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PANHEMATIN®
Following intravenous administration of hematin in non-jaun-diced human patients, an increase in fecal urobilinogen can be observed which is roughly proportional to the amount of hematin administered. This suggests an enterohepatic path- For intravenous infusion only.
way as at least one route of elimination. Bilirubin metabolitesare also excreted in the urine following hematin injections.2 PANHEMATIN® (hemin for injection) should only be used by physi- PANHEMATIN (hemin for injection) therapy for the acute por- cians experienced in the management of porphyrias in hospitals phyrias is not curative. After discontinuation of PANHEMATIN where the recommended clinical and laboratory diagnostic and treatment, symptoms generally return although in some cases monitoring techniques are available.
remission is prolonged. Some neurological symptoms have PANHEMATIN therapy should be considered after an appropriate improved weeks to months after therapy although little or no period of alternate therapy (i.e., 400 g glucose/day for 1 to 2 days).
response was noted at the time of treatment.
(See “WARNINGS”, “PRECAUTIONS” and “DOSAGE AND Other aspects of human pharmacokinetics have not been defined.
INDICATIONS AND USAGE
PANHEMATIN (hemin for injection) is indicated for the amelio-
DESCRIPTION
ration of recurrent attacks of acute intermittent porphyria tem- PANHEMATIN (hemin for injection) is an enzyme inhibitor porally related to the menstrual cycle in susceptible women.
derived from processed red blood cells. Hemin for injection Manifestations such as pain, hypertension, tachycardia, was known previously as hematin. The term hematin has been abnormal mental status and mild to progressive neurologic used to describe the chemical reaction product of hemin and signs may be controlled in selected patients with this disorder.
sodium carbonate solution. Hemin is an iron containing metal-loporphyrin. Chemically hemin is represented as chloro [7,12- Similar findings have been reported in other patients with diethenyl-3,8,13,17-tetramethyl-21H,23H-porphine-2,18-dip acute intermittent porphyria, porphyria variegata and heredi- ropanoato(2-)-N21,N22,N23,N24] iron. The structural formula for tary coproporphyria. PANHEMATIN is not indicated in por- phyria cutanea tarda.
CONTRAINDICATIONS
PANHEMATIN is contraindicated in patients with known hyper-
sensitivity to this drug.
WARNINGS
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 expo-
sure to certain viruses, by testing for the presence of
certain current virus infections, and by inactivating cer-
tain viruses. Despite these measures, such products

