Meta Information
ID:pcsk9-inhibitors
Name:
Schema Version:2.4_uniform_evidence_2026_06_18
Created
2026-05-25T10:30:00Z
Model
wave14_quickwin_pcsk9_class_inference
Interactions
Target id:
/condition/serious-hypersensitivity-pcsk9
Target name:
History of Serious Hypersensitivity to a PCSK9 Inhibitor
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Patients with a history of a serious hypersensitivity reaction to any PCSK9 inhibitor or to excipients in their formulation must not receive this class. Class effect verified in both alirocumab and evolocumab labels. [class-derived from: class_pharmacology]
Actionable advice:
All PCSK9 inhibitors should be avoided after a serious allergic reaction to one of them.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Exact phrase from label:
History of a serious hypersensitivity reaction to alirocumab
Label source:
FDA labels: Alirocumab (PRALUENT) and Evolocumab (REPATHA) [class-derived from: Alirocumab and Evolocumab]
Action type:
avoid
Target id:
/adverse/angioedema
Target name:
Angioedema / Serious Hypersensitivity Reactions
Severity:
major
Interaction type:
adverse
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Angioedema and other serious hypersensitivity reactions have been reported across the PCSK9-inhibitor class (verified in alirocumab and evolocumab labels). [class-derived from: class_pharmacology]
Actionable advice:
If you develop facial/lip/tongue swelling or difficulty breathing on any PCSK9 inhibitor, stop the drug and seek emergency care.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Exact phrase from label:
Angioedema has occurred
Label source:
FDA labels: Alirocumab (PRALUENT) and Evolocumab (REPATHA) [class-derived from: Alirocumab and Evolocumab]
Action type:
avoid
Target id:
/condition/pregnancy
Target name:
Pregnancy
Severity:
moderate
Interaction type:
adverse
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Across the PCSK9-inhibitor class, available data on use in pregnant women are insufficient to evaluate for a drug-associated risk. Discuss continued use with your prescriber. [class-derived from: class_pharmacology]
Actionable advice:
It is important to talk to a prescriber about benefit/risk before continuing a PCSK9 inhibitor during pregnancy.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Exact phrase from label:
Available data from clinical trials and postmarketing reports on PRALUENT use in pregnant women are insufficient to evaluate for a drug-associated risk
Label source:
FDA labels: Alirocumab (PRALUENT) and Evolocumab (REPATHA) [class-derived from: Alirocumab and Evolocumab]
Action type:
informational_none
Target id:
/condition/lactation
Target name:
Lactation / Breastfeeding
Severity:
minor
Interaction type:
adverse
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Both alirocumab and evolocumab labels note that monoclonal IgG antibodies in breast milk do not enter the neonatal and infant circulation in substantial amounts. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the PCSK9 inhibitor. [class-derived from: class_pharmacology]
Actionable advice:
It is a good idea to talk to a prescriber; breastfeeding is generally compatible.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Exact phrase from label:
breastfeeding should be considered along with the mother's clinical need for PRALUENT
Label source:
FDA labels: Alirocumab (PRALUENT) and Evolocumab (REPATHA) [class-derived from: Alirocumab and Evolocumab]
Action type:
informational_none
Target id:
/adverse/injection-site-reaction
Target name:
Injection Site Reactions
Severity:
minor
Interaction type:
adverse
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Injection site reactions are a common class adverse reaction across PCSK9 inhibitors administered subcutaneously. [class-derived from: class_pharmacology]
Actionable advice:
Rotate injection sites; mild local reactions usually resolve.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Exact phrase from label:
injection site reactions
Label source:
FDA labels: Alirocumab (PRALUENT) and Evolocumab (REPATHA) [class-derived from: Alirocumab and Evolocumab]
Action type:
informational_none
Target id:
/condition/renal-impairment
Target name:
Renal Impairment (mild–moderate)
Severity:
minor
Interaction type:
monitoring
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
PCSK9 inhibitors do not require dose adjustment in mild–moderate renal impairment. Severe renal impairment data are limited; discuss with your prescriber. [class-derived from: class_pharmacology]
Actionable advice:
No dose change for mild–moderate renal impairment; severe impairment data are limited.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Exact phrase from label:
No dose adjustment is needed for patients with mild or moderately impaired renal function
Label source:
FDA labels: Alirocumab (PRALUENT) and Evolocumab (REPATHA) [class-derived from: Alirocumab and Evolocumab]
Action type:
informational_none
Target id:
/condition/hepatic-impairment
Target name:
Hepatic Impairment (mild–moderate)
Severity:
minor
Interaction type:
monitoring
Nature:
conditional
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Across the PCSK9-inhibitor class, no dose adjustment is needed in mild–moderate hepatic impairment. Severe (Child-Pugh C) data are lacking. [class-derived from: class_pharmacology]
Actionable advice:
No dose change in mild–moderate hepatic impairment; severe impairment has not been studied.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Exact phrase from label:
No dose adjustment is needed for patients with mild or moderate hepatic impairment
Label source:
FDA labels: Alirocumab (PRALUENT) and Evolocumab (REPATHA) [class-derived from: Alirocumab and Evolocumab]
Action type:
informational_none
Target id:
/class/cns-depressants
Target name:
CNS Depressants
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
null
Description:
General caution when combined with other active therapeutic agents.
Actionable advice:
It is important to talk to a physician before combining this with other medications.
Validation status:
unvalidatable
Evidence tier:
tier_e
Evidence basis:
unvalidatable
Evidence anchors:
Source url:
Scientific literature support not found
Exact phrase from label:
Label source:
Generic placeholder row: the text is non-specific ('general caution') and there is no established CNS-depressant interaction for this agent. No validatable interaction claim - marked unvalidatable (candidate for removal).
Action type:
informational_none