Kevzara

Rheumatoid Arthritis

Kevzara is used to treat adults with moderate to severe active rheumatoid arthritis (RA). It is typically prescribed for individuals who have already tried other medications, such as disease-modifying antirheumatic drugs (DMARDs), but did not see enough improvement or could not tolerate the side effects. It may be used alone or in combination with other arthritis medications like methotrexate.

Polymyalgia Rheumatica

This medication is also used to treat adults with polymyalgia rheumatica (PMR). It is specifically indicated for patients who have not responded well enough to corticosteroids or for those who are having difficulty reducing their dose of corticosteroid medication.

Kevzara works by helping to reduce the inflammation that causes symptoms like joint pain, stiffness, and swelling. By managing these symptoms, the medication can help improve physical function in people living with these chronic inflammatory conditions.

Mechanism of Action

Kevzara is a type of medication called an interleukin-6 (IL-6) receptor antagonist. It is a laboratory-made protein, known as a monoclonal antibody, that targets the body's immune system to manage inflammation.

Targeting IL-6

In a healthy body, IL-6 is a signaling protein that helps regulate the immune response. However, in conditions like rheumatoid arthritis, the body produces too much of this protein. High levels of IL-6 cause the immune system to attack healthy tissues, leading to the persistent inflammation, pain, and stiffness associated with these diseases.

How it Blocks Inflammation

Kevzara works by attaching itself to IL-6 receptors located on the surface of cells. By occupying these receptors, the medication prevents the IL-6 protein from binding to them. This action effectively blocks the inflammatory signals that IL-6 would otherwise send to the rest of the body.

By interrupting this signaling process, Kevzara helps to:

• Reduce the overall inflammatory response.
• Decrease joint swelling and pain.
• Slow down the progression of joint damage.

Common Side Effects

The most frequent side effects reported by people taking Kevzara include:

• Redness, itching, pain, or swelling at the site of injection
• Upper respiratory tract infections, such as the common cold or sinus infections
• Urinary tract infections
• Nasal congestion or sore throat

Serious Side Effects

While less common, some side effects can be severe. Seek medical attention immediately if you experience:

• Signs of infection: Fever, chills, persistent cough, night sweats, muscle aches, or feeling very tired.
• Gastrointestinal issues: Severe stomach pain, especially if accompanied by fever or changes in bowel habits, which may indicate a tear in the stomach or intestines.
• Allergic reactions: Rash, hives, chest pain, feeling faint, or swelling of the face, lips, or tongue.
• Liver problems: Yellowing of the skin or eyes (jaundice), dark urine, or pain on the right side of the stomach area.

Kevzara can also cause changes in laboratory test results, including decreased white blood cell counts, decreased platelet counts, and increased cholesterol or liver enzyme levels. Your healthcare provider will likely perform regular blood tests to monitor these levels during treatment.

Serious Infections

Kevzara includes a boxed warning because it may decrease the body's ability to fight infections. Serious and sometimes fatal infections, including tuberculosis (TB), bacterial, invasive fungal, and viral infections, have occurred in patients taking this medication. Healthcare providers typically screen for TB before starting treatment and monitor for signs of infection throughout therapy.

Gastrointestinal Perforation

Tears in the stomach or intestines, known as gastrointestinal perforation, have been reported. This risk is higher in individuals with a history of diverticulitis or those using concurrent medications like nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.

Laboratory Monitoring

Kevzara can cause significant changes in blood levels, requiring regular laboratory monitoring:

• Neutropenia: A decrease in white blood cells that help fight infection.
• Thrombocytopenia: A decrease in platelets that help the blood clot.
• Liver Enzymes: Potential increases in liver function tests.
• Lipid Levels: Increases in cholesterol and triglycerides.

Hypersensitivity

Serious allergic reactions, including anaphylaxis, can occur. The medication is contraindicated in patients with a known hypersensitivity to sarilumab.

Live Vaccines

Live vaccines should not be administered during treatment with Kevzara, as the medication's effect on the immune system may make the vaccine less safe or effective.

Pregnancy

Data regarding the use of Kevzara in pregnant women are limited. While animal studies did not show evidence of harm to the fetus at doses higher than those used in humans, human studies have not been conducted to confirm safety. Monoclonal antibodies, the class of drug Kevzara belongs to, are known to cross the placenta during the later stages of pregnancy, meaning the medication could reach the developing fetus.

If you are pregnant or planning to become pregnant, it is important to talk to your doctor about the risks and benefits of continuing treatment. Healthcare providers may also suggest enrolling in a pregnancy registry to monitor the health of both the mother and the baby.

Breastfeeding

It is not yet known if Kevzara passes into breast milk or if it has any effect on a nursing infant or milk production. Because many medications can be transferred through breast milk, you should consult your healthcare provider to weigh the benefits of breastfeeding against the potential risks to the infant while using this medication.

Available Forms

Kevzara is supplied as a sterile, preservative-free solution for subcutaneous injection. It is available in the following delivery formats:

• Pre-filled Syringe: A syringe equipped with a needle shield.
• Pre-filled Pen: An autoinjector device.

The medication is a clear liquid that may range from colorless to pale yellow. Each device is intended for use and should be discarded after administration.

FDA Approval and Indications

Kevzara was first approved by the U.S. Food and Drug Administration (FDA) in May 2017. It is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have not responded well to or cannot tolerate other disease-modifying antirheumatic drugs (DMARDs). It is also approved for adults with polymyalgia rheumatica who have had an inadequate response to corticosteroids or are unable to tolerate a corticosteroid taper.

Boxed Warning

The FDA has issued a Boxed Warning for Kevzara because it may increase the risk of developing serious infections that can lead to hospitalization or death. These infections include:

• Tuberculosis (TB)
• Bacterial infections
• Invasive fungal infections
• Viral and other opportunistic infections

Patients should be tested for latent tuberculosis before starting treatment and monitored for signs of infection during and after therapy.

Regulatory Monitoring

The FDA monitors the safety of Kevzara through various reporting systems. In early 2018, the FDA identified potential signals regarding medication administration errors, which are common for self-injectable biologics. Healthcare providers and patients are encouraged to report any adverse events or side effects to the FDA MedWatch program.

Insurance and Pharmacy Factors

The price you pay for Kevzara is primarily determined by your health insurance plan. Most plans cover this medication, but it is often placed on a specialty tier, which may require a higher copayment or coinsurance. The specific pharmacy used can also influence the final price, as Kevzara is typically dispensed through specialty pharmacies rather than standard retail locations.

Financial Assistance Programs

Because biologic medications like Kevzara can be costly, options may be available to help reduce the financial burden:

• Copay Cards: Patients with commercial insurance may be eligible for manufacturer-sponsored copay cards that lower out-of-pocket costs.
• Patient Assistance Programs: For those without insurance or with limited coverage, the manufacturer may provide the medication at a reduced cost or for free based on financial need.
• Support Services: Programs such as KevzaraConnect offer resources to help patients navigate insurance approvals and find financial support.

There are currently no lower-cost biosimilar versions of Kevzara available. Patients are encouraged to speak with their healthcare provider or insurance company to understand their specific coverage details.