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)

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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Images

No images available for this drug.
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Patient Handout

Patient Education
hemin intravenous

HEMIN FOR INJECTION

(HEE-min)

COMMON BRAND NAME(S): Panhematin

USES: This medication is used to treat the symptoms that occur with certain blood disorders (porphyrias). Other treatments are recommended for trial before using hemin, also called hematin.Hemin is not a cure for porphyria. In some cases, this medication may relieve symptoms such as pain, high blood pressure, rapid heartbeat, or mental changes that may occur during an acute attack of porphyria. If you have any questions about the use of this medication, consult your doctor.

HOW TO USE: This medication should only be given in a hospital or clinic setting where you can be monitored closely. It is given by injection into a vein as directed by your doctor, usually once daily.The dosage is based on your weight, medical conditions, and response to therapy.

SIDE EFFECTS: Discoloration of the skin or pain, tenderness, or swelling along your veins may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these highly unlikely but very serious side effects occur: easy bruising or bleeding.A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using hemin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Though unlikely, it is possible for this medication to contain substances that could cause infections because it is made from human plasma. Notify your doctor right away if you develop early signs of an infection such as a persistent sore throat or fever, yellowing eyes or skin, or dark urine.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: barbiturates (e.g., pentobarbital, phenobarbital), "blood thinners" (anticoagulants such as heparin, warfarin), corticosteroids (e.g., prednisone), estrogens.Do not start or stop any medicine without doctor or pharmacist approval.This document does not contain all possible interactions. Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: signs of kidney problems (such as change in the amount of urine).

NOTES: Laboratory and/or medical tests (e.g., blood tests, urine tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.This drug will not fix nerve damage that can occur with untreated acute porphyria attacks. If given early enough, though, it can decrease the amount of permanent nerve damage.

MISSED DOSE: If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Information last revised September 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.