Biogen Idec Inc.

Biogen Idec Inc. Drugs

• Alprolix
  

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  Alprolix

  

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  For intravenous use after reconstitution only

  2.1 Dosing Guidelines

  Initiate treatment with ALPROLIX™ under the supervision of a qualified healthcare professional experienced in the treatment of hemophilia B. Dose and duration of treatment depend on the severity of the Factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses. Base the dose and frequency of ALPROLIX™ on the individual clinical response. Each vial label for ALPROLIX™ states the Factor IX potency in international units (IU). ALPROLIX™ potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. Factor IX activity measurements in the clinical laboratory may be affected by the type of aPTT reagent or laboratory standard used.[see Warnings and Precautions (5.4)]

  One IU of ALPROLIX™ per kg body weight increases the circulating level of Factor IX by 1% [IU/dL]. Estimate the required dose or the expected in vivo peak increase in Factor IX level expressed as IU/dL (or % of normal) using the following formulas:

  IU/dL (or % of normal) =

  [Total Dose (IU)/Body Weight (kg)] x Recovery (IU/dL per IU/kg)

  OR

  Dose (IU) =

  Body Weight (kg) x Desired Factor IX Rise (IU/dL or,

  % of normal) x Reciprocal of Recovery (IU/kg per IU/dL)

  Dose adjustment may be necessary in pediatric patients under 12 years of age [see Use in Specific Populations (8.4)]. For patients 12 years of age or older, dose adjustment is not usually required.

  Control and Prevention of Bleeding Episodes

  ALPROLIX™ dosing for the control and prevention of bleeding episodes is provided in Table 1.

  Table 1: Dosing for Control and Prevention of Bleeding Episodes Type of Bleeding Circulating Factor IX LevelRequired (IU/dLor % of normal) Dosing Interval (hours) Minor and Moderate For example: Uncomplicated hemarthroses, superficial muscle (except iliopsoas) without neurovascular compromise, superficial soft tissue, mucous membranes 30-60 Repeat every 48 hours if there is further evidence of bleeding Major For example: Iliopsoas and deep muscle with neurovascular injury, or substantial blood loss; Pharyngeal, retropharyngeal, retroperitoneal, CNS 80-100 Consider a repeat dose after 6-10 hours and then every 24 hours for the first 3 days.Due to the long half-life of ALPROLIX™, the dose may be reduced and frequency of dosing may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved.

  Perioperative Management

  ALPROLIX™ dosing for perioperative management is provided in Table 2 .

  Table 2: Dosing for Perioperative Management Type of Surgery Circulating Factor IX Level Required (IU/dL or % of normal) Dosing Interval (hours) Minor (including uncomplicated dental extraction) 50 to 80 A single infusion may be sufficient. Repeat as needed after 24-48 hours until bleeding stops and healing is achieved. Major 60 to 100 (initial level) Consider a repeat dose after 6-10 hours and then every 24 hours for the first 3 days.Due to the long half-life of ALPROLIX™, the dose may be reduced and frequency of dosing in the post-surgical setting may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved.

  Routine Prophylaxis

  The recommended starting regimens are either 50 IU/kg once weekly, or 100 IU/kg once every 10 days. Adjust dosing regimen based on individual response.

  2.2 Reconstitution

  Use aseptic technique (clean and germ-free) and a flat work surface during the reconstitution procedure. Allow the vial of ALPROLIX™ and the pre-filled diluent syringe to reach room temperature before use. Remove the plastic cap from the vial and wipe the rubber stopper of the vial with an alcohol wipe. Allow the rubber stopper to dry. Completely remove the backing from the vial adapter package by peeling back the lid. Do not remove the vial adapter from the package or touch the inside of the package of the adapter.

  Place the vial on a flat surface and use one hand to hold the vial steady. Use the other hand to place the vial adapter over the vial. Place the adapter spike directly above the center of the rubber stopper and push the adapter straight down until the spike punctures the center of the vial stopper and is fully inserted.

  Lift the package cover away from the vial adapter and discard the cover.

