Ordering & Support | Lamzede® (velmanase alfa-tycv)

Ordering information

Healthcare providers, please download the Prescription/Nursing Order Form
FAX completed forms to: 1-855-929-2828.

For more information about ordering Lamzede, contact Chiesi Total Care^SM
PHONE: 1-855-282-4883

For billing and coding and insurance information, download the Access Resource Guide

*	For eligible patients only. To receive home infusion support, patient must be referred to home infusion by their prescribing physician. Please refer to the full Terms and Conditions for additional eligibility requirements.

One-stop patient support

Chiesi Total Care is a comprehensive support program that provides exceptional service for you and your patients.

A single call to your dedicated Chiesi Total Care Team is all it takes. They will guide you through the process of getting a patient started on Lamzede.

Chiesi Total Care provides nonfinancial assistance to patients with and without prescription drug coverage.

Get started with
Chiesi Total Care

Infusion assistance^†

Chiesi Total Care may help patients understand their medication and the infusion process, and coordinate a suitable infusion site if needed
If you determine home infusion is right for your patient, Chiesi Total Care may be able to assist eligible patients with delivery of medication and infusion supplies needed^†

Routine testing
Healthcare providers should consider monitoring for the presence of serum oligosaccharides reduction and anti-drug antibodies in patients who demonstrate hypersensitivity reactions and should consider the risks and benefits of continued treatment in patients with serum oligosaccharides reduction and anti-Lamzede antibodies. There are no marketed tests for these antibodies against Lamzede. If monitoring is warranted, Chiesi Total Care may be able to help.

^†	Patients receiving treatment or residing in MA or RI are not eligible for infusion assistance. To receive home infusion support, patient must be referred to home infusion by their prescribing physician. Please refer to the full Terms and Conditions for additional eligibility requirements.

Our goal is to support patients starting on and staying with Lamzede therapy.

Copay Programs

Chiesi Total Care offers 2 copay programs for eligible patients.^‡

To be eligible for these programs:

Your patient must be enrolled in Chiesi Total Care. (Enrollment and Authorization Form will be mailed to your patient's home)
Your patient must have commercial insurance and a valid prescription for a US FDA-approved indication for Lamzede
Your patient must be a resident of the United States or one of its territories

Please refer to the full Terms and Conditions for additional eligibility requirements.

^‡

Government-funded plans are not eligible for patient support services that provide financial support through the programs. Patients receiving treatment or residing in MA or RI are not eligible for home infusion services. To receive home infusion support, patients must be referred to home infusion by their prescribing physician.

Medical information and adverse event reporting

For adverse event reporting, product complaints, or medical information inquiries:

Phone: 1-888-661-9260
Fax: 1-866-443-3092
Email: us.medical@chiesi.com

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

Chiesi Global Rare Disease Commitment

We understand that what matters most is you. Whether you’re an individual affected by a rare disease or a caregiver, you drive us to build a better world. That’s why, after 85 years of experience, Chiesi Group launched Chiesi Global Rare Diseases in 2020. We are proud that the people at Chiesi Global Rare Diseases are motivated to help individuals impacted by rare diseases by finding treatments that are so needed.

Learn more about our commitment to help people affected by rare diseases

Learn more about Chiesi Rare Diseases

1.	Lamzede. Prescribing Information. Chiesi Farmaceutici S.p.A; 2023.
2.	Borgwardt L, Guffon N, Amraoui Y, et al. Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial. J Inherit Metab Dis. 2018;41(6):1215-1223. doi:10.1007/s10545-018-0185-0.
3.	Lund AM, Borgwardt L, Cattaneo F, et al. Comprehensive long-term efficacy and safety of recombinant human alpha-mannosidase (velmanase alfa) treatment in patients with alpha-mannosidosis. J Inherit Metab Dis. 2018;41(6):1225-1233. doi:10.1007/s10545-018-0175-2.
4.	Guffon N, Tylki-Szymanska A, Borgwardt L, et al. Recognition of alpha-mannosidosis in paediatric and adult patients: presentation of a diagnostic algorithm from an international working group. Mol Gen Metab. 2019;126(4):470-474. doi:10.1016/j.ymgme.2019.01.024.
5.	Borgwardt L, Stensland HMFR, Olsen KJ, et al. Alpha-mannosidosis: correlation between phenotype, genotype and mutant MAN2B1 subcellular localisation. Orphanet J Rare Dis. 2015;10:70. doi:10.1186/s13023-015-0286-x.
6.	Beck M, Olsen KJ, Wraith JE, et al. Natural history of alpha mannosidosis a longitudinal study. Orphanet J Rare Dis. 2013;8:88. doi:10.1186/1750-1172-8-88.
7.	Malm D, Nilssen Ø. Alpha-mannosidosis. Orphanet J Rare Dis. 2008;3:21. doi:10.1186/1750-1172-3-21.

