Velsipity (etrasimod) is a prescription medication used to treat moderately to severely active ulcerative colitis in adults. It is a sphingosine 1-phosphate (S1P) receptor modulator that helps reduce inflammation in the colon. However, Velsipity is not appropriate for everyone. Regulatory bodies have outlined specific contraindications and precautions due to potential side effects impacting the heart, liver, and immune system. A thorough medical assessment is necessary before starting treatment.
Serious Cardiovascular Conditions
Velsipity is contraindicated in patients with a history of recent cardiovascular events or certain heart rhythm issues. The drug can affect heart rate and electrical conduction, posing risks for those with pre-existing heart problems. Specific contraindications include a heart attack, unstable angina, stroke, or TIA within the last six months, certain types of decompensated heart failure, or severe Class III/IV heart failure. Uncorrected unusual heartbeats not managed by a pacemaker and specific electrical heart problems like Mobitz type II second- or third-degree AV block, sick sinus syndrome, or sino-atrial block are also contraindications unless a functioning pacemaker is present.
Active Infections and Impaired Immune Response
Velsipity reduces lymphocytes, increasing the risk of serious infections. It is contraindicated in individuals with active or chronic infections and should not be started until a serious active infection is resolved. It is also not for patients unable to fight infections due to disease. Live attenuated vaccines should be avoided during treatment and for at least 5 weeks after stopping, and antibody-negative patients for VZV need vaccination at least 4 weeks before starting.
Liver Disease
Velsipity is processed by the liver and is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Liver function tests are required before and during therapy, and treatment should stop if significant liver injury is confirmed, especially with symptoms.
Pregnancy and Breastfeeding
Animal studies suggest Velsipity may harm an unborn baby. It is contraindicated during pregnancy. Women who can become pregnant must use effective contraception during treatment and for at least one week after stopping. Use is not recommended during breastfeeding.
Significant Drug Interactions
Velsipity can interact with other medications, potentially causing serious side effects. Concomitant use with other immunosuppressants or immune-modulating therapies is not recommended. Drugs controlling heart rhythm (e.g., quinidine, amiodarone) can increase the risk of dangerous heart rhythm problems. Medications affecting certain liver enzymes (CYP2C9 and CYP3A4), like fluconazole or rifampin, can alter Velsipity levels and should be avoided.
Comparison of Patient Groups: Velsipity Suitability
| Health Status Category | Suitable for Velsipity? | Reason |
|---|---|---|
| Cardiovascular Health | ||
| Recent heart attack (≤6 months) | No | Increased risk of serious heart rhythm problems. |
| Stable, controlled heart failure | Consult specialist | Caution is needed; cardiologist advice should be sought. |
| Stable sinus rhythm | Yes, after initial monitoring | Safe with proper monitoring for transient heart rate changes. |
| Uncorrected heart block (Mobitz II/III) | No | High risk of dangerous cardiac events. |
| Infections & Immune System | ||
| No active, serious infections | Yes | Safe, but increased infection risk must be monitored. |
| Active or chronic infection | No | Suppressed immune response increases infection severity. |
| Planning live vaccination | No | Ineffective vaccine and risk of infection from weakened virus. |
| Liver Health | ||
| Mild to moderate impairment | Yes, no dose adjustment | Safe, but requires monitoring of liver enzymes. |
| Severe impairment (Child-Pugh C) | No | Risk of Velsipity buildup and increased side effects. |
| Reproductive Potential | ||
| Pregnant or trying to conceive | No | Potential for fetal harm shown in animal studies. |
| Female of reproductive potential | Yes, with contraception | Use effective birth control during and for 7 days after stopping. |
Important Warnings and Side Effects
Beyond contraindications, patients should be aware of several warnings associated with Velsipity. These include increased susceptibility to infections, temporary slowing of heart rate (bradyarrhythmia), potential macular edema (swelling in the eye), mild increases in blood pressure, increased risk of skin cancer (requiring sun protection and regular checks), a rare neurological condition called PRES, and potential respiratory effects.
Conclusion
Velsipity is effective for moderate to severe ulcerative colitis, but it's not suitable for everyone. Individuals with recent heart events, certain heart rhythm issues, severe liver disease, active infections, or those pregnant or planning pregnancy should avoid it. Due to its effect on the immune system, careful screening and monitoring are crucial for potential side effects. Patients should discuss their medical history and all medications with their healthcare provider to determine if Velsipity is a safe option {Link: velsipity.com https://www.velsipity.com/assets/pdfs/day-one-branded-brochure-digital.pdf}.
