imatinib

Brand: Gleevec, Glivec

ISMP High Alert Prototype Drug
Drug Class: BCR-ABL tyrosine kinase inhibitor
Drug Family: antineoplastic
Subclass: first-generation targeted tyrosine kinase inhibitor
Organ Systems: hematology-oncology

Mechanism of Action

Competitive inhibitor of the ATP-binding site of BCR-ABL tyrosine kinase (product of the Philadelphia chromosome t(9;22) translocation); blocks BCR-ABL from phosphorylating substrates that drive leukemic cell proliferation; also inhibits c-KIT and PDGFR.

BCR-ABL tyrosine kinasec-KITPDGFR

Indications

  • chronic myeloid leukemia (CML) — standard first-line for Ph+ CML
  • acute lymphoblastic leukemia (Ph+ ALL)
  • gastrointestinal stromal tumor (GIST) — c-KIT driven

Contraindications

  • imatinib hypersensitivity

Adverse Effects

Common

  • nausea/vomiting
  • fluid retention/edema (periorbital edema characteristic)
  • muscle cramps
  • fatigue
  • skin rash

Serious

  • severe fluid retention (pleural effusion, pulmonary edema, cardiac tamponade)
  • myelosuppression (usually early in therapy)
  • hepatotoxicity
  • cardiac dysfunction/QTc prolongation
  • growth retardation in children

Pharmacokinetics (ADME)

Absorption 98% oral bioavailability; administer with food to reduce GI upset
Distribution widely distributed; 95% protein-bound
Metabolism hepatic CYP3A4 (primary), CYP2C9, CYP2D6; active metabolite N-desmethyl imatinib
Excretion fecal (68%) and renal (13%)
Half-life 18 hours (parent); 40 hours (N-desmethyl metabolite)
Onset 2–4 hours
Peak 2–4 hours
Duration once-daily
Protein Binding 95%
Vd moderate

Drug Interactions

Drug / Agent Mechanism Severity
CYP3A4 inducers (rifampin, carbamazepine) reduce imatinib levels substantially; may require dose doubling major
warfarin imatinib inhibits CYP2C9; INR elevations — use LMWH instead of warfarin where possible major
simvastatin/lovastatin CYP3A4 inhibition increases statin levels; use pravastatin or rosuvastatin instead major

Nursing Considerations

  1. Administer with a large glass of water and food to minimize GI adverse effects.
  2. Monitor for fluid retention — daily weights and assessment for edema; imatinib-induced fluid retention is common and can range from mild edema to life-threatening fluid accumulation.
  3. Monitor CBC weekly during the first month, biweekly during the second month, then periodically; imatinib causes early myelosuppression.
  4. Conduct therapeutic response monitoring via BCR-ABL PCR — major molecular response (MR3.0 — ≥3 log reduction) should be achieved by 12 months.

Clinical Pearls

  • Imatinib transformed CML from a disease with median survival of 4–5 years (with prior therapies) to one where patients now have near-normal life expectancy when treated, representing the paradigm shift in targeted cancer therapy.
  • BCR-ABL mutations (particularly T315I — the 'gatekeeper' mutation) confer resistance to imatinib; ponatinib is the only TKI active against T315I mutant CML.

Safety Profile

Pregnancy contraindicated
Lactation avoid
Renal Adjustment Not required
Hepatic Adjustment Required
TDM Not required