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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.