"The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.
Overall Adverse Reaction Profile
From the accumulated clinical development experience, expected adverse reactions after administration of Voluven® (hydroxyethyl starch in sodium chloride injection) occurring in less than 10% of patients are as follows:
Immune system disorders (Rare, > 0.01% to < 0.1%): Products containing hydroxyethyl starch may lead to anaphylactoid reactions (hypersensitivity, mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema). In the event of an intolerance reaction, the infusion should be discontinued immediately and the appropriate emergency medical treatment initiated. [see General WARNINGS and PRECAUTIONS]Skin and subcutaneous tissue disorders (Common, > 1 to < 10%, dose dependent): Prolonged administration of high dosages of hydroxyethyl starch may cause pruritus (itching) which is an undesirable effect observed with all hydroxyethyl starches.
Investigations (Common, > 1% to < 10%, dose dependent): The concentration of serum amylase can rise during administration of hydroxyethyl starch and can confound the diagnosis of pancreatitis. At high doses the dilutional effects may result in decreased levels of coagulation factors and other plasma proteins and in a decrease of hematocrit. [see Interference with Laboratory Tests]
Adverse Reactions in Clinical Trials
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug may not reflect the rates observed in practice.
During clinical development, 471 patients were exposed to Voluven® (hydroxyethyl starch in sodium chloride injection) , and a total of 768 patients received the hydroxyethyl starch 130/0.4 drug substance contained in Voluven® (hydroxyethyl starch in sodium chloride injection) at different concentrations (2%, 4%, 6%, or 10%) and at cumulative doses of several mL up to 66 L1). The mean duration of treatment with hydroxyethyl starch 130/0.4 was 3.9 ± 3.3 days, mean cumulative doses were 3338 ± 3695 mL, and the longest follow-up period was 90 days.
In the US trial, 100 patients undergoing elective orthopedic surgery were treated either with Voluven® (hydroxyethyl starch in sodium chloride injection) (N=49) or hetastarch (6% hydroxyethyl starch in 0.9% sodium chloride injection) (N=51) for intraoperative volume replacement. Mean infusion volumes were 1613 ± 778 mL for Voluven® (hydroxyethyl starch in sodium chloride injection) and 1584 ± 958 mL for hetastarch.
Adverse reactions observed in at least 1% of patients: In the US trial comparing Voluven® (hydroxyethyl starch in sodium chloride injection) with hetastarch, a possible relationship to Voluven® (hydroxyethyl starch in sodium chloride injection) was reported in five cases in a total of three patients (aPTT elevated, PT prolonged, wound hemorrhage, anemia, pruritus). A possible relationship to hetastarch was reported in five patients (three cases of coagulopathy; two cases of pruritus). The three coagulopathy cases in the hetastarch group were serious and occurred in patients receiving more than the labeled ceiling dose (20 mL/kg), whereas no serious coagulopathy occurred in the Voluven® (hydroxyethyl starch in sodium chloride injection) group.
The following adverse reactions have been identified during post-approval use of Voluven® (hydroxyethyl starch in sodium chloride injection) and other types of hydroxyethyl starch solutions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The safety profile from postmarketing experience of Voluven® (hydroxyethyl starch in sodium chloride injection) is not different from the profile obtained from clinical trials performed using the product.
Based on spontaneous reporting of hypersensitivity reactions, urticaria, bronchospasm, or hypotension were the most frequently reported serious adverse drug reactions for patients treated with Voluven® (hydroxyethyl starch in sodium chloride injection) .
With the administration of hydroxyethyl starch solutions, disturbances of blood coagulation can occur depending on the dosage2).
Read the Voluven (hydroxyethyl starch in sodium chloride injection) Side Effects Center for a complete guide to possible side effects
No interactions with other drugs or nutritional products are known.
The safety and compatibility of other additives have not been established [see Directions for Use of Voluven (hydroxyethyl starch in sodium chloride injection) ®].
1) Neff TA, Doelberg M, Jungheinrich C, et al. Repetitive large-dose infusion of the novel hydroxyethyl starch HES 130/0.4 in patients with severe head injury. Anest Analg 2003; 96 (5): 1453-9
2) Kozek-Langenecker S. Effects of hydroxyethyl starch solutions on hemostasis. Anesthesiology 2005; 103 (3): 654-60This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/1/2008
Additional Voluven Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.