can still potentially transmit disease. There is also the
PANHEMATIN is a sterile, lyophilized powder suitable for intra- possibility that unknown infectious agents may be
venous administration after reconstit u t i o n . E a c h d i s p e n s - present in such products. ALL infections thought by a
i n g v i a l o f PA N H E M AT I N c o n t a i n s t h e e q u i v a l e n t physician possibly to have been transmitted by this
o f 3 1 3 m g hemin, 215 mg sodium carbonate and 300 mg product should be reported by the physician or other
of sorbitol. The pH may have been adjusted with hydrochloric healthcare provider to Ovation Pharmaceuticals, (800-
acid; the product contains no preservatives. When mixed as 455-1141). The physician should discuss the risks and
directed with Sterile Water for Injection, USP, each 43 mL pro- benefits of this product with the patient.
vides the equivalent of approximately 301 mg hematin (7 Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and the- CLINICAL PHARMACOLOGY
oretically, the Creutzfeldt-Jakob disease (CJD) agent.
Heme acts to limit the hepatic and/or marrow synthesis of PANHEMATIN therapy is intended to limit the rate of porphyrin. This action is likely due to the inhibition of δ- porphyria/heme biosynthesis possibly by inhibiting the enzyme aminolevulinic acid synthetase, the enzyme which limits the δ-aminolevulinic acid synthetase. For this reason, drugs such as rate of the porphyrin/heme biosynthetic pathway. The exact estrogens, barbituric acid derivatives and steroid metabolites mechanism by which hematin produces symptomatic which increase the activity of δ-aminolevulinic acid synthetase improvement in patients with acute episodes of the hepatic Panhematin® Patient Information – Page 1 of 3
Also, because hemin for injection has exhibited transient, mild important to the health and welfare of the patient to outweigh anticoagulant effects during clinical studies, concurrent anti- coagulant therapy should be avoided.9 The extent and duration Nursing Mothers
of the hypocoagulable state induced by PANHEMATIN® has It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution PRECAUTIONS
should be exercised when PANHEMATIN is administered to a Clinical benefit from PANHEMATIN depends on prompt admin- Pediatric Use
istration. Attacks of porphyria may progress to a point where Safety and effectiveness in pediatric patients under 16 years irreversible neuronal damage has occurred. PANHEMATIN therapy is intended to prevent an attack from reaching the Geriatric Use
critical stage of neuronal degeneration. PANHEMATIN is not Clinical studies in PANHEMATIN did not include sufficient numbers of subjects aged 65 and over to determine whether Recommended dosage guidelines should be strictly followed.
they respond differently from younger subjects. Other reported Reversible renal shutdown has been observed in a case where clinical experience has not identified differences in response an excessive hematin dose (12.2 mg/kg) was administered in between the elderly and younger patients. In general, dose a single infusion. Oliguria and increased nitrogen retention selection for an elderly patient should be cautious, usually occurred although the patient remained asymptomatic.4 No starting at the low end of the dosing range, reflecting the worsening of renal function has been seen with administration greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
A large arm vein or a central venous catheter should be utilized ADVERSE REACTIONS
for the administration of PANHEMATIN to avoid the possibility Reversible renal shutdown has occurred with administration of excessive doses (See “PRECAUTIONS” section).
Since reconstituted PANHEMATIN is not transparent, any undis- Phlebitis with or without leucocytosis and with or without mild solved particulate matter is difficult to see when inspected visu- pyrexia has occurred after administration of hematin through ally. Therefore, terminal filtration through a sterile 0.45 micron There have been post-marketing and literature reports of Tests for Diagnosis and Monitoring of Therapy
thrombocytopenia and coagulopathy (including prolonged pro- Before PANHEMATIN therapy is begun, the presence of acute thrombin time and prolonged partial thromboplastin time) in porphyria must be diagnosed using the following criteria:9 patients receiving PANHEMATIN. The initial literature report8 described coagulopathy occurring in a patient receiving b. Positive Watson-Schwartz or Hoesch test. (A negative Wat- hematin therapy. This patient exhibited prolonged prothrombin son-Schwartz or Hoesch test indicates a porphyric attack is time and partial thromboplastin time, thrombocytopenia, mild highly unlikely. When in doubt quantitative measures of δ- hypofibrogenemia, mild elevation of fibrin split products, and aminolevulinic acid and porphobilinogen in serum or urine OVERDOSAGE
Urinary concentrations of the following compounds may be mon- Reversible renal shutdown has been observed in a case where itored during PANHEMATIN therapy. Drug effect will be demon- an excessive hematin dose (12.2 mg/kg) was administered in strated by a decrease in one or more of the following a single infusion. Treatment of this case consisted of 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 treat- Carcinogenesis, Mutagenesis, Impairment of Fertility
ment of acute attacks of porphyria, an intravenous infusion of No data are available on potential for carcinogenicity, muta- PANHEMATIN containing a dose of 1 to 4 mg/kg/day of hematin genicity or impairment of fertility in animals or humans.
should be given over a period of 10 to 15 minutes for 3 to 14 Pregnancy
days based on the clinical signs. In more severe cases this dose Teratogenic effects-Pregnancy Category C: Animal reproduc- may be repeated no earlier than every 12 hours. No more than tion studies have not been conducted with hematin. It is also 6 mg/kg of hematin should be given in any 24 hour period.
not known whether hematin can cause fetal harm when admin- After reconstitution each mL of PANHEMATIN contains the istered to a pregnant woman or can affect reproduction capac- equivalent of approximately 7 mg of hematin. The drug may ity. For this reason PANHEMATIN should not be given to a be administered directly from the vial.
pregnant woman unless the expected benefits are sufficiently Panhematin® Patient Information – Page 2 of 3
Dosage Calculation Table
1 mg hematin equivalent = 0.14 mL PANHEMATIN 2 mg hematin equivalent = 0.28 mL PANHEMATIN3 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 ster-
ile 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.
® Registered Trademark of Ovation Pharmaceuticals, Deerfield, IL 60015, U.S.A.
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.
HOW SUPPLIED
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 pro-
vides the equivalent of approximately 301 mg hematin (7 mg/mL).
Store lyophilized powder in refrigerator (2-8°C) until time of use.
Caution: The packaging (vial stopper) of this product contains
natural rubber latex which may cause allergic reactions.
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 4. Dhar, G J., et al., Effects of Hematin in Hepatic Porphyria, Ann Intern 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 Admin- istration of a Relatively Large Amount of Hematin in a Patient withAcute Intermittent Porphyria in Clinical Remission, Acta Med Scand203:437-443, 1978.
8.Morris, D.L., et al., Coagulopathy Associated with Hematin Treat- ment for Acute Intermittent Prophyria, 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.
Panhematin® Patient Information – Page 3 of 3

Source: http://porfiria.org.br/Bula%20Panhematin%20in%20english.pdf

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