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Hemin: Drug information

Hemin: Drug information
(For additional information see "Hemin: Patient drug information" and see "Hemin: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Panhematin
Brand Names: Canada
  • Panhematin
Pharmacologic Category
  • Blood Modifiers;
  • Blood Product Derivative
Dosing: Adult
Porphyria

Porphyria:

IV: 3 to 4 mg/kg once daily for 4 days (Anderson 2005)

Manufacturer's labeling: Dosing in the prescribing information may not reflect current clinical practice. IV: 1 to 4 mg/kg/day for 3 to 14 days; maximum: 6 mg/kg per 24 hours

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

(For additional information see "Hemin: Pediatric drug information")

Acute intermittent porphyria; attack

Acute intermittent porphyria (AIP); attack: Note: Prior to administration, ensure accurate diagnosis including quantitative urine porphobilinogen (PBG) and delta aminolevulinic acid (ALA).

Adolescent females ≥16 years: IV: Usual dose: 3 to 4 mg/kg/day of hematin once daily for 4 days; for severe cases, more frequent dosing may be necessary and should be separated by at least 12 hours; reported dose range: 1 to 4 mg/kg/day for 3 to 14 days; maximum daily dose: 6 mg/kg/24 hours (Anderson 2005)

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Panhematin: 350 mg (1 ea)

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Panhematin: 268 mg (1 ea)

Administration: Adult

IV: For IV infusion only. Administer through a large vein or central line to prevent phlebitis. Preparing the solution in albumin has been reported to decrease phlebitis (Anderson 2006).

Products reconstituted with sterile water for injection: Infuse over at least 30 minutes through a 0.45 micron or smaller filter. After infusion, flush with 100 mL NS.

Products prepared with albumin 25% (Anderson 2006): Infuse over at least 60 minutes at a rate not to exceed 1 mL/minute; infuse piggybacked through a line containing NS. Information related to use of an in-line filter is not available; however, a larger filter size may be necessary to avoid slowing the infusion. Following completion of hemin, infuse NS for ~10 minutes to clear the IV line.

Administration: Pediatric

IV: Infuse over at least 30 minutes through a 0.45 micron or smaller filter since undissolved particulate will not be visible. Administer through a large vein or central line to prevent phlebitis. After infusion, flush with 100 mL of NS.

Use: Labeled Indications

Porphyria: Management 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 hemin administration, the manufacturer recommends an appropriate period of carbohydrate loading (ie, 400 g glucose/day for 1 to 2 days). However, glucose may be appropriate for mild cases only and hemin should be initiated early for most acute attacks, although glucose may be utilized while awaiting hemin therapy (Anderson 2005). For moderate to severe attacks, immediate hemin treatment is recommended. Porphyria attacks may progress to a point of irreversible neuronal damage; hemin therapy is intended to prevent an attack from reaching a critical stage of neuronal degeneration; hemin is not effective in repairing neuronal damage.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Central nervous system: Pyrexia

Hematologic: Leukocytosis

Local: Phlebitis

Postmarketing and/or case reports: Coagulopathy, fibrin split products increased, hematocrit decreased, hypofibrogenemia, prothrombin time increased, partial thromboplastin time increased, thrombocytopenia

Contraindications

Hypersensitivity to hemin or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Anticoagulation: Transient, mild anticoagulation effects have been observed, although the extent and duration of hypocoagulation have not been determined. Avoid concurrent anticoagulation therapy.

• Iron overload: Repeat administration cycles may result in iron overload; monitor iron and serum ferritin; consider iron chelation therapy if elevated.

• Renal effects: Asymptomatic oliguria, increased nitrogen retention and reversible renal shutdown has been observed (case report) at a single dose above the recommended dose. Recommended dosage guidelines should be followed; worsening of renal function has not been observed with the recommended dose.

Disease-related concerns:

• Porphyria: Clinical benefit depends on prompt administration. Porphyria attacks may progress to result in irreversible neuronal damage. Hemin is intended to prevent attacks from becoming critical; hemin is not effective in repairing neuronal damage resulting from attacks. After discontinuation, although remission may be prolonged, acute porphyria symptoms generally return.

Dosage form specific issues:

• Human plasma: Product of human plasma; may potentially contain infectious agents that could transmit disease, including a theoretical risk of Creutzfeldt-Jakob disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to Recordati Rare Diseases at 1-888-575-8344.

• Latex: Packaging may contain natural latex rubber.

