ZORVOLEX: A low-dose NSAID treatment option forpatients with mild to moderate acute pain or osteoarthritis pain

ZORVOLEX: The lowest FDA-approved dose of diclofenac available

ZORVOLEX is a nonsteroidal anti-inflammatory drug (NSAID) for patients with mild to moderate acute pain or osteoarthritis pain. ZORVOLEX 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 diclofenac available
Why Zorvolex

Why ZORVOLEX?

18-mg dosage

Many patients treated for mild to moderate acute pain or osteoarthritis pain are treated with an NSAID.

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

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

Zorvolex 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 mild to moderate acute pain or OA pain. Then ask about ZORVOLEX, the low-dose SoluMatrix® diclofenac.

Ask Your Doctor About ZORVOLEX
Clinical study results

ZORVOLEX: Clinical study results in patients with mild to moderate acute pain or osteoarthritis pain

In a clinical study, patients taking ZORVOLEX 18 mg or 35 mg three times daily:

  • Had greater reductions in acute pain compared with patients who took placebo.

In a clinical study, patients taking ZORVOLEX 35 mg three times daily:

  • Experienced greater reductions in osteoarthritis pain compared with patients who took placebo.
Possible side effects

ZORVOLEX: Possible side effects

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

  • In clinical studies, the most common side effects reported with ZORVOLEX were swelling, nausea, headache, dizziness, vomiting, constipation, itching, diarrhea, gas, leg or foot pain, abdominal pain, stuffy or runny nose, abnormal blood tests, high blood pressure, and heartburn.
Dosing and adminstration

ZORVOLEX: Dosing and administration

ZORVOLEX is FDA-approved at low, 18-mg and 35-mg doses administered 3 times daily:

  • ZORVOLEX can be used for management of mild to moderate acute pain at low doses of 18 mg and 35 mg 3 times daily.
  • ZORVOLEX can be used for management of osteoarthritis pain at a dose of 35 mg 3 times daily.
  • Zorvolex should be used exactly as prescribed at the lowest dose possible for your treatment, and for the shortest time needed.
Recommendations from FDA

ZORVOLEX 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 mild to moderate acute pain or OA pain. Then ask about ZORVOLEX, the low-dose SoluMatrix®.

Ask Your Doctor About ZORVOLEX

Copay for Commercially Eligible Patients (Non-Government)

Indication
ZORVOLEX is indicated for:
  • Management of mild to moderate acute pain
  • Management of osteoarthritis pain
IMPORTANT SAFETY INFORMATION ABOUT Zorvolex®

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

ZORVOLEX (diclofenac) Capsules is an NSAID.

ZORVOLEX 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 ZORVOLEX
    • with longer use of ZORVOLEX

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

Avoid taking ZORVOLEX 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 ZORVOLEX 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

ZORVOLEX should only be used:

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

What are NSAIDs, including ZORVOLEX?

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 ZORVOLEX:

  • If you are allergic to diclofenac 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 ZORVOLEX 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 ZORVOLEX after 29 weeks of pregnancy.
  • are breastfeeding or plan to breast feed. Some ZORVOLEX 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. ZORVOLEX 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 ZORVOLEX?

ZORVOLEX can cause serious side effects, including:

See “What is the most important information I should know about 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 ZORVOLEX include: swelling, nausea, headache, dizziness, vomiting, constipation, itching, diarrhea, gas, arm/leg pain, abdominal pain, sinusitis, increased liver enzymes, increased blood creatinine level, high blood pressure, and indigestion.

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 your ZORVOLEX 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 ZORVOLEX, 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.