Valuable resources for you and your patients |
|
Hi Calcium QA,
|
| I’d like to share some useful information and resources about Lamzede® (velmanase alfa-tycv). |
Patient and Caregiver Brochure |
 |
|
This is a guide for caregivers and patients diagnosed with alpha-mannosidosis who are considering starting treatment with or have been prescribed Lamzede.
|
 |
|
|
|
Patient and Caregiver Brochure |
| This is a guide for caregivers and patients diagnosed with alpha-mannosidosis who are considering starting treatment with or have been prescribed Lamzede. |
|
|
|
Lamzede Starter Kit for Healthcare Professionals |
 |
|
This resource helps define each stage of the access process to equip you and your office with information about coverage, reimbursement, and initiating treatment with Lamzede.
|
|
|
|
|
Lamzede Starter Kit for Healthcare Professionals |
| This resource helps define each stage of the access process to equip you and your office with information about coverage, reimbursement, and initiating treatment with Lamzede. |
|
|
|
Chiesi Total CareSM Enrollment Form |
 |
|
This is an enrollment form for the Chiesi Total Care patient support program. To initiate enrollment, please print and have patients complete this form; then fax it to 1-866-565-7794.
|
|
|
|
|
Chiesi Total CareSM Enrollment Form |
| This is an enrollment form for the Chiesi Total Care patient support program. To initiate enrollment, please print and have patients complete this form; then fax it to 1-866-565-7794. |
|
|
|
Physician Order Form |
 |
|
This is a prescription order form to begin the process of getting a patient started on Lamzede. To initiate treatment, please print and complete this form; then fax it to 1-855-929-2828.
|
|
|
|
|
Physician Order Form |
| This is a prescription order form to begin the process of getting a patient started on Lamzede. To initiate treatment, please print and complete this form; then fax it to 1-855-929-2828. |
|
|
|
Home Infusion Form |
 |
|
Home infusion could be a convenient option to consider for some patients. This is a form to begin nurse-administered Lamzede infusions at home. To initiate home infusions, please print and complete this form, then fax it to 1-855-929-2828.
|
|
|
|
|
Home Infusion Form |
| Home infusion could be a convenient option to consider for some patients. This is a form to begin nurse-administered Lamzede infusions at home. To initiate home infusions, please print and complete this form, then fax it to 1-855-929-2828. |
|
|
|
Core Leave Behind |
 |
|
This resource provides an overview of the most important facts and features of Lamzede.
|
|
|
|
|
Core Leave Behind |
| This resource provides an overview of the most important facts and features of Lamzede. |
|
|
|
Dosing and Administration Resource |
 |
|
This guide gives instructions for the recommended dosing and proper administration of Lamzede infusions.
|
|
|
|
|
Dosing and Administration Resource |
| This guide gives instructions for the recommended dosing and proper administration of Lamzede infusions. |
|
|
|
|
| If you have any questions about Lamzede, please feel free to get in touch—my contact information is included below. |
| In the meantime, if you’d like to learn more, visit lamzede.com. |
|
Sincerely,
|
|
Don Feiler
|
|
agency@iqvia.com
|
|
123.456.7890
|
Indication
|
| Lamzede® (velmanase alfa-tycv) is indicated for the treatment of non-neurological 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.
Please see Full Prescribing Information for Lamzede.
|
|