  Hold the plunger rod at the circular disk. Place the tip of the plunger rod into the end of the syringe. Turn clockwise until it is securely attached. Only use the diluent syringe provided in the ALPROLIX™ package.

  With one hand, hold the diluent syringe by the ridged part directly under the cap, with the cap pointing up. Do not use if the cap has been removed or is not securely attached. With your other hand, grasp the cap and bend it at a 90° angle until it snaps off. After the cap snaps off, you will see the glass tip of the syringe. Do not touch the glass tip of the syringe or the inside of the cap. With the vial sitting on a flat surface, insert the tip of the syringe into the adapter opening. Turn the syringe clockwise until it is securely attached to the adapter. Slowly depress the plunger rod to inject all of the diluent into the vial. The plunger rod may rise slightly after this process. This is normal. With the syringe still connected to the adapter, gently swirl the vial until the product is completely dissolved. The final solution should be clear to slightly opalescent and colorless. Do not shake. Do not use the reconstituted ALPROLIX™ if it contains visible particles or is cloudy. Make sure the plunger rod is completely depressed. Turn the vial upside-down. Slowly pull on the plunger rod to draw the solution into the syringe. Be careful not to pull the plunger rod completely out of the syringe. Gently unscrew the syringe from the vial adapter and dispose of the vial with the adapter still attached. Do not touch the syringe tip or the inside of the cap. Use the reconstituted ALPROLIX™ as soon as possible, but no later than 3 hours after reconstitution. Protect from direct sunlight. Do not refrigerate after reconstitution.

  To combine two or more vials of ALPROLIX™, after step 12 above, follow these pooling steps:

  Remove the diluent syringe from the vial adapter by turning it counterclockwise until it is completely detached. Do not detach the diluent syringe or the large luer lock syringe until ready to attach the large luer lock syringe to the next vial (with vial adapter attached). Leave the vial adapter attached to the vial, as it is needed for attaching a large luer lock syringe. Attach a separate, large luer lock syringe by turning clockwise until it is securely in place. Slowly pull on the plunger rod to draw the solution into the syringe. Repeat this pooling procedure with each vial necessary to obtain the required dose. Once you have pooled the required dose, proceed to administration using the large luer lock syringe.

  2.3 Administration

  For intravenous injection only

  Inspect the reconstituted ALPROLIX™ solution visually for particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration is observed. Do not administer reconstituted ALPROLIX™ in the same tubing or container with other medications.

  Administration Steps:

  Attach the syringe to the connector end of the infusion set tubing by turning clockwise until it is securely in place. Depress the plunger until all air is removed from the syringe and ALPROLIX™ has reached the end of the infusion set tubing. Do not push ALPROLIX™ through the needle. Remove the protective needle cover from the infusion set tubing. Perform intravenous bolus infusion. The rate of administration should be determined by the patient's comfort level, and no faster than 10 ml per minute.

  After infusing ALPROLIX™, remove and properly discard the infusion set.

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• Eloctate
  

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  Eloctate

  

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  For intravenous use after reconstitution only.

  2.1 Dosing Guidelines

  Dose and duration of treatment depend on the severity of the Factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Careful monitoring of replacement therapy is necessary in cases of major surgery or life-threatening bleeding episodes. Each vial label of ELOCTATE states the Factor VIII potency in international units (IU). One IU corresponds to the activity of Factor VIII contained in one milliliter of normal human plasma. Potency assignment is determined using a chromogenic substrate assay. A field study1 has indicated that plasma Factor VIII levels can be monitored using either a chromogenic substrate assay or a one stage clotting assay routinely used in US clinical laboratories. Calculation of the required dose of Factor VIII is based on the empirical finding that 1 IU of Factor VIII per kg body weight raises the plasma Factor VIII level by 2 IU/dL. The expected in vivo peak increase in Factor VIII level expressed as IU/dL (or % of normal) is estimated using the following formula:Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg)The dose to achieve a desired in vivo peak increase in Factor VIII level may be calculated using the following formula:Dose (IU) = body weight (kg) x Desired Factor VIII Rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL) Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses. Base the dose and frequency of ELOCTATE on the individual clinical response. Dose adjustment may be necessary in pediatric patients under six years of age [see Use in Specific Populations (8.4)]. For patients six years of age or older, dose adjustment is not usually required.

