Kedrion Biopharma, Inc
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Kedrion Biopharma, Inc Drugs
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![Bivigam (Human Immunoglobulin G) Injection, Solution [Kedrion Biopharma, Inc.]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
Bivigam
For Intravenous Use Only
2.1 Preparation and Handling
BIVIGAM is a clear or slightly opalescent, colorless to pale yellow solution. Inspect BIVIGAM visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or turbid, or contains particulate matter. Allow refrigerated product to come to room temperature before use. Do not freeze or heat. Do not use any solution that has been frozen or heated. DO NOT SHAKE. Do not mix BIVIGAM with other IGIV products or other intravenous medications. If large doses of BIVIGAM are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags and infused. Do not dilute BIVIGAM. BIVIGAM contains no preservatives. BIVIGAM vial is for single use only. Any vial of BIVIGAM that has been entered should be used promptly and any unused portion should be discarded immediately. Do not reuse or save for future use. Maintain BIVIGAM at room temperature during administration. Do not use after expiration date.2.2 Recommended Dose
As there are significant differences in the half-life of IgG among patients with primary humoral immunodeficiency, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.
The recommended dose of BIVIGAM for replacement therapy in primary humoral immunodeficiency (PI) is 300 to 800 mg/kg body weight administered every 3 to 4 weeks. The dosage may be adjusted over time to achieve the desired trough levels and clinical response.
BIVIGAM dose adjustments may be required in patients who fail to maintain trough total IgG concentrations of at least 500 mg/dL with a target of 600 mg/dL. Starting with the second infusion, the dose will be adjusted proportionally, targeting a trough of more than equal to 600 mg/dL, based on the previous trough and the associated dose.
2.3 Administration
It has been reported that the frequency of adverse drug reactions to IGIV increases with the infusion rate. Initial infusion rates should be slow. If there are no adverse drug reactions, the infusion rate for subsequent infusions can be slowly increased to the maximum rate. For patients experiencing adverse drug reactions, it is advisable to reduce the infusion rate in subsequent infusions.
Table 1: Recommended Infusion Rates for BIVIGAM Indication Initial Infusion Rate(for first 10 minutes) Maintenance Infusion Rate(if tolerated) PI 0.5 mg/kg/min(0.005 mL/kg/min) Increase every 20 minutes (if tolerated) by 0.8 mg/kg/min up to 6 mg/kg/min.Monitor patient vital signs throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients judged to be at risk for renal dysfunction or thrombotic events, administer BIVIGAM at the minimum infusion rate practicable, and consider discontinuation of administration if renal function deteriorates (see Boxed Warning,Warnings and Precautions [5.1,5.3]
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![Apis Ex Animale 4 Special Order Liquid [Uriel Pharmacy Inc.]](http://www.recallguide.org/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
Apis Ex Animale 4 Special Order
Albuked 25 should always be administered by intravenous infusion. Albuked 25 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Albuked 25 should only be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% Dextrose in Water.
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Hypovolemic Shock—For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.
Burns—After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(2) This is best achieved by the intravenous administration of Albuked 25. The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.
Hypoproteinemia With or Without Edema— Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the intravenous administration of Albuked 25 must be considered purely symptomatic or supportive (see section Situations in Which Albumin Administration is Not Warranted).(2) The usual daily dose of albumin for adults is 50 to 75 g and for children 25 g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of Albuked 25 should not exceed 2 mL per minute, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.
Other dosage recommendations are given under the specific indications referred to above.
Preparation for Administration
Remove seal to expose stopper. Always swab stopper top immediately with a suitable antiseptic prior to entering vial.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
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Albuked
Albuked 20 should always be administered by intravenous infusion. Albuked 20 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Albuked 20 should only be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% Dextrose in Water.
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Hypovolemic Shock — For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.
Burns — After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(2) This is best achieved by the intravenous administration of Albuked 20. The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.
Hypoproteinemia With or Without Edema — Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the intravenous administration of Albuked 20 must be considered purely symptomatic or supportive (see section Situations in Which Albumin Administration is Not Warranted).(2) The usual daily dose of albumin for adults is 50 to 75 g and for children 25 g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of Albuked 20 should not exceed 2 mL per minute, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.
