Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.

Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. Drugs

• Xyntha Plasmaalbumin-fr...
  

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  Xyntha Plasmaalbumin-free

  

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  For intravenous use after reconstitution only.

  2.1 Dose

  Initiate treatment with XYNTHA under the supervision of a physician experienced in the treatment of hemophilia A. Dosage 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. Titrate the administered doses to the patient's clinical response. One International Unit (IU) of factor VIII activity corresponds approximately to the quantity of factor VIII in one milliliter of normal human plasma. The calculation of the required dosage of factor VIII is based upon the empirical finding that, on average, 1 IU of factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2 IU/dL.2

  The expected in vivo peak increase in factor VIII level expressed as IU/dL (or % normal) can be estimated using the following formulas:

  Dosage (International Units) = body weight (kg) × desired factor VIII rise (IU/dL or % of normal) × 0.5 (IU/kg per IU/dL)

  or

  IU/dL (or % normal) = Total Dose (IU)/body weight (kg) × 2 [IU/dL]/[IU/kg]

  Control and Prevention of Bleeding Episodes

  A guide for dosing XYNTHA for the control and prevention of bleeding episodes is provided in Table 1. Maintain the plasma factor VIII activity at or above the levels (in % of normal or in IU/dL) outlined in Table 1 for the indicated period.

  Table 1: Dosing for Control and Prevention of Bleeding Episodes Type of Bleeding Episode Factor VIII Level Required (IU/dL or % of normal) Frequency of Doses (hours) Duration of Therapy Minor Early hemarthrosis, minor muscle or oral bleeds. 20–40 12–24 At least 1 day, depending upon the severity of the bleeding episode. Moderate Bleeding into muscles. Mild head trauma. Bleeding into the oral cavity. 30–60 12–24 3–4 days or until adequate local hemostasis is achieved. Major Gastrointestinal bleeding. Intracranial, intra-abdominal, or intrathoracic bleeding. Fractures. 60–100 8–24 Until bleeding is resolved.

  Perioperative Management

  A guide for dosing XYNTHA during surgery (perioperative management) is provided in Table 2. Maintain the plasma factor VIII activity level at or above the level (in % of normal or in IU/dL) outlined in Table 2 for the indicated period. Monitor the replacement therapy by means of plasma factor VIII activity.

  Table 2: Dosing for Perioperative Management Type of Surgery Factor VIII Level Required (IU/dL or % of normal) Frequency of Doses (hours) Duration of Therapy (days) Minor Minor operations, including tooth extraction. 30–60 12–24 3–4 days or until adequate local hemostasis is achieved. For tooth extraction, a single infusion plus oral antifibrinolytic therapy within 1 hour may be sufficient. Major Major operations. 60–100 8–24 Until threat is resolved, or in the case of surgery, until adequate local hemostasis and wound healing are achieved.

  2.2 Preparation and Reconstitution

  Preparation

  Always wash hands before performing the following procedures. Use aseptic technique during the reconstitution procedures. Use all components in the reconstitution and administration of this product as soon as possible after opening their sterile containers to minimize unnecessary exposure to the atmosphere.

  Note:

  If the patient uses more than one vial of XYNTHA per infusion, reconstitute each vial according to the following instructions. Remove the diluent syringe, leaving the vial adapter in place. Use a separate 10 milliliter or larger luer lock syringe (not included in this kit) to draw back the reconstituted contents of each vial. 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 adapter. If the patient uses one vial of XYNTHA with one XYNTHA SOLOFUSE™ for the infusion, reconstitute the vial and the syringe according to the instructions for each respective product kit. Use a separate 10 milliliter or larger luer lock syringe (not included in this kit) to draw back the reconstituted contents of the vial and the syringe. [see Dosage and Administration (2.4)]

  Reconstitution

  Allow the XYNTHA vial and the prefilled diluent syringe to reach room temperature. Remove the plastic flip-top cap from the XYNTHA vial to expose the central portions of the rubber stopper. Wipe the top of the vial with the alcohol swab provided, or use another antiseptic solution, and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any surface. Peel back the cover from the clear plastic vial adapter package. Do not remove the adapter from the package. Place the XYNTHA vial on a flat surface. While holding the adapter package, place the vial adapter over the XYNTHA vial and press down firmly on the package until the adapter spike penetrates the vial stopper. Grasp the plunger rod as shown in the diagram. Avoid contact with the shaft of the plunger rod. Attach the threaded end of the plunger rod to the diluent syringe plunger by pushing and turning firmly. Break off the tamper-resistant plastic tip cap from the diluent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip. The diluent syringe may need to be recapped (if not administering reconstituted XYNTHA immediately), so place the cap on its top on a clean surface in a spot where it would be least likely to become environmentally contaminated. Lift the package away from the adapter and discard the package. Place the XYNTHA vial, with the adapter attached, on a flat surface. Connect the diluent syringe to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured. Slowly depress the plunger rod to inject all the diluent into the XYNTHA vial.

