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

Watch this video to learn about the Panhematin PL program:

Learn about the PANHEMATIN PL program and how to enroll

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

COMPLETE the AIP MEDICAL EMERGENCY LETTER

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

DOWNLOAD TO A MOBILE DEVICE:
AIP Medical Emergency Letter

Instructional video: How to add the AIP Medical Emergency Letter to a mobile device

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

Financial Assistance

COPAY ASSISTANCE

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

PATIENT ASSISTANCE PROGRAM (PAP)

— Assisting qualified uninsured and underinsured patients with gaining 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

INDICATION(S) AND IMPORTANT SAFETY INFORMATION

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.

IMPORTANT SAFETY INFORMATION

PANHEMATIN is contraindicated in patients with known hypersensitivity to this drug.

Risk of Phlebitis: Phlebitis is possible. Utilize a large arm vein or a central venous catheter for administration to minimize the risk of phlebitis.

Iron and Serum Ferritin: Elevated iron and serum ferritin may occur. Monitor iron and serum ferritin in patients receiving multiple administrations of PANHEMATIN.

Anticoagulant Effects: PANHEMATIN has transient and mild anticoagulant effect. Avoid concurrent anticoagulant therapy.

Renal Effects: Reversible renal shutdown has been observed with an excessive hematin dose (12.2 mg/kg in a single infusion). Strictly follow recommended dosage guidelines.

Transmissible Infectious Agents: PANHEMATIN may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in the product.

The most common adverse reactions (>1% of patients) are headache, pyrexia, infusion site reactions, and phlebitis.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions: 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.

PANHEMATIN^® (hemin for injection), for intravenous infusion only, is available as powder for reconstitution in 350 mg vials.

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

Watch this video to learn about the Panhematin PL program: