Clinical beta

FMBM is currently in clinical beta. Content is for professional review/testing and must not replace local protocols, senior clinical judgment, or official prescribing references.

Drug Monograph

Prasugrel

Prasugrel

P2Y12 inhibitor (thienopyridine prodrug)

DAPTACSPCIAdult

Indication

ACS PCI DAPT (when benefit > bleed per label)

At a glance

INDICATIONS (CORE USE)

ACS undergoing PCI with aspirin β€” **higher bleed** than clopidogrel; **contra** prior stroke/TIA.

ADULT DOSE (STANDARD)

Loading **60 mg** then **10 mg daily** (5 mg if <60 kg or age β‰₯75 per label)

MAX DOSE

10 mg daily maintenance (5 mg reduced cohorts)

Route

PO

PEDIATRIC DOSE

Not used

Do not miss

Must-not-miss safety points

Major warning

- **Prior TIA/stroke β€” contraindicated** - **Bleeding** ↑ vs clopidogrel β€” age β‰₯75 and low weight cautions - Premature DAPT stop β†’ stent thrombosis

Indications

USE IF: ACS PCI when rapid potent P2Y12 needed and no contraindications. AVOID IF: Prior stroke/TIA, active bleed, high bleed elderly/low weight per label.

Primary

  • ACS managed with PCI β€” DAPT with aspirin (label-specific)

Dosing

STANDARD (ADULT PO)

10 mg daily with aspirin after 60 mg load (ACS PCI)

ADULT DOSE

5 mg maintenance if <60 kg or age β‰₯75 per label β€” verify SFDA/FDA.

PEDIATRIC DOSE

N/A

MAX DOSE

10 mg/day maintenance

Practical Note

Discontinue β‰₯7 days before elective surgery if cardiology approves hold.

Warnings

Clinical warnings

  • **Major bleeding** (GI, ICH, post-procedural) β€” higher with **DAPT**, triple therapy, renal failure, age β€” counsel early symptoms
  • **DAPT after PCI/ACS:** duration is **indication- and stent-specific** β€” **do NOT stop prematurely** without **cardiology** (premature stop β†’ **stent thrombosis**, MI, death)
  • Elective surgery after recent stent β†’ **perioperative plan** with cardiology + surgery β€” **do not** assume β€œhold all antiplatelets” is safe
  • **Prasugrel:** **contraindicated** if prior **stroke/TIA**; caution age **β‰₯75** and low body weight per label β€” **bleed > clopidogrel**
  • Coronary artery bypass timing β€” hold prasugrel pre-CABG per guideline

Adverse effects

  • Bleeding
  • thrombocytopenia (rare)
  • rash

Contraindications

  • **Active major bleeding** β€” hold until controlled unless embedded in explicit procedural plan
  • **Prior stroke or TIA** β€” **contraindicated** (near-absolute)
  • Active bleeding
  • prior stroke/TIA
  • hypersensitivity

Drug interactions

  • **Anticoagulant or NSAID added on DAPT** β†’ **bleeding risk ↑** β†’ **reassess duration** (triple therapy only when justified)
  • **Strong CYP3A4 inhibitor/inducer (ticagrelor)** or **CYP2C19 issue (clopidogrel)** β†’ **avoid or switch** per cardiology/pharmacy β€” do not ignore
  • Anticoagulants
  • fibrinolytics
  • NSAIDs

Special populations

Pediatrics

Not used

Pregnancy

Avoid unless benefit outweighs β€” limited data

Lactation

See lactation references and product labeling.

Renal impairment

Mild-moderate renal impairment generally no adjustment β€” still high bleed

Hepatic impairment

Severe hepatic impairment β€” avoid per label

Elderly

β‰₯75 β€” 5 mg dose and bleed discussion

Administration

PO with or without food

Monitoring

  • Monitor: - **Coronary stent / recent PCI** β†’ **do NOT stop DAPT early** without **cardiology** β€” duration **ACS vs stable CAD** differs - **Prior TIA/stroke** β†’ **do not use** (contraindicated) - **Higher bleed than clopidogrel** β†’ age **β‰₯75**, low weight β€” label cautions - **DAPT stop** β†’ **cardiology only** after recent stent β€” **stent thrombosis** risk - **Active bleeding** β†’ **hold** + transfusion/supportive; **surgery** β†’ longer washout than clopidogrel in many protocols - Bleeding with any invasive procedure
  • Recheck: - **Planned invasive procedure in 48–72h** β†’ **pre-op antiplatelet review** with cardiology + surgery β€” document **bleed vs stent thrombosis** - New or worsening **bleeding**, unexplained **Hb drop**, or planned invasive procedure within **48–72h** β†’ reassess antiplatelet plan with cardiology/surgery when on DAPT - If targets not met after reassessment of dose, organ function, and interactions β†’ escalate per protocol (DO NOT continue blindly)
  • Hold if:
    - **Bleeding or unexplained Hb drop** β†’ **hold strategy** is team-based β€” do not stop all agents without plan

Overdose / toxicity

Clinical Picture

**A) Therapeutic complication:** **bleeding** on DAPT/triple therapy or peri-procedure β€” **no** classic β€œsupratherapeutic serum level” syndrome for oral P2Y12. **B) Massive oral overdose:** management is **supportive + bleeding care**; **no** specific antidote β€” **not** salicylate-style toxicology unless co-ingestion.