  Control and Prevention of Bleeding Episodes

  A guide for dosing ELOCTATE for the control and prevention of bleeding episodes is provided in Table 1. Consideration should be given to maintaining a Factor VIII activity at or above the target range.

  Table 1: Dosing for Control and Prevention of Bleeding Episodes Type of Bleeding Factor VIII Level Required (IU/dL or % of normal) Dose (IU/kg) Frequency of Dosing (hours) Duration of Therapy (days) Minor and Moderate Joint, superficial muscle/no neurovascular compromise (except iliopsoas), deep laceration and renal, superficial soft tissue, mucous membranes 40-60 20-30 Repeat every 24-48 hours(12 to 24 hours for patients less than 6 years of age) Until the bleeding episode is resolved Major Life or limb threatening hemorrhage,iliopsoas and deep muscle with neurovascular injury, retroperitoneum, intracranial, or gastrointestinal 80-100 40-50 Repeat every 12-24 hours (8 to 24 hours for patients less than 6 years of age) Until bleeding is resolved(approximately 7-10 days)

  Perioperative Management

  A guide for dosing ELOCTATE during surgery (perioperative management) is provided in Table 2. Consideration should be given to maintaining a Factor VIII activity at or above the target range.

  Table 2: Dosing for Perioperative Management Type of Surgery Factor VIII Level Required (IU/dL or % of normal) Dose (IU/kg) Frequency of Dosing (hours) Duration of Therapy (days) Minor Uncomplicated tooth extraction 50-80 25-40 Repeat every 24 hours (12-24 hours for patients less than 6 years of age) At least 1 day until healing is achieved Major Intracranial, intra-abdominal, or joint replacement surgery 80-120(pre- and post-operative) Preoperative: 40-60Repeat: 40-50 Pre-operative dose of 40 to 60 IU/kg followed by a repeat dose of 40-50 IU/kg after 8-24 hours (6 to 24 for patients less than 6 years of age) and then every 24 hours to maintain FVIII activity within the target range Until adequate wound healing, then continue therapy for at least 7 days to maintain a Factor VIII activity within the target range

  Routine Prophylaxis

  The recommended starting regimen is 50 IU/kg of ELOCTATE administered every 4 days. The regimen may be adjusted based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals. More frequent or higher doses up to 80 IU/kg may be required in children less than 6 years of age. [see Clinical Pharmacology (12.3)]

  2.2 Preparation and Reconstitution

  Use aseptic technique (clean and germ free) and a flat work surface during the reconstitution procedure. Allow the vial of ELOCTATE and pre-filled diluent syringe to reach room temperature before use. Remove the plastic cap from the vial and wipe the rubber stopper of the vial with an alcohol wipe. Allow the rubber stopper to dry. Completely remove the backing from the vial adapter package by peeling back the lid. Do not remove the vial adapter from the package or touch the inside of the package of the adapter.

  Place the vial on a flat and solid surface and use one hand to hold the vial steady. Use the other hand to place the vial adapter over the vial. Place the adapter spike directly above the center of the rubber stopper and push the adapter straight down until the spike punctures the center of the vial stopper and is fully inserted.

  Lift the package cover away from the vial adapter and discard the cover.

  Hold the plunger rod at the circular disk. Place the tip of the plunger rod into the end of the syringe. Turn clockwise until it is securely attached. Only use the diluent syringe provided in the ELOCTATE package.