Other dosage recommendations are given under the specific indications referred to above.
Preparation for Administration
Remove seal to expose stopper. Always swab stopper top immediately with a suitable antiseptic prior to entering vial.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
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Sallys Box Secret Garden Tea Tree Oil Ampoule Mask
Albuked 5 should always be administered by intravenous infusion. The choice between the use of Albuked 5 and Albumin (Human) 25%, USP (Albuked™ 25) depends upon whether the patient requires primarily volume (Albuked 5) or primarily colloid osmotic activity (Albuked 25). Below a serum oncotic level of 20 mm Hg (equal to a total serum protein concentration of 5.2 g per 100 mL) there is evidence which suggests that the risk of complications increases.(1) When the oncotic pressure drops below this level, the patient should be treated with Albuked 25 together with diuretics. This is especially important in high risk patients who have undergone abdominal, cardiovascular, thoracic or urologic surgery or who have acute bacteremia.
The volume administered and the speed of administration should be adapted to the response of the individual patient.
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Hypovolemic Shock
The volume infused should be related to the estimated volume deficit and the speed of administration adapted to the response of the patient.
In neonates or infants, Albuked 5 may be given in large amounts.(7) The recommended dose is 10 to 20 mL/kg equivalent to 0.5 to 1.0 g albumin/kg body weight.
Burns
After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(1) This is best achieved by the intravenous administration of Albuked, usually as Albuked 25. The duration of therapy is decided by the loss of protein from burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.
Other dosage recommendations are given under the specific indications referred to above.
Preparation for Administration
Remove seal to expose stopper. Always swab stopper top immediately with suitable antiseptic prior to entering vial.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
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Koate -dvi
Each bottle of Koāte-DVI has the Factor VIII content in international units (IU) per bottle stated on the label of the bottle. The reconstituted product must be administered intravenously by either direct syringe injection or drip infusion. The product must be administered within 3 hours after reconstitution.
General Approach to Treatment and Assessment of Treatment Efficacy
The dosages described below are presented as general guidance. It should be emphasized that the dosage of Koāte-DVI required for hemostasis must be individualized according to the needs of the patient, the severity of the deficiency, the severity of the hemorrhage, the presence of inhibitors, and the Factor VIII level desired. It is often critical to follow the course of therapy with Factor VIII level assays.
The clinical effect of Koāte-DVI is the most important element in evaluating the effectiveness of treatment. It may be necessary to administer more Koāte-DVI than would be estimated in order to attain satisfactory clinical results. If the calculated dose fails to attain the expected Factor VIII levels, or if bleeding is not controlled after administration of the calculated dosage, the presence of a circulating inhibitor in the patient should be suspected. Its presence should be substantiated and the inhibitor level quantitated by appropriate laboratory tests.
When an inhibitor is present, the dosage requirement for Antihemophilic Factor (Human) is extremely variable and the dosage can be determined only by the clinical response. Some patients with low titer inhibitors (10 Bethesda Units) can be successfully treated with Factor VIII without a resultant anamnestic rise in inhibitor titer.(12) Factor VIII levels and clinical response to treatment must be assessed to insure adequate response. Use of alternative treatment products, such as Factor IX Complex concentrates, Antihemophilic Factor (Porcine) or Anti-Inhibitor Coagulant Complex, may be necessary for patients with high titer inhibitors. Immune tolerance therapy using repeated doses of Factor VIII concentrate administered frequently on a predetermined schedule may result in eradication of the Factor VIII inhibitor. (13,14) Most successful regimens have employed high doses of Factor VIII administered at least once daily, but no single dosage regimen has been universally accepted as the most effective. Consultation with a hemophilia expert experienced with the management of immune tolerance regimens is also advisable.
