Ordering Panhematin

Ordering Panhematin

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How to order PANHEMATIN

Order through Canadian Blood Services and Héma‑Québec

How supplied

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.

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 al1,2 11 13 4 mg/kg/day or 4 mg/kg 2x/day Glucose 58% to 100% reduction in serum ALA & PBG levels (11/11 patients) 91% (10/11 patients)
Pierach CA et al1,3 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 al1,4 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 al1,5 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 al1,6,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 al1,2 Pierach CA et al1,3
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% to 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 al1,4
McColl KE
et al1,5
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 al1,6,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

hcp treatment chart

Additional PANHEMATIN studies1

Study Number of patients treated Clinical response
Compassionate use, multi-centre, open-label non-comparative study1,7 111‡‡ 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 outcomes1,8 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 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

  1. Recordati Rare Diseases Canada Inc. PANHEMATIN® Product Monograph. July 13, 2018.
  2. Watson CJ, Pierach CA, Bossenmaier I, et al. Hematin in “Inducible” Hepatic Porphyrias. Adv Intern Med. 1978;265-286.
  3. Pierach CA, Bossenmaier I, Cardinal R, et al. Hematin Therapy in Porphyric Attacks. Klin Wochenschr. 1980;829-832.
  4. Lamon J, Frykholm B, Hess R, et al. Hematin Therapy for Acute Porphyria. Medicine (Baltimore). 1979;252-269.
  5. McColl KEL, Moore MR, Thompson GG, et al. Treatment with Haematin in Acute Hepatic Porphyria. Q J Med. 1981;161-174.
  6. Lamon JM, Frykholm BC, Hess RA, Tschudy DP. Hematin Therapy in Acute Porphyria. ASCI Genetics. 1977;128.
  7. Anderson KE, Collins S. Open-Label Study of Hemin for Acute Porphyria: Clinical Practice Implications. Am J Med. 2006;119(9):19-24.
  8. 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.