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

Dalteparin

Dalteparin

Low-molecular-weight heparin (LMWH)

VTEProphylaxisSCAdult

Indication

Surgical/medical prophylaxis β€’ Acute VTE β€’ Cancer-associated thrombosis (extended)

At a glance

INDICATIONS (CORE USE)

VTE prophylaxis/treatment; **cancer-associated thrombosis** 1-month dosing schema β€” distinct from acute VTE mg/kg; renal adjustment CrCl <30.

ADULT DOSE (STANDARD)

Prophylaxis 2500–5000 IU SC daily/BID by risk; cancer thrombosis **~200 IU/kg daily Γ—1 month** then ~150 IU/kg β€” label-specific

MAX DOSE

Cancer schema caps daily IU β€” verify label; acute VTE uses IU/kg

Route

SC

PEDIATRIC DOSE

Rare β€” specialist

Do not miss

Must-not-miss safety points

Major warning

- **Cancer dosing β‰  standard VTE dosing** β€” wrong schema β†’ under-treatment - HIT risk as with all heparins - Renal failure β†’ accumulation β€” dose reduction or alternative

Indications

USE IF: Prophylaxis, acute VTE, or extended cancer thrombosis per oncology protocol. AVOID IF: HIT, active bleeding, unmonitored full-dose in severe renal failure.

Primary

  • Thromboprophylaxis
  • Acute VTE treatment
  • Extended treatment of cancer-associated VTE (labeled schema)

Secondary

  • Bridging (selected)

Dosing

STANDARD (ADULT PO)

2500–5000 IU SC for prophylaxis β€” indication-specific

ADULT DOSE

Acute VTE: IU/kg BID or daily per regional label. **Cancer thrombosis:** month-1 higher IU/kg daily then reduced month 2+ β€” **exact table on label**. CrCl **<30:** reduce or monitor anti-Xa.

PEDIATRIC DOSE

Specialist.

MAX DOSE

Cancer dosing has explicit IU caps β€” do not memorize without label.

Practical Note

Confirm units (IU) vs enoxaparin mg β€” not interchangeable mg-for-mg.

Warnings

Clinical warnings

  • **HIT (all heparin):** β€’ **STOP ALL HEPARIN** (including **flushes**) β€’ **DO NOT switch to LMWH** β€’ **Start non-heparin anticoagulant** (per institutional HIT pathway + hematology) β€” **suspected / probable HIT**
  • Neuraxial hematoma
  • Platelet monitoring for HIT

Adverse effects

  • Bleeding
  • bruising
  • thrombocytopenia

Contraindications

  • **Suspected acute HIT** β€” **no UFH or LMWH** until non-heparin pathway per institutional protocol
  • **Active pathological / major bleeding** β€” stabilize/reverse per protocol before routine (re)start unless embedded in explicit reversal plan
  • **Upcoming invasive procedure** β€” **do not continue blindly**; document **hold/bridge/switch** with anesthesia/surgery when applicable
  • Active major bleeding
  • Acute HIT

Drug interactions

  • **NSAID, antiplatelet, or SSRI added** β†’ **bleeding risk ↑** β†’ **reassess stack** and procedure timing
  • **Renal decline** on renally cleared agent β†’ **dose/hold** per CrCl + pharmacy
  • Antiplatelets
  • NSAIDs
  • other anticoagulants

Special populations

Pediatrics

Rare β€” specialist

Pregnancy

**Pregnancy:** used for VTE with specialist; **

Lactation

** generally OK.

Renal impairment

Reduce or avoid high treatment doses if CrCl very low. **CrCl scaffold (FMBM β€” titrate to FDA/SFDA label + pharmacy / anticoagulation clinic):** - **CrCl β‰₯50** β†’ **treatment 1 mg/kg BID** (enoxaparin) or IU/kg (dalteparin) per indication; **prophylaxis** fixed low dose - **CrCl 10–50** β†’ **<30** β†’ enoxaparin treatment often **1 mg/kg daily** (not BID); **anti-Xa peak** 4h post-dose if used β€” **bleed risk** if full BID continued - **CrCl <10** β†’ **avoid therapeutic LMWH** when possible β†’ **UFH infusion** (titratable) or alternate agent; **prophylaxis** may still be contraindicated β€” label

Hepatic impairment

Caution with coagulopathy.

Elderly

Renal clearance; fall risk.

Administration

SC abdominal injection; rotate sites.

Monitoring

  • Monitor:
    - **Bleeding / bruising** β€” clinical surveillance
    - **CBC / hemoglobin** β€” if bleed suspected, unexplained anemia, or peri-procedure context
    - **Platelets** β€” trend vs baseline for **HIT** surveillance
    - **Renal function (CrCl/eGFR)** β€” exposure and interval adjustments per label (LMWH is **not** titrated to **aPTT**)
    - **Anti-Xa level:** **not routine** for standard prophylaxis/treatment β€” consider only in selected cases per pharmacy: **pregnancy**, **obesity / extremes of body weight**, **significant renal impairment**, **unusual bleeding or thrombotic concern**
    - **Therapeutic LMWH** β€” **weight-based** per label; **do not** dose-adjust to **aPTT**
    - β€’ **HIT** β†’ **STOP ALL HEPARIN** (including **flushes**) β†’ **DO NOT switch to another LMWH** β†’ **non-heparin anticoagulant**
    - **Hold if:** active **major bleeding** β€” **protamine** per protocol + escalate
    - **Hold if:** **significant platelet fall** or **HIT** concern β€” stop all heparin per institutional pathway
    - β€’ **Neuraxial** β†’ **β‰₯12h** prophylaxis / **β‰₯24h** therapeutic (typical) β€” **ASRA**
    - β€’ **Major bleed** β†’ **protamine** (based on **recent LMWH dose**; **delayed** = **partial reversal**)
    - Platelet surveillance
    - Anti-Xa if renal/obesity on treatment doses
  • Recheck:
    - **Recheck:** renal function periodically and with **AKI**, dehydration, IV contrast, or new nephrotoxic/interacting drugs
    - **Recheck:** CBC + platelets when clinically appropriate
    - **Recheck:** **CrCl <30** on therapeutic dose β†’ reassess **interval / agent** (often **↓ dose / daily** or **monitored UFH**) per label/pharmacy if **not** HIT
    - **Hold if:** **renal deterioration** requiring label/pharmacy dose reassessment (avoid unsafe continuation)
    - **Interacting drug added or stopped** β†’ **recheck INR (warfarin) or reassess bleed risk / renal (DOAC)** within **48–72h**
    - If targets not met after reassessment of dose, organ function, and interactions β†’ escalate per protocol (DO NOT continue blindly)
  • Hold if:
    - **Bleeding, unexplained Hb drop, thunderclap headache, or focal neuro signs** β†’ **hold** anticoagulant + escalate per bleed protocol

Overdose / toxicity

Clinical Picture

β€’ **No bleed:** Hold β†’ recheck **renal** β†’ interval per protocol β€’ **Minor bleed:** Hold β†’ local measures + **CBC** β€’ **Major bleed:** **Stop LMWH** β†’ **give protamine** (based on **recent LMWH dose**; **delayed** = **partial reversal**) β†’ **PCC** if refractory + **ICU**

Immediate Actions

β€’ **Stop LMWH** β€’ **Major bleed** β†’ **protamine** β€’ **Post-reversal labs:** **anti-Xa** if available and clinically indicated (**aPTT** does **not** reflect LMWH effect) β€’ **Minor** β†’ hold / adjust **dose** per label/pharmacy

Antidote

β€’ **Major bleed** β†’ **give protamine** (based on **recent LMWH dose**; **delayed** = **partial reversal**)

Decontamination

β€’ **Therapeutic SC/IV:** N/A

Escalation

β€’ **Major:** **ICU** / IR / surgery; **PCC** after protamine failure per hematology

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield Summary

**Oncology extended dosing** is a distinct curriculum β€” use **Fragmin cancer tables**. β†’ IU not mg vs enoxaparin. β†’ Renal adjustment.

Clinical pearls

Enoxaparin vs dalteparin β€” institution formulary often picks one for prophylaxis; know cancer label for dalteparin. **Heparin β€” detail (factory)** β€’ **HIT:** **DO NOT** substitute **UFH ↔ LMWH** β€” follow institution pathway + hematology β€’ **UFH neuraxial:** **Last bolus / infusion stop** vs catheter (**ASRA**) β€’ **LMWH neuraxial:** Therapeutic often **β‰₯24h** vs prophylaxis **β‰₯12h** (typical) β€” **ASRA** β€’ **LMWH:** CrCl **<30** therapeutic β†’ **↓ dose / daily / monitored UFH** if **not** HIT; **anti-Xa** only in **selected** cases (pregnancy, obesity/extreme weight, renal impairment, unusual bleed/thrombosis) per pharmacy β€” **not** routine titration β€’ **Protamine refractory bleed:** **PCC** per hematology pathway *Anticoagulation (all agents):* **A/B/C bleed tiers** β€” no bleed (hold/adjust) vs minor (hold/protocol) vs major (reversal + ICU/heme). **Warfarin:** high INR without bleed **β‰ ** major-bleed pathway; **PCC + IV K** for life-threatening bleed. **Bridging:** warfarin **slow on/off**; **parenteral overlap** when indicated for acute VTE; **no routine bridge** low-risk AF; **DOAC↔warfarin** table-specific. **Neuraxial:** explicit **last-dose β†’ procedure** documentation. Never extend therapy without indication review.

Anticoagulant safety

  • Cancer dosing tables
  • HIT
  • IU vs mg

Pharmacokinetics

SC absorption; renal elimination; longer than UFH.

Mechanism of action

AT-mediated factor Xa inhibition (LMWH).

Common brand names

Saudi Arabia

Fragmin

Global

(placeholder β€” verify local prefilled syringe / vial)

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

  • Reversal agents (PCC, andexanet, idarucizumab) availability and dosing vary by hospital β€” follow local protocol.
  • Perioperative interruption and bridging are **indication-specific** β€” do not copy warfarin rules onto DOACs blindly.
  • Switching between anticoagulants requires manufacturer tables + pharmacy to avoid under- or over-anticoagulation.

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)
  • CHEST / ACCP antithrombotic guidance (indication-specific)
  • ESC / AHA stroke and anticoagulation guidelines where applicable
  • ASH β€” HIT and VTE resources
  • FDA / SFDA product labeling
  • Institutional anticoagulation service / formulary
  • CHEST / ACCP antithrombotic guidance (indication-specific)
  • ESC / AHA stroke and anticoagulation guidelines where applicable
  • ASH β€” HIT and VTE resources
  • FDA / SFDA product labeling
  • Institutional anticoagulation service / formulary

Do not miss

  • Document indication, target intensity, and planned duration in the chart
  • Reassess renal/hepatic function after AKI, dehydration, or new interacting medications
  • **HIT** β†’ stop **all heparin** (including **flushes**) β†’ start **non-heparin anticoagulant**
  • **Major bleed** β†’ **protamine** (dose/time dependent)
  • Treating cancer VTE with **standard acute VTE BID mg/kg** may be wrong if extended cancer protocol indicated.
  • Cancer dosing tables
  • HIT
  • IU vs mg