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

Resources for Your Patients

These resources may help your patients get access to the medication and information they need.

Access & Reimbursement:
The PANHEMATIN Support Program

The Recordati Rare Diseases PANHEMATIN Support Program is available to assist you and your patients with:

    Access and Reimbursement Support

  • Benefits investigation
    —
    Determining whether the patient’s insurance will cover PANHEMATIN
  • Insurance counseling
    —
    Helping your patients explore other insurance options if they are uninsured or do not have favorable coverage for PANHEMATIN
  • Claims support
    —
    Appealing denied or underpaid claims for PANHEMATIN
  • Prior authorizations/appeals
    —
    Facilitating the prior authorization process by determining requirements, coordinating paperwork, and following up on the final decision
  • Reimbursement support
    —
    Assisting with inquiries regarding coverage and reimbursement as they relate to PANHEMATIN

    • Financial Assistance

  • Copay assistance
    —
    Assisting eligible patients who receive PANHEMATIN infusions in outpatient care settings with their insurance copays
  • Patient Assistance Program (PAP)
    —
    Assisting qualified uninsured and underinsured patients to gain access to PANHEMATIN

Contact the Recordati Rare Diseases
Patient Support Program for Assistance

Monday-Friday between 9:00 a.m. and 5:00 p.m. ET:

Phone: 866-209-7604 Fax: 866-209-7599

Family discussion guide for patients with AIP

Discussing AIP with Your Family is a printable guide that can give your patients information they need to talk about AIP with family members.

Discussing AIP with Your Family
DOWNLOAD THE DISCUSSION GUIDE

Resources for education and support

Whether your patients are newly diagnosed or have been living with AIP for some time, they are likely to have many questions and concerns. The resources below are appropriate for your practice as well as your patients.

The American Porphyria Foundation educates physicians and the general public, raises funds for research, and advocates for better policy and patient care.

VISIT SITE

The Porphyrias Consortium, part of the Rare Diseases Clinical Research Network founded by the NIH, benefits patients and physicians by enabling a large-scale collaborative effort to develop new strategies and methods for diagnosis, treatment, and prevention of illness and disability resulting from these rare disorders.

VISIT SITE

The National Organization for Rare Diseases (NORD) is a federation of voluntary health organizations dedicated to helping people with rare "orphan" diseases.

VISIT SITE
Dosing & Administration Get step-by-step instructions
About PANHEMATIN Review efficacy and safety data

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

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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.


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