Prescription Drug Information: Albumin (Human)

ALBUMIN (HUMAN)- albumin (human) solution
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.

1 INDICATIONS AND USAGE

1.1 Hypovolemia

ALBUMIN (HUMAN) 5% is indicated in the emergency treatment of hypovolemia with or without shock. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective in patients who are well hydrated. When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [1, 2]

ALBUMIN (HUMAN) 5% should be used when hydration is not adequate. When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% — 25% albumin solutions should be used. [ 1 ]

1.2 Hypoalbuminemia

For subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, ALBUMIN (HUMAN) 5% infusions may be indicated.[ 3 ] When albumin deficit is the result of excessive protein loss, the effect of administration of ALBUMIN (HUMAN) 5% will be temporary unless the underlying disorder is reversed.

1.3 Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites (Treatment Adjunct)

ALBUMIN (HUMAN) 5% may be used to maintain cardiovascular function following the removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites. [ 2 ]

2 DOSAGE AND ADMINISTRATION

2.1 Dosage

General Recommendations

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.

The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 5% per kg of body weight.

Hypovolemia

In adults, an intravenous infusion of 25 g of ALBUMIN (HUMAN) 5% should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

Hemodilution may follow administration of ALBUMIN (HUMAN) 5%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.

Hypoalbuminemia

In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 5% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.

In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 5% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites

In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 5% may be given for every 1,000 mL of ascitic fluid removed.

2.2 Administration

Intravenous use only.

Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.

Do not dilute with sterile water for injection.

Do not use solutions of ALBUMIN (HUMAN) 5% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 5% is not required.

The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.

If large volumes (greater than 1500 ml) are administered, the product should be warmed to room temperature before use.

3 DOSAGE FORMS AND STRENGTHS

ALBUMIN (HUMAN) 5% is supplied in

  • 5.0 g in 100 mL infusion bottle
  • 12.5 g in 250 mL infusion bottle
  • 25.0 g in 500 mL infusion bottle

4 CONTRAINDICATIONS

Do not use in individuals who are hypersensitive to albumin preparations, any ingredient in the formulation, or components of the container.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

Hypersensitivity or allergic reactions have been observed, and may in some cases progress to severe anaphylaxis. Epinephrine should be available immediately to treat any acute hypersensitivity reaction.

5.2 Hypervolemia/Hemodilution

Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. At the first clinical signs of possible cardiovascular overload, e.g., headache, dyspnea, increased blood pressure, jugular venous distention, elevated central venous pressure, pulmonary edema, the infusion should be stopped immediately and the patient reevaluated. Albumin should be used with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk for the patient. Examples of such conditions are:

  • Decompensated cardiac insufficiency
  • Hypertension
  • Esophageal varices
  • Pulmonary edema
  • Hemorrhagic diathesis
  • Severe anemia
  • Renal and post-renal anuria.

5.3 Electrolyte Imbalance

When albumin is given, monitor the electrolyte status of the patient and take appropriate steps to restore or maintain the electrolyte balance.

5.4 Coagulation Abnormalities

If comparatively large volumes are to be replaced, monitoring of coagulation and hematocrit is necessary. Ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).

5.5 Laboratory Monitoring

If ALBUMIN (HUMAN) 5% is to be administered, monitor hemodynamic performance regularly; this may include:

  • Arterial blood pressure and pulse rate
  • Central venous pressure
  • Pulmonary artery occlusion pressure
  • Urine output
  • Electrolytes
  • Hematocrit/hemoglobin.

5.6 Application Precautions

ALBUMIN (HUMAN) 5% must not be diluted with sterile water for injection as this may cause hemolysis in recipients.

5.7 Infection Risk from Human Plasma

This product is a derivative of human plasma. Based on effective donor screening and product manufacturing processes it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have been identified for ALBUMIN (HUMAN) 5%.

6 ADVERSE REACTIONS

6.1 General

The most serious events are anaphylactic shock, circulatory failure, cardiac failure, and pulmonary edema.

The most common adverse events are anaphylactoid type of reactions.

Adverse reactions for ALBUMIN (HUMAN) 5% normally resolve when the infusion rate is slowed down or the infusion is stopped. In case of severe reactions, the infusion should be stopped and appropriate treatment should be initiated.

6.2 Clinical Studies Experience

No clinical studies were done using ALBUMIN (HUMAN) 5%.

6.3 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ALBUMIN (HUMAN) (any strength). Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency.

Table 1 Adverse reactions observed for ALBUMIN HUMAN (any strength) during post-marketing phase (in decreasing order of severity)

Observed Adverse Reactions

anaphylactic shock

cardiac failure

loss of consciousness

circulatory failure

hypersensitivity

congestive heart failure

pulmonary edema

dyspnea

hypotension

hypertension

tachycardia

bradycardia

vomiting

urticaria

angioneurotic edema

rash erythematous

confusional state

headache

chills

pyrexia

flushing

nausea

pruritus

hyperhidrosis

7 DRUG INTERACTIONS

No drug interaction studies have been conducted.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C. Animal reproduction studies have not been performed with ALBUMIN (HUMAN) 5%. It is also not known whether ALBUMIN (HUMAN) 5% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. ALBUMIN (HUMAN) 5% should be given to a pregnant woman only if necessary.

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