  Without removing the syringe, gently swirl the contents of the XYNTHA vial until the powder is dissolved.

  Note: The final solution should be inspected visually for particulate matter before administration. The solution should be clear to slightly opalescent and colorless. If it is not, discard the solution and use a new kit.

  Invert the XYNTHA vial and slowly draw the solution into the syringe. Detach the syringe from the vial adapter by gently pulling and turning the syringe counterclockwise. Discard the empty XYNTHA vial with the adapter attached.

  Note:

  If the solution is not used immediately, carefully replace the syringe cap. Do not touch the syringe tip or the inside of the cap. Store the reconstituted solution at room temperature prior to administration, but use within 3 hours after reconstitution. XYNTHA, when reconstituted, contains polysorbate 80, which is known to increase the rate of di-(2-ethylhexyl) phthalate (DEHP) extraction from polyvinyl chloride (PVC). This should be considered during the preparation and administration of XYNTHA, including storage time elapsed in a PVC container following reconstitution. The tubing of the infusion set included with this kit does not contain DEHP.

  2.3 Administration

  For intravenous infusion after reconstitution only.

  Inspect the final XYNTHA solution visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be clear to slightly opalescent and colorless. If it is not, discard the solution and use a new kit.

  Use the tubing and the prefilled diluent syringe provided in this kit or a single sterile disposable plastic syringe. Do not administer XYNTHA in the same tubing or container with other medicinal products.

  Attach the syringe to the luer end of the infusion set tubing provided. Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab provided in the kit. Remove the protective needle cover and perform venipuncture. Insert the needle on the infusion set tubing into the vein, and remove the tourniquet. Verify proper needle placement. Inject the reconstituted XYNTHA product intravenously over several minutes. The rate of administration should be determined by the patient's comfort level. After infusing XYNTHA, remove and discard the infusion set. The amount of drug product left in the infusion set will not affect treatment.Note: Dispose of all unused solution, the empty vial(s), and other used medical supplies in an appropriate container.

  2.4 Use of a XYNTHA Vial Kit with a XYNTHA SOLOFUSE™ Kit

  These instructions are for the use of only one XYNTHA Vial Kit with one XYNTHA SOLOFUSE™ Kit. For further information, please contact the Medical Information Department at Wyeth Pharmaceuticals, 1-800-438-1985.

  Reconstitute the XYNTHA vial using the instructions described in Preparation and Reconstitution [see Dosage and Administration (2.2)]. Detach the empty diluent syringe from the vial adapter by gently turning and pulling the syringe counterclockwise, leaving the contents in the XYNTHA vial with the vial adapter in place. Reconstitute the XYNTHA SOLOFUSE™ using the instructions included with the product kit, remembering to remove most, but not all, of the air from the drug product chamber. After removing the protective blue vented cap, connect the XYNTHA SOLOFUSE™ to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured. Slowly depress the plunger rod of the XYNTHA SOLOFUSE™ until the contents empty into the XYNTHA vial. The plunger rod may move back slightly after release.

  Detach and discard the empty XYNTHA SOLOFUSE™ from the vial adapter.

  Note: If the syringe turns without detaching from the vial adapter, grasp the white collar and turn.

  Connect a sterile 10 milliliter or larger luer lock syringe to the vial adapter. Inject some air into the vial to make withdrawing the vial contents easier. Invert the vial and slowly draw the solution into the large luer lock syringe. Detach the syringe from the vial adapter by gently turning and pulling the syringe counterclockwise. Discard the vial with the adapter attached. Attach the infusion set to the large luer lock syringe as directed [see Dosage and Administration (2.3)].

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• Gleevec
  

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  Gleevec

  

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  For intravenous use after reconstitution only

  Each vial of BeneFIX has the recombinant Factor IX (rFIX) potency in the International Units (IU) stated on the vial. Initiate treatment under the supervision of a physician experienced in the treatment of hemophilia B. Dosage and duration of treatment with BeneFIX depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX. Dosing of BeneFIX may differ from that of plasma-derived factor IX products [see Clinical Pharmacology (12)]. Subjects at the low end of the observed factor IX recovery may require upward dosage adjustment of BeneFIX to as much as two times (2X) the initial empirically calculated dose in order to achieve the intended rise in circulating factor IX activity. Monitor patients using a factor IX activity assay to ensure that the desired factor IX activity level has been achieved. Titrate the dose using the factor IX activity, pharmacokinetic parameters, such as half-life and recovery, as well as taking the clinical situation into consideration in order to adjust the dose as appropriate. The safety and efficacy of BeneFIX administration by continuous infusion have not been established [see Warnings and Precautions (5.2)].

