ADVERTISEMENT
Search

ADVERTISEMENT
 

Pharmacy Today logo

Updates from FDA
Roger Selvage 2463

Updates from FDA

Previous Article Previous Article Certain medications may affect ICU readmission risk
Next Article News roundup News roundup

New & Approved

New Drugs

TOFERSEN

(Qalsody—Biogen)

Drug class: Qalsody is an antisense oligonucleotide.

Indication: Qalsody is indicated for the treatment of amyotrophic lateral sclerosis in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain observed in patients treated with Qalsody. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

Recommended dosage and administration: Qalsody is administered intrathecally. The recommended dose is 100 mg (15 mL) per administration. Treatment should be initiated with three loading doses administered at 14-day intervals. After initiation, a maintenance dose should be administered once every 28 days. Qalsody should be warmed to room temperature before administration occurs and should be administered within 4 hours of removal from vial. Prior to administration, remove approximately 10 mL of cerebrospinal fluid. Administer as an intrathecal bolus injection over 1 to 3 minutes.

Common adverse effects: The most common adverse reactions were pain, fatigue, arthralgia, increased cerebrospinal fluid white blood cell count, and myalgia.

Warnings and precautions: Serious events of myelitis and radiculitis have been reported. Monitor for symptoms. A diagnostic workup and treatment should be initiated according to the standard of care. Serious events of papilledema and elevated intracranial pressure have been reported. Monitor for symptoms and initiate treatment as needed according to the standard of care. Monitor for symptoms of aseptic meningitis and initiate treatment according to the standard of care.

New Indications

ATOGEPANT

(Qulipta—AbbVie)

Drug class: Qulipta is a calcitonin gene-related peptide receptor antagonist.

Indication: Qulipta is indicated for the preventative treatment of migraine in adults.

Recommended dosage and administration: Qulipta is taken orally with or without food. For episodic migraine, the recommended dosage is 10 mg, 30 mg, or 60 mg taken once daily. For chronic migraine, the recommended dosage is 60 mg taken once daily. For patients with severe renal impairment or end-stage renal disease, the recommended dose is 10 mg once daily for episodic migraine. Avoid use for chronic migraine in these patients.

Common adverse effects: The most common adverse reactions are nausea, constipation, and fatigue/somnolence.

Warnings and precautions: Qulipta is contraindicated in patients with a history of hypersensitivity to atogepant or to any of the components of Qulipta. If a hypersensitivity reaction occurs, discontinue Qulipta and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis and dyspnea. These reactions can occur days after administration. Avoid use in patients with severe hepatic impairment. Based on animal data, use in pregnancy may cause fetal harm. In patients who are concomitantly taking a strong CYP3A4 inhibitor, the episodic migraine dose is 10 mg once daily and use should be avoided in chronic migraines. In patients who are concomitantly taking a strong, moderate, or weak CYP3A4 inducer, the episodic migraine dose is 30 mg or 60 mg once daily and use should be avoided in chronic migraines. In patients taking an OATP inhibitor, the episodic migraine dose is 10 mg or 30 mg once daily and the dose for chronic migraine is 30 mg once daily.

New Dosage Forms

ARIPIPRAZOLE

(Abilify Asimtufii—Otsuka Pharmaceutical)

Drug class: Abilify Asimtufii is an atypical antipsychotic.

Indication: Abilify Asimtufii is indicated for the treatment of schizophrenia in adults and as maintenance monotherapy treatment of bipolar I disorder in adults.

Recommended dosage and administration: For patients naive to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with Abilify Asimtufii. The dose should be administered by intramuscular injection in the gluteal muscle by a health care professional. Do not administer by any other route.

Recommended dosage is 960 mg administered once every 2 months as a single injection. Dose can be reduced to 720 mg in patients with adverse reactions. Dosage adjustments may be required if doses are missed. In known poor metabolizers of CYP2D6, the recommended dosage is 720 mg administered once every 2 months as a single injection.

Common adverse effects: The most commonly observed adverse reactions were increased weight, akathisia (an inability to remain still), injection site pain, and sedation.

Black box warning: Older adult patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Abilify Asimtufii is not approved for the treatment of patients with dementia-related psychosis.

