Panhematin
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Questions & Answers
Side Effects & Adverse Reactions
PANHEMATIN is made from human blood. Products made from human blood may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening blood donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Recordati Rare Diseases, (1-888-575-8344). The physician should discuss the risks and benefits of this product with the patient.
Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
PANHEMATIN therapy is intended to limit the rate of porphyria/heme biosynthesis possibly by inhibiting the enzyme δ-aminolevulinic acid synthetase. For this reason, drugs such as estrogens, barbituric acid derivatives and steroid metabolites which increase the activity of δ-aminolevulinic acid synthetase should be avoided.
Also, because hemin for injection has exhibited transient, mild anticoagulant effects during clinical studies, concurrent anticoagulant therapy should be avoided.[9] The extent and duration of the hypocoagulable state induced by PANHEMATIN has not been established.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
PANHEMATIN (hemin for injection) is indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women.
Manifestations such as pain, hypertension, tachycardia, abnormal mental status and mild to progressive neurologic signs may be controlled in selected patients with this disorder.
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.
History
There is currently no drug history available for this drug.
Other Information
PANHEMATIN (hemin for injection) is an enzyme inhibitor derived from processed red blood cells. Hemin for injection was known previously as hematin. The term hematin has been used to describe the chemical reaction product of hemin and sodium carbonate solution. Hemin is an iron containing metalloporphyrin. Chemically hemin is represented as chloro [7,12-diethenyl-3,8,13,17-tetramethyl-21H,23H-porphine-2,18-dipropanoato(2-)-N21,N22,N23,N24] iron. The structural formula for hemin is:
PANHEMATIN is a sterile, lyophilized powder suitable for intravenous administration after reconstitution. Each dispensing vial of PANHEMATIN contains the equivalent of 313 mg hemin, 215 mg sodium carbonate and 300 mg of sorbitol. The pH may have been adjusted with hydrochloric acid; the product contains no preservatives. When mixed as directed with Sterile Water for Injection, USP, each 43 mL provides the equivalent of approximately 301 mg hematin (7 mg/mL).
Sources
Panhematin Manufacturers
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Recordati Rare Diseases, Inc.
![Panhematin (Hemin) Injection, Powder, Lyophilized, For Solution [Recordati Rare Diseases, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Panhematin | Recordati Rare Diseases, Inc.
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 PANHEMATINSince 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.
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