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).

Dosing calculator

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.

Enter the patient’s weight in kg.
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.

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

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

Indication:

^PrPANHEMATIN^® (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, consider an appropriate period of carbohydrate loading (i.e., 400 g glucose/day for 1 to 2 days).
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.

Clinical use:

Pediatrics (<16 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of PANHEMATIN in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.

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.

Contraindications:

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.

Relevant warnings and precautions:

Do not use in patients with known hypersensitivity to PANHEMATIN.
Risk of phlebitis.
Risk of transmitting infectious agents (e.g., viruses, the variant Creutzfeldt-Jacob disease (vCJD) agent, and theoretically the Creutzfeldt-Jacob disease (CJD) agent).
Transient, mild anticoagulant effects may occur. Avoid concurrent anticoagulant therapy.
Elevated iron and serum ferritin may occur. Monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN.
Reversible renal shutdown has been observed in a case where an excessive hematin dose (12.2 mg/kg) was administered in a single infusion. Recommended dosage guidelines should be strictly followed.
Should be given to a pregnant woman only if clearly needed. Avoid administering hematin in severe pre-eclampsia.
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.
Avoid CYP inducing drugs (such as estrogens, barbituric acid derivatives, and steroid metabolites) while on PANHEMATIN therapy.

For more information:

Please consult the Product Monograph at www.recordatirarediseases.com/sites/www.recordatirarediseases.com/files/inline-files/panhematin-product-monograph-ENG.pdf for important information related to adverse reactions, interactions, and dosing information which has not been discussed on this website. The Product Monograph is also available by calling McKesson Specialized Distribution at 1-877-827-1306 or email customersupport@gmdpharma.ca.

Reference

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

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How to order PANHEMATIN

Dosing calculator

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PANHEMATIN dosing and administration

Reference

Safety Information

Indication:

Limitations of use:

Indication:

Limitations of use:

Clinical use:

Contraindications:

Relevant warnings and precautions:

For more information:

Reference