WARNINGS
PANHEMATIN (hemin for injection) 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 Abbott Laboratories, (800) 633-9110. 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 [dgr ]-aminolevulinic acid synthetase. For this reason, drugs such as estrogens, barbituric acid derivatives and steroid metabolites which increase the activity of [dgr ]-aminolevulinic acid synthetase should be avoided.
Also, because PANHEMATIN 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.
PRECAUTIONS
General:
Clinical benefit from PANHEMATIN depends on prompt administration. Attacks of porphyria may progress to a point where irreversible neuronal damage has occurred. PANHEMATIN therapy is intended to prevent an attack from reaching the critical stage of neuronal degeneration. PANHEMATIN is not effective in repairing neuronal damage.9
Recommended dosage guidelines should be strictly followed. Reversible renal shutdown has been observed in a case where an excessive hematin dose (12.2 mg/kg) was administered in a single infusion. Oliguria and increased nitrogen retention occurred although the patient remained asymptomatic.4 No worsening of renal function has been seen with administration of recommended dosages of hematin.9
A large arm vein or a central venous catheter should be utilized for the administration of hemin for injection to avoid the possibility of phlebitis.
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. Tests for Diagnosis and Monitoring of Therapy:
Before PANHEMATIN therapy is begun, the presence of acute porphyria must be diagnosed using the following criteria: 9
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Presence of clinical symptoms.
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Positive Watson-Schwartz or Hoesch test. (A negative Watson-Schwartz or Hoesch test indicates a porphyric attack is highly unlikely. When in doubt quantitative measures of [dgr ]-aminolevulinic acid and porphobilinogen in serum or urine may aid in diagnosis.)
Urinary concentrations of the following compounds may be monitored during PANHEMATIN therapy. Drug effect will be demonstrated by a decrease in one or more of the following compounds: 3-6
ALA-(deta)-aminolevulinic acid
UPG-uroporphyrinogen
PBG-porphobilinogen
coproporphyrin
Carcinogenesis, Mutagenesis, Impairment of Fertility:
No data are available on potential for carcinogenicity, mutagenicity or impairment of fertility in animals or humans. Pregnancy:
Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with hematin. It is also not known whether hematin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. For this reason hemin for injection should not be given to a pregnant woman unless the expected benefits are sufficiently important to the health and welfare of the patient to outweigh the unknown hazard to the fetus.
Nursing Mothers:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when hemin for injection is administered to a nursing woman. Pediatric Use:
Safety and effectiveness in pediatric patients under 16 years of age have not been established.
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