Panhematin (hemin) dosing, indications, interactions, adverse effects, and more

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Sections hemin
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
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Patient Handout
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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

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

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

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.

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

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

Images

No images available for this drug.

Patient Handout

HEMIN - INJECTION

(HEE-min)

COMMON BRAND NAME(S): Panhematin

USES: This medication is used to treat the symptoms that occur with certain blood disorders (porphyrias). Hemin is not a cure for porphyria. 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.

HOW TO USE: This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once daily.The dosage is based on your weight, medical condition, and response to treatment.

SIDE EFFECTS: Discoloration of the skin or pain, tenderness, or swelling along your veins may occur. If any of these effects last or get worse, tell 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 you have any serious side effects, including: easy bruising/bleeding.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication. Consult your doctor or pharmacist for more information.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).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: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: barbiturates (such as pentobarbital, phenobarbital), "blood thinners" (anticoagulants such as heparin, warfarin), corticosteroids (such as prednisone), estrogens.

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: Lab and/or medical tests (such as iron/ferritin levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

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.

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.

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.

View explanations for tiers and restrictions

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.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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Sections hemin
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
Images
Patient Handout
Formulary

hemin (Rx)