Calculation of Dosage
The in vivo elevation in Factor VIII level (percent of normal) can be estimated by multiplying the dose of Antihemophilic Factor (Human) per kilogram of body weight (IU/kg) by 2%. This method of calculation is based on clinical findings by Abildgaard et al,(15) and is illustrated in the following examples:
The dosage necessary to achieve hemostasis depends upon the type and severity of the bleeding episode, according to the following general guidelines:
Mild Hemorrhage
Mild superficial or early hemorrhages may respond to a single dose of 10 IU per kg,(4) leading to an in vivo rise of approximately 20% in the Factor VIII level. Therapy need not be repeated unless there is evidence of further bleeding.
Moderate Hemorrhage
For more serious bleeding episodes (e.g., definite hemarthroses, known trauma), the Factor VIII level should be raised to 30%–50% by administering approximately 15-25 IU per kg. If further therapy is required, repeated doses of 10-15 IU per kg every 8-12 hours may be given.(16)
Severe Hemorrhage
In patients with life-threatening bleeding or possible hemorrhage involving vital structures (e.g., central nervous system, retropharyngeal and retroperitoneal spaces, iliopsoas sheath), the Factor VIII level should be raised to 80% - 100% of normal in order to achieve hemostasis. This may be achieved in most patients with an initial Antihemophilic Factor (Human) dose of 40-50 IU per kg and a maintenance dose of 20-25 IU per kg every 8-12 hours.(17,18) For major surgical procedures, Factor VIII levels should be checked throughout the perioperative course to ensure adequate replacement therapy.
Surgery
For major surgical procedures, the Factor VIII level should be raised to approximately 100% by giving a preoperative dose of 50 IU/kg. The Factor VIII level should be checked to assure that the expected level is achieved before the patient goes to surgery. In order to maintain hemostatic levels, repeat infusions may be necessary every 6 to 12 hours initially, and for a total of 10 to 14 days until healing is complete. The intensity of Factor VIII replacement therapy required depends on the type of surgery and postoperative regimen employed. For minor surgical procedures, less intensive treatment schedules may provide adequate hemostasis.(17,18)
Prophylaxis
Factor VIII concentrates may also be administered on a regular schedule for prophylaxis of bleeding, as reported by Nilsson et al.(19)
Reconstitution
Vacuum Transfer
Note: Aseptic technique should be carefully followed. All needles and vial tops that will come into contact with the product to be administered via the intravenous route should not come in contact with any non-sterile surface. Any contaminated needles should be discarded by placing in a puncture proof container, and new equipment should be used.
After removing all items from the box, warm the sterile water (diluent) to room temperature (25°C, 77°F).
Remove shrink band from product vial.
If the shrink band is absent or shows signs of tampering, do not use the product and notify Grifols Therapeutics Inc. immediately.Remove the plastic flip tops from each vial (Fig. A). Cleanse vial tops (grey stoppers) with alcohol swab and allow surface to dry. After cleaning, do not allow anything to touch the latex (rubber) stopper.
Carefully remove the plastic sheath from the short end of the transfer needle. Insert the exposed needle into the diluent vial to the hub. (Fig. B)
Carefully grip the sheath of the other end of the transfer needle and twist to remove it.
Invert the diluent vial and insert the attached needle into the vial of concentrate at a 45° angle (Fig. C). This will direct the stream of diluent against the wall of the concentrate vial and minimize foaming. The vacuum will draw the diluent into the concentrate vial. **
Remove the diluent bottle and transfer needle (Fig. D).
Immediately after adding the diluent, agitate vigorously for 10–15 seconds, (Fig. E1) then swirl continuously until completely dissolved (Fig. E2). Some foaming will occur, but attempt to avoid excessive foaming. The vial should then be visually inspected for particulate matter and discoloration prior to administration.
Clean the top of the vial of reconstituted Koāte-DVI again with alcohol swab and let surface dry.
Attach the filter needle (from the package) to a sterile syringe. Withdraw the Koāte-DVI solution into the syringe through the filter needle (Fig. F).
Remove the filter needle from the syringe and replace with an appropriate injection or butterfly needle for administration. Discard filter needle into a puncture proof container.
If the same patient is using more than one vial of Koāte-DVI, the contents of multiple vials may be drawn into the same syringe through the filter needles provided.
