Not an actual patient.

Help patients gain control of their day.
Treat their anxiety with LOREEV XR®, a once-daily extended-release capsule.1

Convenient once-daily dosing

Administer once daily in the morning, with or without food1

Sprinkle dose1

Patients have the option to open the capsule and sprinkle the entire contents over a tablespoon of applesauce, followed by drinking water
Do not crush or chew LOREEV XR

To switch patients from lorazepam IR to LOREEV XR:

Discontinue lorazepam immediate-release (IR) tablets and administer the first dose of LOREEV XR the next morning1
Once-daily dosage of LOREEV XR is equal to the total daily dose of lorazepam IR tablets1

Formulated to deliver a smooth PK profile throughout the day for patients124

Steady-state, 24-hour PK profile2

Median T_max of 9 hours at steady state2
Minimal fluctuations throughout the day2
Bioequivalent to lorazepam IR tablets dosed 3 times daily at steady state4

Chart that shows the benefits of the LoreevXR formulation — **Study design (N=48):**
Randomized, open-label, 2-way crossover, 2-period, 2-sequence, 2-treatment, relative bioavailability study at steady state, with a 10-day washout period. PK proﬁle draws on day 8. Steady state was achieved by day 5.14

Two-bead extended-release delivery system

Diagram showing capsule containing beads — Visual representation. Not actual pill or bead size.

LOREEV XR combines 2 types of extended-release beads to provide a smooth 24-hour profile2

Extended-release beads begin to slowly release after ingestion; delayed extended-release beads begin to release several hours after ingestion2
The combination of different bead-release profiles delivers:
- Slow plasma level rise to C_max (T_max 9 hours)2
- Minimal plasma level fluctuation over 24 hours2

Lorazepam is not metabolized via the cytochrome (CYP450) isoenzyme pathway135

Approximately 70% to 80% of all drugs in clinical use are metabolized through the CYP450 pathway.5

Lorazepam is metabolized via glucuronidation13

Has no active metabolites
Is rapidly conjugated into the inactive lorazepam glucuronide

Help your patients manage their medication costs

With the LOREEV Patient Savings Program, eligible insured patients pay as little as $20/month for LOREEV XR*

Download information about the Patient Savings Program

^* Applies to commercially insured patients. Individual costs may vary. Program eligibility and restrictions apply.

Important Safety Information

Warning: Risks from concomitant use with opioids; abuse, misuse, and addiction; and dependence and withdrawal reactions

Concomitant use with opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant use for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Use of LOREEV XR exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
Abrupt discontinuation or rapid dosage reduction of LOREEV XR after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce this risk, use a gradual taper to discontinue or reduce the dosage.

Indication for Use

LOREEV XR is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets.

Contraindications

LOREEV XR is contraindicated in patients with:

Hypersensitivity to benzodiazepines or any ingredients in LOREEV XR
Acute narrow-angle glaucoma

Warnings and Precautions

Central Nervous System (CNS) Depression

LOREEV XR may produce CNS depression. Caution against engaging in hazardous occupations or activities requiring complete mental alertness.
Use alone and with other CNS depressants may lead to potentially fatal respiratory depression. Alcohol should be avoided, and other CNS depressants used with caution.

Patients with Depression or Psychosis

LOREEV XR is not recommended in patients with a primary depressive disorder or psychosis. Preexisting depression may emerge or worsen.
A possibility for suicide should be kept in mind in patients with depression. Benzodiazepines should not be used without adequate antidepressant therapy.

Risk of Paradoxical Reactions

Paradoxical reactions have occasionally been reported during benzodiazepine use and are more likely to occur in the elderly. If this occurs, discontinue LOREEV XR.

Allergic Reactions to FD&C Yellow No. 5 (Tartrazine)

LOREEV XR 1 mg capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions in certain individuals and is seen frequently in patients who also have aspirin hypersensitivity.

Neonatal Sedation and Withdrawal Syndrome

LOREEV XR use during later stages of pregnancy can result in sedation and/or withdrawal symptoms in the neonate. Monitor neonates during pregnancy and labor for signs of sedation and withdrawal.

Risk in Patients With Impaired Respiratory Function

Closely monitor patients taking LOREEV XR for impaired respiratory function, and consider discontinuing it if signs and symptoms of respiratory depression or apnea occur.

Laboratory Tests

Leukopenia and elevations of lactase dehydrogenase (LDH) have developed in patients receiving lorazepam tablets. Periodic blood counts and liver function tests are recommended during long-term therapy.

Adverse reactions

Most frequent adverse reactions in clinical trials were sedation (15.9%), dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%).

Drug interactions

Avoid initiation of UDP-glucuronosyltransferase (UGT) inhibitors. Dose reduction requires switching to lorazepam tablets for dose adjustment.

Use in specific populations

Because of the potential for serious adverse reactions, breastfeeding is not recommended during treatment with LOREEV XR.

For additional safety information about LOREEV XR, see the LOREEV XR Full Prescribing Information including Boxed Warning and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to Almatica at 1-877-447-7979, or the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Request a rep

References:

LOREEV XR. Prescribing information. Almatica Pharma LLC; 2023.
Saltel DA, Vachon M. Edgemont Pharmaceuticals LLC. Sustained release formulations of lorazepam. US patent 8,999,393 B1. April 7, 2015.
Altamura AC, Moliterno D, Paletta S, Maffini M, Mauri MC, Bareggi S. Understanding the pharmacokinetics of anxiolytic drugs. Expert Opin Drug Metab Toxicol. 2013;9(4):423-440.
Data on file. Almatica Pharma LLC; 2020.
Zanger UM, Schwab M. Cytochrome P450 enzymes in drug metabolism: regulation of gene expression, enzyme activities, and impact of genetic variation. Pharmacol Ther. 2013;138(1):103-141.