ABOUT PANHEMATIN
How PANHEMATIN Treats AIP Attacks
When AIP attacks disrupt the heme cycle, PANHEMATIN can help.
How PANHEMATIN Works
During AIP attacks, the body's heme pool is depleted.1 PANHEMATIN helps replenish the heme pool, which represses the body's signaling to produce more heme.2,3 By restoring heme levels in the liver, and thereby downregulating the overproduction of toxic porphyrin precursors that lead to acute symptoms of AIP attacks, heme production is allowed to slow and the accumulated neurotoxic porphyrin precursors begin to decline.2,3
PANHEMATIN plays a vital role in normalizing heme production
Follow the cycle below to understand where PANHEMATIN enters the cycle and helps replenish the heme pool.
5
PANHEMATIN helps replenish the depleted heme pool and normalize the rate of heme production in women with AIP attacks2,3
- ALA synthase is repressed2,3
- Bottleneck in heme biosynthetic pathway diminishes2,3
- Helps to reduce symptoms and pain2
ALA: δ-aminolevulinic acid
Limitations of Use3
- 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.
Learn how PANHEMATIN replenishes the heme pool
Watch this video to learn more about why prompt treatment of an AIP attack is critical, and how PANHEMATIN works to normalize the heme production process.
Efficacy & Safety
The efficacy and safety of PANHEMATIN is well established in the management of AIP attacks in women.3 Clinical studies have demonstrated that timely administration reduces the severity of attacks.3 PANHEMATIN is generally well tolerated, with a favorable safety profile.3
Clinical and chemical responses after PANHEMATIN infusions2,5,6
Data from open-label studies which supported approval of PANHEMATIN
n = 99 patients and 165 treatment courses
*Clinical response defined as improvement of symptoms and reduction in pain.
**Chemical response defined as reductions in -aminolevulinic acid (ALA) and/or porphobilinogen (PBG) levels.
Results from an observational patient reported outcomes study7
Study included 90 patients with AIP
Treated with PANHEMATIN
55%
reported receiving hemin during acute attacks
74%
of these patients reported PANHEMATIN as being very successful in treating abdominal pain and other symptoms of AIP attacks
Treated with opiates
50%
reported having received treatment with opiates during an acute attack
44%
of these patients reported that opiates were effective
Safety profile of PANHEMATIN3,6
The most common adverse reactions (occurring in >1% of patients) are headache, pyrexia, infusion site reactions, and phlebitis.
Clinical trials experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in clinical practice.
The safety of PANHEMATIN use was evaluated in a compassionate use study3
Overview
130 patients treated with hemin for acute attacks, prophylaxis or both
- 111 of 130 patients administered hemin for treatment of 305 acute porphyria attacks
- 40 of 130 patients for prophylaxis
Demographics
- 92% Caucasian
- 72% female
- Mean age: 40 years (±12)
Dosing
Acute attacks: 2 to 4 mg/kg/day PANHEMATIN intravenously for 1 to 9 doses
Prophylaxis: The most common doses were weekly or biweekly infusions
More females (15 out of 19) received prophylaxis or a combination of acute treatment and prophylaxis (19 out of 21).
The table below summarizes adverse reactions occurring in >1% of patients treated with PANHEMATIN, categorized by body system and order of decreasing frequency.
Adverse reactions in >1% of patients treated with PANHEMATIN3
| System Organ Class Preferred Term |
Adverse Events n (% of total adverse events) |
|
|---|---|---|
| Description | Total | Possibly/ Probably Related to Treatment |
|
Infections and Infestations
Cellulitis
|
3 (1.5%) | 2 (1.0%) |
|
Nervous System Disorders
Headache
|
18 (9.2%) | 5 (2.6%) |
|
Vascular Disorder
Phlebitis/Injection site phlebitis
|
7 (3.6%) | 6 (3.1%) |
|
Skin and subcutaneous tissue disorder
Rash
|
3 (1.5%) | 3 (1.5%) |
|
General Disorder and Administration Site Conditions
Pyrexia
Catheter-related complication
|
9 (4.6%) 7 (3.6%) |
6 (3.1%) 3 (1.5%) |
Dosing & Administration
Determining the right dose of PANHEMATIN, as well as preparing, reconstituting, and administering PANHEMATIN properly, are integral parts of treatment.
PANHEMATIN dosing3*
PANHEMATIN should only be used by or in consultation with physicians experienced in the management of porphyrias. PANHEMATIN is for intravenous infusion only.3
Before PANHEMATIN therapy has begun, the presence of acute porphyria must be diagnosed using the following criteria3:
- Presence of clinical symptoms suggestive of acute porphyric attack.
- Quantitative measurement of porphobilinogen (PBG) in urine. 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.3
*Exercise clinical judgment when determining appropriate dose.
Calculating the dose of reconstituted PANHEMATIN for infusion
When reconstituted as directed with sterile water for injection, each 48mL of reconstituted PANHEMATIN contains the equivalent of approximately 336 mg PANHEMATIN at a concentration of 7mg/ml.3
Use the Interactive PANHEMATIN dosing calculator to calculate the correct dose.
