Practical considerations for using off-label use of DOACS in adolescents
| Guidance . | Comments . |
|---|---|
| Document informed discussion with patient and family regarding alternatives and off-label use | |
| Restrict to adult dosing recommendations (until approved for children) | Only a minority (∼10%) of patients in adult clinical trials were low weight (50-60 kg) |
| Weight >50 kg | |
| Restrict to patients with good renal function | |
| CrCl >60 mL/min | All of the DOACs are renally excreted |
| Guidance in package inserts regarding dose reduction for moderate kidney disease | Rates of bleeding are higher in adults with chronic renal disease |
| Do not use in patients with antiphospholipid antibody syndrome | |
| Higher rate of thrombotic events25 | DOACs interfere with the lupus anticoagulant assay (false-positive) |
| Gastrointestinal considerations | DOACs are absorbed in stomach and proximal intestine |
| No food interactions | |
| Rivaroxaban and dabigatran should be taken with meals | |
| Drug interactions | Good practice to check with pharmacy specialist if patients is on multiple medications |
| Very few drug interactions | |
| Avoid DOACs for patients on drugs that interact, including: amiodarone, azole antifungals, clarithromycin, rifampin, phenytoin, carbamazepine | |
| Heavy menstrual bleeding | Strategies to address HMB in women on anticoagulation are addressed in Boonyawat et al.26 |
| Heavy menstrual bleeding may be more common with direct Xa inhibitors than with warfarin | |
| Education/follow-up/communication | Switching a patient who is nonadherent to warfarin to a DOAC will not solve the problem |
| Although drug monitoring is not necessary, close follow-up improves adherence | |
| Hold for elective procedures59 | |
| Low bleeding risk procedure, normal renal function: 24 h | |
| High bleeding risk procedure, normal renal function: 48-72 h | |
| Reversal for life-threatening bleeding or urgent surgery | Limited data on efficacy27,28 |
| Idarucizumab: reversal agent for dabigatran | |
| Andexanet α: reversal agent for factor Xa inhibitors |
| Guidance . | Comments . |
|---|---|
| Document informed discussion with patient and family regarding alternatives and off-label use | |
| Restrict to adult dosing recommendations (until approved for children) | Only a minority (∼10%) of patients in adult clinical trials were low weight (50-60 kg) |
| Weight >50 kg | |
| Restrict to patients with good renal function | |
| CrCl >60 mL/min | All of the DOACs are renally excreted |
| Guidance in package inserts regarding dose reduction for moderate kidney disease | Rates of bleeding are higher in adults with chronic renal disease |
| Do not use in patients with antiphospholipid antibody syndrome | |
| Higher rate of thrombotic events25 | DOACs interfere with the lupus anticoagulant assay (false-positive) |
| Gastrointestinal considerations | DOACs are absorbed in stomach and proximal intestine |
| No food interactions | |
| Rivaroxaban and dabigatran should be taken with meals | |
| Drug interactions | Good practice to check with pharmacy specialist if patients is on multiple medications |
| Very few drug interactions | |
| Avoid DOACs for patients on drugs that interact, including: amiodarone, azole antifungals, clarithromycin, rifampin, phenytoin, carbamazepine | |
| Heavy menstrual bleeding | Strategies to address HMB in women on anticoagulation are addressed in Boonyawat et al.26 |
| Heavy menstrual bleeding may be more common with direct Xa inhibitors than with warfarin | |
| Education/follow-up/communication | Switching a patient who is nonadherent to warfarin to a DOAC will not solve the problem |
| Although drug monitoring is not necessary, close follow-up improves adherence | |
| Hold for elective procedures59 | |
| Low bleeding risk procedure, normal renal function: 24 h | |
| High bleeding risk procedure, normal renal function: 48-72 h | |
| Reversal for life-threatening bleeding or urgent surgery | Limited data on efficacy27,28 |
| Idarucizumab: reversal agent for dabigatran | |
| Andexanet α: reversal agent for factor Xa inhibitors |
CrCl, creatinine clearance.