Panhematin is made of red blood cells processed from human blood. This medicine works by lowering the production of a certain enzyme in the body.

Panhematin is used to treat the symptoms of occasional attacks of porphyria related to the menstrual cycle in women. This medicine helps control symptoms such as pain, increased heart rate or blood pressure, and changes in mental status.

Panhematin should not be used to treat porphyria that affects the skin, also called porphyria cutanea tarda.

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

Panhematin may also be used for purposes not listed in this medication guide.

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.

Before you start treatment with Panhematin, your doctor may perform tests to make sure you are having an actual porphyria attack.

Panhematin is usually given after other medicines to treat porphyria have been given 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 Panhematin could harm your kidneys.

Panhematin 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 Panhematin at the first sign of a porphyria attack.

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

Panhematin 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 Panhematin and diluent mixture does not contain a preservative.

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

Store at cool room temperature away from moisture and heat.

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

To make sure Panhematin 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.

Panhematin 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 it 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 Panhematin 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.

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

Call your doctor for instructions if you miss a dose of Panhematin.

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.

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

Panhematin may cause serious side effects. Stop using Panhematin and call your doctor at once if you have:

• swelling, pain, or irritation around the IV needle;

• easy bruising or bleeding (nosebleeds, bleeding gums);

• little or no urinating; or

• swelling, rapid weight gain, feeling short of breath.

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

Tell your doctor about all your current medicines 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.