Iprivask

Iprivask (desirudin for injection) is a direct inhibitor of human thrombin used to prevent deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery. Common side effects of Iprivask include:

• hemorrhage
• injection site mass
• wound secretion
• anemia
• deep vein thrombosis (DVT)
• nausea
• low blood pressure (hypotension)
• eg swelling or pain
• blood in urine
• dizziness
• nosebleed, and
• impaired healing

In patients undergoing hip replacement surgery, the recommended dose of Iprivask is 15 mg every 12 hours administered by subcutaneous injection with the initial dose given up to 5 to 15 minutes prior to surgery, but after induction of regional block anesthesia, if used. Iprivask may interact with Dextran 40, systemic glucocorticoids, thrombolytics, anticoagulants, heparins, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, ticlopidine, dipyridamole, sulfinpyrazone, clopidogrel, abciximab, and other glycoprotein IIb/IIIa antagonists. Tell your doctor all medications and supplements you use. During pregnancy, Iprivask should be administered only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding./p>

Our Iprivask (desirudin for injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Iprivask Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Call your doctor at once if you have:

• easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);
• pain, swelling, or drainage from a wound or where a needle was injected in your skin;
• bleeding from wounds or needle injections, any bleeding that will not stop;
• headache, dizziness, weakness, feeling like you might pass out;
• urine that looks red, pink, or brown; or
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Serious side effects may be more likely in adults who are 75 years or older.

Common side effects may include:

• nausea;
• vomiting; or
• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Iprivask (Desirudin for Injection)

 

Iprivask Professional Information

SIDE EFFECTS

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

	Dosing Regimen
	Iprivask	Heparin	Enoxaparin
	15 mg q12h SC N=1561 n (%)	5000 IU q8h SC N=501 n (%)	40 mg QD SC N=1036 n (%)
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 Surgery^a,b

	Iprivask	Heparin	Enoxaparin
Body System (Preferred Term)	15 mg q12h SC N=1561 n (%)	5000 IU q8h SC N=501 n (%)	40 mg QD SC N=1036 n (%)
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].

Read the entire FDA prescribing information for Iprivask (Desirudin for Injection)

&Copy; Iprivask Patient Information is supplied by Cerner Multum, Inc. and Iprivask Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.