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.

Dedicated Total Care team:

  • Pharmacists
  • Patient service coordinators
  • Reimbursement support specialists
  • Nursing support

Infusion assistance†

  • Ensures medication is delivered right to where your patients need it
  • Assists you in finding an appropriate infusion facility
  • Answers questions about administration, storage and disposal, and more
  • Reviews eligibility for home infusion assistance†

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.
DOWNLOAD FACT SHEET

Downloadable Forms
PRESCRIPTION ORDER FORM
HOME INFUSION NURSING ORDER FORM
LETTER OF APPEAL TEMPLATE
LETTER OF NECESSITY TEMPLATE

Helpful Links for Your Patients

For more information about Lamzede® (velmanase alfa-tycv), visit Lamzede.com.
DOWNLOAD LAMZEDE FULL PRESCRIBING INFORMATION

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.

Please see Full Prescribing Information for Lamzede.

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

Indication

Lamzede® (velmanase alfa-tycv) is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.

Please see Full Prescribing Information for Lamzede.

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

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.

Please see Full Prescribing Information for Lamzede.

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

Indication

Lamzede® (velmanase alfa-tycv) is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.

Please see Full Prescribing Information for Lamzede.

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