June 30, 2016
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Mobic

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Mobic




Side Effects
Interactions

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

Osteoarthritis And Rheumatoid Arthritis

The MOBIC Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with MOBIC 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with MOBIC 15 mg/day. MOBIC at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo- and/or active-controlled osteoarthritis trials and 2363 of these patients were treated in ten placebo- and/or active-controlled rheumatoid arthritis trials. Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across MOBIC trials.

A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of MOBIC with placebo and with an active control. Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of MOBIC with placebo.

Table 1a depicts adverse events that occurred in ≥ 2% of the MOBIC treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.

Table 1b depicts adverse events that occurred in ≥ 2% of the MOBIC treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials.

Table 1a : Adverse Events (%) Occurring in ≥ 2% of MOBIC Patients in a 12-Week Osteoarthritis Placebo- and Active-Controlled Trial

  Placebo MOBIC 7.5 mg daily MOBIC 15 mg daily Diclofenac 100 mg daily
No. of Patients 157 154 156 153
Gastrointestinal 17.2 20.1 17.3 28.1
  Abdominal pain 2.5 1.9 2.6 1.3
  Diarrhea 3.8 7.8 3.2 9.2
  Dyspepsia 4.5 4.5 4.5 6.5
  Flatulence 4.5 3.2 3.2 3.9
  Nausea 3.2 3.9 3.8 7.2
Body as a Whole
  Accident household 1.9 4.5 3.2 2.6
  Edema1 2.5 1.9 4.5 3.3
  Fall 0.6 2.6 0.0 1.3
  Influenza-like symptoms 5.1 4.5 5.8 2.6
Central and Peripheral Nervous System
  Dizziness 3.2 2.6 3.8 2.0
  Headache 10.2 7.8 8.3 5.9
Respiratory
  Pharyngitis 1.3 0.6 3.2 1.3
  Upper respiratory tract infection 1.9 3.2 1.9 3.3
Skin
  Rash2 2.5 2.6 0.6 2.0
1 WHO preferred terms edema, edema dependent, edema peripheral, and edema legs combined
2 WHO preferred terms rash, rash erythematous, and rash maculo-papular combined

Table 1b : Adverse Events (%) Occurring in ≥ 2% of MOBIC Patients in two 12-Week Rheumatoid Arthritis Placebo-Controlled Trials

  Placebo MOBIC 7.5 mg daily MOBIC 15 mg daily
No. of Patients 469 481 477
Gastrointestinal Disorders 14.1 18.9 16.8
  Abdominal pain NOS2 0.6 2.9 2.3
  Dyspeptic signs and symptoms 3.8 5.8 4.0
  Nausea2 2.6 3.3 3.8
General Disorders and Administration Site Conditions
  Influenza-like illness2 2.1 2.9 2.3
Infection and Infestations
  Upper respiratory tract infections-pathogen class unspecified1 4.1 7.0 6.5
Musculoskeletal and Connective Tissue Disorders
  Joint related signs and symptoms1 1.9 1.5 2.3
Nervous System Disorders
  Headaches NOS2 6.4 6.4 5.5
Skin and Subcutaneous Tissue Disorders
  Rash NOS 1.7 1.0 2.1
1 MedDRA high level term (preferred terms): dyspeptic signs and symptoms (dyspepsia, dyspepsia aggravated, eructation, gastrointestinal irritation), upper respiratory tract infections-pathogen unspecified (laryngitis NOS, pharyngitis NOS, sinusitis NOS), joint related signs and symptoms (arthralgia, arthralgia aggravated, joint crepitation, joint effusion, joint swelling)
2 MedDRA preferred term: nausea, abdominal pain NOS, influenza-like illness, headaches NOS, and rash NOS

The adverse events that occurred with MOBIC in ≥ 2% of patients treated short-term (4 to 6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table 2.

Table 2 : Adverse Events (%) Occurring in ≥ 2% of MOBIC Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials

  4 to 6 Weeks Controlled Trials 6 Month Controlled Trials
MOBIC 7.5 mg daily MOBIC 15 mg daily MOBIC 7.5 mg daily MOBIC 15 mg daily
No. of Patients 8955 256 169 306
Gastrointestinal 11.8 18.0 26.6 24.2
  Abdominal pain 2.7 2.3 4.7 2.9
  Constipation 0.8 1.2 1.8 2.6
  Diarrhea 1.9 2.7 5.9 2.6
  Dyspepsia 3.8 7.4 8.9 9.5
  Flatulence 0.5 0.4 3.0 2.6
  Nausea 2.4 4.7 4.7 7.2
  Vomiting 0.6 0.8 1.8 2.6
Body as a Whole
  Accident household 0.0 0.0 0.6 2.9
  Edema1 0.6 2.0 2.4 1.6
  Pain 0.9 2.0 3.6 5.2
Central and Peripheral Nervous System
  Dizziness 1.1 1.6 2.4 2.6
  Headache 2.4 2.7 3.6 2.6
  Hematologic
  Anemia 0.1 0.0 4.1 2.9
Musculoskeletal
  Arthralgia 0.5 0.0 5.3 1.3
  Back pain 0.5 0.4 3.0 0.7
Psychiatric
  Insomnia 0.4 0.0 3.6 1.6
Respiratory
  Coughing 0.2 0.8 2.4 1.0
  Upper respiratory tract infection 0.2 0.0 8.3 7.5
Skin
  Pruritus 0.4 1.2 2.4 0.0
  Rash2 0.3 1.2 3.0 1.3
  Urinary Micturition frequency 0.1 0.4 2.4 1.3
  Urinary tract infection 0.3 0.4 4.7 6.9
1 WHO preferred terms edema, edema dependent, edema peripheral, and edema legs combined
2 WHO preferred terms rash, rash erythematous, and rash maculo-papular combined

Higher doses of MOBIC (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of MOBIC should not exceed 15 mg.