**If vacuum is lost in the concentrate vial during reconstitution, use a sterile syringe and needle to remove the sterile water from the diluent vial and inject it into the concentrate vial, directing the stream of fluid against the wall of the vial.
Rate of Administration
The rate of administration should be adapted to the response of the individual patient, but administration of the entire dose in 5 to 10 minutes is generally well-tolerated.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Albuked
Albuked 20 should always be administered by intravenous infusion. Albuked 20 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Albuked 20 should only be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% Dextrose in Water.
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Hypovolemic Shock — For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.
Burns — After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(2) This is best achieved by the intravenous administration of Albuked 20. The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.
Hypoproteinemia With or Without Edema — Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the intravenous administration of Albuked 20 must be considered purely symptomatic or supportive (see section Situations in Which Albumin Administration is Not Warranted).(2) The usual daily dose of albumin for adults is 50 to 75 g and for children 25 g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of Albuked 20 should not exceed 2 mL per minute, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.
Other dosage recommendations are given under the specific indications referred to above.
Preparation for Administration
Remove seal to expose stopper. Always swab stopper top immediately with a suitable antiseptic prior to entering vial.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
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Albuked
Albuked 5 should always be administered by intravenous infusion. The choice between the use of Albuked 5 and Albumin (Human) 25%, USP (Albuked™ 25) depends upon whether the patient requires primarily volume (Albuked 5) or primarily colloid osmotic activity (Albuked 25). Below a serum oncotic level of 20 mm Hg (equal to a total serum protein concentration of 5.2 g per 100 mL) there is evidence which suggests that the risk of complications increases.(1) When the oncotic pressure drops below this level, the patient should be treated with Albuked 25 together with diuretics. This is especially important in high risk patients who have undergone abdominal, cardiovascular, thoracic or urologic surgery or who have acute bacteremia.
The volume administered and the speed of administration should be adapted to the response of the individual patient.
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Hypovolemic Shock
The volume infused should be related to the estimated volume deficit and the speed of administration adapted to the response of the patient.
In neonates or infants, Albuked 5 may be given in large amounts.(7) The recommended dose is 10 to 20 mL/kg equivalent to 0.5 to 1.0 g albumin/kg body weight.
Burns
After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(1) This is best achieved by the intravenous administration of Albuked, usually as Albuked 25. The duration of therapy is decided by the loss of protein from burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.
Other dosage recommendations are given under the specific indications referred to above.
Preparation for Administration
Remove seal to expose stopper. Always swab stopper top immediately with suitable antiseptic prior to entering vial.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
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Albuked
Albuked 25 should always be administered by intravenous infusion. Albuked 25 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Albuked 25 should only be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% Dextrose in Water.
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Hypovolemic Shock—For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.
Burns—After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(2) This is best achieved by the intravenous administration of Albuked 25. The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.
Hypoproteinemia With or Without Edema— Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the intravenous administration of Albuked 25 must be considered purely symptomatic or supportive (see section Situations in Which Albumin Administration is Not Warranted).(2) The usual daily dose of albumin for adults is 50 to 75 g and for children 25 g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of Albuked 25 should not exceed 2 mL per minute, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.
Other dosage recommendations are given under the specific indications referred to above.
Preparation for Administration
Remove seal to expose stopper. Always swab stopper top immediately with a suitable antiseptic prior to entering vial.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
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Gammaked
GAMMAKED consists of 9%–11% protein in 0.16–0.24 M glycine. The buffering capacity of GAMMAKED is 35.0 mEq/L (0.35 mEq/g protein). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45–50 mEq/L of blood, or 3.6 mEq/kg body weight. Thus, the acid load delivered with a dose of 1 g/kg of GAMMAKED would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously.
