Albumin (Human)

What is Albumin (Human)?

• Albumin (Human) (Albuminar; Albunex; Albutein) is a sterile, liquid preparation of albumin derived from large pools of human plasma used for the restoration and maintenance of circulating blood volume.

ALB structure

What are the uses of this medicine?

Albumin (Human) (Albuminar; Albunex; Albutein) isused for the restoration and maintenance of circulating blood volume for:

• Hypovolemia.
• Hypoalbuminemia.
• Prevention of central volume depletion after paracentesis due to cirrhotic ascites.
• Ovarian hyperstimulation syndrome (OHSS).
• Adult respiratory distress syndrome (ARDS).
• Acute nephrosis.
• Hemolytic disease of the newborn (HDN).

How does this medicine work?

Albumin is responsible for 75-80% of the colloid osmotic pressure of normal plasma. Albumin stabilizes circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins. When injected intravenously, 50 mL of 25% albumin draws approximately 175 mL of additional fluid into the circulation within 15 minutes, except in the presence of marked dehydration. This extra fluid reduces hemoconcentration and blood viscosity.

• The degree of volume expansion is dependent on the initial blood volume.
• When the circulating blood volume has been depleted, the hemodilution following albumin administration persists for many hours.
• In individuals with normal blood volume, it usually lasts only a few hours.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who are hypersensitive to albumin preparations, any ingredient in the formulation, or components of the container.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• No drug interaction studies have been conducted.

Is this medicine FDA approved?

• Initial U.S. Approval: 2006

How should this medicine be used?

Recommended dosage:

• Daily dose should not exceed 2 g per kg body weight.

Hypovolemia:

• Adults: 25 g
• Children (less than 13 years):2.5 to 1.25 g to children

Hypoalbuminemia:

• Adults: 50 to 75 g

Prevention of volume depletion after paracentesis:

• Adults: 8 g for every 1,000 mL of ascitic fluid removed

Ovarian hyperstimulation syndrome:

• Adults: 50 to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary

Adult respiratory distress syndrome:

• Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary

Acute nephrosis:

• Adults: 25 g together with diuretic once a day for 7-10 days

Hemolytic Disease of the Newborn:

• 1 g per kilogram body weight prior or during exchange transfusion

Administration:

• For Intravenous use only.
• Do not dilute with sterile water for injection as this may cause hemolysis in recipients.
• Store protected from light.
• Do not freeze.
• If large volumes (greater than 1500 ml) are administered, warm the product to room temperature before use.
• Bottles are for single use only.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As ALBUMIN (HUMAN) 25% is supplied in
• 12.5 g in 50 mL infusion bottle
• 25 g in 100 mL infusion bottle

This medicine is available in fallowing brand namesː

• ALBUMINAR®-25
• Albuminar®-20
• Albutein
• Albunex

What side effects can this medication cause?

The most common side effects of this medicine include:

• anaphylactoid type 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

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

What special precautions should I follow?

• 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.
• Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. Use with caution in patients who are at risk of hypervolemia or hemodilution. Stop infusion if signs of cardiovascular overload occur.
• Electrolyte imbalances have been observed. Monitor electrolyte status.
• 20-25% Albumin (Human) is relatively low in electrolytes compared to the 4-5% Albumin (Human) solutions. When albumin is given, monitor the electrolyte status of the patient and take appropriate steps taken to restore or maintain the electrolyte balance.
• If comparatively large volumes are to be replaced, monitoring of coagulation and hematocrit is necessary. Ensure adequate substitution of other blood constituents. Monitor coagulation status and hematocrit.
• Do not dilute solution with sterile water for injection.
• This product is a derivative of human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
• Hypotension has been observed. Monitor hemodynamic performance.
• This product is usually given in a hospital setting.
• Discontinue immediately if allergic symptoms occur (e.g. skin rashes, hives, itching, breathing difficulties, coughing, nausea, vomiting, fall in blood pressure, increased heart rate).

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• It is also not known whether ALBUMIN (HUMAN) 25% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
• ALBUMIN (HUMAN) 25% should be given to a pregnant woman only if necessary.

Can this medicine be used in children?

• Data on the use of ALBUMIN (HUMAN) 25% in children including premature babies are very limited.
• The product should be administered to pediatric patients only if needed.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• ALBUMIN (HUMAN)

Inactives ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured by:

• Octapharma Pharmazeutika Produktionsges.m.b.H.
• Oberlaaer Strasse
• Vienna, Austria

Octapharma AB Elersvägen 40 Sweden

Distributed by:

• Octapharma USA Inc.
• 121 River Street, 12 th floor
• Hoboken, NJ

What should I know about storage and disposal of this medication?

• ALBUMIN (HUMAN) 25% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture.
• Store protected from light.
• Do not freeze.
• Do not use after expiration date.
• Do not use if turbid.

• Dailymed label info on Albumin (Human)
• FDA Albumin (Human)