1.	Lamzede. Prescribing Information. Chiesi Farmaceutici S.p.A; 2023.
2.	Borgwardt L, Lund AM, Dali CI. Alpha-mannosidosis—a review of genetic, clinical findings and options for treatment. Pediatr Endocrinol Rev. 2014;12(suppl1):185-191.
3.	Borgwardt L, Stensland HMFR, Olsen KJ, et al. Alpha-mannosidosis: correlation between phenotype, genotype and mutant MAN2B1 subcellular localisation. Orphanet J Rare Dis. 2015;10:70. doi:10.1186/s13023-015-0286-x.
4.	Beck M, Olsen KJ, Wraith JE, et al. Natural history of alpha mannosidosis a longitudinal study. Orphanet J Rare Dis. 2013;8:88. doi:10.1186/1750-1172-8-88.
5.	Wiesinger T, Schwarz M, Mechtler TP, et al. α-Mannosidosis—An underdiagnosed lysosomal storage disease in individuals with an ‘MPS-like’ phenotype. Mol Genet Metab. 2020;130(2):149-152. doi:10.1016/j.ymgme.2020.04.001
6.	Malm D, Nilssen Ø. Alpha-mannosidosis. Orphanet J Rare Dis. 2008;3:21. doi:10.1186/1750-1172-3-21.
7.	Guffon N, Tylki-Szymanska A, Borgwardt L, et al. Recognition of alpha-mannosidosis in paediatric and adult patients: presentation of a diagnostic algorithm from an international working group. Mol Gen Metab. 2019;126(4):470-474. doi:10.1016/j.ymgme.2019.01.024.

1.	Lamzede. Prescribing Information. Chiesi Farmaceutici S.p.A; 2023.
2.	Guffon N, Tylki-Szymanska A, Borgwardt L, et al. Recognition of alpha-mannosidosis in paediatric and adult patients: presentation of a diagnostic algorithm from an international working group. Mol Gen Metab. 2019;126(4):470-474. doi:10.1016/j.ymgme.2019.01.024.
3.	Wiesinger T, Schwarz M, Mechtler TP, et al. α-Mannosidosis—An underdiagnosed lysosomal storage disease in individuals with an ‘MPS-like’ phenotype. Mol Genet Metab. 2020;130(2):149-152. doi:10.1016/j.ymgme.2020.04.001
4.	Malm D, Nilssen Ø. Alpha-mannosidosis. Orphanet J Rare Dis. 2008;3:21. doi:10.1186/1750-1172-3-21.

1.	Lamzede. Prescribing Information. Chiesi Farmaceutici S.p.A; 2023.
2.	Borgwardt L, Lund AM, Dali CI. Alpha-mannosidosis – a review of genetic, clinical findings and options for treatment. Pediatr Endocrinol Rev. 2014;12(suppl1):185-191.
3.	The natural history of alpha-mannosidosis (HUE-MAN). ClinicalTrials.gov identifier: NCT00498420. Updated August 3, 2020. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT00498420.
4.	Safety study of recombinant human alpha-mannosidase for the treatment of patients with alpha-mannosidosis. ClinicalTrials.gov identifier: NCT01268358. Updated August 3, 2020. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT01268358.
5.	Dose finding study of recombinant human alpha-mannosidase for the treatment of patients with alpha-mannosidosis. ClinicalTrials.gov identifier: NCT01285700. Updated September 26, 2012. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT01285700.
6.	Long-term efficacy and safety of lamazym for the treatment of patients with alpha-mannosidosis. ClinicalTrials.gov identifier: NCT01681940. Updated March 29, 2017. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT01681940.
7.	Trial on safety and efficacy of velmanase alfa treatment in pediatric patients with alpha-mannosidosis (rhLaman-08). ClinicalTrials.gov identifier: NCT02998879. Updated October 26, 2021. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT02998879.
8.	A placebo-controlled phase 3 trial of repeated lamazym treatment of subjects with alpha-mannosidosis. ClinicalTrials.gov identifier: NCT01681953. Updated August 3, 2020. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT01681953.
9.	Borgwardt L, Guffon N, Amraoui Y, et al. Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial. J Inherit Metab Dis. 2018;41(6):1215-1223. doi: 10.1007/s10545-018-0185-0.
10.	Lund AM, Borgwardt L, Cattaneo F, et al. Comprehensive long-term efficacy and safety of recombinant human alpha-mannosidase (velmanase alfa) treatment in patients with alpha-mannosidosis. J Inherit Metab Dis. 2018;41(6):1225-1233. doi:10.1007/s10545-018-0175-2.
11.	Evaluation of long-term efficacy of treatment with lamazym (rhLAMAN-10). ClinicalTrials.gov identifier: NCT02478840. Updated November 20, 2020. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT02478840.

Lamzede ordering and support

Ordering information

One-stop patient support

Copay Programs

Medical information and adverse event reporting

Chiesi Global Rare Disease Commitment

Lamzede ordering
and support