Vimovo (naproxen and esomeprazole magnesium)

WARNING

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of Vimovo, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• Vimovo is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

• NSAIDs, a component of Vimovo cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Side effects of Vimovo include:

• chest pain spreading to your jaw or shoulder,
• sudden numbness or weakness on one side of the body,
• slurred speech,
• shortness of breath,
• severe stomach pain,
• diarrhea that is watery or bloody,
• bloody or tarry stools,
• coughing up blood or vomit that looks like coffee grounds,
• swelling,
• rapid weight gain,
• shortness of breath,
• little or no urination,
• blood in your urine,
• loss of appetite,
• stomach pain (upper right side),
• dark urine,
• yellowing of the skin or eyes (jaundice),
• dizziness,
• fast or irregular heartrate,
• tremors,
• jerking muscle movements,
• feeling jittery,
• muscle cramps,
• muscle spasms in your hands and feet,
• cough,
• choking feeling,
• pale skin,
• unusual tiredness,
• lightheadedness,
• cold hands and feet,
• joint pain, and
• skin rash on your cheeks or arms that worsens in sunlight

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Vimovo include:

• stomach discomfort, and
• diarrhea

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Vimovo. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Important Administration Instructions

• Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals.
• Carefully consider the potential benefits and risks of Vimovo and other treatment options before deciding to use Vimovo.
• Vimovo does not allow for administration of a lower daily dose of esomeprazole magnesium. If a total daily dose of less than 40 mg esomeprazole is more appropriate, a different treatment should be considered.
• Swallow Vimovo tablets whole with liquid. Do not split, chew, crush or dissolve the tablet. Take Vimovo at least 30 minutes before meals.
• Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
• Antacids may be used while taking Vimovo.

Recommended Dosage

The recommended dosage of Vimovo by indication is shown in the table:

Use In Renal Impairment Or Hepatic Impairment

Renal Impairment

Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance less than 30 mL/min).

Hepatic Impairment

Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen component of Vimovo.

Vimovo should be avoided in patients with severe hepatic impairment.

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 Naproxen and Esomeprazole Magnesium - Affecting Drugs Co-Administered with Vimovo and Interactions with Diagnostics

Table 4: Clinically Significant Interactions with Esomeprazole Magnesium --Affecting Co-Administered Drugs

• Use of NSAIDs, including Vimovo, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
• Avoid use of NSAIDs, including Vimovo, in pregnant women starting at 30 weeks of gestation (third trimester).
• There are no adequate and well-controlled studies of Vimovo in pregnant women.
• 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 in plasma.
• Esomeprazole is the S-isomer of omeprazole and limited data from published literature suggest omeprazole may be present in human milk.
• There is no information on the effects of naproxen or omeprazole on the breastfed infant or on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Vimovo and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.