur so avoid use with drugs that also increase the QT interval. Warn patients of the risk and symptoms of hypotension. There may be an increased risk of bleeding while taking Raldesy. Cases of painful and prolonged penile erections and priapism have been reported. Screen for bipolar disorder and monitor for mania or hypomania. Raldesy has the potential to impair judgment, thinking, and motor skills. Avoid use in patients with untreated angle-closure glaucoma. Raldesy may interact with central nervous system depressants, CYP3A4 inhibitors and inducers, digoxin, phenytoin, and warfarin.
New formulations
MINOCYCLINE HYDROCHLORIDE
(Emrosi—BridgeBio Pharma)
Drug class: Emrosi is a tetracycline-class drug.
Indication: Emrosi is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults. This formulation of minocycline has not been evaluated in the treatment or prevention of infections. To reduce the development of drug-resistant bacteria and to maintain the effectiveness of other antibacterial drugs, use Emrosi only as indicated.
Recommended dosage and administration: The recommended dosage of Emrosi is 40 mg orally, once daily.
Common adverse effects: The most common adverse reaction is dyspepsia.
Warnings and precautions: Emrosi is contraindicated in patients with a known hypersensitivity to any tetracycline medication. Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms syndrome. Discontinue Emrosi immediately if symptoms occur. The use of Emrosi during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to 8 years old) may cause permanent discoloration of the teeth. Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 18 years may cause reversible inhibition of bone growth. Discontinue Emrosi if Clostridioides difficile–associated diarrhea occurs. Discontinue Emrosi if liver injury is suspected. Central nervous system adverse effects including lightheadedness, dizziness, or vertigo may occur. Emrosi may cause idiopathic intracranial hypertension in adults and adolescents. Discontinue Emrosi if symptoms occur. Minocycline has been associated with autoimmune syndromes. Discontinue Emrosi immediately if symptoms occur. If renal impairment exists, monitor serum levels of Emrosi during treatment and discontinue Emrosi if necessary. Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Breastfeeding while taking Emrosi is not recommended. ■