Vivlodex (meloxicam)

WARNING

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) 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.
• Vivlodex is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

• NSAIDs 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.

Common side effects of Vivlodex include:

• diarrhea,
• nausea,
• abdominal discomfort,
• joint pain,
• urinary tract infection,
• high blood pressure,
• diarrhea,
• headache,
• upper respiratory tract infection,
• back pain,
• runny or stuffy nose,
• bronchitis,
• sinus infection,
• constipation,
• indigestion,
• nausea, and
• pain and swelling in the extremities.

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• For management of osteoarthritis pain, the recommended starting dosage is 5 mg orally once daily. Dose may be increased to 10 mg in patients who require additional analgesia. The maximum recommended daily oral dose of Vivlodex is 10 mg.
• In patients on hemodialysis, the maximum daily dosage is 5 mg

Non-Interchangeability With Other Formulations Of Meloxicam

• Vivlodex capsules have not shown equivalent systemic exposure to other formulations of oral meloxicam. Therefore, Vivlodex capsules are not interchangeable with other formulations of oral meloxicam even if the total milligram strength is the same.
• Do not substitute similar dose strengths of other meloxicam products.

See Table 3 for clinically significant drug interactions with meloxicam.

Table 3 : Clinically Significant Drug Interactions with meloxicam

• Use of NSAIDs, including Vivlodex, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
• Avoid use of NSAIDs, including Vivlodex, in pregnant women starting at 30 weeks of gestation (third trimester).
•  There are no adequate and well-controlled studies of Vivlodex in pregnant women.
• Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.
• There are no human data available on whether meloxicam is present in human milk, or on the effects on breastfed infants, or on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Vivlodex and any potential adverse effects on the breastfed infant from the Vivlodex or from the underlying maternal condition.