2.1 Preparation and Handling
Visually inspect GAMMAKED for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid. Do not freeze. Do not use solutions that have been frozen. The GAMMAKED vial is for single use only. GAMMAKED contains no preservative. Use any vial that has been entered promptly. Discard partially used vials. Infuse GAMMAKED using a separate line by itself, without mixing with other intravenous fluids or medications the subject might be receiving. The GAMMAKED infusion line can be flushed with 5% dextrose in water (D5/W) or 0.9% sodium chloride for injection. If dilution is required, GAMMAKED may be diluted with 5% dextrose in water (D5/W). Do not dilute with saline. No other drug interactions or compatibilities have been evaluated. Content of vials may be pooled under aseptic conditions into sterile infusion bags and infused within 8 hours after pooling. Avoid simultaneous administration of GAMMAKED and Heparin through a single lumen delivery device due to GAMMAKED, Heparin incompatibilities. Flush Heparin Lock (Hep-Lock) through which GAMMAKED was administered with 5% dextrose in water (D5/W) or 0.9% sodium chloride for injection, and do not flush with Heparin. See table below. Additional Solutions Dilution Line Flush Delivery Device Flush 5% Dextrose in water Yes Yes Yes 0.9% Sodium Chloride No Yes Yes Heparin No No No Do not mix with immune globulin intravenous (IGIV) products from other manufacturers. Do not use after expiration date.2.2 PI
As there are significant differences in the half-life of IgG among patients with primary humoral immunodeficiencies, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.
Intravenous (IV) The dose of GAMMAKED for patients with PI is 300 to 600 mg/kg body weight (3-6 mL/kg) administered every 3 to 4 weeks. The dosage may be adjusted over time to achieve the desired trough levels and clinical responses.
The recommended initial infusion rate is 1 mg/kg/min (0.01 mL/kg/min). If the infusion is well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/min (0.08 mL/kg/min). For patients judged to be at risk for renal dysfunction or thrombosis, administer GAMMAKED at the minimum infusion rate practicable. (see Warnings and Precautions [5.2, 5.4])
If a patient routinely receives a dose of less than 400 mg/kg of GAMMAKED every 3 to 4 weeks (less than 4 mL/kg), and is at risk of measles exposure (i.e., traveling to a measles endemic area), administer a dose of at least 400 mg/kg (4 mL/kg) just prior to the expected measles exposure. If a patient has been exposed to measles, a dose of 400 mg/kg (4 mL/kg) should be administered as soon as possible after exposure.
Subcutaneous (SC) The dose should be individualized based on the patient’s clinical response to GAMMAKED therapy and serum IgG trough levels. Begin treatment with GAMMAKED one week after the patient’s last IGIV infusion. See below under "Initial Weekly Dose". Prior to switching treatment from IGIV to GAMMAKED, obtain the patient’s serum IgG trough level to guide subsequent dose adjustments. See below under "Dose Adjustment".
Establish the initial weekly dose of GAMMAKED by converting the monthly IGIV dose into a weekly equivalent and increasing it using a dose adjustment factor. The goal is to achieve a systemic serum IgG exposure (Area Under the Concentration-Time Curve [AUC]) not inferior to that of the previous IGIV treatment. If the patient has not been previously treated with IV GAMMAKED, convert the monthly IGIV dose by multiplying by 1.37, then dividing this dose into weekly doses based on the patient’s previous IGIV treatment interval. Monitor the patient’s clinical response, and adjust dose accordingly.
Initial Weekly DoseTo calculate the initial weekly dose of subcutaneous administration of GAMMAKED, multiply the previous IGIV dose in grams by the dose adjustment factor of 1.37; then divide this by the number of weeks between doses during the patient’s IGIV treatment (i.e., 3 or 4).
To convert the GAMMAKED dose (in grams) to milliliters (mL), multiply the calculated dose (in grams) by 10.
Dose Adjustment Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level. To determine if a dose adjustment may be considered, measure the patient’s serum IgG trough level on IGIV and as early as 5 weeks after switching from IGIV to subcutaneous. The target serum IgG trough level on weekly SC treatment is projected to be the last IGIV trough level plus 340 mg/dL. To determine if further dose adjustments are necessary, monitor the patient’s IgG trough level every 2 to 3 months.
To adjust the dose based on trough levels, calculate the difference (in mg/dL) of the patient’s serum IgG trough level from the target IgG trough level (the last IGIV trough level + 340 mg/dL). Then find this difference in Table 1 and the corresponding amount (in mL) by which to increase or decrease the weekly dose based on the patient’s body weight. However, the patient’s clinical response should be the primary consideration in dose adjustment.
