Albumin human

Albumin is injected into a vein through an IV. A healthcare provider will give you this injection.

Your breathing, pulse, blood pressure, electrolyte levels, kidney function, and other vital signs will be watched closely while you are receiving albumin. Your blood will also need to be tested regularly during treatment.

Drink plenty of liquids while you are being treated with albumin.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Because you will receive albumin in a clinical setting, you are not likely to miss a dose.

Albumin is a protein produced by the liver that circulates in plasma (the clear liquid portion of your blood). Medicinal albumin is made of plasma proteins from human blood. This medicine works by increasing plasma volume or levels of albumin in the blood.

Albumin is used to replace blood volume loss resulting from trauma such as a severe burns or an injury that causes blood loss. This medicine is also used to treat low albumin levels caused by surgery, dialysis, abdominal infections, liver failure, pancreatitis, respiratory distress, bypass surgery, ovarian problems caused by fertility drugs, and other many other conditions.

Albumin may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Peritonitis:

Albumin 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional albumin within 15 to 30 minutes if the response is inadequate.

Albumin 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of albumin 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of albumin 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Adult Dose for Shock:

Albumin 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional albumin within 15 to 30 minutes if the response is inadequate.

Albumin 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of albumin 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of albumin 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Adult Dose for Pancreatitis:

Albumin 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional albumin within 15 to 30 minutes if the response is inadequate.

Albumin 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of albumin 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of albumin 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Adult Dose for Burns - External:

Albumin 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional albumin within 15 to 30 minutes if the response is inadequate.

Albumin 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of albumin 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of albumin 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Adult Dose for Hypoproteinemia:

Albumin 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional albumin within 15 to 30 minutes if the response is inadequate.

Albumin 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of albumin 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of albumin 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Adult Dose for Postoperative Albumin Loss:

Albumin 5%:

Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional albumin within 15 to 30 minutes if the response is inadequate.

Albumin 25%:

Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of albumin 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of albumin 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.

Usual Pediatric Dose for Peritonitis:

Albumin 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

Usual Pediatric Dose for Shock:

Albumin 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

Usual Pediatric Dose for Pancreatitis:

Albumin 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

Usual Pediatric Dose for Burns - External:

Albumin 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

Usual Pediatric Dose for Hypoproteinemia:

Albumin 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

Usual Pediatric Dose for Postoperative Albumin Loss:

Albumin 5%:

Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.

No drug interaction studies have been conducted.

No non-clinical toxicology studies with Albumin (Human) 20% have been conducted. Human Albumin is a normal constituent of human plasma and acts like physiological albumin.

A protein colloid; a sterile solution of serum albumin prepared by fractionating pooled plasma from healthy human donors.133 139 204 205 206 207 208 210 211 212 213 214 215 254 255 256

Administration

Administer by IV infusion.204 205 206 207 208 210 211 212 213 214 215 254 255 256

Concentration administered depends on fluid and protein requirements of the patient.21 204 205 208 210 213 215

Albumin human 5% solution: Generally preferred for treatment of acute blood volume deficits in the absence of adequate or excessive hydration.204 205 208 213 215

Albumin human 20 or 25% solutions: May be preferred in patients with oncotic deficits or in those with long standing hypovolemia and hypoalbuminemia that exists in the presence of adequate or excessive hydration.204 205 208 210 215 Also recommended when albumin human is used for its binding rather than oncotic properties (e.g., treatment of neonatal hyperbilirubinemia).204 205 206 208 211 212 214 215

When used for treatment of hypovolemia, most effective in well-hydrated patients.208 215 254 255 256 If patient is dehydrated, albumin human 5% solution usually preferred;204 205 208 213 215 if albumin human 20 or 25% solution used in dehydrated patients, administer additional crystalloids or fluids.204 205 206 207 208 214 215

Use immediately after vial or container is opened;254 255 256 discard if >4 hours have elapsed since container was first entered.204 205 206 207 208 210 211 212 213 214 215

Consult manufacturers' prescribing information for specific directions regarding use of IV administration sets and filters.204 205 206 207 208 210 211 212 213 214 215 254 255 256 Some manufacturers state that adequate filtration is required;206 208 210 212 215 others state that filtration is not required.254 255 256

IV Infusion

Depending on indication, protein and fluid requirements, sodium restrictions, and availability, commercially available albumin human solutions can be administered undiluted or can be further diluted in a compatible IV solution (e.g., 0.9% sodium chloride, 5% dextrose).37 124 125 126 127 128 129 130 131 132 133 134 135 136 137 184 204 205 206 207 208 214 215 For solution and drug compatibility information, see Compatibility under Stability.

