KYGEVVI safety and side effects

The most common side effects of KYGEVVI

Diarrhea

Vomiting

Stomach (abdominal) pain including pain in the upper stomach area

Increase in liver enzymes in your blood

KYGEVVI may cause serious side effects, including:

Elevated liver enzyme levels

Your healthcare provider will do blood tests to check your liver enzyme levels before starting treatment and during treatment
Your healthcare provider may temporarily or permanently stop your treatment if you develop liver problems
Call your healthcare provider right away if you develop any signs or symptoms of liver problems, including:
- Loss of appetite
- Pain on the right side of your stomach area
- Dark, amber-colored urine
- Yellowing of your skin or the white part of your eyes
- Nausea and vomiting
- Itching

Stomach and intestinal problems

Contact your healthcare provider promptly if you experience diarrhea and/or vomiting that lasts longer than a few days while taking KYGEVVI

Starting KYGEVVI

See KYGEVVI preparation, dosing, and administration.

INDICATION

KYGEVVI is a prescription medicine used for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and children with a symptom onset on or before 12 years of age.

IMPORTANT SAFETY INFORMATION

KYGEVVI may cause serious side effects including elevated liver enzyme levels. Increased liver enzyme levels in your blood are common with KYGEVVI. Your healthcare provider will do blood tests to check your liver enzyme levels before starting treatment and during treatment with KYGEVVI.

Tell your healthcare provider right away if you develop any signs or symptoms of liver problems, including loss of appetite, pain on the right side of your stomach area, dark or amber-colored urine, yellowing of your skin or the white part of your eyes, nausea and vomiting, or itching.

KYGEVVI may cause stomach and intestinal (gastrointestinal) problems. Diarrhea and vomiting are common with KYGEVVI, but may also be severe and lead to hospitalization. Tell your healthcare provider right away if you have diarrhea or vomiting during treatment with KYGEVVI that lasts longer than a few days.

The most common side effects of KYGEVVI include diarrhea, stomach area (abdominal) pain including pain in the upper stomach area, vomiting, and increased liver enzyme levels in your blood.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with KYGEVVI if you develop certain side effects.

Before taking or giving KYGEVVI, tell your healthcare provider about all of your medical conditions, including if you have or have had liver problems. In addition, tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if KYGEVVI will harm your unborn baby. Also, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if KYGEVVI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take KYGEVVI. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

These are not all of the possible side effects of KYGEVVI. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UCB, Inc. at UCBCares® (1-844-599-CARE [2273]).

Please see additional information in the Patient Information Leaflet.