Iprivask

Mechanism of Action

Recombinant hirudin product; selective inhibitor of free circulating and clot-bound human thrombin, with protein structures similar to naturally occurring hirudin (an anticoagulant present in medicinal leeches)

Inhibits activation of thrombin-induced platelet aggregation, coagulation factors V, VII, and XIII, which in turn results in prolongation of the activated partial thromboplastin time

Pharmacokinetics

Half-Life: 2-4 hr

Vd: 25 L/kg

Peak Plasma Time: 1-3 hr  

Clearance: 1.5-2.7 mL/min/kg

Excretion: Unchanged in urine (40-50%)  

Serious side effects have been reported with Iprivask including the following:

Spinal/Epidural Hematoma. In patients who receive Iprivask and need to have spinal or epidural anesthesia at the same time, there is a risk of accumulating blood in the subdural or epidural space in the spine, called a hematoma. This is a serious condition that requires immediate medical attention. Alert your physician if you develop back pain, tingling, numbness (especially in the lower limbs), muscle weakness, or the inability to hold in urine or stool.

Increased risk of bleeding. Iprivask increased the risk of major bleeding in certain patients. Tell your doctor if you have any signs of bleeding or bruising, or if you have or have had any of the following:

• kidney disease
• recent major surgery
• organ biopsy in the last month
• history of hemorrhagic stroke
• bleeding that occurred inside your skull or in your eyes
• recent ischemic stroke
• severe uncontrolled high blood pressure
• an infection of the heart's inner lining or heart valves, called bacterial endocarditis
• a disorder that affects bleeding, such as hemophilia, Von Willebrand disease, sickle cell disease, or liver disease

You should not receive Iprivask if you:

• are allergic to Iprivask or to any of its ingredients 
• have had an allergic reaction to similar medications such as bivalirudin (Angiomax)
• have an active bleed
• have a disorder that affects your ability to clot blood that cannot be reversed

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Iprivask falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. Based on animal data, Iprivask may cause harm to your unborn baby. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

If you inject too much Iprivask, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Iprivask is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Get emergency medical help if you have any of these 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.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with desirudin, especially other medicines used to treat or prevent blood clots, such as:

• abciximab, clopidogrel, dipyridamole, eptifibatide, ticlopidine, tirofiban;

• alteplase, reteplase, tenecteplase, urokinase;

• argatroban, bivalirudin, dabigatran, fondaparinux, lepirudin, rivaroxaban; or

• dalteparin, enoxaparin, heparin, tinzaparin.

This list is not complete. Other drugs may interact with desirudin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Thromboprophylaxis in Hip-Replacement Surgery

Prevention of postoperative DVT, which may lead to PE in patients undergoing elective total hip-replacement surgery.1 2 3 4

Lower rates of venous thromboembolism with desirudin compared with either heparin or low molecular weight heparin.1 2 3 17

Drugs Affecting Hemostasis

Potential increased risk of hemorrhage with concomitant use of drugs that affect hemostasis. Discontinue such drugs, if possible, prior to initiation of desirudin therapy.1 If concomitant use cannot be avoided, monitor clinical status of patient and laboratory parameters (e.g., aPTT) for bleeding and coagulopathy.1

Protein-bound Drugs

Pharmacokinetic interaction unlikely.1

Drugs Affecting Platelet Function

Potential increased risk of bleeding complications. 1 Use with caution.1

Specific Drugs

In the U.S.

• Iprivask

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Anticoagulant

Pharmacologic Class: Thrombin Inhibitor, Direct

Chemical Class: Hirudin Related

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Very bad dizziness or passing out.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Product Assembly                          Iprivask® 
Instructions for Use                    (desirudin for injection)

Patients are encouraged to refer to complete Patient Instruction Sheet for additional information on Iprivask assembly and administration.

Reconstitution should be carried out under sterile conditions.

Step 1:

Remove plastic flip-top cap from Iprivask Vial. Remove back cover of Vial Adapter package. Attach Vial Adapter to Vial by using the outer package to handle Adapter. Push Adapter down onto Vial until spike pierces rubber stopper and snaps into place. Discard Vial Adapter package.

Step 2:

Remove Syringe cap by twisting and pulling gently. Attach Syringe to Adapter on Vial by twisting. Slowly push plunger down to completely transfer solution into Vial. Leaving Syringe connected to Vial, gently swirl; lyophilized powder in Vial will dissolve within 10 seconds.

Step 3:

With Syringe still connected to Vial, turn Vial upside down and withdraw entire contents of Vial back into Syringe. Remove Syringe from Vial and hold it with plunger-end down.

Step 4:

You must use enclosed Eclipse™ needle. Attach Needle to Syringe by twisting. Pull pink lever down and uncap needle. You are ready to inject Iprivask.

After injection, flip up pink lever to cover needle until it snaps into place. Dispose of the used Syringe in a Sharps® container.

Eclipse is a registered trademark of Becton, Dickinson and Company.
Sharps is a registered trademark of Sharps Compliance Corporation.

Iprivask is a trademark of Valeat Pharmaceuticals International, Inc. or its affiliates.

© Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA

9469300

Rev. 06/15

Applies to desirudin: subcutaneous powder for injection

Hematologic

Hematologic side effects including hemorrhage (30%) and hematomas are among the most serious and commonly reported side effects. In addition, anemia, thrombosis, thrombophlebitis, decreased hemoglobin, and cerebrovascular disorder have been reported.[Ref]

Other

Other reported side effects have included wound secretion, leg edema, fever, hematuria, dizziness, epistaxis, impaired healing, leg pain and hematemesis.[Ref]

Cardiovascular

Cardiovascular side effects including hypotension have been rarely reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting have been reported rarely.[Ref]

Local

Local side effects including injection site mass have been reported infrequently.[Ref]

Hypersensitivity

Hypersensitivity reactions including at least one case report of acute urticaria following desirudin (the active ingredient contained in Iprivask) administration have been reported.[Ref]

Some side effects of Iprivask may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.