Arthritis/rheumatic disorders:

Indications for: VIMOVO

Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis (JIA): to relieve signs/symptoms and reduce risk of developing naproxen-associated gastric ulcers.

Limitations of Use:

Not interchangeable with its individual components. Not for initial treatment of acute pain.

Adult Dosage:

Use lowest effective dose for shortest duration. Swallow whole. Take at least 30mins before meals. ≥18yrs: one 375mg/20mg or 500mg/20mg tab twice daily. Consider dose reduction in mild to moderate hepatic impairment.

Children Dosage:

Use lowest effective dose for shortest duration. Swallow whole. Take at least 30mins before meals. JIA: <12yrs or <38kg: not established. ≥12yrs (≥38kg–<50kg): one 375mg/20mg tab twice daily; (>50kg): one 375mg/20mg or 500mg/20mg tab twice daily.

VIMOVO Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery. Concomitant rilpivirine-containing products.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

VIMOVO Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure, advanced renal disease; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease, GI bleeding, or inflammatory bowel disease (eg, ulcerative colitis, Crohn’s disease). Hypertension; monitor BP closely. Moderate to severe renal impairment (CrCl <30mL/min) or severe hepatic impairment: not recommended. Discontinue if signs/symptoms of liver disease develop, if abnormal LFTs persist or worsen, or if acute tubulointerstitial nephritis, cutaneous/systemic lupus erythematosus, bleeding occurs. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Symptomatic response does not preclude gastric malignancy. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels during prolonged therapy. Consider monitoring magnesium, calcium levels in those with preexisting risk of hypocalcemia (eg, hypoparathyroidism). Increased risk of fundic gland polyps with long-term use (esp. >1yr) or osteoporosis-related fractures (hip, wrist or spine) with long-term (>1yr) and multiple daily dose PPI therapy. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.

VIMOVO Classification:

NSAID + proton pump inhibitor.

VIMOVO Interactions:

See Contraindications. Concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs: not recommended. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. Avoid concomitant St. John's wort, rifampin, nelfinavir, voriconazole. Antagonizes clopidogrel; consider alternative anti-platelets. May antagonize atazanavir (see full labeling). May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin, saquinavir, tacrolimus, diazepam; monitor. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Consider dose reduction of concomitant cilostazol (50mg twice daily). May affect absorption of pH-dependent drugs (eg, ketoconazole, erlotinib, mycophenolate mofetil, iron salts). May interfere with neuroendocrine diagnostic tests; discontinue esomeprazole ≥14 days prior to CgA level assessment.

Adverse Reactions:

Gastritis, diarrhea; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), anemia, bone fracture; possible C. difficile-associated diarrhea; rare: hypomagnesemia and mineral metabolism.

Generic Drug Availability:

NO

How Supplied:

Tabs—60

Pricing for VIMOVO

500mg/20mg tablet (Qty: 60)
Appx. price $740
GoodRx