  2.1 Dose

  Calculating Initial Dose

  Use the following formula to calculate the initial dose of BeneFIX:

  number of factor IX IU required (IU) = body weight (kg) × desired factor IX increase (% or IU/dL) × reciprocal of observed recovery (IU/kg per IU/dL)

  Average Recovery

  Adult Patients (≥15 years)

  In adults, on average, one International Unit (IU) of BeneFIX per kilogram of body weight increased the circulating activity of factor IX by 0.8 ± 0.2 IU/dL (range 0.4 to 1.2 IU/dL). Use the following formula to estimate the dose with 0.8 IU/dL average increase of factor IX per IU/kg body weight administered:

  number of factor IX IU required (IU) = body weight (kg) × desired factor IX increase (% or IU/dL) × 1.3 (IU/kg per IU/dL)

  Pediatric Patients (<15 years)

  In pediatric patients, on average, one international unit of BeneFIX per kilogram of body weight increased the circulating activity of factor IX by 0.7 ± 0.3 IU/dL (range 0.2 to 2.1 IU/dL; median of 0.6 IU/dL per IU/kg). Use the following formula to estimate the dose with 0.7 IU/dL average increase of factor IX per IU/kg body weight administered:

  number of factor IX IU required (IU) = body weight (kg) × desired factor IX increase (% or IU/dL) × 1.4 (IU/kg per IU/dL)

  Doses administered should be titrated to the patient's clinical response. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to BeneFIX. Although the dose can be estimated by the calculations above, it is highly recommended that, whenever possible, appropriate laboratory tests, including serial factor IX activity assays, be performed.

  Dosing Guide for Control and Prevention of Bleeding Episodes and Peri-operative Management

  Table 1 Type of Hemorrhage Circulating Factor IX Activity Required [% or (IU/dL)] Dosing Interval [hours] Duration of Therapy [days] Adapted from: Roberts and Eberst1 Minor Uncomplicated hemarthroses, superficial muscle, or soft tissue 20–30 12–24 1–2 Moderate Intramuscle or soft tissue with dissection, mucous membranes, dental extractions, or hematuria 25–50 12–24 Treat until bleeding stops and healing begins, about 2 to 7 days Major Pharynx, retropharynx, retroperitoneum, CNS, surgery 50–100 12–24 7–10

  2.2 Preparation and Reconstitution

  The procedures below are provided as general guidelines for the preparation and reconstitution of BeneFIX.

  Preparation

  Always wash hands before performing the following procedures. Use aseptic technique (meaning clean and germ-free) during the reconstitution procedure. Use all components in the reconstitution and administration of this product as soon as possible after opening their sterile containers to minimize unnecessary exposure to the atmosphere. Pooling: If needing more than one vial of BeneFIX per infusion, reconstitute each vial according to the following instructions. Remove the diluent syringe leaving the vial adapter in place, and use a separate large luer lock syringe to draw back the reconstituted contents of each vial. Do not detach the diluent syringes or the large luer lock syringe until you are ready to attach the large luer lock syringe to the next vial adapter.

  Reconstitution

  If refrigerated, allow the vial of lyophilized BeneFIX and the pre-filled diluent syringe to reach room temperature. Remove the plastic flip-top cap from the BeneFIX vial to expose the central portions of the rubber stopper. Wipe the top of the vial with the alcohol swab provided, or use another antiseptic solution, and allow to dry. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface. Peel back the cover from the clear plastic vial adapter package. Do not remove the adapter from the package. Place the vial on a flat surface. While holding the adapter in the package, place the vial adapter over the vial and press down firmly on the package until the adapter spike penetrates the vial stopper. Grasp the plunger rod as shown in the diagram. Avoid contact with the shaft of the plunger rod. Attach the threaded end of the plunger rod to the diluent syringe plunger by pushing and turning firmly. Break off the tamper-resistant plastic-tip cap from the diluent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip. The diluent syringe may need to be recapped (if not administering reconstituted BeneFIX immediately), so place the cap on its top on a clean surface in a spot where it would be least likely to become environmentally contaminated. Lift the package away from the adapter and discard the package. Place the vial on a flat surface. Connect the diluent syringe to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured. Slowly depress the plunger rod to inject all the diluent into the BeneFIX vial. Without removing the syringe, gently swirl the contents of the vial until the powder is dissolved. Invert the vial and slowly draw the solution into the syringe. Detach the syringe from the vial adapter by gently pulling and turning the syringe counter-clockwise. Discard the vial with the adapter attached. The reconstituted solution should be clear and colorless. If it is not, discard and use a new kit. If the solution is not to be used immediately, recap the syringe. Do not touch the syringe tip or the inside of the cap. Store the reconstituted solution at room temperature and use it within 3 hours.