Whenever dilution of albumin human is necessary, the oncotic and osmotic properties as well as the tonicity of the resultant dilution must be considered.37 124 125 126 127 128 129 130 131 132 133 134 135 136 137 184

Substantially hypotonic solutions when admixed with erythrocytes result in hemolysis.131 132 Such hemolysis occurs when erythrocytes are admixed in vitro with albumin human solutions containing less than 90 mEq of sodium per L;37 127 the sodium concentration not the suspending medium (albumin) or cell concentration determines the hemolytic risk.37 131 132

Because of risk of potentially life-threatening hemolysis and acute renal failure, do not dilute albumin human with sterile water since tonicity can be reduced substantially by such dilution.125 127 128 129 130 133 134 135 136 137 138 184 204 205 206 207 208 210 214 215 254 255 256 (See Oncotic, Osmotic, and Tonicity Considerations under Cautions.)

If necessary, albumin human 5% solutions may be prepared from albumin human 25% solutions by adding 1 volume of the 25% solution to 4 volumes of 0.9% sodium chloride or 5% dextrose.208 Since albumin human 25% solution diluted with 0.9% sodium chloride or 5% dextrose results in 5% dilutions that are approximately isotonic and iso-oncotic with citrated plasma, these diluents are preferred for such dilutions.133 136 137

Do not use dilutions with substantially reduced tonicity as replacement fluids in plasmapheresis procedures or other situations where administration of large volumes and resultant replacement of a significant fraction of blood volume could result.125 126 127 128 129 130 133 136 137 138 184

When sodium restriction is necessary, administer albumin human solutions either undiluted or diluted in sodium-free carbohydrate solution such as 5% dextrose.133 184 204 205 However, because administration of large volumes of albumin human 5% prepared by diluting 25% solutions with 5% dextrose could result in hyponatremia and potentially serious adverse effects (e.g., cerebral swelling),136 137 0.9% sodium chloride is the preferred diluent when administration, particularly rapid administration, of large volumes is anticipated (e.g., during plasmapheresis or plasma exchange) and the fluid and electrolyte status of the patient permits.136 137 184

Alternatively, more physiologic diluents (e.g., those closely resembling plasma) can be used to dilute albumin human for use in plasmapheresis or plasma exchange.136

Individualize rate of IV infusion based on indication, concentration of albumin human solution used, and patient's clinical status and response.204 205 206 207 208 210 211 212 213 214 215 254 255 256 Consult manufacturers’ prescribing information for specific recommendations.204 205 206 207 208 210 211 212 213 214 215 254 255 256

Albumin human 5% solution: When used for treatment of hypovolemic shock in patients with greatly reduced blood volume, a rapid rate of administration may be necessary initially to provide clinical improvement and restore normal blood volume.210 211 212 However, in patients with a history of cardiac or vascular disease, some manufacturers suggest a slow infusion rate (e.g., 5–10 mL/minute) to avoid too rapid a BP increase.210 In patients with normal or slightly low blood volume, some manufacturers suggest an infusion rate of 1–2 mL/minute.211 212

Albumin human 20 or 25% solutions: When used for treatment of hypovolemic shock in patients with greatly reduced blood volume, a rapid rate of administration may be necessary initially to provide clinical improvement and restore normal blood volume.206 However, in patients with normal or slightly low blood volume, some manufacturers state that the IV infusion rate should not exceed 1 mL/minute since more rapid infusion rates may result in circulatory overload or pulmonary edema.206 207 208 215 Slower rate also is recommended in patients with hypertension.207 When albumin human 20 or 25% solution is used in hypoproteinemic patients with approximately normal blood volume, a maximum rate of 2 mL/minute (Plasbumin-20, Plasbumin-25)204 205 or 2–3 mL/minute (Albuminar-25) has been recommended.207

