One-stop Patient Support
Chiesi Total CareSM is a comprehensive support program that provides service for you and your patients.
Because of the risk of anti--metreleptin antibodies with neutralizing activity and risk of lymphoma, Myalept® (metreleptin) is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Myalept REMS Program.
To enroll your patients in Chiesi Total Care*, complete the Myalept REMS prescriber training module and Myalept REMS Program Prescriber Enrollment Form online and fax the completed form to 1-877-328-9682.
Call toll free:
1-855-669-2537
*Chiesi Total Care provides non-financial assistance to patients with and without prescription drug coverage.
Lorelai, actual Myalept patient, and family
Myalept REMS Program
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associates with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits fo the drug outweigh its risks.
STEP 1
Complete REMS certification
Visit the Myalept REMS Program website to review the Myalept REMS Program introductory information, complete the online Myalept REMS training program, and fill out the Prescriber Enrollment Form.
STEP 2
Write the prescription
A prescription for Myalept can only be written on the Myalept REMS Authorization Form. Complete, sign, and fax the completed form to 1-877-328-9682 for each new prescription.
STEP 3
Let your patients know they will be receiving a call from Chiesi Total Care
A member of the Chiesi Total Care team will contact patients to complete and fulfill their prescriptions for Myalept.
The Chiesi Total Care Program Assists With:
Commercial insurance
If your patients have private insurance through their job or their own business
Government insurance
If your patients have Medicare, Medicaid, Veterans Affairs Healthcare, or other similar government insurance
No insurance
If your patients have no insurance, they may be eligible for additional financial assistance
The dedicated Chiesi Total Care team is made up of:
- Pharmacists
- Patient Service Coordinators
- Reimbursement Support Specialists
- Nursing and injection support
Worry-free refills
A pharmacist is always available and medication is delivered right to your patient’s door
Prior Authorization and Appeals
Raeya, actual Myalept patient and caregiver
Download a Myalept Starter Kit today
If you are ready to start a patient on Myalept, a Myalept Starter Kit can help streamline the process. The Kit provides you with everything you need to get a patient started on Myalept including:
Prior Authorization and Appeals Guide
Contact Information
Phone
Fax
1-877-328-9682
Hours of operation
Monday to Friday
8:00 AM – 8:00 PM (Eastern Standard Time)
Location
Accredo Health Group, Inc. c/o The Myalept Program, 1640 Century Center Parkway Memphis, TN 38134
Troy, actual Myalept patient
Helpful Links
Myalept (metreleptin) for injection
Indication and Important Safety Information
INDICATION: MYALEPT®(metreleptin) for injection is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
LIMITATIONS OF USE: The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy or for the treatment of liver disease, including non-alcoholic steatohepatitis (NASH), have not been established.
MYALEPT is not indicated for use in patients with HIV-related lipodystrophy. MYALEPT is not indicated for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of generalized lipodystrophy.
WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences of these neutralizing antibodies are not well characterized but could include inhibition of endogenous leptin action and/or loss of MYALEPT efficacy. Severe infection and/or worsening metabolic control have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients who develop severe infections or show signs suspicious for loss of MYALEPT efficacy during treatment. Contact Chiesi Farmaceutici S.p.A. at 1-888-661-9260 for neutralizing antibody testing of clinical samples.
T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with MYALEPT. Carefully consider the benefits and risks of treatment with MYALEPT in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy.
Because of these risks associated with the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT and the risk for lymphoma, MYALEPT is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYALEPT REMS PROGRAM.
CONTRAINDICATIONS: MYALEPT is contraindicated in general obesity not associated with congenital leptin deficiency. MYALEPT has not been shown to be effective in treating general obesity. The development of anti-metreleptin neutralizing antibodies have been reported in obese patients treated with MYALEPT. MYALEPT is contraindicated in patients with prior severe hypersensitivity reactions to metreleptin or to any of its components.
