VIVLODEX: A low-dose NSAID treatment option for patients with osteoarthritis pain

VIVLODEX: The lowest FDA-approved dose of meloxicam available (5 mg)

VIVLODEX is a nonsteroidal anti-inflammatory drug (NSAID) for patients with osteoarthritis pain. VIVLODEX was developed to align with recommendations from FDA, medical organizations, and advocacy groups: Use the lowest NSAID dose possible for the shortest time needed for your treatment.

The lowest FDA-approved dose of meloxicam available
Why Vivlodex

Why VIVLODEX?

18-mg dosage

Many patients treated for osteoarthritis pain are treated with an NSAID.

SoluMatrix<sup>®</sup> Fine Particle Technology

VIVLODEX was created using SoluMatrix® Fine Particle Technology®, a technology that helps drugs dissolve quickly so they can be absorbed by the body.

Vivlodex logo

Low-dose SoluMatrix® NSAIDs were developed to align with recommendations from FDA, medical organizations, and advocacy groups: Use the lowest dose possible for the shortest time needed for your treatment.

Ask your doctor

Do you know your NSAID dose?

Ask your doctor if you are taking the lowest dose possible for the treatment of OA pain. Then ask about VIVLODEX, the low-dose SoluMatrix® meloxicam.

Ask Your Doctor About VIVLODEX
Clinical study results

VIVLODEX: Clinical study results in patients with osteoarthritis pain

In a clinical study, patients taking VIVLODEX 5 mg or 10 mg once daily:

List number one

Experienced greater reductions in osteoarthritis pain compared with patients who took placebo.

List number two

Did better on measures of stiffness compared with patients who took placebo.

List number three

Did better on measures of function compared with patients who took placebo.

Possible side effects

VIVLODEX: Possible side effects

Before beginning treatment with VIVLODEX, it is important to be aware of potential side effects and to discuss these potential problems with your doctor

The most common side effects reported in a 12-week osteoarthritis pain clinical study using VIVLODEX were:
  • Diarrhea
  • Nausea
  • Abdominal discomfort
Dosing and adminstration

VIVLODEX: Dosing and administration

VIVLODEX is FDA-approved at 5 mg and 10 mg doses administered once daily:

  • In a clinical study, VIVLODEX helped patients manage osteoarthritis pain at these low doses.
  • 5 mg is the lowest FDA-approved dose of meloxicam available.
  • 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.
Recommendations from FDA

VIVLODEX was developed to align with recommendations from FDA, medical organizations, and advocacy groups: Use the lowest NSAID dose possible for the shortest time needed for your treatment.

Ask your doctor

Do you know your NSAID dose?

Ask your doctor if you are taking the lowest dose possible for the treatment of OA pain. Then ask about VIVLODEX, the low-dose SoluMatrix® meloxicam.
 

Ask Your Doctor About VIVLODEX

Copay for Commercially Eligible Patients (Non-Government)

Indication
VIVLODEX is indicated for:
  • Management of osteoarthritis pain
IMPORTANT SAFETY INFORMATION ABOUT VIVLODEX®

What is the most important information I should know about VIVLODEX and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

VIVLODEX (meloxicam) Capsules is an NSAID.

VIVLODEX can cause serious side effects, including:

  • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
    • with increasing doses of VIVLODEX
    • with longer use of VIVLODEX

Do not take VIVLODEX right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking VIVLODEX after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take VIVLODEX after a recent heart attack.

  • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
    • anytime during use
    • without warning symptoms
    • that may cause death

The risk of getting an ulcer or bleeding increases with:

    • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
    • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
    • increasing doses of NSAIDs
    • longer use of NSAIDs
    • smoking
    • drinking alcohol
    • older age
    • poor health
    • advanced liver disease
    • bleeding problems

VIVLODEX should only be used:

    • Exactly as prescribed
    • At the lowest dose possible for your treatment
    • For the shortest time needed

What are NSAIDs, including VIVLODEX?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

Do not use VIVLODEX:

  • If you are allergic to meloxicam or any components of the drug product
  • If you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs
  • Right before or after heart bypass surgery
  • If you have active ulcer disease or any history of bleeding in the stomach or intestines
  • If you have had bleeding in the brain, a tendency to bleed, or have decreased ability for your blood to clot
  • If you have kidney disease

Before taking VIVLODEX or any NSAID, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver or kidney problems
  • have high blood pressure or heart failure
  • have asthma
  • have bleeding problems
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take VIVLODEX after 29 weeks of pregnancy.
  • are breastfeeding or plan to breast feed. Some VIVLODEX can pass into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. VIVLODEX and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of VIVLODEX?

VIVLODEX can cause serious side effects, including:

See “What is the most important information I should know about VIVLODEX and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Most common side effects with VIVLODEX include: diarrhea, nausea, abdominal discomfort, joint pain, urinary tract infection, osteoarthritis, high blood pressure, headache, respiratory tract infections, back pain, constipation, indigestion, swelling, and arm/leg pain.

Get emergency help right away if you get any of the following symptoms:

  • Shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop taking VIVLODEX and call your healthcare provider right away if you get any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or eyes look yellow
  • indigestion or stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms, legs, hands and feet

If you take too much VIVLODEX, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

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

Please see full Prescribing Information, including Boxed Warning and patient Medication Guide.