Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Risk of Infections
Inform patients that they may be more likely to get infections, some of which could be life-threatening, when taking VELSIPITY and for 5 weeks after stopping it, and that they should contact their healthcare provider if they develop symptoms of infection [see Warnings and Precautions (5.1)]. Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection.
Advise patients that some vaccines containing live virus (live attenuated vaccines) should be avoided during treatment with VELSIPITY. Advise patients that if immunizations are planned, they should be administered at least 4 weeks prior to initiation of VELSIPITY. Inform patients that the use of live attenuated vaccines should be avoided during and for 5 weeks after treatment with VELSIPITY.
Cardiac Effects
Advise patients that initiation of VELSIPITY treatment may result in transient decrease in heart rate [see Warnings and Precautions (5.2)].
Liver Injury
Inform patients that VELSIPITY may increase liver enzymes. Advise patients that they should contact their healthcare provider if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine [see Warnings and Precautions (5.3)].
Macular Edema
Advise patients that VELSIPITY may cause macular edema, and that they should obtain an eye exam near the start of treatment with VELSIPITY, have their eyes monitored periodically by an eye care professional while receiving therapy, and contact their healthcare provider if they experience any changes in their vision while taking VELSIPITY [see Warnings and Precautions (5.4)].
Fetal Risk
VELSIPITY may cause fetal harm. Advise females to immediately inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with VELSIPITY and for one week after stopping VELSIPITY [see Use in Specific Populations (8.3)].
Pregnancy and Pregnancy Registry
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to VELSIPITY during pregnancy [see Use in Specific Populations (8.1)].
Cutaneous Malignancies
Advise patients to limit exposure to sunlight and ultraviolet (UV) light, wear protective clothing, and use a sunscreen with a high protection factor. Concomitant phototherapy with UV-B radiation or PUVA‑photochemotherapy is not recommended in patients taking VELSIPITY. If a suspicious skin lesion is observed, patients should immediately report it to their healthcare provider [see Warnings and Precautions (5.7)].
Posterior Reversible Encephalopathy Syndrome
Advise patients to immediately report to their healthcare provider any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead to permanent neurological consequences [see Warnings and Precautions (5.8)].
Respiratory Effects
Advise patients that they should contact their healthcare provider if they experience new onset or worsening dyspnea [see Warnings and Precautions (5.9)].
Immune System Effects after Stopping VELSIPITY
Advise patients that VELSIPITY continues to have effects, such as lowering effects on peripheral lymphocyte count, for up to 5 weeks after the last dose, and to monitor for signs and symptoms of infection during that time [see Warnings and Precautions (5.11)].
This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
For Medical Information about VELSIPITY, please visit www.pfizermedinfo.com or call 1-800-438-1985.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Risk of Infections
Inform patients that they may be more likely to get infections, some of which could be life-threatening, when taking VELSIPITY and for 5 weeks after stopping it, and that they should contact their healthcare provider if they develop symptoms of infection [see Warnings and Precautions (5.1)]. Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection.
Advise patients that some vaccines containing live virus (live attenuated vaccines) should be avoided during treatment with VELSIPITY. Advise patients that if immunizations are planned, they should be administered at least 4 weeks prior to initiation of VELSIPITY. Inform patients that the use of live attenuated vaccines should be avoided during and for 5 weeks after treatment with VELSIPITY.
Cardiac Effects
Advise patients that initiation of VELSIPITY treatment may result in transient decrease in heart rate [see Warnings and Precautions (5.2)].
Liver Injury
Inform patients that VELSIPITY may increase liver enzymes. Advise patients that they should contact their healthcare provider if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine [see Warnings and Precautions (5.3)].
Macular Edema
Advise patients that VELSIPITY may cause macular edema, and that they should obtain an eye exam near the start of treatment with VELSIPITY, have their eyes monitored periodically by an eye care professional while receiving therapy, and contact their healthcare provider if they experience any changes in their vision while taking VELSIPITY [see Warnings and Precautions (5.4)].
Fetal Risk
VELSIPITY may cause fetal harm. Advise females to immediately inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with VELSIPITY and for one week after stopping VELSIPITY [see Use in Specific Populations (8.3)].
Pregnancy and Pregnancy Registry
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to VELSIPITY during pregnancy [see Use in Specific Populations (8.1)].
Cutaneous Malignancies
Advise patients to limit exposure to sunlight and ultraviolet (UV) light, wear protective clothing, and use a sunscreen with a high protection factor. Concomitant phototherapy with UV-B radiation or PUVA‑photochemotherapy is not recommended in patients taking VELSIPITY. If a suspicious skin lesion is observed, patients should immediately report it to their healthcare provider [see Warnings and Precautions (5.7)].
Posterior Reversible Encephalopathy Syndrome
Advise patients to immediately report to their healthcare provider any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead to permanent neurological consequences [see Warnings and Precautions (5.8)].
Respiratory Effects
Advise patients that they should contact their healthcare provider if they experience new onset or worsening dyspnea [see Warnings and Precautions (5.9)].
Immune System Effects after Stopping VELSIPITY
Advise patients that VELSIPITY continues to have effects, such as lowering effects on peripheral lymphocyte count, for up to 5 weeks after the last dose, and to monitor for signs and symptoms of infection during that time [see Warnings and Precautions (5.11)].
This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
For Medical Information about VELSIPITY, please visit www.pfizermedinfo.com or call 1-800-438-1985.
{{section_body_html_patient}}
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
Pfizer Safety
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
Pfizer Safety Reporting Site*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.