Cangene Biopharma Inc.

Cangene Biopharma Inc. Drugs

• Hepagam B
  

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  Hepagam B

  

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  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration; if these are seen, vials should not be used. During preparation, do not shake vials; avoid foaming.

  Any vial of HepaGam B that has been entered should be used promptly. Do not reuse or save for future use. This product contains no preservative; therefore, partially used vials should be discarded immediately.

  2.1 Prevention of Hepatitis B recurrence following liver transplantation

  For the prevention of hepatitis B recurrence following liver transplantation in HBsAg positive liver transplant patients, HepaGam B is administered intravenously according to a set dosing regimen designed to attain serum levels of antibodies to hepatitis B surface antigen (anti-HBs) greater than 500 IU/L3.

  Based upon the HepaGam B clinical trial, patients should receive 20,000 IU/dose [see Clinical Trials in Liver Transplant Patients (14.1)]. The volume of each 20,000 IU dose should be calculated from the measured potency of the particular lot of HepaGam B as stamped on the vial label.

  The first dose should be administered concurrently with the grafting of the transplanted liver (the anhepatic phase) with subsequent dosing as recommended in Table 1.

  Table 1 - HepaGam B Dosing Regimen

  Anhepatic Phase

  Week 1 Post-Operative

  Weeks 2-12

  Post-Operative

  Month 4 onwards

  First dose Daily from Day 1-7 Every two weeks from Day 14 Monthly

  * Each dose should contain 20,000 IU calculated from the measured potency as stamped on the vial label [see Dosage Forms and Strengths (3)].

  HepaGam B dose adjustments may be required in patients who fail to reach anti-HBs levels of 500 IU/L within the first week post-liver transplantation4. Patients who have surgical bleeding or abdominal fluid drainage (> 500 mL) or patients who undergo plasmapheresis are particularly susceptible to extensive loss of circulated anti-HBs. In these cases, the dosing regimen should be increased to a half-dose (10,000 IU calculated from the measured potency as stamped on the vial label) intravenously every 6 hours until the target anti-HBs is reached.

  Hepatitis B Immune Globulin (HBIG) products are most effective in patients with no or low levels of HBV replication at the time of transplantation5.

  Regular monitoring of serum HBsAg and levels of anti-HBs antibody should be performed pre-infusion to track treatment response and allow for treatment adjustment.

  HepaGam B should be prepared for intravenous administration under aseptic conditions. HepaGam B should be administered through a separate intravenous line using an intravenous administration set via infusion pump.

  The rate of administration should be set at 2 mL per minute.

  The rate of infusion should be decreased to 1 mL per minute or slower if the patient develops discomfort, infusion-related adverse events or there is concern about the speed of infusion.

  2.2 Postexposure Prophlyaxis

  For postexposure prophylaxis indications, HepaGam B must be administered intramuscularly only as directed below.

  It is important to use a separate vial, sterile syringe, and needle for each individual patient, to prevent transmission of infectious agents from one person to another.

  HepaGam B may be administered at the same time (but at a different site), or up to one month preceding hepatitis B vaccination without impairing the active immune response to Hepatitis B Vaccine1,2.

  Acute Exposure to Blood Containing HBsAg

  Table 2 summarizes prophylaxis for percutaneous (needlestick, bite, sharps), ocular, or mucous membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with HepaGam B should be given as soon as possible after exposure, as its value after seven days following exposure is unclear1,2. An injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure, and within 24 hours if possible. Consult the Hepatitis B Vaccine package insert for dosage information regarding the vaccine.

  For persons who refuse Hepatitis B Vaccine or are known non-responders to vaccine, a second dose of HepaGam B should be given one month after the first dose2.

  Table 2 - Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure¹,² * Hepatitis B Immune Globulin Intravenous (Human) dose of 0.06 mL/kg IM † See manufacturers’ recommendation for appropriate dose. ‡ Less than 10 mIU/mL anti-HBs by radioimmunoassay, negative by enzyme immunoassay. § Two doses of Hepatitis B Immune Globulin Intravenous (Human) is preferred if no response after at least four doses of vaccine. Source Exposed Person Unvaccinated Vaccinated HBsAg-positive 1. Hepatitis B Immune Globulin Intravenous (Human) (HBIGIV) x 1 immediately* 2. Initiate HB vaccine series† 1. Test exposed person for anti-HBs 2. If inadequate antibody‡, Hepatitis B Immune Globulin Intravenous (Human) x 1 immediately plus either HB vaccine booster dose, or a second dose of HBIGIV*, 1 month later§ Known Source – High Risk for HBsAg-positive 1. Initiate HB vaccine series 2. Test source of HBsAg. If positive, Hepatitis B immune Globulin Intravenous (Human) (HBIGIV) x 1 1. Test source for HBsAg only if exposed is vaccine nonresponder; if source is HBsAg-positive, give Hepatitis B Immune Globulin Intravenous (Human) x 1 immediately plus either HB vaccine booster dose, or a second dose of HBIGIV*, 1 month later§ Known Source – Low Risk for HBsAg-positive Initiate HB vaccine series Nothing required Unknown Source Initiate HB vaccine series Nothing required

