Hemin

Hemin is made from red blood cells that come from human blood. Hemin works by reducing the production of a specific enzyme in the body.

Hemin is used to treat the symptoms of occasional attacks of porphyria linked to the menstrual cycle in women. Hemin helps manage symptoms such as pain, increased heart rate or blood pressure, and changes in mental status.

Hemin should not be used to treat porphyria that affects the skin, which is known as porphyria cutanea tarda.

Hemin is not a cure for porphyria. It will only help control the symptoms of a porphyria episode.

Hemin may also be used for purposes not mentioned in this medication guide.

Before you start treatment with hemin, your doctor may perform tests to ensure you are having an actual porphyria attack.

Hemin is usually given after other medicines to treat porphyria have been used for a certain amount of time.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Using too much hemin could harm your kidneys.

Hemin is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

For best results, start using hemin at the first sign of a porphyria attack.

You may need to use hemin once or twice per day for up to 2 weeks, depending on how your body responds to the medicine.

Hemin is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Prepare your dose only when you are ready to give an injection.

After mixing the powder with the diluent, shake the mixture for 2 to 3 minutes.

Give the injection right away after mixing. Do not save it for later use. Throw away any unused mixture after one use. The hemin and diluent mixture does not contain a preservative.

While using hemin, you may need frequent blood and urine tests.

Store at cool room temperature away from moisture and heat.

Follow all directions on your medicine label and package.

Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use hemin if you are allergic to it.

To make sure hemin is safe for you, tell your doctor if you have:

• iron overload syndrome (hemochromatosis);
• if you take iron supplements; or
• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

Hemin is made from human plasma (part of the blood), which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

It is not known whether hemin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether hemin passes into breast milk or if it could affect a nursing baby. Tell your doctor if you are breast-feeding a baby.

Hemin is not approved for use by anyone younger than 16 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Hemin may cause serious side effects. Stop using hemin and call your doctor immediately if you experience:

• swelling, pain, or irritation around the IV needle;
• easy bruising or bleeding (nosebleeds, bleeding gums);
• little or no urinating; or
• swelling, rapid weight gain, or feeling short of breath.

This is not a complete list of side effects and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Porphyria:

1 to 4 mg/kg/day IV over at least 30 minutesMaximum dose: 6 mg/kg per 24 hoursDuration: For 3 to 14 days based on clinical signsComments: -In severe cases, dose may be repeated every 12 hours.Use: This drug is indicated for the amelioration 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

Usual Pediatric Dose for Porphyria:

16 years and older:1 to 4 mg/kg/day IV over at least 30 minutesMaximum dose: 6 mg/kg per 24 hoursDuration: For 3 to 14 days based on clinical signsComments:-In severe cases, dose may be repeated every 12 hoursUse: This drug is indicated for the amelioration 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

Call your doctor for instructions if you forget to take a dose of hemin.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor about all the medicines you are currently taking and any you start or stop using, especially:

• birth control pills or hormone replacement therapy;
• a blood thinner—warfarin, Coumadin, Jantoven;
• a steroid medicine—prednisone, dexamethasone, methylprednisolone, and others; or
• a barbiturate—butabarbital, phenobarbital, and others.

This list is not complete. Other drugs may interact with hemin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.