- Resource Centers
Eisai Inc (Woodcliff Lake, NJ) recently received FDA approval for a new indication for Fragmin. The new indication is for the extended treatment of symptomatic venous thromboembolism (VTE; proximal deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) to reduce the recurrence of VTE in patients with cancer. Patients with cancer have an increased risk of VTE, compared with those without cancer and thus VTE is a frequent medical complication for patients with cancer. Additionally, patients with cancer may be immobilized, predisposing them to this condition. Fragmin also is indicated for the prevention of DVT, which may lead to PE, in patients undergoing hip replacement surgery, in at-risk patients undergoing abdominal surgery, and in at-risk acutely ill patients whose mobility is severely restricted. In addition, Fragmin is approved for the prophylaxis of ischemic complications resulting from unstable angina and non?Q-wave myocardial infarction, when concurrently administered with aspirin therapy. The product is administered by subcutaneous injection. It must not be administered by intramuscular injection. For more information, visit www.fragmin.com, or call 800-272-8804.
(Human), 10% Liquid]
CSL Behring (King of Prussia, Pa) recently received FDA approval to market Privigen, an intravenous immunoglobulin (IVIg) for treating patients diagnosed with primary immunodeficiency. Privigen also is indicated for the treatment of chronic immune thrombocytopenic purpura to rapidly raise platelet counts to prevent bleeding. A 10% liquid preparation of polyvalent human immunoglobulin, Privigen offers health care professionals convenience and ease of use. The product is the first and only proline-stabilized IVIg that is always ready for immediate use, requiring no refrigeration or reconstitution. For additional information, visit www.CSLBehring.com.
Supprelin LA (histrelin
Indevus Pharmaceuticals Inc (Lexington, Mass) recently announced the availability of Supprelin LA subcutaneous implant, 50 mg, for the treatment of children with central precocious puberty (CCP). Children with CCP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in girls and 9 years of age in boys). These children also show a significantly advanced bone age that can result in diminished height attainment. The recommended dose of Supprelin LA is 1 implant every 12 months. Each implant contains 50 mg of histrelin acetate. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of histrelin acetate (65 ?g per day) for 12 months of hormonal therapy. At the time an implant is removed, another implant may be inserted to continue therapy. For more information, visit www.supprelinla.com, or call 888-282- 5372.
King Pharmaceuticals Inc (Bristol, Tenn) recently introduced Thrombi-Pad (3x3 Hemostatic Pad). Each Thrombi- Pad is a lyophilized pad containing thrombin, sodium carboxylmethylcellulose, and calcium chloride in a nonwoven gauze. The product is applied topically and is indicated as a trauma dressing for temporary control of moderate- to-severe bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters and tubes. Thrombi- Pad offers health care professionals in the emergency room a new option to achieve active hemostasis at bleeding sites where they would typically use trauma dressing. The product is easily accessible and requires no special storage, preparation, or assembly. For additional information, visit www.thrombi-pad.com.
Caffeine Citrate Injection
Abraxis Pharmaceutical Products (Schaumburg, Ill) recently received FDA approval for its abbreviated new drug application for Caffeine Citrate Injection, USP, 20 mg/mL. The product is the generic equivalent of Cafcit Injection (Mead Johnson and Co). Caffeine Citrate Injection is indicated for the short-term treatment of apnea of prematurity (AOP) in infants between 28 and <33 weeks gestational age. AOP is a condition in which cessation of breathing in preterm infants can cause dangerously low levels of blood oxygen. The product is available in 60-mg/3-mL single-use vials. For more information, visit www.appdrugs.com, or call 800-551-7176.
Wyeth Pharmaceuticals (Collegeville, Pa), a division of Wyeth, recently received FDA approval for Torisel. The product is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. Torisel is the first targeted renal cancer therapy proven to extend median overall survival versus interferon-alpha, an active comparator, in this patient population. The recommended dose of Torisel is 25 mg infused over a 30- to 60-minute period once a week. Treatment should continue until disease progression or unacceptable toxicity occurs. The product is supplied as a kit consisting of Torisel injection 25 mg/mL. The Torisel vial includes an overfill of 0.2 mL. The kit also contains diluent for Torisel. The diluent vial includes a deliverable volume of 1.8 mL. For more information, visit www.wyeth.com.