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PANHEMATIN is a brand name for Hemin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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, after initial carbohydrate therapy is known or suspected to be inadequate. Limitations of Use Before administering PANHEMATIN,…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations PANHEMATIN should only be used by or in consultation with physicians experienced in the management of porphyrias. Before PANHEMATIN therapy is begun, the presence of acute porphyria must be diagnosed using the following criteria: 1.
Presence of clinical symptoms suggestive of acute porphyric attack. 2. Quantitative measurement of porphobilinogen (PBG) in urine. The single-void urine sample should be refrigerated or frozen without additives and shielded from light for subsequent quantitative δ-aminolevulinic acid (ALA), PBG, and total porphyrin determinations.
(Note: the classical Watson-Schwartz or Hoesch tests are considered to be less reliable). Page 4 of 18 Clinical benefit from PANHEMATIN depends on prompt administration. For mild porphyric attacks (mild pain, no vomiting, no paralysis, no hyponatremia, no seizures), a trial of glucose therapy is recommended while awaiting hemin treatment or if hemin is unavailable.
For moderate to severe attacks, immediate hemin treatment is recommended. Symptoms of severe attacks are severe or prolonged pain, persistent vomiting, hyponatremia, convulsion, psychosis, and neuropathy. In addition to treatment with PANHEMATIN, consider other necessary measures such as the elimination of triggering factors.
Monitor urinary concentrations of the following compounds during PANHEMATIN therapy. Effectiveness is demonstrated by a decrease in one or more of the following compounds. 1 mg/kg/day of hematin for 3 to 14 days based on the clinical signs.
1 mg/kg/day. In more severe cases this dose may be repeated no earlier than every 12 hours. 6 mg/kg of hematin in any 24 hour period. 4 mg of hematin (see dosage calculation table below). 74 mL PANHEMATIN Health Canada has not authorized an indication for pediatric use.
3 Administration For intravenous infusion only. PANHEMATIN may be administered directly from the vial. After the first withdrawal from the vial, discard any solution remaining. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Since reconstituted PANHEMATIN is not transparent, any undissolved particulate matter is difficult to see when inspected visually. 45 micron or smaller filter is recommended. Infuse the dose over a period of at least 30 minutes via a separate line.
1 Adverse Reaction Overview The most common adverse reactions (occurring in >1% of patients) are: headache, pyrexia, infusion site reactions, and phlebitis. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The safety of PANHEMATIN use was evaluated in a compassionate use study. A total of 130 patients were treated with hemin for acute attacks, prophylaxis or both.
Of those, Page 8 of 18 111 patients were administered hemin for treatment of 305 acute porphyria attacks and to 40 patients for prophylaxis. The majority (92%) of patients were Caucasian. 3 years. Proportionally more females (15 out of 19) received prophylaxis or a combination of acute treatment and prophylaxis (19 out of 21).
For the treatment of acute attacks, patients received 2 to 4 mg/kg/day PANHEMATIN intravenously for 1 to 9 doses. For prophylaxis patients, the most common doses were weekly or biweekly infusions. Table 3 summarizes adverse reactions occurring in >1% of patients treated with PANHEMATIN, categorized by body system and order of decreasing frequency.
2% of the labelled content. Therefore, the actual amount of drug given to the patients was less than the calculated dose. 3 Post-Market Adverse Reactions The following adverse reactions associated with the use of PANHEMATIN were identified in open-label clinical trials or postmarketing reports.
Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: thrombocytopenia, coagulopathy (including prolonged prothrombin time and prolonged partial thromboplastin time), and hemolysis Immune System Disorders: hypersensitivity reactions including a report of infusion-related anaphylactoid reaction presenting as circulatory collapse Vascular Disorders: injection site venous thrombosis including some that occurred in large veins such as venae cavae Page 9 of 18 General Disorders and Administration Site Conditions: infusion site reactions (such as erythema, pain, bleeding and extravasation) Metabolism and Nutrition Disorders: iron overload and serum ferritin increased (see Warnings and Precautions)
General There are insufficient data available for a long term use of PANHEMATIN for prevention. Risk of Phlebitis A large arm vein or a central venous catheter should be utilized for the administration of PANHEMATIN to minimize the risk of phlebitis.
Since reconstituted PANHEMATIN is not transparent, any undissolved particulate matter is difficult to see when inspected visually. 45 micron or smaller filter is recommended (see Dosage and Administration). , viruses, the variant Creutzfeldt-Jacob disease (vCJD) agent, and theoretically the Creutzfeldt-Jacob disease (CJD) agent.
The risk that this product may 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, this product can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in the product. 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 Canada Inc.
at 905-827-1300.
Carcinogenesis and Mutagenesis See Part II:
Scientific Information – Non-Clinical Toxicology. Hematologic Because PANHEMATIN has exhibited transient, mild anticoagulant effects during clinical studies, avoid concurrent anticoagulant therapy. The extent and duration of the hypocoagulable state induced by PANHEMATIN has not been established.
Monitoring and Laboratory Tests Because increased levels of iron and serum ferritin have been reported in post-marketing experience, physicians must monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN (see Adverse Reactions).
PANHEMATIN is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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9% NaCl. 4 Reconstitution Parenteral Products: Reconstitute PANHEMATIN by aseptically adding 48 mL of Sterile Water for Injection, USP, to the dispensing vial. Shake the vial well for a period of 2 to 3 minutes to aid dissolution. 4 mg/mL Because PANHEMATIN contains no preservative and undergoes rapid chemical decomposition in solution, it must be reconstituted immediately before use.
Do not add other drug or chemical agent to a PANHEMATIN fluid admixture.
In case of elevated iron or serum ferritin levels, consider iron chelation therapy. Renal Recommended dosage guidelines should be strictly followed. 2 mg/kg) was administered in a single infusion. Oliguria and increased nitrogen retention occurred although the patient Page 7 of 18 remained asymptomatic.
No worsening of renal function has been seen with administration of recommended dosages of hematin. 1 Pregnant Women The available human data is not sufficient to assess the risks of PANHEMATIN during pregnancy. It is also not known whether hematin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
PANHEMATIN should be given to a pregnant woman only if clearly needed. Avoid administering hematin in severe pre-eclampsia because of a theoretical risk of potentiation of the coagulation disorder (see Warnings and Precautions). 2 Breast-feeding It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PANHEMATIN and any potential adverse effects on the breastfed child from PANHEMATIN or from the underlying maternal condition.
3 Pediatrics Pediatrics (< 16 years of age): Safety and effectiveness in pediatric patients under 16 years of age have not been established. 4 Geriatrics Geriatrics (≥ 65 years of age): Clinical data for subjects aged 65 and over was not sufficient to determine whether they respond differently from younger subjects.
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.