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).

PANHEMATIN summary of chemical and clinical response

Chemical and clinical response to the treatment of AIP attacks was assessed in 72 patients.^1,†

Summary of clinical and chemical response data from PANHEMATIN open-label studies¹

Investigator/ publication	AIP patients	Treatment courses	Dose	Other treatments prior to PANHEMATIN	Chemical response^†	Clinical response^†
Watson CJ et al^1,2	11	13	4 mg/kg/day or 4 mg/kg 2x/day	Glucose	58-100% reduction in serum ALA & PBG levels (11/11 patients)	91% (10/11 patients)
Pierach CA et al^1,3	43	82	2-4 mg/kg/day	...^§	For those patients with elevated urinary ALA & PBG levels prior to treatment	90% (74/82 treatment courses)
Lamon JM et al^1,4	11	20	~2-4 mg/kg/day or 2-4 mg/kg 2x/day^‡	High carbohydrate intake	Significant reductions in ALA and/or PBG levels (p<0.001 to 0.05) (11/11 patients)	70% (14/20 treatment courses)
McColl KE et al^1,5	7	12	4 mg/kg/day or 4 mg/kg 2x/day^‡	...^§	50% reduction in urinary ALA and PBG levels from pre-treatment values (7/7 patients)	58% (7/12 treatment courses)
Lamon JM et al^1,6,II	7	11	1 mg/kg every 24 hours for 3 to 13 days	250-300 g/24 h carbohydrate diet	Decrease in ALA and PBG occurred in every patient (except one PBG value in one patient) when treatment lasted 5 days or longer (p<0.001)	...

Investigator/ publication	Watson CJ et al^1,2	Pierach CA et al^1,3
AIP patients	11	43
Treatment courses	13	82
Dose	4 mg/kg/day or 4 mg/kg 2x/day	2-4 mg/kg/day
Other treatments prior to PANHEMATIN	Glucose	...^§
Chemical response^†	58-100% reduction in serum ALA & PBG levels (11/11 patients)	For those patients with elevated urinary ALA & PBG levels prior to treatment
Clinical response^†	91% (10/11 patients)	90% (74/82 treatment courses)

Investigator/ publication	Lamon JM et al^1,4	McColl KE et al^1,5
AIP patients	11	7
Treatment courses	20	12
Dose	~2-4 mg/kg/ day or 2-4 mg/kg/ 2x/day^‡	4 mg/kg/ day or 4 mg/kg 2x/day^‡
Other treatments prior to PANHEMATIN	High carbohydrate intake	...^§
Chemical response^†	Significant reductions in ALA and/or PBG levels (p<0.001 to 0.05) (11/11 patients)	50% reduction in urinary ALA and PBG levels from pre-treatment values (7/7 patients)
Clinical response^†	70% (14/20 treatment courses)	58% (7/12 treatment courses)

Investigator/ publication	Lamon JM et al^1,6,II
AIP patients	7
Treatment courses	11
Dose	1 mg/kg every 24 hours for 3 to 13 days
Other treatments prior to PANHEMATIN	250-300 g/24 h carbohydrate diet
Chemical response^†	Decrease in ALA and PBG occurred in every patient (except one PBG value in one patient) when treatment lasted 5 days or longer (p < 0.001)
Clinical response^†	...

PANHEMATIN efficacy data from 5 open-label studies

Patients experienced a clinical response^¶ in 85.5% (141/165) of treatment courses (open-label trials).¹

hcp treatment chart

Additional PANHEMATIN studies¹

Study	Number of patients treated	Clinical response^†
Compassionate use, multi-centre, open-label, non-comparative study^1,7	111^‡‡	73% (81/111) of patients achieved clinical response for all acute attacks^§§ 85% (94/111) of patients had ≥1 clinical response and 15% (17/111) had no response
Observational study with patient-reported outcomes^1,8	90	55% (50/90) reported receiving hemin during acute attacks Of these patients, 74% (37/50) reported PANHEMATIN as being very successful in treatment of abdominal pain and other symptoms. Hemin therapy effectiveness was assessed along with glucose infusions, high carbohydrate diets, and pain medications on a scale from zero being least effective to 10 highly effective. Hemin infusions received a 7.9, glucose infusions a 4.4 (p=0.0781), high carbohydrate diets a 4.7 (p=0.0021), and pain medications a 4.2 (p=0.0049).

† Chemical and clinical responses were individually defined by each investigator in each study.

‡ 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.

§ PANHEMATIN is indicated for the amelioration of recurrent attacks of acute intermittent porphyria (AIP) temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be inadequate.

II Clinical response in Lamon et al (1977) was not evaluated.

¶ Clinical response defined as improvement of symptoms and reduction in pain.

†† Chemical response defined as normalization of urinary aminolevulinic acid (ALA) and porphobilinogen (PBG).

‡‡ 90 patients were treated for acute attacks and 21 patients for both acute attacks and prophylaxis. PANHEMATIN is not indicated for prophylaxis.

§§ Clinical response was achieved if the physician determined that the admitting symptoms were resolved, there was a clinically acceptable response, or the patient went into remission.

References

Recordati Rare Diseases Canada Inc. PANHEMATIN Product Monograph. July 13, 2018.
Watson CJ, Pierach CA, Bossenmaier I, et al. Hematin in “inducible” hepatic porphyrias. Adv Intern Med. 1978;265-286.
Pierach CA, Bossenmaier I, Cardinal R, et al. Hematin therapy in porphyric attacks. Klin Wochenschr. 1980;829-832.
Lamon J, Frykholm B, Hess R, et al. Hematin therapy for acute porphyria. Medicine (Baltimore). 1979;252-269.
McColl KEL, Moore MR, Thompson GG, et al. Treatment with haematin in acute hepatic porphyria. Q J Med. 1981;161-174.
Lamon JM, Frykholm BC, Hess RA, Tschudy DP. Hematin therapy in acute porphyria. ASCI Genetics. 1977;128.
Anderson KE, Collins S. Open-label study of hemin for acute porphyria: clinical practice implications. Am J Med. 2006;119(9):19-24.
Bonkovsky HL, Maddukuri VC, Yazici C, et al. Acute porphyrias in the USA: features of 108 subjects from porphyrias consortium. Am J Med. 2014;127(12):1233-1241.

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

PANHEMATIN summary of chemical and clinical response

PANHEMATIN efficacy data from 5 open-label studies

Additional PANHEMATIN studies1

References

Safety Information

Indication:

Limitations of use:

Indication:

Limitations of use:

Clinical use:

Contraindications:

Relevant warnings and precautions:

For more information:

Reference

Additional PANHEMATIN studies¹