Pronunciation:

HEM-in

Brand Names:

• Panhematin

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Blood Modifier Agent

Uses of This Medicine:

Hemin injection is used to reduce the repeated attacks of porphyria (blood disorder) in some women during their menstrual periods after other treatments (eg, carbohydrate therapy) did not work.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hemin in children 16 years of age and older. Safety and efficacy have not been established in children younger than 16 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hemin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bosentan
• Carbamazepine
• Dexamethasone
• Efavirenz
• Enzalutamide
• Etravirine
• Fosphenytoin
• Lumacaftor
• Mitotane
• Modafinil
• Nafcillin
• Nevirapine
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Prednisone
• Primidone
• Rifabutin
• Rifampin
• Ritonavir
• St John's Wort

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Use with caution. May make this condition worse.

• Pre-eclampsia (high blood pressure during pregnancy), severe—Avoid use with this medicine. May increase the risk of bleeding.

Proper Use of This Medicine:

Your doctor or other healthcare provider will give you this medicine. This medicine is given through a needle placed into one of your veins. It should be given slowly, so the needle will have to stay in place for at least 30 minutes.

Before starting treatment with this medicine, your doctor will test you for the presence of an acute porphyria attack. It is important for you to work closely with your doctor during your treatment.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause a vein inflammation where the needle was placed. Check with your doctor if you have bluish skin color, pain, swelling, or tenderness at the injection site, or swelling of the foot or leg.

Hemin injection may increase iron levels in the blood. Talk to your doctor if you have concerns.

Check with your doctor if you have a decrease in the amount of your urine. This may be a symptom of a kidney problem.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Bluish color

changes in skin color

fever

itching, pain, redness, swelling, tenderness, or warmth on the skin

redness or pain at the catheter site

swelling of the foot or leg tenderness

Incidence not known

Back pain

black, tarry stools

bleeding gums

blood in the urine or stools

dark urine

decreased urination

dizziness

fainting

fever

irregular heartbeat

lightheadedness

pinpoint red spots on the skin

stomach pain

tiredness

unusual bleeding or bruising

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

Less common

Rash

Incidence not known

Dry, red, hot, or irritated skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.