Important Safety Information | Prescribing Information | Indications and Usage | Medical Information | Report An Adverse Event
Important Safety Information
Prescribing Information | Indications & Usage
Medical Information | Report An Adverse Event
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For U.S. Healthcare Professionals For U.S. Patients

Resources for Patients

Patient Liaison (PL) Program


The Patient Liaison* will call enrolled patients to:

1Provide education and answer questions about AIP and PANHEMATIN

2Help patients if issues arise accessing PANHEMATIN

3Connect patients with other resources regarding AIP

Calls are available in English and Spanish. Translation services can be utilized for other languages.

*These services are provided at no additional cost to your patients by Recordati Rare Diseases to help them manage their PANHEMATIN therapy. Information provided by the PL program is for educational purposes only and is not intended to replace the advice of patients' healthcare providers.

To get started, your patients can complete the program enrollment opt-in form:

COMPLETE THE OPT-IN FORM

To learn more about the PL program, watch these videos

Video 1:Introducing the Patient Liaison program for patients using PANHEMATIN
Video 2:Meet Helga, a Patient Liaison for patients using PANHEMATIN
Video 3:How the PANHEMATIN Patient Liaison program has helped individuals and families

Resources for your patients to help them prepare for AIP attacks

Living with AIP can be challenging, but having a plan in place will allow your patients to focus on getting the care they need when they have an AIP attack.

DOWNLOAD an AIP ATTACK PLAN

template for your patients to fill out with key action steps and contact information

DOWNLOAD an EMERGENCY PROTOCOL LETTER

template for your patients to have on hand if they need to seek emergency care

PANHEMATIN Patient Support Program

Contact the Recordati Rare Diseases Patient Support Program for Assistance

Monday-Friday between 9:00 AM and 5:00 PM ET

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

Access and Reimbursement Support

BENEFITS INVESTIGATION

— Determining whether the patient's insurance will cover 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


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


Financial Assistance

COPAY ASSISTANCE

— Assisting eligible patients who receive PANHEMATIN infusions in outpatient settings with their insurance copays

CLAIMS SUPPORT

— Assisting qualified uninsured and underinsured patients gain access to PANHEMATIN

Advocacy Support

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

The United Porphyrias Association is committed to improving the quality of life of people with porphyria and focuses on advancing disease awareness, research, and therapies.

VISIT SITE
About PANHEMATIN Review Efficacy and Safety Data
Resources for Patients Review Signs and Symptoms

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 1-800-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 PANHEMATIN Full Prescribing Information at www.recordatirarediseases.com.

Important Safety Information

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