  With one hand, hold the diluent syringe by the ridged part directly under the cap, with the cap pointing up. Do not use if the cap has been removed or is not securely attached. With your other hand, grasp the cap and bend it at a 90° angle until it snaps off. After the cap snaps off, you will see the glass tip of the syringe. Do not touch the glass tip of the syringe or the inside of the cap. With the vial sitting on a flat surface, insert the tip of the syringe into the adapter opening. Turn the syringe clockwise until it is securely attached to the adapter. Slowly depress the plunger rod to inject all of the diluent into the vial. The plunger rod may rise slightly after this process. This is normal. With the syringe still connected to the adapter, gently swirl the vial until the product is completely dissolved. Do not shake. The reconstituted solution should be clear to slightly opalescent and colorless. Do not use the reconstituted ELOCTATE if it contains visible particles or is cloudy. Make sure the plunger rod is completely depressed. Turn the vial upside-down. Slowly pull on the plunger rod to draw the solution into the syringe. Be careful not to pull the plunger rod completely out of the syringe. Gently unscrew the syringe from the vial adapter and dispose of the vial with the adapter still attached. Do not touch the syringe tip or the inside of the cap. Use the reconstituted ELOCTATE as soon as possible, but no later than 3 hours after reconstitution. Do not touch the glass tip of the syringe if not used immediately after reconstitution. Protect from direct sunlight. Do not refrigerate after reconstitution.

  To combine two or more vials of ELOCTATE, after step 12 above, follow these pooling steps:

  Remove the diluent syringe from the vial adapter by turning it counterclockwise until it is completely detached. Leave the vial adapter attached to the vial, as it is needed for attaching a large luer lock syringe (not included in kit). Do not detach the diluent syringe until ready to attach the large luer-lock syringe. Attach a separate, large luer-lock syringe by turning clockwise until it is securely in place. Slowly pull on the plunger rod to draw the solution into the syringe. Repeat this pooling procedure with each vial that is needed to obtain the required dose. When pooling, do not detach the large luer-lock syringe until ready to attach it to the next vial (with vial adapter attached). Once you have pooled the required dose, proceed to administration using the large luer-lock syringe.

  2.3 Administration

  For intravenous injection only

  Inspect the reconstituted ELOCTATE solution visually for particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration is observed. Do not administer reconstituted ELOCTATE in the same tubing or container with other medications.

  Administration Steps:

  Attach the syringe to the connector end of the infusion set tubing by turning clockwise until it is securely in place. Depress the plunger until all air is removed from the syringe and ELOCTATE has reached the end of the infusion set tubing. Do not push ELOCTATE solution through the needle. Remove the protective needle cover from the infusion set tubing. Perform intravenous bolus infusion. The rate of administration should be determined by the patient's comfort level, and no faster than 10 ml per minute. After infusing ELOCTATE, remove and properly discard the infusion set.

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• Plegridy Prefilled Syri...
  

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  Plegridy Prefilled Syringe Starter Kit

  

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  2.1 Dosing Information

  PLEGRIDY is administered subcutaneously.

  The recommended dosage of PLEGRIDY is 125 micrograms injected subcutaneously every 14 days.

  Treatment initiation

  Patients should start treatment with 63 micrograms on day 1. On day 15 (14 days later), the dose is increased to 94 micrograms, reaching the full dose of 125 micrograms on day 29 (after another 14 days). Patients continue with the full dose (125 micrograms) every 14 days thereafter (see Table 1). A PLEGRIDY Starter Pack is available containing two prefilled pens or syringes: 63 micrograms (dose 1) and 94 micrograms (dose 2).

  Table 1: Schedule for Dose Titration Dose Time* Amount (micrograms) Color of Pen or Syringe Label

  *Dosed every 14 days

  Dose 1 On day 1 63 Orange Dose 2 On day 15 94 Blue Dose 3 On day 29 and every 14 days thereafter 125 (full dose) Grey

  2.2 Important Administration Instructions (All Dosage Forms)

  Healthcare professionals should train patients in the proper technique for self-administering subcutaneous injections using the prefilled pen or syringe. Patients should be advised to rotate sites for subcutaneous injections. The usual sites for subcutaneous injections are abdomen, back of the upper arm, and thigh.

  Each PLEGRIDY pen and syringe is provided with the needle pre-attached. Prefilled pens and syringes are for a single dose only and should be discarded after use.

  2.3 Premedication for Flu-like Symptoms

  Prophylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during treatment with PLEGRIDY.

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