Important Safety Information
Prescribing Information
Indications and Usage
For Healthcare Professionals For Patients

PANHEMATIN Dosing

  • Attacks of porphyria may progress to a point where irreversible neuronal damage has occurred. PANHEMATIN therapy is intended to prevent an attack from reaching the critical stage of neuronal degeneration. PANHEMATIN is not effective in repairing neuronal damage.
  • PANHEMATIN should only be used by or in consultation with physicians experienced in the management of porphyrias.
  • Before PANHEMATIN therapy is begun, the presence of acute porphyria must be diagnosed using the following criteria:
    1. Presence of clinical symptoms suggestive of acute porphyric attack.
    2. Quantitative measurement of porphobilinogen (PBG) in urine.

  • PANHEMATIN is for intravenous use only. Dose is 1 to 4 mg/kg/day for 3-14 days based on the clinical signs
  • Standard dose in clinical practice is 3 to 4 mg/kg/day.
  • Repeat dose in more severe cases no earlier than every 12 hours. Do not exceed 6 mg/kg in any 24-hour period.

Calculating the dose of reconstituted
PANHEMATIN for infusion

When PANHEMATIN is reconstituted with 48 mL Sterile Water for Injection, USP, it contains the equivalent of ~336 mg hematin
at a concentration of 7 mg/mL.1

mL to infuse =

Prescribed Dosage (mg/kg) x Patient Weight (kg)

7 mg/mL Concentration of Reconstituted PANHEMATIN

PANHEMATIN Administration

  • Reconstitute PANHEMATIN by adding 48 mL of Sterile Water for Injection, USP.
  • Because PANHEMATIN contains no preservative and undergoes rapid chemical decomposition in solution, it must be reconstituted immediately before use.
  • Administer over a period of at least 30 minutes

PANHEMATIN Administration Video

View this step-by-step tutorial on how to administer PANHEMATIN to a patient with AIP, including dose calculations.

PANHEMATIN Administration Guide

Download this step-by-step guide to dosing, preparation, and infusion.


DOWNLOAD GUIDE

Ordering PANHEMATIN

Contact:

Your primary wholesaler, or

ASD Healthcare:

Ordering Tips:

Orders placed Monday – Thursday by 6:30 PM central time:

  • Sent UPS Next Day Air Saver for mid-afternoon delivery

Orders placed Friday by 6:00 PM central time:

  • Sent UPS Next Day Air Saver for Monday mid-afternoon delivery
  • For next day delivery, Saturday delivery must be requested

Earlier, same day, and weekend delivery are available with an additional shipping cost

Include any specific delivery instructions when ordering

How supplied

PANHEMATIN is supplied as a sterile, lyophilized black powder in single dose dispensing vials (NDC 55292-702-54) in a carton (NDC 55292-702-55).

The vial stopper contains natural rubber latex.

Store lyophilized powder at 20-25°C (68-77°F).

Resources for Your Patients Help your patients access support

Indications And Usage

PANHEMATIN® is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible 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 neuronal damage has occurred. PANHEMATIN therapy is intended to prevent an attack from reaching the critical stage of neuronal degeneration. PANHEMATIN is not effective in repairing neuronal damage.

Indications and Important
Safety Information

+ See More

Indications And Usage

PANHEMATIN® is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be inadequate.

Important Safety Information

  • Do not use in patients with known hypersensitivity to PANHEMATIN.
  • Phlebitis is possible. Utilize a large arm vein or a central venous catheter for administration to minimize the risk of phlebitis.
  • Elevated iron and serum ferritin may occur. Monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN.
  • PANHEMATIN has transient and mild anticoagulant effect. Avoid concurrent anticoagulant therapy.
  • Reversible renal shutdown has been observed with an excessive hematin dose (12.2 mg/kg in a single infusion). Strictly follow recommended dosage guidelines.
  • PANHEMATIN may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • Most common adverse reactions in >1% of patients are headache, pyrexia, infusion site reactions, and phlebitis.
  • To report SUSPECTED ADVERSE EFFECTS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1800-FDA-1088 or www.fda.gov/medwatch.
  • Avoid CYP inducing drugs such as estrogens, barbituric acid derivatives and steroid metabolites which induce δ‑aminolevulinic acid synthetase 1 (ALAS1) through a feedback mechanism.

For more information, please see Full Prescribing Information at www.recordatirarediseases.com.


References

  1. PANHEMATIN® package insert. Recordati Rare Diseases Inc., Lebanon, NJ 08833 USA; 2017

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