Iprivask

Iprivask Manufacturers

• Marathon Pharmaceuticals, Llc
  

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  Iprivask | Energique, Inc.

  

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  Adults and children 5 to 10 drops orally, 3 times a day or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

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• Valeant Pharmaceuticals North America Llc
  

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  Iprivask | Valeant Pharmaceuticals North America Llc

  

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  2.1 Recommended Dose

  All patients should be evaluated for bleeding disorder risk before prophylactic administration of Iprivask [ see Drug Interactions (7.1)] .

  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/1.73m 2 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:

  Interrupt therapy until the value returns to less than 2 times control. Resume therapy at a reduced dose guided by the initial degree of aPTT abnormality

  Severe a

  <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:

  Interrupt therapy until the value returns to less than 2 times control. Consider further dose reductions guided by the initial degree of aPTT abnormality

  a See Clinical Pharmacology (12.3) and Warnings and Precautions (5.3).

  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 (2.2)] . 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 (12.2)].

  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 (7.1)] .

  Instructions for Administration

  Directions on Preparation

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

  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. 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. 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. 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. 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.

  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° to 30°C (59° to 86°F)[See USP Controlled Room Temperature]. Protect from light. After 24 hours, discard the solution.

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