Avodart Pre-Surgery Hold Window: How Long to Stop Dutasteride Before an Operation

At a glance

  • Pre-surgery stop interval in the label / None specified [1]
  • Waiting period the label sets / 6 months after the last dose before blood donation [1]
  • Terminal half-life / About 5 weeks at steady state [1]
  • Detectable after the last dose / Above 0.1 ng/mL for up to 4 to 6 months [1]
  • PSA effect / About 50% lower within 3 to 6 months [1]
  • Isolated PSA after 3+ months / Double the value [1]

Does the Avodart label require a stop before surgery?

The Avodart prescribing information gives no preoperative stop interval. It lists no bleeding warning, and dutasteride 0.5 mg daily taken with warfarin for 3 weeks did not change warfarin pharmacokinetics or its effect on prothrombin time [1].

The one waiting period the label sets is 6 months: men treated with Avodart should not donate blood until at least 6 months after the last dose, to avoid giving dutasteride to a pregnant transfusion recipient [1]. That reflects the pharmacokinetics: terminal half-life about 5 weeks at steady state, with serum levels above 0.1 ng/mL for up to 4 to 6 months after the last dose [1].

What a pre-operative PSA looks like on dutasteride

Serum PSA falls by approximately 50% within 3 to 6 months of starting [1]. The label's rules for reading PSA on treatment: set a new baseline at least 3 months after starting; double an isolated value in a man treated 3 months or more; evaluate any confirmed rise from the lowest on-treatment value, even if still within the normal range for untreated men; percent free PSA needs no adjustment; and missed doses can affect results [1].

If the operation is prostate surgery or a biopsy

A randomized trial of a 5-alpha reductase inhibitor before prostate surgery tested finasteride, not dutasteride. Seventy men scheduled for transurethral resection of the prostate were randomized to finasteride 5 mg daily or placebo for 2 weeks; among the 68 who had surgery, mean blood loss in irrigation fluid was lower with finasteride: 43.6 versus 69.3 g of hemoglobin, P=0.011 [2]. That trial does not establish a preoperative dutasteride hold or benefit. Around prostate procedures, the label's PSA guidance is the doubling rule and evaluation of any confirmed rise from the lowest on-treatment value [1].

Jalyn and cataract surgery

The Avodart label describes combination treatment as Avodart 0.5 mg once daily plus tamsulosin 0.4 mg once daily [1]. Jalyn is the fixed-dose capsule containing dutasteride 0.5 mg and tamsulosin 0.4 mg. Dutasteride is a 5-alpha-reductase inhibitor, not an alpha blocker [1].

In a retrospective review of 511 cataract patients, intraoperative floppy iris syndrome occurred in 10 of 16 patients taking tamsulosin (63%) and in none of 11 taking other alpha-1 blockers; overall 2.0% of the 511 patients had it [4]. This evidence concerns tamsulosin, not dutasteride.

Frequently asked questions

How long before surgery should I stop dutasteride?
The Avodart label gives no stop interval before an operation. The only waiting period it specifies is 6 months after the last dose before blood donation [1].
Should dutasteride be stopped for an accurate pre-operative PSA?
The label does not instruct stopping. It says to double an isolated PSA in a man treated 3 months or more and to evaluate any confirmed rise from the lowest on-treatment value [1].
Does dutasteride increase bleeding during surgery?
The Avodart label lists no bleeding warning, and dutasteride with warfarin for 3 weeks did not alter warfarin pharmacokinetics or prothrombin time [1].
Does dutasteride help before prostate surgery?
The randomized trial of a 5-alpha reductase inhibitor before transurethral resection used finasteride 5 mg for 2 weeks and reported less blood loss (43.6 versus 69.3 g of hemoglobin, P=0.011) among 68 men; it did not test dutasteride [2].

References

  1. U.S. National Library of Medicine, DailyMed. Avodart (dutasteride) soft gelatin capsules, Waylis Therapeutics prescribing information. Avodart (dutasteride) soft gelatin capsules, Waylis Therapeutics label
  2. Donohue JF, Sharma H, Abraham R, Natalwala S, Thomas DR, Foster MC. Transurethral prostate resection and bleeding: a randomized, placebo controlled trial of role of finasteride for decreasing operative blood loss. J Urol. 2002;168(5):2024-6. Transurethral prostate resection and bleeding: a randomized, placebo controlled trial of role of finasteride for decreasing operative blood loss
  3. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  4. Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin. J Cataract Refract Surg. 2005;31(4):664-73. Intraoperative floppy iris syndrome associated with tamsulosin
Evidence overview for dutasteride: Avodart Pre-Surgery Hold Window: How Long to Stop Dutasteride Before an Operation