  Prophylaxis of Infants Born to Mothers who are Positive for HBsAg with or without HBeAg

  Table 3 contains the recommended schedule of Hepatitis B prophylaxis for infants born to mothers that are either known to be positive for HBsAg or have not been screened. Infants born to mothers known to be HBsAg-positive should receive 0.5 mL HepaGam B after physiologic stabilization of the infant and preferably within 12 hours of birth. The Hepatitis B Vaccine series should be initiated simultaneously, if not contraindicated, with the first dose of the vaccine given concurrently with the HepaGam B, but at a different site. Subsequent doses of the vaccine should be administered in accordance with the recommendations of the manufacturer. Women admitted for delivery, who were not screened for HBsAg during the prenatal period, should be tested. While test results are pending, the newborn infant should receive Hepatitis B Vaccine within 12 hours of birth (see manufacturers’ recommendations for dose). If the mother is later found to be HBsAg-positive, the infant should receive 0.5 mL HepaGam B as soon as possible and within seven days of birth; however, the efficacy of HepaGam B administered after 48 hours of age is not known6. Testing for HBsAg and anti-HBs is recommended at 12-15 months of age. If HBsAg is not detectable and anti-HBs is present, the child has been protected1.

  Table 3 - Recommended Schedule of Hepatitis B Immunoprophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus Infection¹ * See manufacturers’ recommendations for appropriate dose. † 0.5 mL administered IM at a site different from that used for the vaccine. ‡ See ACIP recommendation¹ Age of Infant Administer Infant born to mother known to be HBsAg-positive Infant born to mother not screened for HBsAg First Vaccination* Hepatitis B Immune Globulin Intravenous (Human)† Birth (within 12 hours)Birth (within 12 hours) Birth (within 12 hours)If mother is found to be HBsAg-positive, administer dose to infant as soon as possible, not later than 1 week after birth Second Vaccination* 1 month 1-2 months Third Vaccination* 6 months‡ 6 months‡

  Sexual Exposure to HBsAg-positive Persons

  All susceptible persons whose sexual partners have acute hepatitis B infection should receive a single dose of HepaGam B (0.06 mL/kg) and should begin the Hepatitis B Vaccine series, if not contraindicated, within 14 days of the last sexual contact or if sexual contact with the infected person will continue. Administering the vaccine with HepaGam B may improve the efficacy of post exposure treatment. The vaccine has the added advantage of conferring long-lasting protection1,2.

  Household Exposure to Persons with Acute HBV Infection

  Prophylaxis of an infant less than 12 months of age with 0.5 mL HepaGam B and Hepatitis B Vaccine is indicated if the mother or primary caregiver has acute HBV infection. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless they had an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive Hepatitis B Vaccine1,2.

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• Winrho
  

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  Winrho

  

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  2.1 Preparation and Handling

  Bring WinRho® SDF to room temperature prior to use. Inspect WinRho® SDF for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. WinRho® SDF is for single use only. Discard any unused portion. The solution is ready to use, no reconstitution required. See Table 1 for the target fill volumes for each of the dosage sizes for WinRho® SDF. Table 1 Liquid WinRho® SDF Dosage size and target fill volumes Vial Size Target Fill Volume 600 international unit (120 mcg) 0.5 mL 1,500 international unit (300 mcg) 1.3 mL 2,500 international unit (500 mcg) 2.2 mL 5,000 international unit (1,000 mcg) 4.4 mL 15,000 international unit (3,000 mcg) 13.0 mL

  Note: Remove the entire contents of the vial to obtain the labelled dosage of WinRho® SDF. If partial vials are required for dosage calculation, withdraw the entire contents of the vial to ensure accurate calculation of the dosage requirement. For ease in withdrawing the contents of the vial, draw back the plunger of a sterile syringe (with the needle and needle cover in place) to admit air into the syringe. Depress the plunger of the syringe to inject air into the vial. Invert vial and aspirate contents of vial into syringe.

  2.2 Treatment of ITP

  ADMINISTER WinRho®  SDF BY THE INTRAVENOUS ROUTE ONLY (see Preparation and Handling [2.1] ). Do not administer intramuscularly.

