Raeya, Myalept patient,is a paid spokesperson for Chiesi
Comprehensive Support for Your Patients on Myalept
Chiesi Total Care is a comprehensive support program that provides services to patients and healthcare providers. Our dedicated team is ready to assist you and your patients with services and resources, including:
Clinical Educators
GL and Myalept education and support
A dedicated team can provide your patients one-on-one education about GL and Myalept. They are here to support your patient for the duration of their treatment to help them stay on track, supporting your treatment plan for them.
Personalized nutrition consultations
A nutrition program was developed by dietitians with expertise in GL to help support your GL patients with a healthy eating plan.
A dedicated team can provide your patients one-on-one education about GL and Myalept. They are here to support your patient for the duration of their treatment to help them stay on track, supporting your treatment plan for them.
A nutrition program was developed by dietitians with expertise in GL to help support your GL patients with a healthy eating plan.
Access and Affordability
Insurance support
Contact a Chiesi Total Care Coordinator to help verify your patient's insurance coverage and walk you through the prior authorization and appeals process.
Copay program*,†
Eligible, commercially insured patients may pay as little as $0 per dispense. Please see terms and conditions for all eligibility requirements at https://chiesitotalcare.com.
Patient assistance program*
Uninsured and underinsured patients may be eligible for financial assistance through the Chiesi Total Care Patient Assistance Program.‡
Contact a Chiesi Total Care Coordinator to help verify your patient's insurance coverage and walk you through the prior authorization and appeals process.
Eligible, commercially insured patients may pay as little as $0 per dispense. Please see terms and conditions for all eligibility requirements at https://chiesitotalcare.com.
Uninsured and underinsured patients may be eligible for financial assistance through the Chiesi Total Care Patient Assistance Program.‡
*Applicants with federal and state government insurance such as Medicare, Medicaid, VA/DoD, and TRICARE are not eligible.
†This program is operated by Chiesi USA, Inc., and can be modified at any time without notice.
‡Subject to other eligibility criteria.
*Applicants with federal and state government insurance such as Medicare, Medicaid, VA/DoD, and TRICARE are not eligible.
†This program is operated by Chiesi USA, Inc., and can be modified at any time without notice.
‡Subject to other eligibility criteria.
Injection Training, Adherence, and Pharmacy Support
Injection training and adherence support
When starting your patients on Myalept, a registered nurse may be available to help your patients with injection training. Keep your patients motivated to stay on track with refill reminders and helpful tips for staying on therapy.
Myalept fulfillment support
Utilize key pharmacy services to fulfill your patient’s prescription, such as direct-to-patient medication, Myalept refills and replacement, and a 24/7 pharmacist and nurse hotline.
When starting your patients on Myalept, a registered nurse may be available to help your patients with injection training. Keep your patients motivated to stay on track with refill reminders and helpful tips for staying on therapy.
Utilize key pharmacy services to fulfill your patient’s prescription, such as direct-to-patient medication, Myalept refills and replacement, and a 24/7 pharmacist and nurse hotline.
Get Your Patients Started With Myalept
See HowINDICATION: 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 nonalcoholic 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 1-866-216-1526 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: 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 nonalcoholic 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 1-866-216-1526 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.