VIMOVO Delayed release tablet (2022)

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Horizon Therapeutics USA, Inc.

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1. Indications and Usage

VIMOVO, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief ...

2. Dosage and Administration

2.1 Important Administration Instructions Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.1)]. Carefully ...

3. Dosage Forms and Strengths

VIMOVO is an oval, yellow, delayed-release tablets for oral administration containing either: 375 mg enteric-coated naproxen and 20 mg immediate-release esomeprazole tablets printed with 375/20 in black, ...

4. Contraindications

VIMOVO is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen, esomeprazole magnesium, substituted benzimidazoles, or ...

5. Warnings and Precautions

5.1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] GI Bleeding, Ulceration ...

6.1. Clinical Trials Experience

Clinical Trials Experience with VIMOVO Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared ...

6.3. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VIMOVO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

See Table 3 and Table 4 for clinically significant drug interactions and interactions with diagnostics with naproxen and esomeprazole magnesium. Table 3. Clinically Significant Drug Interactions with ...

8.1. Pregnancy

Risk Summary Use of NSAIDs, including VIMOVO, can cause premature closure of the fetal ductus arteriosus and fetal and renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. ...

8.2. Lactation

Risk Summary Limited data from published literature report that naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration ...

8.3. Females and Males of Reproductive Potential

Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including VIMOVO, may delay or prevent rupture of ovarian follicles that may lead to reversible infertility ...

8.4. Pediatric Use

The safety and effectiveness of VIMOVO have been established in adolescent patients 12 years of age and older weighing at least 38 kg for the symptomatic relief of JIA and to decrease the risk of developing ...

8.5. Geriatric Use

Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly ...

8.6. Renal Impairment

Naproxen-containing products, including VIMOVO, are not recommended for use in patients with advanced renal disease [see Dosage and Administration (2), Warnings and Precautions (5.6)].

8.7. Hepatic Impairment

VIMOVO should be avoided in patients with severe hepatic impairment because naproxen may increase the risk of renal failure or bleeding and esomeprazole doses should not exceed 20 mg daily in these patients ...

10. Overdosage

There is no clinical data on overdosage with VIMOVO. Overdosage of naproxen Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric ...

11. Description

The active ingredients of VIMOVO are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). VIMOVO (naproxen and esomeprazole magnesium) is combination of a nonsteroidal ...

12.1. Mechanism of Action

VIMOVO consists of an immediate-release esomeprazole magnesium layer and an enteric-coated naproxen core. As a result, esomeprazole is released first in the stomach, prior to the dissolution of naproxen ...

12.2. Pharmacodynamics

Interaction with Aspirin In a healthy volunteer study, 10 days of concomitant administration of naproxen 220 mg once-daily with low-dose immediate-release aspirin (81 mg) showed an interaction with the ...

12.3. Pharmacokinetics

Absorption Naproxen At steady state following administration of VIMOVO twice daily, peak plasma concentrations of naproxen are reached on average 3 hours following both the morning and the evening dose. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Naproxen A 2-year study was performed in rats to evaluate the carcinogenic potential of naproxen at rat doses of 8, 16, and 24 mg/kg/day (0.05, 0.1, and 0.16 times the maximum recommended ...

13.2. Animal Toxicology and/or Pharmacology

Naproxen Reproduction studies have been performed in rats at 20 mg/kg/day (125 mg/m²/day, 0.23 times the maximum recommended human dose), rabbits at 20 mg/kg/day (220 mg/m²/day, 0.27 times the maximum ...

14. Clinical Studies

Two randomized, multi-center, double-blind trials (Study 1 and Study 2) compared the incidence of gastric ulcer formation in 428 patients taking VIMOVO and 426 patients taking enteric-coated naproxen. ...

16.1. How Supplied

VIMOVO (375 mg naproxen/20 mg esomeprazole magnesium) delayed-release tablets are oval, yellow film-coated tablets printed with 375/20 in black ink, supplied as: NDC 75987-031-04 Bottles of 60 tablets ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store in the original container and keep the bottle tightly closed to protect from moisture. Dispense ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients, families, or caregivers of the following before initiating therapy with VIMOVO and periodically during ...