Pediatrics

Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)

Three hundred and eighty-seven patients with pauciarticular and polyarticular course JRA were exposed to MOBIC with doses ranging from 0.125 to 0.375 mg/kg per day in three clinical trials. These studies consisted of two 12-week multicenter, double-blind, randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study. The adverse events observed in these pediatric studies with MOBIC were similar in nature to the adult clinical trial experience, although there were differences in frequency. In particular, the following most common adverse events, abdominal pain, vomiting, diarrhea, headache, and pyrexia, were more common in the pediatric than in the adult trials. Rash was reported in seven ( < 2%) patients receiving MOBIC. No unexpected adverse events were identified during the course of the trials. The adverse events did not demonstrate an age or gender-specific subgroup effect.

The following is a list of adverse drug reactions occurring in < 2% of patients receiving MOBIC in clinical trials involving approximately 16,200 patients.

Body as a Whole :allergic reaction, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase

Cardiovascular : angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis

Central and Peripheral Nervous System : convulsions, paresthesia, tremor, vertigo

Gastrointestinal : colitis, dry mouth, duodenal ulcer, eructation, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage, hematemesis, hemorrhagic duodenal ulcer, hemorrhagic gastric ulcer, intestinal perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, stomatitis ulcerative

Heart Rate and Rhythm :arrhythmia, palpitation, tachycardia

Hematologic : leukopenia, purpura, thrombocytopenia

Liver and Biliary System :ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis

Metabolic and Nutritional :dehydration

Psychiatric : abnormal dreaming, anxiety, appetite increased, confusion, depression, nervousness, somnolence

Respiratory: asthma, bronchospasm, dyspnea

Skin and Appendages :alopecia, angioedema, bullous eruption, photosensitivity reaction, pruritus, sweating increased, urticaria

Special Senses :abnormal vision, conjunctivitis, taste perversion, tinnitus

Urinary System : albuminuria, BUN increased, creatinine increased, hematuria, renal failure

Postmarketing Experience

The following adverse reactions have been identified during post approval use of MOBIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug. Adverse reactions reported in worldwide post marketing experience or the literature include: acute urinary retention; agranulocytosis; alterations in mood (such as mood elevation); anaphylactoid reactions including shock; erythema multiforme; exfoliative dermatitis; interstitial nephritis; jaundice; liver failure; Stevens-Johnson syndrome; toxic epidermal necrolysis, and infertility female.

Read the Mobic (meloxicam) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

See Table 3 for clinically significant drug interactions with meloxicam. See also WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY.

Table 3 : Clinically Significant Drug Interactions with Meloxicam

Drugs that Interfere with Hemostasis
Clinical Impact:
  • Meloxicam and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of meloxicam and anticoagulants have an increased 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.
Intervention: Monitor patients with concomitant use of MOBIC 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 [see WARNINGS AND PRECAUTIONS].
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 [see WARNINGS AND PRECAUTIONS].
Intervention: Concomitant use of MOBIC and low dose aspirin or analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS]. MOBIC is not a substitute for low dose aspirin for cardiovascular protection.
ACE Inhibitors, Angiotensin Receptor Blockers, or 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, coadministration 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 MOBIC and ACE inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
  • During concomitant use of MOBIC and ACE inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see WARNINGS AND PRECAUTIONS].
  • When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
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. However, studies with furosemide agents and meloxicam have not demonstrated a reduction in natriuretic effect. Furosemide single and multiple dose pharmacodynamics and pharmacokinetics are not affected by multiple doses of meloxicam.
Intervention: During concomitant use of MOBIC with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS].
Lithium
Clinical Impact: NSAIDs have produced elevations in 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 [see CLINICAL PHARMACOLOGY].
Intervention: During concomitant use of MOBIC and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Intervention: During concomitant use of MOBIC and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine
Clinical Impact: Concomitant use of MOBIC and cyclosporine may increase cyclosporine’s nephrotoxicity.
Intervention: During concomitant use of MOBIC and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates
Clinical Impact: Concomitant use of meloxicam with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS].
Intervention: The concomitant use of meloxicam with other NSAIDs or salicylates is not recommended.
Pemetrexed
Clinical Impact: Concomitant use of MOBIC and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention: During concomitant use of MOBIC and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. Patients taking meloxicam should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. In patients with creatinine clearance below 45 mL/min, the concomitant administration of meloxicam with pemetrexed is not recommended.
Kayexalate® (sodium polystyrene sulfonate)
Clinical Impact: Cases of intestinal necrosis (possibly fatal) have been described in patients who received concomitant sorbitol and Kayexalate® (sodium polystyrene sulfonate). Due to the presence of sorbitol in MOBIC Oral Suspension, use with Kayexalate® is not recommended.
Intervention: The concomitant use of MOBIC Oral Suspension with Kayexalate® is not recommended.

Read the Mobic Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/23/2016

Side Effects
Interactions

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