Table 1: Adjustment (±mL) of the Weekly Subcutaneous Dose Based on the Difference (±mg/dL) From the Target Serum IgG Trough Level * Dose adjustment in mL is based on the slope of the serum IgG trough level response to subcutaneous administration of GAMMAKED dose increments (about 6.0 mg/dL per increment of 1 mg/kg per week). Difference From Target IgG Trough Level (mg/dL) Body Weight (kg) 10 15 20 30 40 50 60 70 80 90 100 110 120 Dose Adjustment (mL per Week)* 50 1 1 2 3 3 4 5 6 7 8 8 9 10 100 2 3 3 5 7 8 10 12 13 15 17 18 20 150 3 4 5 8 10 13 15 18 20 23 25 28 30 200 3 5 7 10 13 17 20 23 27 30 33 37 40 250 4 6 8 13 17 21 25 29 33 38 42 46 50 300 5 8 10 15 20 25 30 35 40 45 50 55 60 350 6 9 12 18 23 29 35 41 47 53 58 64 70 400 7 10 13 20 27 33 40 47 53 60 67 73 80 450 8 11 15 23 30 38 45 53 60 68 75 83 90 500 8 13 17 25 33 42 50 58 67 75 83 92 100For example, if a patient with a body weight of 70 kg has an actual IgG trough level of 900 mg/dL and the target level is 1000 mg/dL, this results in a difference of 100 mg/dL. Therefore, increase the weekly dose of subcutaneous dose by 12 mL.
Monitor the patient’s clinical response, and repeat the dose adjustment as needed.
Dosage requirements for patients switching to GAMMAKED from another Immune Globulin Subcutaneous (IGSC) product have not been studied. If a patient on GAMMAKED does not maintain an adequate clinical response or a serum IgG trough level equivalent to that of the previous IGSC treatment, the physician may want to adjust the dose. For such patients, Table 1 also provides guidance for dose adjustment to achieve a desired IGSC trough level.
2.3 ITP
DO NOT ADMINISTER SUBCUTANEOUSLY (see Warnings and Precautions [5.10])
GAMMAKED may be administered at a total dose of 2 g/kg, divided in two doses of 1 g/kg (10 mL/kg) given on two consecutive days or into five doses of 0.4 g/kg (4 mL/kg) given on five consecutive days. If after administration of the first of two daily 1 g/kg (10 mL/kg) doses, an adequate increase in the platelet count is observed at 24 hours, the second dose of 1 g/kg (10 mL/kg) body weight may be withheld.
Forty-eight ITP subjects were treated with 2 g/kg GAMMAKED, divided in two 1 g/kg doses (10 mL/kg) given on two successive days. With this dose regimen 35/39 subjects (90%) responded with a platelet count from less than or equal to 20 x109/L to more than or equal to 50 x109/L within 7 days after treatment. The high dose regimen (1 g/kg × 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.
The recommended initial infusion rate is 1 mg/kg/min (0.01 mL/kg/min). If the infusion is well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/min (0.08 mL/kg/min). For patients judged to be at risk for renal dysfunction or thrombosis, administer GAMMAKED at the minimum infusion rate practicable. (see Warnings and Precautions [5.2, 5.4])
2.4 CIDP
GAMMAKED may be initially administered as a total loading dose of 2 g/kg (20 mL/kg) given in divided doses over two to four consecutive days. GAMMAKED may be administered as a maintenance infusion of 1 g/kg (10 mL/kg) administered over 1 day or divided into two doses of 0.5 g/kg (5 mL/kg) given on two consecutive days, every 3 weeks.
The recommended initial infusion rate is 2 mg/kg/min (0.02 mL/kg/min). If the infusion is well tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/min (0.08 mL/kg/min). For patients judged to be at risk for renal dysfunction or thrombosis, administer GAMMAKED at the minimum infusion rate practicable. (see Warnings and Precautions [5.2, 5.4])
2.5 Administration
Administer intravenously for PI, ITP and CIDP.
