Product information and disease description Place of product in therapy Approaches to treatment

Ongoing post-approval monitoring

4 evidence topics · 2 sources

Adverse reaction reporting

“To report SUSPECTED ADVERSE REACTIONS, contact Asahi Kasei Therapeutics, Inc. at 1-844-835-6947 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.” (opens the prescribing information at this quote)
“Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.” (opens the prescribing information at this quote)

Monitoring and follow-up actions stated in the prescribing information

“In the event of an overdose, patients should be monitored for adverse reactions and managed with supportive care, as appropriate.” (opens the prescribing information at this quote)
“Refer to the prescribing information for co-administered drugs for additional information.” (opens the prescribing information at this quote)
“Inform patients that HOVILPRI may interact with some drugs; therefore, advise patients to report the use of any other medications to their healthcare provider” (opens the prescribing information at this quote)
“Concomitant use of HOVILPRI with certain acid-reducing agents may reduce pritelivir exposure, potentially resulting in reduced therapeutic effect and development of resistance.” (opens the prescribing information at this quote)

Hepatic laboratory abnormalities reported in the prescribing information

“Hepatic laboratory abnormalities were observed in both treatment groups in PRIOH-1, Part C.” (opens the prescribing information at this quote)
“ALT elevations ≥2.5 × upper limit of normal (ULN) were reported in 4/51 (8%) participants receiving HOVILPRI and 1/50 (2%) receiving Investigator’s Choice, while AST elevations ≥2.5 × ULN were reported in 3/51 (6%) and 2/50 (4%) participants, respectively.” (opens the prescribing information at this quote)
“One participant discontinued HOVILPRI due to elevated liver enzymes.” (opens the prescribing information at this quote)

Laboratory monitoring schedule required by the prescribing information

No evidence found.

Risk evaluation and mitigation strategy

No evidence found.

Monitoring within the expanded access protocol

“Each subject considered for the EAP will undergo minimal assessment at baseline for lesion assessment and safety (laboratory tests and general physical evaluation).” (opens the source at this quote in a new tab)
“After eligibility check and starting the treatment, the subjects will be monitored on a weekly basis.” (opens the source at this quote in a new tab)
“Negative pregnancy test for females of childbearing potential at Day 1 and every 4 weeks thereafter.” (opens the source at this quote in a new tab)

Post-approval registry or observational study

No evidence found.