Voluven Tetrastarch (Hydroxyethyl starch 130/0.4)

Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is a plasma expander. It is used in the management of hypovolemia and hypotension (due to volume loss).

Tetrastarch Uses:

Used in treatment and prevention of hypovolemia, acts as a blood volume expander

Voluven Dose in Adults

Voluven Dose in the treatment of Plasma volume expansion:

Intravenous infusion:
- May administer up to 50 mL/kg/day (or up to 3500 milli litre per day in a 70 kilogram patient);
- Administer repetitively over several days.

Note:

Administer crystalloid first, when severe dehydration present.
Daily dose and rate of infusion depend on the amount of blood lost, on maintenance or restoration of hemodynamics, and on the amount of hemodilution.
Titration should be done according to individual colloid needs, hemodynamics, and hydration status.
Not to be used in the critically ill including patients with sepsis, those with preexisting renal dysfunction or receiving dialysis, those with preexisting bleeding disorders, or those with ICB (intracranial bleeding).

Voluven Dose in Childrens

Note:

Administer crystalloid first, when severe dehydration present.
Daily dose and rate of infusion depend on the amount of blood lost, on maintenance or restoration of hemodynamics, and on the amount of hemodilution.
Titration should be done according to individual colloid needs, hemodynamics, and hydration status.
Not to be used in the critically ill including patients with sepsis, those with preexisting renal dysfunction or receiving dialysis, those undergoing open-heart surgery with cardiopulmonary bypass, those with preexisting bleeding disorders, or those with ICB (intracranial bleeding).
Critical Care Medicine societies (ACCM, SCCM) recommend against the use of hydroxyethyl starch (HES) solutions for fluid resuscitation in case of severe sepsis and septic shock in neonatal and pediatric patients.

Voluven (Tetrastarch) Dose in Volume expansion:

Infants and Children <2 years:
- Intravenous infusion:
  - Usual range: 7 to 25 mL/kg/dose
  - Mean reported dose: 16 ± 9 mL/kg/dose
  - Maximum daily dose: 50 mL/kg/day;

In clinical trials of intraoperative use, a dose of 10 mL/kg/dose has been reported.

Children 2 to 12 years:
- Intravenous infusion:
  - Usual range: 25 to 47 mL/kg/dose
  - Mean reported dose: 36 ± 11 mL/kg/dose
  - Maximum daily dose: 50 mL/kg/day

In clinical trials of intraoperative use, a dose of 10 mL/kg/dose has been reported.

Adolescents:
- Intravenous Infusion:
  - Administer up to 50 mL/kg/day (or up to 3,500 mL daily in a 70 kg patient)
  - May administer repetitively over several days.

Pregnancy Risk Factor C

Negative events in animal reproduction have been documented

Use of Tetrastarch during breastfeeding

It is unknown if tetrastarch is found in breast milk.
Tetrastarch should not be administered to nursing mothers, according to the manufacturer.

Voluven Dose in Kidney Disease:

In patients with preexisting renal dysfunction use should be avoided.
It is contraindicated in oliguric/anuric renal failure unrelated to hypovolemia or patients on regular dialysis. At the first sign of renal injury use should be discontinued.

Voluven Dose in Liver disease:

No dosage adjustment provided in manufacturer’s labeling; contraindicated in severe liver disease.

Side Effects of Tetrastarch (Voluven):

Dermatologic:
- Pruritus
- Skin rash
Gastrointestinal:
- Increased serum amylase
Hematologic & Oncologic:
- Anemia
- Coagulation Time Increased
- Decreased Clotting Factors
- Decreased Hematocrit
- Prolonged Prothrombin Time
- Wound Hemorrhage

Contraindications to Tetrastarch (Voluven):

Hypersensitivity to HES and any component of the formulation
Adult patients who are critically ill, such as patients with sepsis and patients at higher risk for death, should be treated with renal replacement therapy.
Hypovolemia is not related to renal failure.
Dialysis
Any fluid overload condition (eg pulmonary edema or congestive heart failure).
Hypernatremia severe
Severe hyperchloremia
Patients suffering from intracranial bleeding
Grave liver disease
Preexisting coagulation
Bleeding disorders.

Only Volulyte: Severe hyperkalemia.

Warnings and precautions

Anaphylactoid reactions
- Solutions containing HES have been reported to cause mild anaphylactoid reactions, including bradycardia-like symptoms, bronchospasm and noncardiacpulmonary edema.
- If you notice signs of hypersensitivity, stop using the product immediately and seek appropriate treatment.
Bleeding
- Patients undergoing open-heart surgery should monitor their coagulation status.
- Patients with excessive bleeding have had HES treatments.
- Stop using it immediately if you feel that there is a coagulopathy.
- Patients with bleeding disorders or coagulation problems are not advised to use this product.
Fluid overload:
- Fluid overload: Patients at high risk (eg, young patients, elderly) should be used with caution
- Contraindicated for heart failure and any other preexisting condition where volume overload may be a concern
- Patients with pre-existing cardiac dysfunction may require dose adjustment.
- Preexisting renal dysfunction should be avoided
Hemodilution
- Hemodialysis can lead to a decrease in HCT, coagulation and other plasma proteins in large volumes.
- The ability to coagulate may become impaired, e.g. prolonged PT, PTT and clotting time, and temporary prolongation of bleeding may occur.
Hepatic effects
- It is important to monitor the liver function at baseline and regularly during treatment.
Hepatic impairment
- Patients with hepatic impairment should be cautious.
- Monitor LFTs during treatment and at baseline.
- Patients with severe liver disease should not use this medication. It may reduce coagulation factors and increase the chance of bleeding.
Renal impairment
- Patients with preexisting renal impairment should avoid fluid intake. Fluid status, including urine output, should be closely monitored.
- Stop using the drug immediately you feel any signs of kidney injury.
- Patients with hypovolemia, oliguria, or patients on hemodialysis are not advised to use this product.

Tetrastarch (Hydroxyethyl starch 130/0.4; Voluven): Drug Interaction

Risk Factor X (Avoid combination)
Arbekacin	Tetrastarch may enhance the nephrotoxic effect of Arbekacin.

Monitoring parameters:

Blood pressure
heart rate
capillary refill time
CVP
RAP, MAP
If pulmonary artery catheter in place, monitor cardiac index, PCWP, SVR, and PVR
Hb
Coagulation profile
RFTs (continue to monitor for at least 90 days after administration)
LFTs
Urine output
Acid-base balance

How to administer Tetrastarch (voluven)?

Intravenous:

Administer IV only; may be administered via pressure infusion or infusion pump.
Infuse the initial 10-20 mL slowly and concomitantly observe for a possible anaphylactoid reaction; have epinephrine and resuscitative equipment available.
In the case of administration via pressure infusion, air should be withdrawn or expelled from the bag prior to infusion to prevent air embolus.
Do not use if crystalline precipitate forms or is a turbid deep brown.
Change IV tubing at least q 24 hrs.