WARNINGS AND PRECAUTIONS: A dose adjustment, including possible large reductions, of insulin or insulin secretagogue may be necessary in some patients to minimize risk of hypoglycemia. Closely monitor blood glucose in patients on concomitant insulin, especially those on high doses, or insulin secretagogue.
Cases of progression of autoimmune hepatitis and membranoproliferative glomerulonephritis (associated with massive proteinuria and renal failure) were observed in some patients with acquired generalized lipodystrophy treated with MYALEPT. A causal relationship between MYALEPT and the development and/or progression of autoimmune disease has not been established. Carefully consider the benefits and risks of MYALEPT treatment in patients with autoimmune disease.
Hypersensitivity reactions (eg, anaphylaxis, urticaria or generalized rash) have been reported. Patient should promptly seek medical advice about discontinuation of MYALEPT if a hypersensitivity reaction occurs.
MYALEPT contains benzyl alcohol when reconstituted with Bacteriostatic Water for Injection. The preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients, particularly in neonates and premature infants. Preservative-free Water for Injection is recommended for use in neonates and infants.
ADVERSE REACTIONS: Most common adverse reactions (≥10%) in clinical trials were headache, hypoglycemia, decreased weight, and abdominal pain.
Please see full Prescribing Information. including Boxed Warning.
Indication and Important Safety Information
INDICATION: MYALEPT®(metreleptin) for injection is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
LIMITATIONS OF USE: The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy or for the treatment of liver disease, including non-alcoholic steatohepatitis (NASH), have not been established.
MYALEPT is not indicated for use in patients with HIV-related lipodystrophy. MYALEPT is not indicated for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of generalized lipodystrophy.
WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences of these neutralizing antibodies are not well characterized but could include inhibition of endogenous leptin action and/or loss of MYALEPT efficacy. Severe infection and/or worsening metabolic control have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients who develop severe infections or show signs suspicious for loss of MYALEPT efficacy during treatment. Contact Chiesi Farmaceutici S.p.A. at 1-888-661-9260 for neutralizing antibody testing of clinical samples.
T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with MYALEPT. Carefully consider the benefits and risks of treatment with MYALEPT in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy.
Because of these risks associated with the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT and the risk for lymphoma, MYALEPT is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYALEPT REMS PROGRAM.
CONTRAINDICATIONS: MYALEPT is contraindicated in general obesity not associated with congenital leptin deficiency. MYALEPT has not been shown to be effective in treating general obesity. The development of anti-metreleptin neutralizing antibodies have been reported in obese patients treated with MYALEPT. MYALEPT is contraindicated in patients with prior severe hypersensitivity reactions to metreleptin or to any of its components.
WARNINGS AND PRECAUTIONS: A dose adjustment, including possible large reductions, of insulin or insulin secretagogue may be necessary in some patients to minimize risk of hypoglycemia. Closely monitor blood glucose in patients on concomitant insulin, especially those on high doses, or insulin secretagogue.
Cases of progression of autoimmune hepatitis and membranoproliferative glomerulonephritis (associated with massive proteinuria and renal failure) were observed in some patients with acquired generalized lipodystrophy treated with MYALEPT. A causal relationship between MYALEPT and the development and/or progression of autoimmune disease has not been established. Carefully consider the benefits and risks of MYALEPT treatment in patients with autoimmune disease.
Hypersensitivity reactions (eg, anaphylaxis, urticaria or generalized rash) have been reported. Patient should promptly seek medical advice about discontinuation of MYALEPT if a hypersensitivity reaction occurs.
MYALEPT contains benzyl alcohol when reconstituted with Bacteriostatic Water for Injection. The preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients, particularly in neonates and premature infants. Preservative-free Water for Injection is recommended for use in neonates and infants.
ADVERSE REACTIONS: Most common adverse reactions (≥10%) in clinical trials were headache, hypoglycemia, decreased weight, and abdominal pain.
Please see full Prescribing Information. including Boxed Warning.
