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Panhematin (Hemin) - Warnings and Precautions

 
 



PANHEMATIN (hemin for injection) should only be used by physicians experienced in the management of porphyrias in hospitals where the recommended clinical and laboratory diagnostic and monitoring techniques are available.

PANHEMATIN therapy should be considered after an appropriate period of alternate therapy (i.e., 400 g glucose/day for 1 to 2 days). (See " WARNINGS ", " PRECAUTIONS " and " DOSAGE AND ADMINISTRATION " sections.)

 

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 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.

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 PANHEMATIN 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.

Because increased levels of iron and serum ferritin have been reported in post-marketing experience, physicians should monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN (See " ADVERSE REACTIONS " section).

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 ]

  1. Presence of clinical symptoms.
  2. 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 δ-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 - δ-aminolevulinic acid
    UPG - uroporphyrinogen
    PBG - porphobilinogen
    coproporphyrin

Carcinogenesis, Mutagenesis, Impairment of Fertility

PANHEMATIN was not mutagenic in bacteria systems in vitro and was not clastogenic in mammalian systems in vitro and in vivo. No data are available on potential for carcinogenicity 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 PANHEMATIN 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 PANHEMATIN is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients under 16 years of age have not been established.

Geriatric Use

Clinical studies in PANHEMATIN did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Page last updated: 2013-02-01

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