Other warnings and precautions: There is an increased incidence of cerebrovascular adverse reactions in older adult patients with dementia-related psychosis. If neuroleptic malignant syndrome occurs, manage with immediate discontinuation and close monitoring. If tardive dyskinesia occurs, discontinue if clinically appropriate. Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. If pathological gambling and other compulsive behaviors occur, consider dose reduction or discontinuation. Monitor heart rate and BP and caution patients with known cardiovascular or cerebrovascular disease and risk of dehydration or syncope. Perform complete blood counts in patients with a history of clinically significant low white blood cell count or a history of leukopenia or neutropenia. Consider discontinuing Abilify Asimtufii if there is a clinically significant decline in white blood cell count in the absence of other causative factors. Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. Use caution when operating machinery as there is potential for cognitive and motor impairment. Dosage adjustments may be necessary for patients taking CYP2D6 inhibitors, CYP3A4 inhibitors, or CTP3A4 inducers for >14 days. Abilify Asimtufii may cause extrapyramidal or withdrawal symptoms in neonates with third-trimester exposure.

 

RIZATRIPTAN

(RizaFilm—IntelGenx)

Drug class: RizaFilm is a serotonin (5-HT) 1B/1D receptor agonist.

Indication: RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 12 to 17 years weighing ≥40 kg. RizaFilm is not indicated for the preventative treatment of migraine or for the treatment of cluster headache. Use only after a clear diagnosis of migraine has been established.

Recommended dosage and administration: RizaFilm is administered on the tongue. The recommended dosage for adults is 10 mg single dose. Doses should be separated by at least 2 hours and the maximum cumulative dosage in a 24-hour period is 30 mg. The recommended dosage in pediatric patients 12 to 17 years weighing ≥40 kg is 10 mg as a single dose.

Common adverse effects: The most common adverse reactions in adults were asthenia/fatigue, somnolence, pain/pressure sensation, dizziness, and nausea.

Warnings and precautions: RizaFilm is contraindicated in patients with a history of ischemic heart disease or coronary artery vasospasm, history of stroke or transient ischemic attack, Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders, peripheral vascular disease, ischemic bowel disease, uncontrolled hypertension, recent (within 24 hours) use of another 5-HT1 agonist or of an ergotamine-containing medication, hemiplegic or basilar migraine, MAOI use in the past 2 weeks, co-administration with propranolol, or hypersensitivity to rizatriptan or any of the ingredients of RizaFilm. Based on animal data, use in pregnancy may cause fetal harm. Perform cardiac evaluation in patients with multiple cardiovascular risk factors.

Discontinue dosing if arrhythmias occur. Chest/throat/neck/jaw pain, tightness, pressure, or heaviness is generally not associated with myocardial ischemia. Discontinue dosing if cerebral hemorrhage, subarachnoid hemorrhage, or stroke occurs. Discontinue dosing if gastrointestinal ischemic events or peripheral vasospastic reactions occur. Angioedema and anaphylaxis have occurred. If medication overuse headache occurs, detoxification may be necessary. Discontinue dosing if serotonin syndrome occurs.

 

LACOSAMIDE

(Motpoly XR—Aucta Pharmaceuticals)

Drug class: Motpoly XR is an anticonvulsant.

Indication: Motpoly XR is indicated for the treatment of partial-onset seizures in adults and pediatric patients weighing at least 50 kg.

Recommended dosage and administration: In adults 17 years and older, the initial dosage for monotherapy for the treatment of partial-onset seizures is 200 mg once daily. Initial dosage for adjunctive therapy for treatment of partial-onset seizures is 100 mg daily. The maximum recommended dosage for monotherapy and adjunctive therapy is 400 mg once daily. In pediatric patients weighing at least 50 kg, the initial dosage for treatment of partial-onset seizures is 100 mg once daily. Dosage should be increased based on clinical response and tolerability but should not be increased more frequently than once a week. Motpoly XR capsules should be swallowed whole and can be taken with or without food.

Common adverse effects: The most common adverse reactions in patients taking Motpoly XR include diplopia, headache, dizziness, nausea, and somnolence.

Warnings and precautions: Pregnant patients should be advised that Motpoly XR may cause fetal harm. Dosage adjustments are recommended for severe renal impairment and mild and moderate hepatic impairment. Use in patients with severe hepatic impairment is not recommended. Monitor patients for suicidal behavior and ideation. Obtain an ECG before beginning therapy and after titration to steady-state maintenance in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction and closely monitor these patients. Motpoly XR should be gradually withdrawn to minimize the potential of increased seizure frequency. Drug reaction with eosinophilia and system symptoms or multiorgan hypersensitivity may occur and Motpoly XR should be discontinued if no alternate etiology exists. ■

Also in this issue

FDA approves Zavzpret (Pfizer) for the acute treatment of migraine with or without aura in adults.

Share

Print

Documents to download

ADVERTISEMENT