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
PANHEMATIN DOSING CALCULATOR
(mL to infuse)
Preparing PANHEMATIN for administration
PANHEMATIN contains no preservative, and undergoes rapid chemical decomposition in solution. Administration should begin immediately after the reconstitution process is completed.3
Do not reconstitute until immediately before use.
Make sure that all needed supplies are available and assembled as needed ahead of initiating the reconstitution process. Collect all items before prepping the patient for infusion.
Having the patient prepped before the reconstitution and infusion process begins is critical to ensuring that PANHEMATIN is administered promptly with no delays. It is good practice to protect the patient’s clothing with a towel or pad, as PANHEMATIN can stain clothes and skin.
PANHEMATIN should only be used by or in consultation with physicians experienced in the management of porphyrias. PANHEMATIN is for intravenous infusion only. Use the dosing calculation formula to determine the correct dose.
Reconstituting and infusing PANHEMATIN3
Reconstitute PANHEMATIN by adding 48 mL of Sterile Water for Injection, USP.
Because PANHEMATIN contains no preservative and undergoes rapid chemical decomposition in solution, it must be reconstituted immediately before use.
Use sterile 0.45 micron or smaller filter to remove any undissolved particulate matter.
Administer over a period of at least 30 minutes via a separate line.
After the infusion, flush the vein with 100 mL of 0.9% normal saline.
For more detailed information, including step-by-step instructions and supplies needed for reconstituting and administering PANHEMATIN:
Dosing & Administration Video
Watch this video for more detailed information, including step-by-step instructions and supplies needed for reconstituting and administering PANHEMATIN. You can also choose a chapter below.
Please click here to view Prescribing Information.
Dosing & Administration Guide
A step-by-step guide to preparing, reconstituting, and administering PANHEMATIN, including list of needed infusion supplies.
References: 1. Khanderia U, Bhattacharya A. Acute intermittent porphyria: Pathophysiology and treatment. Pharmacotherapy. 1984;4(3):144-150. 2. Anderson KE, Bloomer JR, Bonkovsky HL, et al. Recommendations for the diagnosis and treatment of the acute porphyrias. Ann Intern Med. 2005;142:439-450. 3. PANHEMATIN® package insert. Recordati Rare Diseases Inc., Bridgewater, NJ 08807 USA; 2025. 4. Balwani M, Wang B, Anderson KE, et al. Acute hepatic porphyrias: recommendations for evaluation and long-term management. Hepatology. 2017;66(4):1314-1322. 5. McColl KEL, Moore MR, Thompson GG, Goldberg A. Treatment with haematin in acute hepatic porphyria. Q J Med. 1981;50(198):161-174. 6. Watson CJ, Pierach CA, Bossenmaier I, Cardinal R. Use of hematin in the acute attack of the "inducible" hepatic porphyrias. Adv Intern Med. 1978;23:265-286. 7. 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 AND USAGE
PANHEMATIN is a hemin for injection 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.
IMPORTANT SAFETY INFORMATION
PANHEMATIN is contraindicated in patients with known hypersensitivity to this drug.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE
PANHEMATIN is a hemin for injection 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.
IMPORTANT SAFETY INFORMATION
PANHEMATIN is contraindicated in patients with known hypersensitivity to this drug.
Risk of Phlebitis: Phlebitis is possible. Utilize a large arm vein or a central venous catheter for administration to minimize the risk of phlebitis.
Iron and Serum Ferritin: Elevated iron and serum ferritin may occur. Monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN.
Anticoagulant Effects: PANHEMATIN has transient and mild anticoagulant effect. Avoid concurrent anticoagulant therapy.
Renal Effects: Reversible renal shutdown has been observed with an excessive hematin dose (12.2 mg/kg in a single infusion). Strictly follow recommended dosage guidelines.
Transmissible Infectious Agents: PANHEMATIN may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in the product.
The most common adverse reactions (>1% of patients) are headache, pyrexia, infusion site reactions, and phlebitis.
To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions: Avoid CYP inducing drugs such as estrogens, barbituric acid derivatives and steroid metabolites which induce δ-aminolevulinic acid synthetase 1 (ALAS1) through a feedback mechanism.
PANHEMATIN® (hemin for injection), for intravenous infusion only, is available as powder for reconstitution in 350 mg vials.
Please see full Prescribing Information.
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How to Order PANHEMATIN
Contact your primary wholesaler or Cencora.
| Orders placed by | Delivered |
|---|---|
Monday-Thursday by 6:30 pm CT |
Priority Overnight for 10:30 am delivery* |
Friday by 6:30 pm CT |
Priority Overnight for Monday 10:30 am delivery* |
Saturday delivery |
Saturday delivery must be requested when order is placed. |
*10:30am delivery in most areas.
Earlier, same day, and weekend delivery are available with an additional shipping cost.
Be sure to include any specific delivery instructions when ordering.
PANHEMATIN is supplied as a sterile, lyophilized black powder in single dose dispensing vials (NDC 55292-702-54) in a carton (NDC 55292-702-55). The vial stopper contains natural rubber latex. Store lyophilized powder at 20-25°C (68-77°F).
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