Primary Contraindications: When to Absolutely Avoid Kevzara
Kevzara is a powerful interleukin-6 (IL-6) receptor blocker used to treat conditions like rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR) by modulating the immune system. However, its immunosuppressive nature means it is not safe for all individuals. The prescribing information specifies several conditions that absolutely contraindicate its use.
Known Hypersensitivity or Allergic Reaction
Patients who have experienced a previous serious allergic reaction (hypersensitivity) to sarilumab, the active ingredient in Kevzara, or any of its inactive ingredients should not take the medication. Signs of a severe allergic reaction can include hives, chest pain, difficulty breathing, or swelling of the face, tongue, or lips. Any such reaction necessitates immediate medical attention and discontinuation of the drug.
Active Severe Infection
Due to its effect on the immune system, Kevzara should not be started in a patient who has an active, severe infection, whether localized or systemic. Using an immunosuppressant during an active infection significantly increases the risk of the infection becoming more serious, spreading, or even becoming fatal. The medication should be held until the infection is completely controlled. This includes bacterial, viral, fungal, and opportunistic infections.
Active Hepatic Disease or Impairment
Treatment with Kevzara is not recommended for patients with active hepatic disease or significant liver impairment. The drug can cause elevated liver enzymes, which can worsen pre-existing liver problems. For this reason, liver function tests are monitored before and during therapy, and treatment may be discontinued if levels become too high.
Increased Risks Requiring Caution and Monitoring
Even in the absence of absolute contraindications, certain medical conditions and concurrent therapies require careful consideration and close monitoring by a healthcare professional.
Chronic or Recurrent Infections
Patients with a history of chronic or recurrent infections, including latent tuberculosis (TB) or certain fungal infections, are at a higher risk of reactivation or more severe illness. Before starting Kevzara, all patients should be tested for latent TB. If the test is positive, the TB infection must be treated before initiating Kevzara. Close monitoring for signs of infection is necessary throughout treatment.
Gastrointestinal Perforation Risk
There is an increased risk of gastrointestinal (GI) perforation, or a tear in the stomach or intestines, associated with Kevzara, particularly for those with pre-existing conditions like diverticulitis or ulcers. This risk is further elevated when the medication is taken alongside nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Patients experiencing new or persistent abdominal pain and fever should be promptly evaluated.
Abnormal Laboratory Values
Pre-existing blood abnormalities and changes in laboratory parameters during treatment require dosage adjustment or discontinuation of Kevzara.
Reasons for Dose Adjustment or Discontinuation:
- Neutropenia: Initiation is not recommended if the absolute neutrophil count (ANC) is below 2000/mm³. Dosing must be held or discontinued if ANC levels drop significantly during treatment.
- Thrombocytopenia: Kevzara should not be initiated if the platelet count is less than 150,000/mm³. Doses must be held or discontinued based on monitoring results.
- Elevated Liver Enzymes (ALT/AST): Treatment initiation is not recommended if transaminase levels are above 1.5 times the upper limit of normal (ULN). Levels are monitored regularly and therapy may be discontinued if they exceed certain thresholds.
Avoiding Dangerous Drug and Vaccine Interactions
Concomitant Use with Other Biologic DMARDs
Kevzara is not recommended for use with other biologic DMARDs, such as TNF antagonists, IL-1 antagonists, or anti-CD20 monoclonal antibodies. Combining these powerful immunosuppressants can significantly increase the risk of severe infections. A healthcare provider will determine the most appropriate biologic therapy for a patient's condition.
Live Vaccines
Patients on Kevzara should not receive live vaccines. Live vaccines contain a weakened form of the virus or bacteria, and because Kevzara suppresses the immune system, there is a risk that the weakened microbes could cause a serious infection. It is recommended that patients receive all necessary live vaccines before starting Kevzara therapy.
Special Populations and Conditions
Pregnancy and Lactation
It is currently not known if Kevzara can harm an unborn baby or if it passes into human breast milk. The medication should only be used during pregnancy if the potential benefits outweigh the risks. Women of childbearing potential should use effective contraception during and for at least three months after treatment. Lactation should also be considered and discussed with a healthcare provider.
History of Cancer
Kevzara may increase the risk of certain cancers by altering immune function. For individuals with a past history of cancer, a doctor must carefully evaluate the risks and benefits before prescribing the medication.
Summary of Contraindications and Risk Factors
| Condition / Risk Factor | Why Kevzara is Not Recommended / Cautious | Primary Concern(s) |
|---|---|---|
| Known Hypersensitivity to Sarilumab | Risk of serious allergic reaction (anaphylaxis). | Allergic reaction |
| Active Severe Infection | High risk of the infection becoming more severe or fatal. | Infection |
| Active Hepatic Disease | May exacerbate liver problems and elevate liver enzymes. | Liver damage |
| Absolute Neutrophil Count (ANC) <2000/mm³ | Increases the risk of serious bacterial infections. | Neutropenia, infection |
| Platelet Count <150,000/mm³ | May lead to excessive bleeding and bruising. | Thrombocytopenia |
| Concomitant Biologic DMARD Use | Increases the risk of significant immunosuppression and serious infections. | Immunosuppression, infection |
| Live Vaccines | Risk of developing the illness the vaccine is meant to prevent. | Vaccine-induced infection |
Conclusion
Kevzara is an effective treatment for certain autoimmune conditions, but it carries significant warnings and is not suitable for everyone. Patients with active infections, known hypersensitivity to the drug, or active hepatic disease must avoid it. Furthermore, careful consideration and monitoring are required for individuals with a history of chronic infections, diverticulitis, certain laboratory abnormalities, or cancer. The concurrent use of other biologic DMARDs or live vaccines is also strictly contraindicated. Given these risks, patients must have a thorough discussion with their healthcare provider about their full medical history and all other medications they are taking before starting Kevzara. This proactive approach ensures a comprehensive risk-benefit assessment for safe and effective treatment. For detailed safety information, consult the official FDA prescribing information: Kevzara prescribing information.
Important Precautions
- Active Infection: Kevzara should be avoided in patients with an active infection, and treatment should be held if a serious infection develops.
- Known Allergy to Sarilumab: Individuals with a known hypersensitivity to sarilumab or its ingredients are contraindicated from using Kevzara due to the risk of a serious allergic reaction.
- Active Liver Disease: Patients with active hepatic disease or significant liver impairment are not recommended to take Kevzara because of the risk of elevated liver enzymes and potential liver damage.
- Blood Count Abnormalities: Kevzara should not be started if the patient has low neutrophil or platelet counts, as it can worsen these conditions and increase infection or bleeding risk.
- History of Gastrointestinal Issues: Patients with a history of diverticulitis or stomach ulcers face a higher risk of GI perforation, especially when also taking NSAIDs or corticosteroids.
- Concomitant Biologic Use: Using Kevzara with other biologic DMARDs is not recommended due to the potential for increased immunosuppression and higher risk of infection.
- Live Vaccines: Live vaccines must be avoided during Kevzara treatment, as the weakened immune system can increase the risk of developing a serious infection from the vaccine itself.
