Panhematin Indications, Dosage, Storage, Stability - Hemin

Panhematin Indications, Dosage, Storage, Stability - Hemin

INDICATIONS

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.

Before administering hemin for injection, 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.

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 (hemin for injection) is supplied as a sterile, lyophilized black powder in single dose dispensing vials ( NDC 0074-2000-43). 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 in refrigerator (2-8°C) until time of use.

REFERENCES

1. Bickers, D., Treatment of the Porphyrias: Mechanisms of Action, J Invest Dermatol 77(1):107-113, 1981.
2. Watson, C. J., Hematin and Porphyria, editorial, N Engl J Med 293(12):605-607, September 18, 1975.
3. Lamon, J. M., Hematin Therapy for Acute Porphyria, Medicine 58(3):252-269, 1979.
4. Dhar, G. J., et al., Effects of Hematin in Hepatic Porphyria, Ann Intern Med 83:20-30, 1975.
5. Watson, C. J., et al., Use of Hematin in the Acute Attack of the "Inducible" Hepatic Porphyrias, Adv Intern Med 23:265-286, 1978.
6. McColl, K. E., et al., Treatment with Haematin in Acute Hepatic Porphyria, Q J Med, New Series L (198):161-174, Spring, 1981.
7. Dhar, G. J., et al., Transitory Renal Failure Following Rapid Administration of a Relatively Large Amount of Hematin in a Patient with Acute Intermittent Porphyria in Clinical Remission, Acta Med Scand 203:437-443, 1978.
8. Morris, D. L., et al., Coagulopathy Associated with Hematin Treatment for Acute Intermittent Porphyria, Ann Intern Med 95:700-701, 1981.
9. Pierach, C. A., Hematin Therapy for the Porphyric Attack, Semin Liver Dis 2(2):125-131, May, 1982.