Ordering Panhematin

Ordering Panhematin

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How to order PANHEMATIN

Order through Canadian Blood Services and Héma‑Québec

PANHEMATIN is supplied as a sterile, lyophilized black powder in single dose dispensing vials in a carton.

The vial stopper contains natural rubber latex.

Store lyophilized powder at 20-25°C (68-77°F).

Hemin for injection. PANHEMATIN.

Dosing calculator

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Dosing calculator

  1. Enter the desired amount of hematin (mg/kg/day).
    • The dose of PANHEMATIN is 0.8 to 3.1 mg/kg/day of hematin for 3 to 14 days based on the clinical signs. The standard dose in clinical practice is 2.3 to 3.1 mg/kg/day. Do not exceed 4.6 mg/kg of hematin in any 24-hour period.
  2. Enter the patient’s weight in kg.
  3. The calculated amount of hematin and dosage of PANHEMATIN will be displayed.
  • After the first withdrawal from the vial, discard any solution remaining.
  • If the required dosage of PANHEMATIN is >48 mL, a second vial will be required.
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PANHEMATIN dosing and administration

Dosing considerations1

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:

  • Presence of clinical symptoms suggestive of acute porphyric attack.
  • 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).

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.

  • ALA – δ-aminolevulinic acid
  • PBG – porphobilinogen
  • Uroporphyrin
  • Coproporphyrin

Recommended dose and dosage adjustment1

  • The dose of PANHEMATIN is 0.8 to 3.1 mg/kg/day of hematin for 3 to 14 days based on the clinical signs.
  • The standard dose in clinical practice is 2.3 to 3.1 mg/kg/day.
  • In more severe cases this dose may be repeated no earlier than every 12 hours.
  • Do not exceed 4.6 mg/kg of hematin in any 24-hour period.

After reconstitution each mL of PANHEMATIN contains the equivalent of approximately 5.4 mg of hematin.

Dosage calculation table
1 mg hematin equivalent = 0.18 mL PANHEMATIN
2 mg hematin equivalent = 0.37 mL PANHEMATIN
3 mg hematin equivalent = 0.55 mL PANHEMATIN
4 mg hematin equivalent = 0.74 mL PANHEMATIN

Administration1

  • 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. Therefore, terminal filtration through a sterile 0.45 micron or smaller filter is recommended.
  • Infuse the dose over a period of at least 30 minutes via a separate line.
  • After the infusion, flush the vein with 100 mL of 0.9% NaCl.

Reconstitution1

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.

Vial size Volume of diluent to be added to vial Approximate available volume Nominal concentration per mL
268 mg 48 mL 48 mL 5.4 mg/mL
Vial size 268 mg
Volume of diluent to be added to vial 48 mL
Approximate available volume 48 mL
Nominal concentration per mL 5.4 mg/mL
  • When mixed as directed with Sterile Water for Injection, USP, each 48 mL provides the equivalent of approximately 261 mg hematin (5.4 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.

Reference

  1. Recordati Rare Diseases Canada Inc. PANHEMATIN Product Monograph. July 13, 2018.
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