Vimovo (naproxen/esomeprazole magnesium): Side Effects & Dosage

Generic drug: naproxen and esomeprazole magnesium

Brand name: Vimovo

What is Vimovo (naproxen and esomeprazole magnesium), and how does it work?

Vimovo (naproxen and esomeprazole magnesium) is a prescription medicine used to treat the symptoms of Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis. Vimovo may be used alone or with other medications.

Vimovo belongs to a class of drugs called Pain Management, Other.

It is not known if Vimovo is safe and effective in children.

What are the side effects of Vimovo?

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.

What is the dosage for Vimovo?

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:

Indication
Patient Population
Recommended Dosage

Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis
Adults
One Vimovo tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole

Juvenile Idiopathic Arthritis in Adolescent Patients 12 Years of Age and Older and Weighing at Least 38 kg
Greater than 50 kg

38 kg to less than 50 kg
One Vimovo tablet twice daily of: 375 mg naproxen/20 mg of esomeprazole

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.

What drugs interact with Vimovo?

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

Drugs That Interfere with Hemostasis

Clinical Impact:
Naproxen

• Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have increased the risk of serious bleeding compared to the use of either drug alone.
• Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.

Esomeprazole Magnesium

• Increased INR and prothrombin time in patients treated with PPIs, including esomeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
• Concomitant use of esomeprazole 40 mg resulted in reduced plasma
  concentrations of the active metabolite of clopidogrel and a reduction
  in platelet inhibition.
• There are no adequate combination studies of a lower dose of esomeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel.

Intervention:
Monitor patients with concomitant use of Vimovo with anticoagulants
(e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin
reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake
inhibitors (SNRIs) for signs of bleeding.
Clopidogrel: Avoid concomitant use of clopidogrel with Vimovo.
Consider use of alternative anti-platelet therapy.

Aspirin

Clinical Impact:
Controlled clinical studies showed that the concomitant use of NSAIDs
and analgesic doses of aspirin does not produce any greater therapeutic
effect than the use of NSAIDs alone. In a clinical study, the concomitant
use of an NSAID and aspirin was associated with a significantly increased
incidence of GI adverse reactions as compared to use of the NSAID alone.

Intervention:
Concomitant use of Vimovo and analgesic doses of aspirin is not
generally recommended because of the increased risk of bleeding. Vimovo is not a substitute for low dose aspirin for cardiovascular protection.

ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers

Clinical Impact:

• NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
• In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

Intervention:

• During concomitant use of Vimovo and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
• During concomitant use of Vimovo and ACE-inhibitors or ARBs in
  patients who are elderly, volume-depleted or have impaired renal function,
  monitor for signs of worsening renal function.

Diuretics

Clinical Impact:
Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.

Intervention:
During concomitant use of Vimovo with diuretics, observe patients for
signs of worsening renal function, in addition to assuring diuretic efficacy
including antihypertensive effects.

Antiretrovirals

Clinical Impact:
The effect of esomeprazole magnesium on antiretroviral drugs is variable. The clinical importance and mechanisms behind these interactions are not always known.

• Decreased exposure of some antiretroviral drugs (e.g., rilpivirine,
  atazanavir, and nelfinavir) when used concomitantly with esomeprazole
  magnesium may reduce antiviral effect and promote the development of
  drug resistance.
• Increased exposure of other antiretroviral drugs (e.g., saquinavir)
  when used concomitantly with esomeprazole magnesium may increase
  toxicity.
• There are other antiretroviral drugs which do not result in clinically relevant interactions with esomeprazole magnesium.

Intervention:

Rilpivirine-containins products: Concomitant use with Vimovo
is contraindicated.
Atazanavir: See prescribing information for atazanavir for dosing information.
Nelfinavir: Avoid concomitant use with Vimovo.
Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities.
Other antiretrovirals: See prescribing information of specific drugs.

Cilostazol

Clinical Impact:
Increased exposure of cilostazol and one of its active metabolites
(3,4-dihydro-cilostazol) when coadministered with omeprazole magnesium, the
racemate of esomeprazole.

Intervention:
Consider reducing the dose of cilostazol to 50 mg twice daily.

Digoxin

Clinical Impact:
Naproxen

• The concomitant use of naproxen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

Esomeprazole Magnesium

• Potential for increased exposure of digoxin.

Intervention:
Monitor digoxin concentrations during concomitant use of Vimovo. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations.

Lithium

Clinical Impact:
NSAIDs have produced elevations of plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.

Intervention:
During concomitant use of Vimovo and lithium, monitor patients for signs of lithium toxicity.

Methotrexate

Clinical Impact:
Naproxen

• Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).

Esomeprazole Magnesium

• Concomitant use of esomeprazole magnesium with methotrexate
  (primarily at high dose) may elevate and prolong serum concentrations of
  methotrexate and/or its metabolite hydroxymethotrexate, possibly leading
  to methotrexate toxicities.

Intervention:
During concomitant use of Vimovo and methotrexate, monitor patients for methotrexate toxicity. A temporary withdrawal of
Vimovo may be considered in some patients receiving high-dose methotrexate.

Cyclosporine

Clinical Impact:
Concomitant use of naproxen and cyclosporine may increase cyclosporine’s nephrotoxicity.

Intervention:
During concomitant use of Vimovo and cyclosporine, monitor patients for signs of worsening renal function.

Tacrolimus

Clinical Impact:
Concomitant use of esomeprazole magnesium and tacrolimus may increase exposure of tacrolimus

Intervention:
During concomitant use of Vimovo and tacrolimus, monitor tacrolimus whole blood concentrations.

NSAIDs and Salicylates

Clinical Impact:
Concomitant use of naproxen with other NSAIDs or salicylates (e.g.,
diflunisal, salsalate) increases the risk of GI toxicity, with little or no
increase in efficacy.

Intervention:
The concomitant use of Vimovo with other NSAIDs or salicylates is not recommended.

Pemetrexed

Clinical Impact:
Concomitant use of Vimovo and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).

Intervention:
During concomitant use of Vimovo and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.

Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, mycophenoloate mofetil, ketoconazole)

Clinical Impact:
Esomeprazole magnesium can reduce the absorption of other drugs due to its effect on reducing intragastric acidity

Intervention:
Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which
esomeprazole magnesium is an enantiomer, in healthy subjects and in
transplant patients receiving MMF has been reported to reduce the exposure
to the active metabolite, mycophenolic acid (MPA), possibly due to a
decrease in MMF solubility at an increased gastric pH. The clinical
relevance of reduced MPA exposure on organ rejection has not been
established in transplant patients receiving esomeprazole and MMF. Use
Vimovo with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption.

Interactions with Investigations of Neuroendocrine Tumors

Clinical Impact:
Serum chromogranin A (CgA) levels increase secondary to PPI-induced
decreases in gastric acidity. The increased CgA levels may cause false
positive results in diagnostic investigations for neuroendocrine tumors.

Intervention:
Temporarily stop Vimovo treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.

Diazepam

Clinical Impact:
Increased exposure of diazepam.

Intervention:
Monitor patients for increased sedation and adjust the dose of diazepam as needed.

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

CYP2C19 or CYP3A4 Inducers

Clinical Impact:
Decreased exposure of esomeprazole when used concomitantly
with strong inducers.

Intervention:
St. John’s Wort, rifampin: Avoid concomitant use with Vimovo.

CYP2C19 or CYP3A4 Inhibitors

Clinical Impact:
Increased exposure of esomeprazole.

Intervention:
Voriconazole: Avoid concomitant use with Vimovo.

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Is Vimovo safe to use while pregnant or breastfeeding?

• 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.