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We would like to share some information about Lamzede—an enzyme replacement therapy (ERT) for patients with alpha-mannosidosis. Lamzede is designed to reduce mannose-rich oligosaccharides by supplementing the natural α-mannosidase enzyme.1
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For patients with alpha-mannosidosis, consider updating your medical policy to include Lamzede.
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Lamzede ordering information
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EVERSANA®, operated by the Chiesi Total Care Team, is the exclusive distributor of Lamzede.
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Refer to the following NDC:
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| Product Description1 |
NDC # |
Package Size |
| Lamzede 10 mg single dose |
10122-180-02 |
1 vial |
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Lamzede is administered via a once-weekly intravenous infusion for appropriate patients1
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The recommended dose is 1 mg/kg of body weight for pediatric and adult patients1
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Infusion duration is calculated individually, with a maximum infusion rate of 25 mL/hour1
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Minimum infusion time is 60 minutes1
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Chiesi Total CareSM: A comprehensive patient
support program
For detailed information, call 1-855-282-4883.
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Let me know if you have time for {{customText[a call | a video chat | an in-person meeting]}} in the next few weeks to discuss how Lamzede can be a viable treatment option for your patients. Please don’t hesitate to get in touch if you have any questions.
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| Thank you for considering Lamzede for your patients with alpha-mannosidosis. |
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Please see Important Safety Information including Boxed Warning below and Full Prescribing Information for Lamzede.
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Indication
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| Lamzede® (velmanase alfa-tycv) is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. |
| Important Safety Information |
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WARNING: SEVERE HYPERSENSITIVITY REACTIONS
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Hypersensitivity Reactions Including Anaphylaxis
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Patients treated with Lamzede have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during Lamzede administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue Lamzede immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reaction, a desensitization procedure to Lamzede may be considered.
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Considerations Due to Hypersensitivity Reactions and/or Infusion-Associated Reactions (IARs)
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Prior to Lamzede administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids. Inform patients and caregivers of the signs and symptoms of hypersensitivity reactions and IARs and instruct them to seek medical care immediately if such symptoms occur.
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If a severe hypersensitivity reaction (including anaphylaxis) or severe IAR occurs, immediately discontinue Lamzede administration and initiate appropriate medical treatment.
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In the event of a mild to moderate hypersensitivity reaction or a mild to moderate IAR, consider temporarily holding the infusion for 15 to 30 minutes, slowing the infusion rate to 25% to 50% of the recommended rate, and initiating appropriate medical treatment.
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Hypersensitivity Reactions Including Anaphylaxis
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Anaphylaxis and severe hypersensitivity signs and symptoms included cyanosis, hypotension, emesis, urticaria, erythema, facial swelling, pyrexia, and tremor.
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Infusion-Associated Reactions (IARs)
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The most frequent symptoms of IARs that occurred in >10% of the population were pyrexia, chills, erythema, vomiting, cough, urticaria, rash, and conjunctivitis.
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Females of Reproductive Potential
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Advise females of reproductive potential to use effective contraception during treatment and for 14 days after the last dose if Lamzede is discontinued. For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment with Lamzede.
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Embryo-Fetal Toxicity
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Based on findings from animal reproduction studies, Lamzede may cause embryo-fetal harm when administered to a pregnant female.
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Common Adverse Reactions
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The most common adverse reactions (incidence >20%) are hypersensitivity reactions including anaphylaxis, nasopharyngitis, pyrexia, headache, and arthralgia.
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Please see Full Prescribing Information for Lamzede.
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Reference: 1. Lamzede. Prescribing Information. Chiesi Farmaceutici S.p.A.; 2023.
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