Hemin

Heme acts to limit the hepatic and/or marrow synthesis of porphyrin. This action is likely due to the inhibition of δ-aminolevulinic acid synthetase, the enzyme which limits the rate of the porphyrin/heme biosynthetic pathway.

• 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) [ See Dosage and Administration ( 2.1 ) ].

• PANHEMATIN is contraindicated in patients with known hypersensitivity to this drug. Do not use in patients with known hypersensitivity to PANHEMATIN.contraindicated

For intravenous infusion only. For intravenous infusion only. Dose ( 2.1 ) 1 to 4 mg/kg/day for 3 to 14 days based on the clinical signs. The standard dose in clinical practice is 3 to 4 mg/kg/day. Repeat dose in more severe cases no earlier than every 12 hours. Do not exceed 6 mg/kg in any 24 hour period. Administration ( 2.2 ) Use sterile 0.45 micron or smaller filter to remove any undissolved particulate matter. The dose may be administered directly from the vial over a period of at least 30 minutes. After the infusion, flush the vein with 100 mL of 0.9% NaCl. 2.1 Dosing • 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: 1. Presence of clinical symptoms suggestive of acute porphyric attack. 2. 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.

• Phlebitis is possible. Utilize a large arm vein or a central venous catheter for administration to minimize the risk of phlebitis. ( 5.1 ) • Elevated iron and serum ferritin may occur. Monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN. ( 5.2 ) • PANHEMATIN has transient and mild anticoagulant effect. Avoid concurrent anticoagulant therapy. ( 5.3 ) • Reversible renal shutdown has been observed with an excessive hematin dose (12.2 mg/kg in a single infusion). Strictly follow recommended dosage guidelines. ( 5.4 ) • PANHEMATIN may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ( 5.5 ) 5.1 Risk of Phlebitis A large arm vein or a central venous catheter should be utilized for the administration of PANHEMATIN to minimize the risk of phlebitis. 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. [See Dosage and Administration ( 2.2 )] 5.2 Iron and Serum Ferritin Because increased levels of iron and serum ferritin have been reported in post-marketing experience, physicians must monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN [See Adverse Reactions ( 6.2 )] . In case of elevated iron or serum ferritin levels, consider iron chelation therapy.

The most common adverse reactions (occurring in >1% of patients) are: headache, pyrexia, infusion site reactions, and phlebitis. Most common adverse reactions in >1% of patients are headache, pyrexia, infusion site reactions, and phlebitis. ( 6.1 ) 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PANHEMATIN use was evaluated in a compassionate use study. A total of 130 patients were treated with hemin for acute attacks, prophylaxis or both. Of those, 111 patients were administered hemin for treatment of 305 acute porphyria attacks and to 40 patients for prophylaxis. The majority (92%) of patients were Caucasian. Most (72%) were female; all adult patients had a mean age ± SD of 40.3 ± 12.3 years. Proportionally more females (15 out of 19) received prophylaxis or a combination of acute treatment and prophylaxis (19 out of 21). For the treatment of acute attacks, patients received 2 to 4 mg/kg/day PANHEMATIN intravenously for 1 to 9 doses. For prophylaxis patients, the most common doses were weekly or biweekly infusions. Table 1 summarizes adverse reactions occurring in >1% of patients treated with PANHEMATIN, categorized by body system and order of decreasing frequency.

8.1 Pregnancy Risk Summary About 50% of the women with acute intermittent porphyria experience an acute attack of porphyria in pregnancy and/or the puerperium. It is most severe in early pregnancy and the puerperium, and can result in fatal outcome. Although anecdotal evidence suggests safe use of hematin during pregnancy, the available human data is not sufficient to establish the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with hematin. It is also not known whether hematin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PANHEMATIN should be given to a pregnant woman only if clearly needed. Avoid administering hematin in severe pre-eclampsia because of a theoretical risk of potentiation of the coagulation disorder [see Warnings and Precautions ( 5.3 )] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary It is not known whether this drug is excreted in human milk.

Metabolism

Following intravenous administration of hematin in non-jaundiced human patients, an increase in fecal urobilinogen can be observed which is roughly proportional to the amount of hematin administered. This suggests an enterohepatic pathway as at least one route of elimination.

Reversible renal shutdown has been observed in a case where an excessive hematin dose (12.2 mg/kg) was administered in a single infusion [see Warnings and Precautions ( 5.4 )] . Treatment of this case consisted of ethacrynic acid and mannitol.

1. 1Off Label Use11021%
2. 2Porphyria Acute5310%
3. 3Nausea397.4%
4. 4Pain346.4%
5. 5Phlebitis346.4%
6. 6Vomiting295.5%
7. 7Headache264.9%
8. 8Abdominal Pain224.2%
9. 9Porphyria224.2%
10. 10Device Occlusion214.0%
11. 11Fatigue193.6%
12. 12Condition Aggravated183.4%
13. 13Malaise183.4%
14. 14Seizure183.4%
15. 15Drug Ineffective173.2%

