VIVLODEX gives patients with osteoarthritis pain a low-dose NSAID treatment option

To find out more about nonsteroidal anti–inflammatory drugs (NSAIDs)—and to learn how SoluMatrix® Fine Particle Technology® created a low–dose NSAID treatment option for managing osteoarthritis pain—click these links:

About
VIVLODEX

About Vivlodex

Talking with your
doctor

Talking with your doctor

Why
VIVLODEX?

Why Vivlodex

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

VIVLODEX is the first low-dose SoluMatrix® meloxicam for osteoarthritis pain approved by the US Food and Drug Administration (FDA).

The lowest FDA-approved dose of meloxicam available
About Vivlodex

VIVLODEX: A low-dose SoluMatrix® NSAID for management of osteoarthritis pain

VIVLODEX was created with appropriate patients in mind:

  • VIVLODEX is the first low-dose SoluMatrix® meloxicam.
  • Meloxicam is a trusted NSAID that is used to manage pain caused by osteoarthritis.
  • Low-dose SoluMatrix® NSAIDs were 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.
5-mg and 10-mg Vivlodex doses

VIVLODEX is FDA approved at low 5-mg and 10-mg doses administered once daily for management of osteoarthritis pain.

In addition to being the first low-dose SoluMatrix® meloxicam available, clinical studies demonstrated that VIVLODEX:

  • Helped patients experience significant improvements in osteoarthritis pain compared with patients who took placebo.
The lowest FDA-approved dose of meloxicam available

VIVLODEX was developed using SoluMatrix® Fine Particle Technology®, a proprietary technology used to create NSAID drug particles that are approximately 10 to 20 times smaller than their original size.

  • Helps drugs dissolve quickly so they can be absorbed in the body.
Original NSAID particles

Original NSAID particle size

SoluMatrix<sup>®</sup> NSAID particles

SoluMatrix® NSAID particle size

See how SoluMatrix® Fine Particle Technology® reduces the size of drug particles!

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Ask your doctor

Looking for a low-dose NSAID option to manage OA pain?

Ask Your Doctor About VIVLODEX

VIVLODEX matters because:

List number one

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

List number two

Meloxicam is a trusted NSAID physicians commonly use to help patients with osteoarthritis pain.

FDA recommends that NSAIDs be used:

  • Exactly as your doctor prescribes them.
  • At the lowest dose possible for your treatment.
  • For the shortest time needed.
FDA recommendation

VIVLODEX (5 mg) provides the lowest available dose of meloxicam.

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Looking for a low-dose NSAID option to manage OA pain?
 

Ask Your Doctor About VIVLODEX

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Learn More About VivlodexLearn More About VIVLODEX
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.

SoluMatrix® is a registered trademark of iCeutica Pty Ltd, and is licensed to Zyla Life Sciences US, Inc.
Fine Particle Technology® is a registered trademark of iCeutica Inc., and the technology is licensed to Zyla Life Sciences US, Inc. for exclusive use in NSAIDs.
© August 2020, Assertio Therapeutics, Inc. All rights reserved. APL-VVX-0001 Rev. 1