Lamzede (velmanase alfa or velmanase alfa-tycv) is the first and only medication approved to treat certain symptoms of a rare genetic problem called alpha-mannosidosis. It's infused into the veins every week by a healthcare provider. Lamzede (velmanase alfa) infusions might cause side effects, such as headache, body chills, fever, and joint pain.
Lamzede (velmanase alfa) is an enzyme replacement therapy. It acts like an enzyme (protein) called alpha-mannosidase. This enzyme is important for your body to break down certain types of sugars in your cells.
People with alpha-mannosidosis are missing alpha-mannosidase. Without alpha-mannosidase, harmful sugars build up in the cells, which cause tissue and organ damage. This leads to symptoms of alpha-mannosidosis, such as abnormal bone structure, physical disabilities, and intellectual disabilities.
By restoring alpha-mannosidase levels in the body, Lamzede (velmanase alfa) helps prevent sugars from building up in cells. This is thought to help improve certain symptoms of alpha-mannosidosis.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Contact your healthcare provider immediately if you experience any of the following.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Alpha-mannosidosis can affect many parts of your body, causing symptoms like abnormal bone structure, vision or hearing problems, movement problems, enlarged organs, and intellectual disabilities. Lamzede (velmanase alfa) can help improve certain symptoms of the genetic condition. One study showed that Lamzede (velmanase alfa) improved physical ability (e.g., climb stairs, walk) and lung function in adults and children after 1 year of treatment.
Your provider will likely have you continue Lamzede (velmanase alfa) treatment as long as it's improving some symptoms of your alpha-mannosidosis condition and you don't have severe allergic or infusion reactions. Remember, alpha-mannosidosis is a genetic problem, and Lamzede (velmanase alfa) only treats symptoms; it isn't a cure. Talk with your provider about how long you need Lamzede (velmanase alfa) treatment.
No. Lamzede (velmanase alfa) is an IV infusion that's given only by a provider at an infusion center or a healthcare provider's office. This is because the provider has the proper resources, training, and technique to prepare and give the medication safely.
Your provider might give you certain medications to take before your infusion to help lower your risk for infusion reactions from Lamzede (velmanase alfa). These medications include corticosteroids, antihistamines, or medications to relieve fever. They might be prescribed for you to take at home before your Lamzede (velmanase alfa) dose, or you might receive these medications at your appointments. If you're prescribed these medications to take at home, make sure to take them about 30 minutes before your Lamzede (velmanase alfa) dose. That's typically the amount of time it takes for most of these medications to start working.
Based on findings from animal studies, Lamzede (velmanase alfa) can cause serious harm to an unborn baby if taken during pregnancy. If you're a female who can have children, use birth control during treatment and for at least 2 weeks after your last dose of medication. Additionally, there's no information on how safe Lamzede (velmanase alfa) is during breastfeeding. If you're pregnant, thinking of becoming pregnant, or breastfeeding, talk to your provider about the risks and benefits of continuing Lamzede (velmanase alfa) treatment.
Lamzede (velmanase alfa) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Lamzede (velmanase alfa) can cause severe and sometimes life-threatening allergic reactions, including anaphylaxis. Get medical attention right away if you experience symptoms of an allergic reaction, such as hives, facial swelling, trouble breathing, tightness in your throat, and a fast heartbeat.
Lamzede (velmanase alfa) can cause infusion-related reactions. These reactions include fever, chills, skin redness, vomiting, cough, hives, rash, and eye redness. These reactions can happen during any Lamzede (velmanase alfa) infusion or after you've gone home. To lower your risk, your provider might give you pretreatment medications, such as diphenhydramine (Benadryl), acetaminophen (Tylenol), and corticosteroids. If you experience a reaction while you're getting an infusion, your provider might stop, pause, or slow the infusion. Get medical help immediately if you experience symptoms of a serious reaction, such as trouble breathing, tightness in your throat, hives and itching, and a fast heartbeat.
Based on animal studies, Lamzede (velmanase alfa) can potentially cause harm to an unborn baby (e.g., brain and other developmental problems) during pregnancy. If you're a female who's able to have children, your provider will ask you take a pregnancy test before you start Lamzede (velmanase alfa). You should use birth control during treatment and for at least 2 weeks after your last dose of medication. If you're pregnant or thinking of becoming pregnant, talk to your provider about the risks and benefits of using Lamzede (velmanase alfa) during pregnancy.
Your healthcare provider will calculate the right dose for you based on your body weight.
The typical dose is 1 mg/kg of body weight given as an infusion into the veins (intravenous or IV) once per week.