hemin (Rx)

Brand and Other Names:Panhematin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • ~301mg/vial
  • ~7mg/mL (after reconstitution)
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Acute Intermittent Porphyria

Indicated for amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle susceptible women

Similar efficacy reported in other patients with acute intermittent porphyria, porphyria variegata, and hereditary coproporphyria

Before administering hemin, consider an appropriate period of alternate therapy (ie, 400 g glucose/day for 1-2 days); if improvement is unsatisfactory, then initiate hemin

1-4 mg/kg/day IV infused over 10-15 minutes for 3-14 days based on the clinical signs

In more severe cases this dose may be repeated no earlier than q12hr

Not to exceed 6 mg/kg/24 hr

Dosing Considerations

Confirm presence of acute porphyria by presence of clinical symptoms and a positive Watson-Schwartz or Hoesch test

May monitor declining urinary concentrations of aminolevulinic acid, uroporphyrinogen, porphobilinogen, and coproporphyrin to demonstrate hemin’s efficacy

<16 years: Safety and efficacy not established

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Adverse Effects

Frequency Not Defined

Phlebitis with or without leucocytosis or pyrexia when administered through small arm veins

Postmarketing Reports

Reversible renal shutdown has occurred with excessive doses

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Warnings

Black Box Warnings

Only be used by physicians experienced in the management of porphyrias in hospitals where the recommended clinical and laboratory diagnostic and monitoring techniques are available

Hemin therapy should be considered after an appropriate period of alternate therapy (ie, 400 g glucose/day for 1-2 days)

Contraindications

Hypersensitivity

Cautions

Made from human blood; may carry risk of infectious agents including Creutzfeldt-Jakob disease

Clinical benefit from hemin depends on prompt administration; attacks of porphyria may progress to a point where irreversible neuronal damage has occurred; hemin therapy is intended to prevent an attack from reaching the critical stage of neuronal degeneration and is not effective in repairing neuronal damage

May increase iron and serum ferritin levels

Not indicated in porphyria cutanea tarda

Reversible renal shutdown has been observed in a case where an excessive hematin dose (12.2 mg/kg) was administered in a single infusion; treatment of this case consisted of ethacrynic acid and mannitol

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Limits rate of hepatic and/or marrow porphyria/heme biosynthesis, possibly by inhibiting the enzyme aminolevulinic acid synthetase

Also exhibited transient, mild anticoagulant effects during clinical trials

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Administration

IV Preparation

Reconstitute lyophilized powder by aseptically adding 43 mL of sterile water for injection

Immediately after adding diluent, vigorously shake vial for 2-3 minutes to aid dissolution

The reconstituted solution 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

Contains no preservative and undergoes rapid chemical decomposition in solution; do not reconstitute until immediately before use

After the first withdrawal from the vial, any solution remaining must be discarded

IV Administration

Infuse IV over 10-15 minutes

Administer via large arm vein or central venous catheter to avoid phlebitis

Terminal filtration advised

Storage

Unreconstituted lyophilized powder: Store at controlled room temperature of 20-25°C (68-77°F)

Reconstituted solution: Contains no preservative and undergoes rapid chemical decomposition; use immediately and do not store

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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