About PANHEMATIN | PANHEMATIN® (hemin for injection)

About PANHEMATIN

PANHEMATIN is the only FDA-approved medicine indicated to relieve repeated acute intermittent porphyria (AIP) attacks that are in progress.

PANHEMATIN (hemin for injection) is a prescription medicine used to relieve repeated attacks of acute intermittent porphyria related to the menstrual cycle in affected women, after initial carbohydrate therapy is known or suspected to be inadequate.

How It Works Taking PANHEMATIN

How It Works

Hemin, the active ingredient of PANHEMATIN, is a form of heme, a molecule that carries oxygen throughout your body. PANHEMATIN slows the AIP attack cycle by helping to replenish the heme that the body is trying to produce, that in turn:

Helps to normalize the rate of heme production

Slows the build-up of the molecules that can be harmful to the body

Helps to reduce symptoms and pain

Image of a doctor talking to a woman, a patient portrayal

PANHEMATIN is proven effective in improving symptoms and reducing pain

Clinical studies of PANHEMATIN for patients with AIP attacks involved 72 patients treated with PANHEMATIN.

PANHEMATIN was shown to be effective:

In 85.5% of treatment courses, there was an improvement in symptoms and a reduction in pain.

In 100% of patients, the molecules that caused AIP symptoms to develop returned to normal levels.

Taking PANHEMATIN

If you are having an AIP attack, your doctor will determine the best course of treatment. The faster PANHEMATIN treatment is started, the better the outcome is likely to be.

For a mild attack (mild pain, no vomiting, no paralysis, no abnormally low blood sodium level, no seizures), your doctor may consider trying carbohydrates in the form of glucose. If your doctor suspects or confirms this therapy is not working, they may start you on PANHEMATIN therapy.

For a moderate to severe attack (severe or prolonged pain, persistent vomiting, and other serious symptoms), your doctor may begin PANHEMATIN treatment right away.

Image of woman holding her stomach, a patient portrayal.

How is PANHEMATIN administered?

PANHEMATIN is given through an IV infusion into a large arm vein or a central venous catheter line. PANHEMATIN should not be given through small arm veins since vein inflammation has been reported. PANHEMATIN should be given by infusion over a period of at least 30 minutes. Infusions can be done on an inpatient basis at a hospital or on an outpatient basis at an infusion center or doctor’s office.

Treatment can last for 3-14 days, depending on how your symptoms improve. Your doctor will continually monitor your condition while you are treated with PANHEMATIN. Depending on your signs and symptoms, you may need different types of treatment in addition to PANHEMATIN.

What is PANHEMATIN?

PANHEMATIN (hemin for injection) is a prescription medicine used to relieve repeated attacks of acute intermittent porphyria related to the menstrual cycle in affected women, after initial carbohydrate therapy is known or suspected to be inadequate.

Limitations of Use

  • Before administering PANHEMATIN, consider an appropriate period of carbohydrate loading (i.e., 400 g glucose/day for 1 to 2 days).
  • Attacks of porphyria may progress to a point where irreversible nerve damage has occurred. PANHEMATIN therapy is intended to prevent an attack from reaching the critical stage of nerve breakdown. PANHEMATIN is not effective in repairing nerve damage that has already occurred.

IMPORTANT SAFETY INFORMATION

Who should not use PANHEMATIN?

Do not take PANHEMATIN if you are allergic to this drug.

Before starting PANHEMATIN, tell your healthcare provider (HCP) about all your medical conditions, including if you are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. Tell your HCP about all the...

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INDICATION(S) AND IMPORTANT SAFETY INFORMATION

What is PANHEMATIN?

PANHEMATIN (hemin for injection) is a prescription medicine used to relieve repeated attacks of acute intermittent porphyria related to the menstrual cycle in affected women, after initial carbohydrate therapy is known or suspected to be inadequate.

Limitations of Use

  • Before starting PANHEMATIN, your doctor may consider an appropriate trial of carbohydrates or sugar per day for 1 to 2 days.
  • Attacks of porphyria may progress to a point where irreversible nerve damage has occurred. PANHEMATIN therapy is intended to prevent an attack from reaching the critical stage of nerve breakdown. PANHEMATIN is not effective in repairing nerve damage that has already occurred.

IMPORTANT SAFETY INFORMATION

Who should not use PANHEMATIN?
Do not take PANHEMATIN if you are allergic to this drug.

Before starting PANHEMATIN, tell your healthcare provider (HCP) about all your medical conditions, including if you are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. Tell your HCP about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements.

What are the possible side effects of PANHEMATIN?

PANHEMATIN may cause side effects including:

  • Vein inflammation is possible. Your doctor will use a large arm vein or a central line to administer PANHEMATIN to minimize the possibility of vein inflammation.
  • Elevated iron levels may occur. Your doctor must monitor your iron levels if you receive multiple courses of PANHEMATIN.
  • PANHEMATIN has a short-term and mild blood thinning effect. Avoid blood thinners during PANHEMATIN therapy.
  • Reversible kidney shutdown has occurred when too high a dose of PANHEMATIN was given in a single dose.
  • PANHEMATIN may carry a risk of transmitting agents that can cause infections, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent or other unknown agents.

The most common side effects of PANHEMATIN include headache, fever, infusion site reactions, and vein inflammation.

These are not all the possible side effects of PANHEMATIN. Call your HCP for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch.

When taking PANHEMATIN, do not take drugs such as estrogens (e.g., oral contraceptives), barbiturates (drugs that help with sleep and used to treat epilepsy) or steroids (body hormone-like drugs), because such drugs can trigger an attack or make an attack worse.

PANHEMATIN® (hemin for injection), for intravenous infusion only, is available as powder for reconstitution in 350 mg vials.

Please see the accompanying full Prescribing Information.