Other warnings/precautions:

• Appropriate use: Although the manufacturer's labeling recommends initial therapy with glucose (ie, 400 g/day for 1 to 2 days), glucose may be appropriate for mild cases only and hemin should be initiated early for most acute attacks, although glucose may be utilized while awaiting hemin therapy (Anderson 2005). For moderate to severe attacks, immediate hemin treatment is recommended. Follow recommended dosage; excessive single doses have resulted in reversible renal shutdown, with asymptomatic oliguria and increased nitrogen retention. Administer through a large vein (or central line) to prevent phlebitis.

• Preparation in albumin: Reconstitution in albumin 25% (instead of sterile water for injection) is recommended to prevent formation of degradation byproducts and reduce phlebitis, as well as prevent transient coagulopathy/bleeding (Anderson 2006).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Anticoagulants: Hemin may enhance the anticoagulant effect of Anticoagulants. Risk X: Avoid combination

Barbiturates: May diminish the therapeutic effect of Hemin. Risk X: Avoid combination

Estrogen Derivatives: May diminish the therapeutic effect of Hemin. Risk X: Avoid combination

Pregnancy Considerations

Use of hemin for acute attacks of porphyria during pregnancy has been described (Anderson 2005; Marsden 2010; Stein 2013). Avoid use in severe pre-eclampsia (theoretical risk of potentiation of the coagulation disorder).

Breastfeeding Considerations

It is not known if hemin is present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Prior to treatment: Urinary levels of porphobilinogen (PBG), delta aminolevulinic acid (ALA), and total porphyrin. (Note: Classical Watson-Schwartz or Hoesch tests are less reliable)

During treatment: Urinary levels of ALA, uroporphyrin (UPG), PBG, and coproporphyrin; monitor iron and serum ferritin (if receiving multiple hemin doses). Monitor serum creatinine and electrolytes (including magnesium) daily; monitor vital capacity, neurologic status, including proximal muscle strength, monitor for bladder retention, monitor for signs/symptoms of progressing porphyria (Anderson 2005). In a study where hemin was prepared in albumin 25%, vital signs were monitored every 10 to 15 minutes during infusion and for 2 hours following infusion (Bonkovsky 1991).

Mechanism of Action

Limits hepatic and/or marrow porphyrin synthesis by inhibiting synthesis of aminolevulinic acid synthase, the enzyme that regulates the porphyrin/heme pathway

Pharmacokinetics

Onset: Clinical improvement begins within 1 to 2 days if hemin is initiated early (Anderson 2005).

Excretion: Feces; urine (as metabolites)

Pricing: US

Solution (reconstituted) (Panhematin Intravenous)

350 mg (per each): $11,266.21

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Human Hemin Orphan Europe (PL);
  • Normosang (AT, CH, CZ, DK, EE, ES, FI, GB, HR, IE, JP, LT, MT, NO, PT, RO, SE, SI, SK, TW);
  • Panhematin (AU, KR)


For country code abbreviations (show table)
  1. Anderson KE, Bloomer JR, Bonkovsky HL, et al. Recommendations for the diagnosis and treatment of the acute porphyrias [published correction appears in Ann Intern Med. 2015;143(4):316]. Ann Intern Med. 2005;142(6):439-450. [PubMed 15767622]
  2. Anderson KE, Bonkovsky HL, Bloomer JR, Shedlofsky SI. Reconstitution of hematin for intravenous infusion. Ann Intern Med. 2006;144(7):537-538. [PubMed 16585674]
  3. Bonkovsky HL, Healey JF, Lourie AN, Gerron GG. Intravenous heme-albumin in acute intermittent porphyria: evidence for repletion of hepatic hemoproteins and regulatory heme pools. Am J Gastroenterol. 1991;86(8):1050-1056. [PubMed 1713408]
  4. Marsden JT, Rees DC. A retrospective analysis of outcome of pregnancy in patients with acute porphyria. J Inherit Metab Dis. 2010;33(5):591-596. [PubMed 20567908]
  5. Panhematin (hemin) [prescribing information]. Lebanon, NJ: Recordati Rare Diseases Inc; May 2020.
  6. Stein P, Badminton M, Barth J, et al; British and Irish Porphyria Network. Best practice guidelines on clinical management of acute attacks of porphyria and their complications. Ann Clin Biochem. 2013;50(pt 3):217-223. [PubMed 23605132]
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