"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Similar findings have been reported in other patients with acute intermittent porphyria, porphyria variegata and hereditary coproporphyria. PANHEMATIN is not indicated in porphyria cutanea tarda.
DOSAGE AND ADMINISTRATION
Before administering PANHEMATIN, an appropriate period of alternate therapy (i.e., 400 g glucose/day for 1 to 2 days) must be considered. If improvement is unsatisfactory for the treatment of acute attacks of porphyria, an intravenous infusion of PANHEMATIN containing a dose of 1 to 4 mg/kg/day of hematin should be given over a period of 10 to 15 minutes for 3 to 14 days based on the clinical signs. In more severe cases this dose may be repeated no earlier than every 12 hours. No more than 6 mg/kg of hematin should be given in any 24 hour period.
After reconstitution each mL of PANHEMATIN contains the equivalent of approximately 7 mg of hematin. The drug may be administered directly from the vial.
Dosage Calculation Table
1 mg hematin equivalent = 0.14 mL PANHEMATIN
2 mg hematin equivalent = 0.28 mL PANHEMATIN
3 mg hematin equivalent = 0.42 mL PANHEMATIN
4 mg hematin equivalent = 0.56 mL PANHEMATIN
Since reconstituted PANHEMATIN is not transparent, any undissolved particulate matter is difficult to see when inspected visually. Therefore, terminal filtration through a sterile 0.45 micron or smaller filter is recommended.
Preparation of Solution
Reconstitute PANHEMATIN by aseptically adding 43 mL of Sterile Water for Injection, USP, to the dispensing vial. Immediately after adding diluent, the product should be shaken well for a period of 2 to 3 minutes to aid dissolution. NOTE: Because PANHEMATIN contains no preservative and because PANHEMATIN undergoes rapid chemical decomposition in solution, it should not be reconstituted until immediately before use. After the first withdrawal from the vial, any solution remaining must be discarded.
No drug or chemical agent should be added to a PANHEMATIN fluid admixture unless its effect on the chemical and physical stability has first been determined.
PANHEMATIN is supplied as a sterile, lyophilized black powder in single dose dispensing vials (NDC 67386-701-54). When mixed as directed with Sterile Water for Injection, USP, each 43 mL provides the equivalent of approximately 301 mg hematin (7 mg/mL). Store lyophilized powder at 20-25°C (68-77°F). See USP controlled room temperature.
Caution: The packaging (vial stopper) of this product contains natural rubber latex which may cause allergic reactions.
Manufactured by: APP Pharmaceuticals, Raleigh, NC 27616, U.S.A. For: Lundbeck, Deerfield, IL 60015, U.S.A. Revised: November 2012
Last reviewed on RxList: 9/18/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Panhematin Information
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