Recent PubMed references pinned to Hemin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Hemin activates interleukin-17 signaling and CCAAT/enhancer-binding protein beta to promote neuroinflammation and blood-brain barrier disruption.
  International journal of biological macromolecules · 2026 · Chen M, Zhu X, Gao Q, et al.
  PMID 42107562DOI 10.1016/j.ijbiomac.2026.152476
• Antioxidant peptides from porcine blood meal: Mechanisms of interaction with hemin via spectroscopy and molecular docking.
  Food chemistry · 2026 · Jia R, Du J, Cao J, et al.
  PMID 42102457DOI 10.1016/j.foodchem.2026.149475
• Engineering the Iron Center: Hemin Nanozymes for Programmable Cancer Catalysis.
  Nano letters · 2026 · Alsharabasy AM, Isaac GT, Pandit A, et al.
  PMID 42091109DOI 10.1021/acs.nanolett.6c00429
• Self-powered photoelectrochemical aptasensor based on CHA-triggered G-quadruplex/hemin cascade for homogeneous detection of ochratoxin A in a separated-coupling electrolysis system.
  Biosensors & bioelectronics · 2026 · Zhang Q, Chen C, Miao R, et al.
  PMID 42090817DOI 10.1016/j.bios.2026.118763
• Leveraging hemin-incorporated bioMOF to strengthen the photocathodic COF: Toward cathodic organic photoelectrochemical transistor bioanalysis of cortisol.
  Biosensors & bioelectronics · 2026 · Hu J, Chen Q, Huang C, et al.
  PMID 42090816DOI 10.1016/j.bios.2026.118762
• Hemin-Based Polymer Nanomicelles for Ferroptosis-Mediated Tumor Therapy.
  ACS applied bio materials · 2026 · Sarkar AR, Chanda A, Mukherjee N, et al.
  PMID 42053244DOI 10.1021/acsabm.6c00403
• Hemin-functionalized metal-organic frameworks with peroxidase-like activity for colorimetric detection of glyphosate.
  Talanta · 2026 · Zhou Y, Long Y, Zhou X, et al.
  PMID 42008911DOI 10.1016/j.talanta.2026.129852
• Hemin-Engineered UiO-66(Ce) as a Highly Active Nanozyme for Electrochemical Sensing of Hydrogen Peroxide and Hydrogen in Beverages.
  Journal of agricultural and food chemistry · 2026 · Chen Y, Lv R, Chen Z, et al.
  PMID 41961274DOI 10.1021/acs.jafc.6c01253

The 10 most recently updated of 12 ClinicalTrials.gov registrations naming Hemin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Acute Porphyria Biomarkers for Disease Activity
  Active not recruiting · Observational · 50 enrolled · The University of Texas Medical Branch, Galveston
  NCT02935400updated 2026-05-12
• Reframing Endometrial Physiology by Advanced Integrated Research
  Recruiting · Observational · 100 enrolled · University Hospital Southampton NHS Foundation Trust
  NCT07557992updated 2026-04-30
• A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in Detection of UGIB
  Completed · Interventional · 30 enrolled · Chinese University of Hong Kong
  NCT06409182updated 2026-04-22
• Panhematin for Prevention of Acute Attacks of Porphyria
  Terminated · Phase 2 · Interventional · 13 enrolled · The University of Texas Medical Branch, Galveston
  NCT02922413updated 2026-01-30
• Controlled Trial of Panhematin in Treatment of Acute Attacks of Porphyria
  Completed · Phase 2 · Interventional · 20 enrolled · The University of Texas Medical Branch, Galveston
  NCT02180412updated 2025-04-11
• Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique
  Completed · Observational · 10 enrolled · Isabelle Herter-Aeberli
  NCT05788172updated 2023-11-22
• Hemin to Prevent Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) Acute Pancreatitis
  Completed · Phase 2 · Interventional · 284 enrolled · Erasme University Hospital
  NCT01855841updated 2021-07-07
• A Pilot Study of Hemin Therapy for Gastroparesis (Diabetes Mellitus)
  Completed · Phase 2 · Interventional · 20 enrolled · Mayo Clinic
  NCT01206582updated 2016-02-04
• Induction of HO-1; a Therapeutic Approach to Reduce Ischaemia Reperfusion Injury (IRI) Following Deceased Donor Renal Transplantation
  Completed · Phase 3 · Interventional · 40 enrolled · University of Edinburgh
  NCT01430156updated 2015-05-27
• A New Treatment Option for Heavy Menstrual Bleeding
  Unknown · Phase 4 · Interventional · 30 enrolled · Sydney Centre for Reproductive Health Research
  NCT01715025updated 2014-11-19

Frequently asked questions

How does Hemin work?

Heme acts to limit the hepatic and/or marrow synthesis of porphyrin. This action is likely due to the inhibition of δ-aminolevulinic acid synthetase, the enzyme which limits the rate of the porphyrin/heme biosynthetic pathway.

What is Hemin used for?

According to FDA labeling, Hemin carries indications including: 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) [ See Dosage and Administration ( 2.1 ) ].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Hemin?

Hemin is classified as Heme products, Enzyme Inhibitors, Cellular Activity Alteration.

What are the brand names for Hemin?

Hemin is marketed under brand names including Panhematin.

What are the contraindications for Hemin?

Hemin labeling lists contraindications including: PANHEMATIN is contraindicated in patients with known hypersensitivity to this drug. Do not use in patients with known hypersensitivity to PANHEMATIN.. Always consult the full prescribing information and a clinician.