Pediatric patients: Some manufacturers recommend that rate of administration be reduced to 25% of the usual adult rate.206 212

Dosage

Dosage is variable; individualize based on specific indication, concentration of albumin human solution used, and patient's clinical status and response.204 205 206 207 208 210 211 212 213 214 215 254 255 256 Consult manufacturers' prescribing information for specific dosage recommendations.204 205 206 207 208 210 211 212 213 214 215

Predetermined formulas for dosage calculation generally are avoided since they assume that the same dose is appropriate for all patients.187

In the absence of acute hemorrhage, total daily albumin dosage should not exceed the theoretical amount present in total normal plasma volume (i.e., 2 g/kg body weight).21 204 205 208 210 214 215 254 255 256

To assess response to therapy, monitor hemodynamic response (e.g., BP), degree of pulmonary congestion, and hematocrit.207 211 214 Measurement of serum protein usually not necessary, but may be useful to guide dosage selection in some cases of hypoproteinemia.214

Pediatric Patients

Some manufacturers suggest 25–50% of the usual adult dose, depending on child's weight and clinical condition.206 212

For specific dosage recommendations, consult manufacturers' prescribing information.206 208 210 211 212 213 215

0.5–1 g/kg is recommended by some clinicians.311

Albumin human 5% solution: Some manufacturers recommend initial dose of 0.5–1 g/kg 213 254 254 or 2.5–12.5 g.254 Dose may be repeated after 15–30 minutes if response is inadequate.210 254

Albumin human 20% solution: One manufacturer recommends initial dose of 0.5–1 g/kg or 2.5–12.5 g.255 Dose may be repeated after 15–30 minutes if response is inadequate.255

Albumin human 25% solution: Some manufacturers recommend initial dose of 0.5–1 g/kg256 or 2.5–12.5 g.256 Dose may be repeated after 15–30 minutes if response is inadequate.208 215 255 256

0.5–1 g/kg given over 0.5–2 hours and repeated once every 1–2 days as needed is recommended by some clinicians.311

Albumin human 20 or 25% solution: 25 g daily recommended by one manufacturer; larger amounts may be required in those with severe hypoproteinemia who continue to lose albumin.204 205

Albumin human 20 or 25% solutions: 1 g/kg as an adjunct to exchange transfusions.204 205 206 208 214 215 255 256

Has been given prior to exchange transfusion (as a primer) or during the procedure (as a substitute for a portion of the blood).187 204 205 208 214 215 255 256 (See Neonatal Hyperbilirubinemia under Uses.)

Adults

For hypovolemic shock, some manufacturers recommend the following initial dose.206 208 210 211 212 215 254 255 256 Dose may repeated after 15–30 minutes if response is inadequate.206 208 210 211 212 215 254 255 256

Albumin human 5% solution: 12.5–25 g (250–500 mL of a 5% solution).210 211 212 254

Albumin human 20% solution: 25 g (125 mL of a 20% solution).255

Albumin human 25% solution: 25–50 g (100–200 mL of a 25% solution).206 208 215 256

Optimum regimen of crystalloids, colloids, electrolytes, and fluid not clearly established.204 205 207 208 211 213 214 215 218 302 305 306 307 309 Duration of replacement therapy varies, depending on such factors as extent of protein loss from renal excretion, denuded skin areas, and decreased albumin production.204 205 207 213 214

A suggested goal is to maintain plasma albumin concentration of 2–3 g/dL and plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g/dL).204 205 213 214

One manufacturer recommends use of large volumes of crystalloids initially to maintain plasma volume; after 24 hours, albumin human may be added.254 255 256 Initially, 25 g; adjust dosage thereafter to maintain a plasma protein concentration of 2.5 g/dL or serum protein concentration of 5.2 g/dL.254 255 256

Albumin human 20 or 25% solutions: 20–25 g once daily for 7–10 days recommended by some manufacturers (in conjunction with an appropriate diuretic).204 205 214 255 256