  Note: BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl) phthalate (DEHP) extraction from polyvinyl chloride (PVC). This should be considered during the preparation and administration of BeneFIX, including storage time elapsed in a PVC container following reconstitution. It is important that the recommendations for dosage and administration be followed closely [see Dosage and Administration (2.1, 2.3)].

  Note: The tubing of the infusion set included with this kit does not contain DEHP.

  2.3 Administration

  For intravenous use after reconstitution only.

  The safety and efficacy of administration by continuous infusion have not been established [see Warnings and Precautions (5.2)].

  Inspect BeneFIX solution for particulate matter and discoloration prior to administration, whenever solution and container permit. Administer BeneFIX using the tubing provided in this kit, and the pre-filled diluent syringe provided, or a single sterile disposable plastic syringe. Do not mix or administer BeneFIX in the same tubing or container with other medicinal products.

  Administration

  Attach the syringe to the luer end of the infusion set tubing provided. Apply a tourniquet and prepare the injections site by wiping the skin well with an alcohol swab provided in the kit. Perform venipuncture. Insert the needle on the infusion set tubing into the vein, and remove the tourniquet. Inject the reconstituted BeneFIX intravenously over several minutes. Adjust the rate of administration based on the patient's comfort level. Note: Agglutination of red blood cells in the tubing/syringe has been reported with the administration of BeneFIX. No adverse events have been reported in association with this observation. To minimize the possibility of agglutination, it is important to limit the amount of blood entering the tubing. Blood should not enter the syringe. If red blood cell agglutination is observed in the tubing or syringe, discard all material (tubing, syringe and BeneFIX solution) and resume administration with a new package. Following completion of BeneFIX treatment, remove and discard the infusion set. Dispose of all unused solution, empty vial(s), and used needles and syringes in an appropriate container.

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• Neumega
  

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  Neumega

  

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  The recommended dose of Neumega in adults without severe renal impairment is 50 mcg/kg given once daily. Neumega should be administered subcutaneously as a single injection in either the abdomen, thigh, or hip (or upper arm if not self-injecting). A safe and effective dose has not been established in children (see PRECAUTIONS, Pediatric Use).

  The recommended dose of Neumega in adults with severe renal impairment (creatinine clearance <30 mL/min) is 25 mcg/kg. An estimate of the patient's creatinine clearance (CLcr) in mL/min is required. CLcr in mL/min may be estimated from a spot serum creatinine (mg/dL) determination using the following formula:

  CLcr ≈ [140 - age (years)] x weight (kg) {x 0.85 for female patients} 72 x serum creatinine (mg/dL)

  Dosing should be initiated six to 24 hours after the completion of chemotherapy. Platelet counts should be monitored periodically to assess the optimal duration of therapy. Dosing should be continued until the post-nadir platelet count is ≥50,000/μL. In controlled clinical trials, doses were administered in courses of 10 to 21 days. Dosing beyond 21 days per treatment course is not recommended.

  Treatment with Neumega should be discontinued at least two days before starting the next planned cycle of chemotherapy.

  Preparation of Neumega

  Neumega is a sterile, white, preservative-free, lyophilized powder for subcutaneous injection upon reconstitution. Reconstitute the Neumega 5 mg vial using the 1.0 mL of Sterile Water for Injection, USP (without preservative) contained in the pre-filled syringe included in the kit. The reconstituted Neumega solution is clear, colorless, isotonic, with a pH of 7.0, and contains 5 mg/mL of Neumega. Any unused portion of the reconstituted Neumega solution should be discarded. During reconstitution, the Sterile Water for Injection, USP should be directed at the side of the vial and the contents gently swirled. Excessive or vigorous agitation should be avoided. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter is present or the solution is discolored, the vial should not be used. Administer Neumega within 3 hours following reconstitution. Reconstituted Neumega may be refrigerated [2°C to 8°C (36°F to 46°F)] or maintained at room temperature [up to 25°C (77°F)]. Do not freeze or shake the reconstituted solution.

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