The following serious reactions are described further in other sections of the prescribing information
- Spinal/Epidural Hematoma [see WARNINGS AND PRECAUTIONS]
- Hemorrhagic Events [see WARNINGS AND PRECAUTIONS]
- Increased Risk of Bleeding with Renal Impairment [see WARNINGS AND PRECAUTIONS]
- Antibodies/Re-exposure [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the Phase II and III clinical studies, desirudin was administered to 2159 patients undergoing elective hip replacement surgery to determine the safety and efficacy of Iprivask in preventing VTE in this population. Below is the safety profile of the Iprivask 15 mg (q12h) regimen.
Hemorrhagic Events [see WARNINGS AND PRECAUTIONS]: The following rates of hemorrhagic events have been reported during clinical trials.
Hemorrhage in Patients Undergoing Hip Replacement Surgery
|Iprivask15 mg q12h SC
|Heparin5000 IU q8h SC
|Enoxaparin40 mg QD SC
|Patients with Any Hemorrhagea||464 (30)||111 (22)||341 (33)|
|Patients with Serious Hemorrhageb||41 (3)||15 (3)||21 (2)|
|Patients with Major Hemorrhagec||13 ( < 1)||0 (0)||2 ( < 1)|
|aIncludes hematomas which occurred at an incidence of 6% in the Iprivask and enoxaparin treatment groups and 5% in the heparin treatment group [see WARNINGS AND PRECAUTIONS].
bBleeding complications were considered serious if perioperative transfusion requirements exceeded 5 units of whole blood or packed red cells, or if total transfusion requirements up to postoperative Day 6 inclusive exceeded 7 units of whole blood or packed red cells, or total blood loss up to postoperative Day 6 inclusive exceeded 3500 mL.
cBleeding complications were considered major if the hemorrhage was: (1) overt and it produced a fall in hemoglobin of ≥ 2g/dL or if it lead to a transfusion of 2 or more units of whole or packed cells outside the perioperative period (the time from start of surgery until up to 12 hours after); (2) Retroperitoneal, intracranial, intraocular, intraspinal, or occurred in a major prosthetic joint.
Non-hemorrhagic Events: Non-hemorrhagic adverse events occurring at ≥ 2% incidence in patients treated with Iprivask 15 mg (q 12h) during elective hip replacement surgery and considered to be remotely, possibly, or probably related to desirudin are provided below.
Adverse Events Occurring at ≥ 2% in Iprivask Treated Patients Undergoing Hip Replacement Surgerya,b
|Body System (Preferred Term)||Iprivask 15 mg q12h SC
|Heparin 5000 IU q8h SC
|Enoxaparin 40 mg QD SC
|Injection Site Mass||56 (4)||32 (6)||7 ( < 1)|
|Wound Secretion||59 (4)||23 (5)||34 (3)|
|Anemia||51 (3)||11 (2)||37 (4)|
|Deep Venous Thrombosis (DVT)||24 (2)||41 (8)||22 (2)|
|Nausea||24 (2)||5 ( < 1)||10 ( < 1)|
|aRepresents events reported while on treatment, excluding unrelated adverse events
bAll hemorrhages that occurred are included in ADVERSE REACTIONS, Hemorrhagic Events.
Related Adverse Events with a Frequency of < 2% and > 0.2% (in decreasing order of frequency): thrombosis, hypotension, leg edema, fever, decreased hemoglobin, hematuria, dizziness, epistaxis, vomiting, impaired healing, cerebrovascular disorder, leg pain, hematemesis.
Allergic Reactions. In clinical studies, allergic events were reported < 2% overall and in 2% of patients who were administered 15 mg desirudin. [see WARNINGS AND PRECAUTIONS].
Post Marketing Experience
In addition to adverse events reported from clinical trials the following adverse events have been identified during post approval use of Iprivask. These events were reported voluntarily from a population of unknown size and the frequency of occurrence cannot be determined precisely: reports of major hemorrhages [see WARNINGS AND PRECAUTIONS], some of which were fatal, and anaphylactic/anaphylactoid reactions [see WARNINGS AND PRECAUTIONS].