Albumin human 20 or 25% solutions: If used for treatment of volume or oncotic deficit in patients undergoing long-term dialysis or for treatment of shock or hypotension in these patients, some manufacturers state that usual dose is about 100 mL204 205 (initial dose should not be >100 mL).214 Carefully monitor for signs of circulatory overload.204 205 212 214

Usually 6–8 g of albumin for each liter of ascitic fluid removed.187 236 254 255 256 286

A single paracentesis involving removal of ≤4–5 L of fluid usually can be performed safely without colloid support; use of albumin human may be considered when larger volumes (>5 L) are removed.187 236 261 264 286 287

Optimum regimens not identified.226 236 243 244 264 286 287 288 289 290 291 292 293 294

Some experts recommend 1 g/kg (up to 100 g) on day 1, followed by 20–40 g once daily.289 293 294 If a response is obtained, continue until S cr <1.5 mg/dL.294 May discontinue if serum albumin >4.5 g/dL; discontinue if pulmonary edema is present.289

Optimum regimens not identified (see Spontaneous Bacterial Peritonitis under Uses).236 267 268 269 286 289 293

AASLD recommends that adults with ascitic PMN counts ≥250 cells/mm3 and clinical suspicion of spontaneous bacterial peritonitis who also have S cr >1 mg/dL, BUN >30 mg/dL, or total bilirubin concentration >4 mg/dL receive 1.5 g/kg of albumin human within 6 hours of detection and 1 g/kg on day 3.236

Albumin human 5% solution: 50–75 g recommended by one manufacturer.254

Albumin human 20 or 25% solutions: 50–75 g daily (e.g., 250–375 mL of a 20% solution or 200–300 mL of a 25% solution) is recommended by some manufacturers;204 205 207 255 256 larger amounts may be required in those with severe hypoproteinemia who continue to lose albumin.204 205 Some manufacturers recommend a maximum dosage of 2 g/kg daily.208 210

Consider total body albumin deficit (including hidden extravascular albumin deficiency) when determining dosage necessary to reverse hypoalbuminemia.208 210 215 255 256 When using serum albumin concentrations to estimate protein deficit, calculate body albumin compartment based on 80–100 mL/kg to account for any hidden extravascular albumin deficits.208 210 215

Albumin human 20 or 25% solutions: One manufacturer recommends 50–100 g given by IV infusion over 4 hours every 4–12 hours as necessary.255 256

Albumin human 20 or 25% solutions: For management of fluid overload in conjunction with a diuretic (see Acute Respiratory Distress Syndrome and Acute Lung Injury under Uses), one manufacturer recommends 25 g given by IV infusion over 30 minutes and repeated at 8-hour intervals for 3 days, if necessary.255 256

Optimum fluid regimen to ensure adequate blood volume during cardiopulmonary bypass unclear.206 214 (See Cardiac Surgery under Uses.)

Some manufacturers suggest that albumin human and crystalloid pump prime solution be adjusted to achieve plasma albumin concentration of 2.5 g/dL and hematocrit of 20%.204 205 213 214

Albumin human 20 or 25% solutions: If used to resuspend RBCs during certain types of exchange transfusion or to resuspend large volumes of previously frozen or washed RBCs, some manufacturers recommend adding approximately 20–25 g of albumin per liter of isotonic suspended RBCs immediately prior to transfusion;204 205 214 greater amounts may be required in patients with preexisting hepatic impairment or hypoproteinemia.204 205

Prescribing Limits

Pediatric Patients

Hypovolemia or hypoproteinemia: maximum 2 g/kg daily recommended by some manufacturers.254 255 256

Maximum 6 g/kg in 24 hours or 250 g in 48 hours recommended by some clinicians.311

Adults

Maximum 2 g/kg daily recommended by some manufacturers.254 255 256

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Applies to albumin human: intravenous solution

Dermatologic

Dermatologic side effects have included urticaria, skin rash, pruritus, edema, and erythema.[Ref]

Nervous system

Nervous system side effects have included headache, chills, and febrile reactions.[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting and increased salivation.[Ref]

Respiratory

Respiratory side effects have included bronchospasm.[Ref]

Some side effects of albumin human may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Plasbumin-25 should always be administered by intravenous infusion. Plasbumin-25 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Plasbumin-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 Plasbumin-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 Plasbumin-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 Plasbumin-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.