Lamzede: New Treatment Option Available For Ultra-rare LSD – 2/22/23

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We are pleased to announce the recent FDA approval of Lamzede® (velmanase alfa-tycv); a recombinant human lysosomal alpha-mannosidase indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.1 AM patients have waited a long time for a treatment option and Chiesi is proud to have it now available for them.

Dosage and administration:

  • The recommended dosage is 1mg/kg (actual body weight) administered once every week as an intravenous infusion, for appropriate patients. 1
  • Minimum infusion time is 60 minutes for patients weighing up to 49kg 1
  • Patients weighing 50kg and greater should be infused at a maximum infusion rate of 25 mL/hour 1

Ordering Information:

Lamzede will solely be available through Eversana Life Sciences Specialty Pharmacy.

Product Description

NDC #

Package Size

Lamzede® (velmanase alfa-tycv)

10122-180-02

1 single-use/10-mg vial

Lamzede has a 3-year shelf life. 2

For more information, please contact

Your Chiesi Global Rare Disease National Account Directors:



Garrick Campbell Garrick.Campbell@chiesi.com


Tim Hambacher

Tim.Hambacher@chiesi.com


Lee Stout (Medicaid Plans)

Lee.Stout@chiesi.com

Eversana

(Via Chiesi Total CareSM)


www.chiesitotalcare.com

Phone: (855) 282-4883

Fax: (855) 929-2828

o

Medical Information


Phone: (888) 661-9260

Fax: (866) 443-3092

Email: us.medical@chiesi.com


Or visit www.lamzede.com

Indication

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

WARNING: SEVERE HYPERSENSITIVITY REACTIONS


Hypersensitivity Reactions Including Anaphylaxis


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.

Considerations Due to Hypersensitivity Reactions and/or Infusion-Associated Reactions (IARs)

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.


  • If a severe hypersensitivity reaction (including anaphylaxis) or severe IAR occurs, immediately discontinue Lamzede administration and initiate appropriate medical treatment.


  • 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.


Hypersensitivity Reactions Including Anaphylaxis

Anaphylaxis and severe hypersensitivity signs and symptoms included cyanosis, hypotension, emesis, urticaria, erythema, facial swelling, pyrexia, and tremor.


Infusion-Associated Reactions (IARs)

The most frequent symptoms of IARs that occurred in >10% of the population were pyrexia, chills, erythema, vomiting, cough, urticaria, rash, and conjunctivitis.


Females of Reproductive Potential

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.


Embryo-Fetal Toxicity

Based on findings from animal reproduction studies, Lamzede may cause embryo-fetal harm when administered to a pregnant female.


Common Adverse Reactions

The most common adverse reactions (incidence >20%) are hypersensitivity reactions including anaphylaxis, nasopharyngitis, pyrexia, headache, and arthralgia.

 

References: 1. Lamzede. Prescribing information. Chiesi USA, Inc.; 2023. 2. Date on file.

 

Please see Prescribing Information for Lamzede

©Chiesi USA, Inc. 2023. All rights reserved.

Lamzede® is a registered trademark of CHIESI FARMACEUTICI S.p.A.

Chiesi Total CareSM is a service mark of CHIESI FARMACEUTICI S.p.A.

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