Panhematin

What is Panhematin used for?

Panhematin is a prescription medicine that is used to treat acute intermittent porphyria.

Description

PANHEMATIN (hemin for injection) is an enzyme inhibitor derived from processed red blood cells. Hemin for injection was known previously as hematin. The term hematin has been used to describe the chemical reaction product of hemin and sodium carbonate solution. Hemin and hematin are iron containing metalloporphyrin complexes with either bound chloride or hydroxide ions, respectively. Chemically hemin is represented as chloro [7,12-diethenyl-3,8,13,17-tetramethyl- 21H,23H-porphine-2,18-dipropanoato(2-)-N21,N22,N23,N24] iron. The structural formula for hemin is:

PANHEMATIN is formatted as a sterile, lyophilized powder for intravenous administration after reconstitution. Each dispensing vial of PANHEMATIN contains the equivalent of 350 mg hemin, 240 mg sodium carbonate and 335 mg of sorbitol. The pH may have been adjusted with hydrochloric acid. When mixed as directed with Sterile Water for Injection, USP, each 48 mL provides the equivalent of approximately 336 mg hematin (7 mg/ mL). The product contains no preservatives.

Mechanism of Action

Heme acts to limit the hepatic and/or marrow synthesis of porphyrin. This action is likely due to the inhibition of δ-aminolevulinic acid synthetase, the enzyme which limits the rate of the porphyrin/heme biosynthetic pathway. The exact mechanism by which hematin produces symptomatic improvement in patients with acute episodes of the hepatic porphyrias has not been elucidated.

PANHEMATIN therapy for the acute porphyrias is not curative. After discontinuation of PANHEMATIN treatment, symptoms generally return although in some cases remission is prolonged. Some neurological symptoms have improved weeks to months after therapy although little or no response was noted at the time of treatment.

Before taking Panhematin, tell your doctor:

• If you are allergic to Panhematin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Barbiturates like phenobarbital, blood thinners, estrogens like some birth control pills, or steroids like prednisone.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Panhematin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Panhematin?

• Tell all of your health care providers that you take Panhematin. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Panhematin while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Panhematin best taken?

Use Panhematin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Panhematin that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Panhematin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Irritation where the shot is given.
• Fever.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store Panhematin at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• NDC 55292-702-54      Single Dose Vial
• Hemin For Injection
  Panhematin®
• 350 mg
  Hemin per Vial
• For Intravenous Infusion Only
  Sterile Powder for Injection
• RECORDATI
  RARE DISEASES
  GROUPRx only
• PCR-780-09239-1Lot:Exp:

• NDC 55292-702-55       Contains One Vial
• Hemin For Injection
  Panhematin®
• 350 mg
  Hemin per Vial
• For Intravenous Infusion Only
  Sterile Powder for Injection
• RECORDATI
  RARE DISEASES
  GROUPRx only.
• GTIN   XXXXXXXXXXXXXX
  SN       XXXXXXXXXXXX
  LOT     XXXXXXX
  EXP     MMM YYYY
• PCR-710-09242-3

SRC: NLM .