GAMMAKED may also be administered subcutaneously for the treatment of PI.
Administer GAMMAKED at room temperature. Inspect GAMMAKED visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Do not use if turbid and/or if discoloration is observed.Intravenous
Use only 18 gauge needles to penetrate the stopper for dispensing product from the 10 mL vial. Use 16 gauge needles or dispensing pins only with 25 mL vial sizes and larger. Insert needles or dispensing pins only once and be within the stopper area delineated by the raised ring. Penetrate the stopper perpendicular to the plane of the stopper within the ring. GAMMAKED™ vial size Gauge of needle to penetrate stopper 10 mL 18 gauge 25, 50, 100, 200 mL 16 gauge Use promptly any vial that has been opened. Discard partially used vials. If dilution is required, GAMMAKED may be diluted with 5% dextrose in water (D5/W). Do not dilute with saline. Infuse GAMMAKED using a separate line by itself, without mixing with other intravenous fluids or medications the subject might be receiving. The GAMMAKED infusion line can be flushed with 5% dextrose in water (D5/W) or 0.9% sodium chloride for injection.Subcutaneous for PI Only
Instructions for Administration
Prior to use, allow the solution to reach ambient room temperature. DO NOT SHAKE. Do not use if the solution is cloudy or has particulates. Check the product expiration date on the vial. Do not use beyond the expiration date. Use aseptic technique when preparing and administering GAMMAKED for injection. Remove the protective cap from the vial to expose the central portion of the rubber stopper. Wipe the rubber stopper with alcohol and allow to dry. Using a sterile syringe and needle, prepare to withdraw GAMMAKED by first injecting air into the vial that is equivalent to the amount of GAMMAKED to be withdrawn. Then withdraw the desired volume of GAMMAKED. If multiple vials are required to achieve the desired dose, repeat this step. (Figure 1) Follow the manufacturer’s instructions for filling the pump reservoir and preparing the pump, administration tubing and Y-site connection tubing, if needed. Be sure to prime the administration tubing to ensure that no air is left in the tubing or needle by filling the tubing/needle with GAMMAKED. Select the number and location of injection sites. (Figure 2) Cleanse the injection site(s) with antiseptic solution using a circular motion working from the center of the site and moving to the outside. Sites should be clean, dry, and at least two inches apart. (Figure 3) Grasp the skin between two fingers and insert the needle into the subcutaneous tissue. (Figure 4) Repeat priming and needle insertion steps using a new needle, administration tubing and a new infusion site. Secure the needle in place by applying sterile gauze or transparent dressing over the site. (Figure 5) If using multiple, simultaneous injection sites, use Y-site connection tubing and secure to the administration tubing. Infuse GAMMAKED following the manufacturer’s instructions for the pump. (Figure 6)Rate of Administration
Intravenous
Following initial infusion (see table below), the infusion rate may be gradually increased to a maximum of 0.08 mL/kg per minute (8 mg/kg per minute) as tolerated.
Indication Initial Infusion Rate(first 30 minutes) Maximum Infusion Rate(if tolerated) PI 1 mg/kg/min 8 mg/kg/min ITP 1 mg/kg/min 8 mg/kg/min CIDP 2 mg/kg/min 8 mg/kg/minMonitor patient vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
Certain severe adverse drug reactions may be related to the rate of infusion. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.
Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients at risk of renal dysfunction or thrombosis, administer GAMMAKED at the minimum infusion rate practicable and discontinue GAMMAKED if renal function deteriorates.
Subcutaneous for PI Only
For PI, it is recommended that GAMMAKED is infused at a rate of 20 mL/hr per infusion site.
In the SC clinical study, the mean volume administered per infusion site was 34 mL (17–69 mL) and the majority of infusions were administered at a rate of 20 mL/hr per site. Multiple simultaneous infusion sites were enabled by administration tubing and Y-site connection tubing. Most subjects utilized 4 infusion sites per infusion with abdomen and thighs being the most commonly used sites. The maximum number of infusion sites is 8. Injection sites should be at least 2 inches apart.
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