Immediate Actions

**A:** Stop P2Y12 (and often aspirin in DAPT) per **cardiology + surgery** plan β†’ mechanical hemostasis; transfuse as indicated β€” **stent timing** if interruption considered. **B:** Charcoal if very early massive ingestion + protected airway; otherwise **observe + bleed surveillance**

Antidote

No specific antidote; treat complications (supportive care, platelets / hemostasis per protocol, anaphylaxis β†’ epinephrine per ACLS)

Decontamination

**B:** Charcoal only if massive ingestion within narrow window; **A:** N/A maintenance therapy

Escalation

**ICH** or unstoppable surgical bleed β†’ **ICU**; platelet transfusion **does not fully reverse** P2Y12 β€” **procedural/heme judgment**

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield Summary

**Stroke history = no prasugrel.** β†’ More bleed than clopidogrel β€” label age/weight rules.

Clinical pearls

CABG timing β€” washout per ACC guidance. *Antiplatelet (all agents):* **Primary vs secondary (aspirin):** primary **not routine**; secondary **strong** when guideline-supported. **DAPT:** **do not stop early** post-stent without expert; duration **ACS vs stable CAD**; procedures need **explicit review**. **Bleeding-first:** GI/ICH/peri-op; **duplicate/hidden aspirin** on med rec. **Aspirin toxicity** (salicylate) is a **separate pathway** from antiplatelet bleed.

Antiplatelet safety

  • TIA/stroke screen
  • Weight/age dose
  • DAPT stop plan

Pharmacokinetics

Rapid onset; offset ~7–14d clinically for surgery planning.

Mechanism of action

Irreversible P2Y12 inhibition β€” active metabolite.

Common brand names

Saudi Arabia

Efient, Prasugrel

Global

Effient, (placeholder β€” verify local product)

Common trade names are curated examples only β€” formulations and availability vary. Verify the exact product name with your local pharmacy and national regulator before prescribing or dispensing.

Country practice notes

  • DAPT duration and perioperative management follow **ESC/AHA/ACC** and local cardiology consensus β€” not one-size rules.
  • Primary prevention aspirin thresholds differ by guideline and age β€” verify regional primary-care policy.

References

Saudi Arabia

  • SFDA (Saudi Food & Drug Authority)
  • Saudi National Formulary / MOH (where available)

International

  • WHO Model List of Essential Medicines (verify current edition)
  • US FDA or EU EMA product information (when national SmPC is unavailable)
  • ACC / AHA / ESC cardiovascular guidelines (CAD, ACS, PCI)
  • FDA / SFDA product labeling
  • Local cath lab / antithrombotic protocol
  • ACC / AHA / ESC cardiovascular guidelines (CAD, ACS, PCI)
  • FDA / SFDA product labeling
  • Local cath lab / antithrombotic protocol

Do not miss

  • Document antiplatelet indication (primary vs secondary prevention vs stent DAPT)
  • Med reconciliation: OTC aspirin, NSAIDs, fish oil, anticoagulants
  • **Prior stroke/TIA:** **Contraindicated** β€” **near-absolute**; do not initiate.
  • **Bleed > clopidogrel:** Age β‰₯75, low weight β€” relative contraindications per label.
  • **Premature DAPT stop / peri-op:** Same **stent thrombosis** risk β€” **indexed cardiology plan** before any interruption.
  • **Surgery:** Longer washout than clopidogrel in many protocols β€” document **last dose**.
  • Starting prasugrel in patient with old stroke β€” **black box territory**.
  • **DAPT (factory rules):**
  • **Do NOT stop early** after coronary stent unless **cardiology/expert**-directed β€” premature stop β†’ **stent thrombosis**.
  • **Duration** depends on **ACS vs stable CAD/PCI** context β€” not one schedule for all.
  • **Planned procedure** β†’ **explicit antiplatelet review** with cardiology + surgery β€” document **bleed vs thrombosis** tradeoff.
  • TIA/stroke screen
  • Weight/age dose
  • DAPT stop plan