"The US Food and Drug Administration (FDA) is investigating the "rare but serious" risk for slowed or difficult breathing in children 17 and younger treated with the opioid analgesic tramadol.
"This risk may be increased in children tr"...
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 Lundbeck, (1-800-455-1141). The physician should discuss the risks and benefits of this product with the patient.
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.
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
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 postmarketing 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
- Presence of clinical symptoms.
- 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.
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.
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.
Safety and effectiveness in pediatric patients under 16 years of age have not been established.
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.
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.
9. Pierach, C. A., Hematin Therapy for the Porphyric Attack, Semin Liver Dis 2(2):125-131, May, 1982.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/18/2013
Additional Panhematin Information
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