Etrasimod
Generic Name: etrasimod
Brand Names:
Velsipity
11 DESCRIPTION VELSIPITY contains etrasimod, a sphingosine 1-phosphate (S1P) receptor modulator, supplied as etrasimod arginine. Etrasimod arginine is a white, off-white to light brown solid that is slightly soluble in water. The chemical name of etrasimod arginine is L-Arginine, (3 R )-7-[[4-cyclopentyl-3-(trifluoromethyl)phenyl]methoxy]-1,2,3,4-tetrahydrocyclopent[ b ]indole-3-acetate (1:1) having a molecular formula of C 32 H 40 F 3 N 5 O 5 and a molecular weight of 631.69 g/mol.
Overview
11 DESCRIPTION VELSIPITY contains etrasimod, a sphingosine 1-phosphate (S1P) receptor modulator, supplied as etrasimod arginine. Etrasimod arginine is a white, off-white to light brown solid that is slightly soluble in water. The chemical name of etrasimod arginine is L-Arginine, (3 R )-7-[[4-cyclopentyl-3-(trifluoromethyl)phenyl]methoxy]-1,2,3,4-tetrahydrocyclopent[ b ]indole-3-acetate (1:1) having a molecular formula of C 32 H 40 F 3 N 5 O 5 and a molecular weight of 631.69 g/mol.
Uses
1 INDICATIONS AND USAGE VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. VELSIPITY is a sphingosine 1-phosphate receptor modulator indicated for the treatment of moderately to severely active ulcerative colitis in adults. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION • Assessments are required prior to initiating VELSIPITY. ( 2.1 ) • The recommended dosage is 2 mg orally once daily. ( 2.2 ) 2.1 Assessments, Medications, and Vaccinations Prior to First Dose of VELSIPITY Before initiation of treatment with VELSIPITY, assess the following: Complete Blood Count Obtain a recent (i.e., within the last 6 months or after discontinuation of prior UC therapy) complete blood count (CBC), including lymphocyte count [see Warnings and Precautions (5.1) ]. Cardiac Evaluation Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present. In patients with certain preexisting conditions, advice from a cardiologist should be sought [see Warnings and Precautions (5.2) ] .
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Infections [see Warnings and Precautions (5.1) ] • Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions (5.2) ] • Liver Injury [see Warnings and Precautions (5.3) ] • Macular Edema [see Warnings and Precautions (5.4) ] • Increased Blood Pressure [see Warnings and Precautions (5.5) ] • Fetal Risk [see Warnings and Precautions (5.6) ] • Cutaneous Malignancies [see Warnings and Precautions (5.7) ] • Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.8) ] • Respiratory Effects [see Warnings and Precautions (5.9) ] • Unintended Additive Immune System Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs [see Wa...
Interactions
7 DRUG INTERACTIONS Etrasimod is primarily metabolized by CYP2C8, CYP2C9, and CYP3A4. Table 3 includes drugs with clinically important drug interactions when administered concomitantly with VELSIPITY and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information. The effect of concomitant use of VELSIPITY with a combination of separate drugs that are moderate to strong inhibitors or inducers of either CYP2C8, CYP2C9, or CYP3A4 is unknown. However, based on the information below, a similar clinically significant change in exposure cannot be ruled out when two or more metabolic pathways are affected.
Warnings
5 WARNINGS AND PRECAUTIONS • Infections : May increase the risk of infections. Obtain a complete blood count (CBC) before initiation of treatment. Monitor for infection during treatment and for 5 weeks after discontinuation. Consider interruption of treatment if a serious infection develops. Avoid use of live attenuated vaccines during and for up to 5 weeks after treatment. ( 5.1 ) • Bradyarrhythmia and Atrioventricular Conduction Delays : May result in a transient decrease in heart rate and AV conduction delays. Obtain an electrocardiogram (ECG) to assess for preexisting cardiac conduction abnormalities before starting treatment. Consider cardiology consultation for conduction abnormalities or concomitant use with other drugs that decrease heart rate. 4 CONTRAINDICATIONS VELSIPITY is contraindicated in patients who: • In the last 6 months, have experienced a myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure [see Warnings and Precautions (5.2) ] .
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to VELSIPITY during pregnancy. Pregnant females exposed to VELSIPITY and healthcare providers are encouraged to contact the pregnancy registry by calling 1-800-616-3791. Risk Summary Based on findings from animal studies, VELSIPITY may cause fetal harm when administered to a pregnant woman.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied VELSIPITY tablet is available as a round, green film-coated 2 mg etrasimod tablet, debossed with “ETR” on one side and “2” on the other side.
Frequently Asked Questions
What is Etrasimod used for?▼
1 INDICATIONS AND USAGE VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. VELSIPITY is a sphingosine 1-phosphate receptor modulator indicated for the treatment of moderately to severely active ulcerative colitis in adults. ( 1 )
What are the side effects of Etrasimod?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Infections [see Warnings and Precautions (5.1) ] • Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions (5.2) ] • Liver Injury [see Warnings and Precautions (5.3) ] • Macular Edema [see Warnings and Precautions (5.4) ] • Increased Blood Pressure [see Warnings and Precautions (5.5) ] • Fetal Risk [see Warnings and Precautions (5.6) ] • Cutaneous Malignancies [see Warnings and Precautions (5.7) ] • Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.8) ] • Respiratory Effects [see Warnings and Precautions (5.9) ] • Unintended Additive Immune System Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs [see Wa...
Can I take Etrasimod during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to VELSIPITY during pregnancy. Pregnant females exposed to VELSIPITY and healthcare providers are encouraged to contact the pregnancy registry by calling 1-800-616-3791. Risk Summary Based on findings from animal studies, VELSIPITY may cause fetal harm when administered to a pregnant woman.
What are the important warnings for Etrasimod?▼
5 WARNINGS AND PRECAUTIONS • Infections : May increase the risk of infections. Obtain a complete blood count (CBC) before initiation of treatment. Monitor for infection during treatment and for 5 weeks after discontinuation. Consider interruption of treatment if a serious infection develops. Avoid use of live attenuated vaccines during and for up to 5 weeks after treatment. ( 5.1 ) • Bradyarrhythmia and Atrioventricular Conduction Delays : May result in a transient decrease in heart rate and AV conduction delays. Obtain an electrocardiogram (ECG) to assess for preexisting cardiac conduction abnormalities before starting treatment. Consider cardiology consultation for conduction abnormalities or concomitant use with other drugs that decrease heart rate. 4 CONTRAINDICATIONS VELSIPITY is contraindicated in patients who: • In the last 6 months, have experienced a myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure [see Warnings and Precautions (5.2) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.