  Administer the entire dose of WinRho® SDF into a suitable vein over three to five minutes. Administer WinRho® SDF separately from other drugs. If dilution of WinRho SDF is preferred prior to intravenous administration, use normal saline as diluent. Do not use Dextrose (5%) in water (D5W). No other diluents have been tested.

  Initial Dosing: An initial dose of 250 international unit/kg (50 mcg/kg) body weight, given as a single injection is recommended for the treatment of ITP. The initial dose may be administered in two divided doses given on separate days, if desired. If the patient has a hemoglobin level less than 10 g/dL, a reduced dose of 125 to 200 international unit/kg (25 to 40 mcg/kg) should be given to minimize the risk of increasing the severity of anemia in the patient. All patients should be monitored to determine clinical response by assessing platelet counts, RBCs, hemoglobin (Hgb), and reticulocyte levels [see Warnings and Precautions (5.2)].

  Subsequent Dosing: If subsequent therapy is required to elevate platelet counts, an intravenous dose of 125 to 300 international unit/kg (25 to 60 mcg/kg) body weight of WinRho® SDF is recommended. The frequency of dosing and the dose used in maintenance therapy should be determined by the patient’s clinical response by assessing platelet counts, RBCs, Hgb, and reticulocyte levels.

  If a patient responded to initial dose with a satisfactory increase in platelets, maintenance dose at 125 to 300 international unit/kg (25 to 60 mcg/kg), individualized based on platelet and Hgb levels. An international consensus report on the investigation and management of primary immune thrombocytopenia states that treatment is rarely indicated in patients with platelet counts above 50 x 109/L and this has been generally accepted as the threshold for satisfactory response.1 Evaluate whether patient responded with a satisfactory increase in platelets based on the clinical situation and bleeding risks for the individual patient.

  If patient did not respond to initial dose, administer a subsequent dose based on Hgb:

  If Hgb between 8-10 g/dL, redose between 125 to 200 international unit/kg (25 to 40 mcg/kg).

  If Hgb >10 g/dL, redose between 250 to 300 international unit/kg (50 to 60 mcg/kg).

  If Hgb < 8 g/dL, alternative treatments should be used.

  The following equations are provided to determine the dosage and number of vials needed for the treatment of ITP:

  weight in lbs/2.21 = weight in kg weight in kg X selected international unit (mcg) dosing level = dosage dosage / vial size = number of vials needed

  Safety and efficacy of WinRho® SDF  in the treatment of ITP at doses exceeding 300 international unit/kg (60 mcg/kg) has not been established.

  2.3 Supression of Rh Isoimmunization

  Intravenous or intramuscular use.

  For intravenous administration, administer WinRho® SDF separately from other drugs. WinRho® SDF should be administered at a rate of 2 mL per 5 to 15 seconds. For intramuscular administration, administer into the deltoid muscle of the upper arm or the anterolateral aspects of the upper thigh. Due to the risk of sciatic nerve injury, avoid the gluteal region. If the gluteal region is used, use only the upper, outer quadrant.

  Pregnancy and other Obstetric Indications

  Table 2 provides dosing guidelines based on the condition being treated.

  Table 2 Obstetric Indications and Recommended Dose Indication Timing of Administration

  Dose

  (Administer IM or IV) Rh-incompatible Pregnancy: Routine antepartum prophylaxis 28 weeks gestation* 1,500 international unit (300 mcg)

  Postpartum

  (if newborn is Rho(D)-positive) Within 72 hours of birth** 600 international unit (120 mcg) Obstetric Conditions: Threatened abortion at any time Immediately 1,500 international unit (300 mcg) Amniocentesis and chorionic villus sampling before 34 weeks gestation Immediately after procedure† 1,500 international unit (300 mcg) Abortion, amniocentesis, or any other manipulation after 34 weeks gestation Within 72 hours 600 international unit (120 mcg)

  * If WinRho® SDF is administered early in the pregnancy, it is recommended that WinRho® SDF be administered at 12-week intervals in order to maintain adequate levels of passively acquired anti-Rh.

  ** In the event that the Rh status of the baby is not known at 72 hours, WinRho® SDF should be administered to the mother at 72 hours after delivery. If more than 72 hours have elapsed, WinRho® SDF should not be withheld but administered as soon as possible up to 28 days after delivery.

  †Repeat every 12 weeks during pregnancy

   Incompatible Transfusion

  Administer WinRho® SDF within 72 hours after exposure for treatment of incompatible blood transfusions or massive fetal hemorrhage.

  Table 3 provides dosing guidelines based on the condition being treated.

