Lamzede (velmanase alfa-tycv)

In the event of a mild to moderate hypersensitivity reaction or a mild to moderate infusion-associated reaction (IAR), consider temporarily holding the infusion for 15-30 minutes, slowing the infusion rate to 25-50% of the recommended rate, and initiating appropriate medical treatment. If symptoms persist after slowing the infusion, stop the infusion and monitor the patient. If symptoms continue to persist, consider re-initiating the infusion within 7-14 days at 25-50% of the recommended rate with appropriate pretreatment. If symptoms subside after holding or slowing the infusion, resume the infusion at 25-50% of the recommended rate. If tolerated, increase the infusion rate by 25% of the recommended rate until the recommended infusion rate is reached. Closely monitor the patient.

In the event of a severe hypersensitivity reaction, including anaphylaxis, or severe IAR, immediately discontinue the infusion and initiate appropriate medical treatment.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been performed to date. Velmanase alfa-tycv is not a substrate or inhibitor/inducer of major cytochrome P-450 (CYP) enzymes, or a substrate or inhibitor of major transporters.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

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

More Frequent

• Anaphylaxis
• Hypersensitivity drug reaction

Less Frequent

• Gastroenteritis
• Influenza

Rare or Very Rare

• Angioedema
• Hearing loss
• Hypotension
• IgA vasculitis
• Seizure disorder

More Frequent

• Fever
• Headache disorder
• Pharyngitis

Less Frequent

• Arthralgia
• Back pain
• Infection of ear
• Ocular itching
• Syncope
• Tonsillitis
• Toothache
• Urinary tract infection

Rare or Very Rare

• Agitation
• Anorexia
• Arthritis
• Ataxia
• Drowsy
• Drug-induced psychosis
• Eye tearing
• Fecal incontinence
• General weakness
• Nervousness
• Odynophagia
• Palpitations
• Pharyngeal edema
• Tachycardia
• Wheezing

No enhanced messaging available.

The safety and effectiveness of velmanase alfa-tycv have been established in pediatric patients. Pediatric patients treated with velmanase alfa-tycv experienced a higher incidence of hypersensitivity reactions compared to adults.

There is no adequate data regarding use of velmanase alfa-tycv in pregnant women. Based on findings from animal reproductive studies, velmanase alfa-tycv may cause embryo-fetal harm when administered to pregnant females.

The decision to continue or discontinue velmanase alfa-tycv during pregnancy should consider the patient's need for the drug, the potential drug-related risk to the fetus, and the potential adverse outcomes from untreated disease.

It is not known whether velmanase alfa-tycv or its metabolite is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for velmanase alfa-tycv and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.

Alpha-mannosidosis is largely a disease of pediatric and young adult patients. Safety and efficacy of velmanase alfa-tycv have not been established in geriatric patients 65 years of age and older.