What You Should Know About Zorvolex (Diclofenac)

Zorvolex is a low-dose, quick-dissolving form of diclofenac, an NSAID (nonsteroidal anti-inflammatory drug). It was approved for the treatment of osteoarthritis pain in 2014. What makes it different from other forms of diclofenac and other NSAIDs?

Zorvolex, produced by Iroko Pharmaceuticals, LLC, was previously approved for the treatment of mild to moderate acute pain in adults. The approval for osteoarthritis pain is an additional indication. Since not all medications and treatments are equally effective for any given individual, it was welcomed as a new option for people with osteoarthritis.

Types of Diclofenac

Zorvolex and Voltaren are two formulations of diclofenac. Other brand names of diclofenac, such as Zipsor, are also available.

Zorvolex is formulated with submicron particles of diclofenac that are about 20 times smaller than those in other diclofenac medications, and they allow the drug to dissolve more quickly. Zorvolex is the first low-dose NSAID developed using SoluMatrix Fine Particle Technology that has been approved by the FDA.

Need for Low-Dose NSAIDs

Several years ago, the FDA updated and increased warnings for all NSAID drugs. It was clearly stated that NSAIDs are associated with an increased risk of cardiovascular problems (e.g., heart attack and stroke) and potentially fatal gastrointestinal bleeding.

Around that time, two COX-2 selective NSAIDs—Vioxx (rofecoxib) and Bextra (valdecoxib)—were pulled from the market, but most remained. The FDA also advised healthcare providers to prescribe (and patients to use) the lowest effective dose of an NSAID for the shortest time possible, while taking into consideration the therapeutic goal. A low-dose NSAID like Zorvolex helps address those FDA warnings and recommendations.

Oral NSAIDs remain the backbone of drug therapy for osteoarthritis, and a 2020 guideline from the American College of Rheumatology (ACR) strongly recommends their use. The ACR cautions that doses should be as low as possible, and that NSAID treatment should continue for as short a time as possible.

Administration/Dosage

The recommended dosage of Zorvolex (an oral drug) for osteoarthritis pain is 35 milligrams three times a day. (Note: Zorvolex capsules are not interchangeable with Voltaren or generic diclofenac pills. The dosage and strength are not equivalent.) Zorvolex 35 milligrams is a blue and green capsule with IP-204 imprinted on the body and 35 milligrams on the cap in white ink.

Whether or not taking Zorvolex with food may decrease the drug's effectiveness has not been studied. Patients with known hepatic (liver) disease may require a dosage adjustment.

Common Adverse Reactions

Based on clinical trials, the most common adverse events associated with Zorvolex include edema, nausea, headache, dizziness, vomiting, constipation, pruritis (itching), diarrhea, flatulence, pain in extremities, abdominal pain, sinusitis, changes in liver or kidney function, hypertension, and indigestion.

Contraindications

You should avoid Zorvolex if you have a known hypersensitivity to diclofenac. The drug is also not for use by people with asthma or who have had hives or any allergic reaction after taking aspirin or any NSAID. Zorvolex is not used for pain associated with coronary artery bypass graft surgery.

Warnings and Precautions

The usual warnings associated with all other NSAIDs, including increased risk of cardiovascular events and gastrointestinal ulcers and bleeding, also apply to Zorvolex. Your healthcare provider will be cautious if you've had gastrointestinal ulcers or bleeding. Blood tests for liver function and kidney function will be performed periodically along with monitoring for hypertension and fluid retention.

Zorvolex should not be taken with aspirin since doing so would increase the risk of gastrointestinal bleeding. Similarly, Zorvolex should not be taken with anticoagulants because that combination also would increase bleeding risk. If you already are taking an ACE inhibitor, diuretic, lithium, cyclosporine, or methotrexate, make sure your healthcare provider is aware, because these drugs may interact with Zorvolex.

If you are pregnant, you should not take Zorvolex after 30 weeks gestation. Your healthcare provider may advise using the drug with caution if you are breastfeeding.