  Table 3 Transfusion Indication and Recommended Dose Route of Administration Rate of Administration WinRho® SDF Dose If exposed to Rho(D)-Positive Whole Blood: If exposed to Rho(D)-Positive Red Blood Cells: Intravenous 3,000 international unit (600 mcg) every 8 hours 45 international unit (9 mcg)/mL blood 90 international unit (18 mcg)/mL cells Intramuscular 6,000 international unit (1,200 mcg) every 12 hours 60 international unit (12 mcg)/mL blood 120 international unit (24 mcg)/mL cells

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• Hepagam B
  

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  Hepagam B

  

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  2.1 Prevention of Hepatitis B recurrence following Liver Transplantation

  Administer the first dose of HepaGam B during the grafting of the transplanted liver (the anhepatic phase) with subsequent dosing as recommended in Table 1.

  Calculate the dosing from the measured potency of the particular lot of HepaGam B as stamped on the vial label.

  Administer by intravenous infusion (Table 2).

  Table 1 - HepaGam B Dosing Regimen for HBV-Related Liver Transplant Patients

  Anhepatic Phase

  Week 1 Post-Operative

  Weeks 2-12

  Post-Operative

  Month 4 onwards

  First dose

  Daily from Day 1-7

  Every two weeks from Day 14

  Monthly

  * Each dose should contain 20,000 IU calculated from the measured potency as stamped on the vial label [see 3 DOSAGE FORMS AND STRENGTHS].

  Table 2 – HepaGam B Intravenous Infusion Rate

  Route of Administration

  Dosage

  Infusion Rate

  Intravenous

  20,000 IU per dose

  2 milliliters per minute.

  Decrease to 1 milliliter per minute or slower if the patient develops discomfort or infusion-related adverse reactions.

  HepaGam B dose adjustments may be required in patients who fail to reach anti-HBs levels of 500 International Units per liter within the first week post-liver transplantation1. Patients who have surgical bleeding or abdominal fluid drainage (> 500 milliliters) or patients who undergo plasmapheresis are particularly susceptible to extensive loss of circulated anti-HBs. In these cases, the dosing regimen should be increased to a half-dose (10,000 International Units calculated from the measured potency as stamped on the vial label) intravenously every 6 hours until the target anti-HBs is reached.

  2.2 Postexposure Prophlyaxis

  Administer HepaGam B intramuscularly as recommended in Table 3.

  Table 3 – HepaGam B Dosing Regimen for Postexposure Prophylaxis (Intramuscular)

  Indication

  Dosage

  Instructions

  Acute Exposure to Blood Containing HBsAg

  0.06 milliliter per kilogram

  Administer HepaGam B as soon as possible after exposure. The value after seven days following exposure is unclear2, 3.

  For persons who refuse Hepatitis B vaccine or who are known non-responders to vaccine, give a second dose of HepaGam B one month after the first dose2.

  Perinatal exposure of Infants Born to HBsAg-positive mothers

  0.5 milliliter

  Administer after physiologic stabilization of the infant and preferably within twelve hours of birth. Administer concurrently with Hepatitis B vaccine.

  Sexual Exposure to HBsAg-Positive Persons

  0.06 milliliter per kilogram

  Administer HepaGam B and Hepatitis B Vaccine series within 14 days of sexual contact or if sexual contact with the infected person will continue.

  Household Exposure to Person with Acute HBV Infection

  0.5 milliliter

  For infants less than twelve months of age administered concurrently with Hepatitis B Vaccine. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless there is an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Treat such exposures like sexual exposures.

  HepaGam B may be administered at the same time (but at a different site), or up to one month preceding Hepatitis B vaccination without impairing the active immune response to Hepatitis B vaccine2,3.

  2.3 Preparation

  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid. • Do not shake vials during preparation to avoid foaming. • The HepaGam B vial is for single use only. HepaGam B contains no preservatives. • Promptly use any vial of HepaGam B that has been entered. Do not reuse or save for future use. • For intravenous administration, administer HepaGam B through a separate intravenous line using an infusion pump. • Use normal saline as the diluent if dilution of HepaGam B is preferred prior to intravenous administration. [see Clinical Trials in Liver Transplant Patients (14.1)] • Do not use dextrose (5%) in water (D5W). • Use a separate vial, sterile syringe, and needle for each individual patient, to prevent transmission of infectious agents from one person to another.

  2.3 Preparation

  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid. • Do not shake vials during preparation to avoid foaming. • The HepaGam B vial is for single use only. HepaGam B contains no preservatives. • Promptly use any vial of HepaGam B that has been entered. Do not reuse or save for future use. • For intravenous administration, administer HepaGam B through a separate intravenous line using an infusion pump. • Use normal saline as the diluent if dilution of HepaGam B is preferred prior to intravenous administration. [see Clinical Trials in Liver Transplant Patients (14.1)] • Do not use dextrose (5%) in water (D5W). • Use a separate vial, sterile syringe, and needle for each individual patient, to prevent transmission of infectious agents from one person to another.

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