Iprivask

IPRIVASK- desirudin
Marathon Pharmaceuticals, LLC

WARNING: SPINAL/EPIDURAL HEMATOMAS

When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with selective inhibitors of thrombin such as Iprivask may be at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.

The risk of these events may be increased by the use of indwelling spinal catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non- steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. Likewise with such agents, the risk appears to be increased by traumatic or repeated epidural or spinal puncture.

Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

The physician should consider the potential benefit versus risk before neuraxial intervention, in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions ( 5.1)].

1 INDICATIONS AND USAGE

Iprivask is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose

All patients should be evaluated for bleeding disorder risk before prophylactic administration of Iprivask [see DRUG INTERACTIONS (7)].

Initial Dosage: 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 [see WARNINGS AND PRECAUTIONS (5.1)]. Up to 12 days administration (average duration 9 to 12 days) of Iprivask has been well tolerated in controlled clinical trials.

2.2 Dose Adjustment in Renal Impairment

Degree of Renal Impairment

Creatinine Clearance [mL/min/1.73m2 body surface area]

aPTT Monitoring & Dosing Instructions

Moderate

≥31 to 60

Initiate therapy at 5 mg every 12 hours by subcutaneous injection. Monitor aPTT and serum creatinine at least daily. If aPTT exceeds 2 times control:1. Interrupt therapy until the value returns to less than 2 times control.2. Resume therapy at a reduced dose guided by the initial degree of aPTT abnormality

Severea

<31

Initiate therapy at 1.7 mg every 12 hours by subcutaneous injection. Monitor aPTT and serum creatinine at least daily. If aPTT exceeds 2 times control:1. Interrupt therapy until the value returns to less than 2 times control.2. Consider further dose reductions guided by the initial degree of aPTT abnormality

a See CLINICAL PHARMACOLOGY (12.3) and WARNINGS AND PRECAUTIONS(5.2) .

2.3 Clinical Monitoring

Activated partial thromboplastin time (aPTT) should be monitored daily in patients with increased risk of bleeding and/or renal impairment. Serum creatinine should be monitored daily in patients with renal impairment. Adjust Iprivask dosage according to creatinine levels [see Dosage and Administration (2.2) ].

Peak aPTT should not exceed two times control. Should peak aPTT exceed this level, reduce the dosage of Iprivask based on the degree of aPTT abnormality [see Dosage and Administration (2.1) ]. If necessary, interrupt therapy with desirudin until aPTT falls to less than two times control, at which time treatment with desirudin can be resumed at a reduced dose. Thrombin time (TT) is not a suitable test for routine monitoring of Iprivask therapy [see Clinical Pharmacology (12.1) ].

2.4 Conversion from Other Anticoagulants

If a patient is switched from oral anticoagulants to Iprivask therapy or from Iprivask to oral anticoagulants, the anticoagulant activity should continue to be closely monitored with appropriate methods [see Drug Interactions (7.2) ].

2.5 Instructions for Administration

Directions on Preparation

Use Iprivask before the expiration date given on the carton and container.

1. To prepare the reconstituted aqueous solution, 0.5 mL of the mannitol diluent is added under aseptic conditions to the vial containing the sterile powder.

2. 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.

3. 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.

4. 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.

5. 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.

Iprivask should not be mixed with other injections, solvents, or infusions. Iprivask is administered by subcutaneous injection. It must not be administered by intramuscular injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Subcutaneous Injection Technique:

Patients should be sitting or lying down and Iprivask injection administered by deep subcutaneous injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral thigh or abdominal wall. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.

2.6 Storage after Reconstitution

Once Iprivask is reconstituted it may be used for up to 24 hours, when stored at 25° C (77° F); excursions permitted to 15–30° C (59-86° F). [See USP Controlled Room Temperature.]. Protect from light. After 24 hours, discard the solution.

3 DOSAGE FORMS AND STRENGTHS

Iprivask (desirudin for injection) is supplied as a single dose (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6 mL of Mannitol USP (3%) in Water for Injection]. The reconstituted solution delivers 15 mg of Iprivask in 0.5 mL.

4 CONTRAINDICATIONS

Iprivask is contraindicated in patients with known hypersensitivity to natural or recombinant hirudins due to risk of anaphylaxis, and in patients with active bleeding and/or irreversible coagulation disorders due to risk of hemorrhage.

5 WARNINGS AND PRECAUTIONS

5.1 Spinal/Epidural Hematoma

There is a risk of neuraxial hematoma formation with the concurrent use of desirudin and spinal/epidural anesthesia, which has the potential to result in long term or permanent paralysis. The risk may be greater with the use of post-operative indwelling catheters or the concomitant use of additional drugs affecting hemostasis such as NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), platelet inhibitors or other anticoagulants [see Drug Interactions (7.1) ]. The risk may also be increased by traumatic or repeated neuraxial puncture.

To reduce the potential risk of bleeding associated with the concurrent use of desirudin and epidural or spinal anesthesia/analgesia, the pharmacokinetic profile of the drug should be considered [see Clinical Pharmacology (12.3) ] when scheduling or using epidural or spinal anesthesia in proximity to desirudin administration. The physician should consider placement of the catheter prior to initiating desirudin and removal of the catheter when the anticoagulant effect of desirudin is low [see Dosage and Administration (2.1) ].

Should the physician decide to administer anticoagulation in the context of epidural/spinal anesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurological impairment such as midline back pain, sensory and motor deficits (numbness or weakness in lower limbs), bowel and/or bladder dysfunction. Patients should be instructed to inform their physician immediately if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, urgent diagnosis and treatment including spinal cord decompression should be initiated.

The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis

Iprivask cannot be used interchangeably with other hirudins as they differ in manufacturing process and specific biological activity (ATUs). Each of these medicines has its own instructions for use.

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