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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(HEE min)
Generic Available (U.S.)
No
Index Terms
Brand Names: U.S.
Pharmacologic Category
Use: Labeled Indications
Treatment of recurrent attacks of acute intermittent porphyria (AIP)
Pregnancy Risk Factor
C
Pregnancy Considerations
Animal reproduction studies have not been conducted. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit out weighs the potential risk to the fetus.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to hemin or any component of the formulation; porphyria cutanea tarda
Warnings/Precautions
Boxed warnings:
• Experienced physician: See “Other warnings/precautions” below.
• Porphyria: Appropriate use: See “Disease-related concerns” below.
Disease-related concerns:
• Porphyria: Appropriate use: [U.S. Boxed Warning]: Should only be used after an appropriate period of alternate therapy (carbohydrate loading) has been tried. Intended to prevent porphyria attacks from becoming critical; not intended to repair neuronal damage resulting from attacks.
Special populations:
• Pediatrics: Safety and efficacy have not been established in children <16 years of age.
Dosage form specific issues:
• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit 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 Ovation Pharmaceuticals at 1-800-455-1141.
• Latex: Packaging may contain natural latex rubber.
Other warnings/precautions:
• Experienced physician: [U.S. Boxed Warning]: Should be administered under the supervision of a physician experienced in the management of porphyrias.
Adverse Reactions
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
Metabolism/Transport Effects
None known.
Drug Interactions
There are no known significant interactions.
Storage
Undergoes rapid chemical decomposition in solution; prepare immediately before administration. Prior to reconstitution, store vials at 2°C to 8°C (36°F to 46°F).
Reconstitution
Immediately before use, reconstitute each vial with 43 mL sterile water for injection, resulting in a final concentration of 7 mg/mL. Shake well for 2-3 minutes to dissolve.
Mechanism of Action
Inhibits the hepatic and/or marrow synthesis of ALA synthase, the enzyme that regulates the porphyrin/heme pathway
Dosage
I.V.: Children ≥16 years and Adults: 1-4 mg/kg/day administered over 10-15 minutes for 3-14 days; may be repeated no earlier than every 12 hours; not to exceed 6 mg/kg in any 24-hour period
Administration: I.V.
Infuse over 10-15 minutes using a 0.45 micron or smaller filter. Administer through a large vein or central line to prevent phlebitis.
Monitoring Parameters
Urinary levels of delta-aminolevulinic acid (ALA), uroporphyrinogen (UPG), porphobilinogen (PBG), coproporphyrin
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
Avoid concurrent use with barbiturates
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injection, powder for reconstitution:
Panhematin®: 313 mg [contains natural rubber/natural latex in packaging; provides 7 mg/mL when reconstituted]
Injection, powder for reconstitution [preservative free]:
Panhematin®: 313 mg [DSC] [provides 7 mg/mL when reconstituted]
References
Anderson KE, Bloomer JR, Bonkovsky HL, et al, “Recommendations for the diagnosis and Treatment of the Acute Porphyrias,” Ann Intern Med, 2005, 142(6):439-50.
International Brand Names
Lexi-Comp.com
Last full review/revision January 2012
Content last modified January 2012
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