Lamzede
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.
What is Lamzede (velmanase alfa)?
What is Lamzede (velmanase alfa) used for?
Treatment of certain symptoms of alpha-mannosidosis in adults and children
How Lamzede (velmanase alfa) works
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.
Drug Facts
What are the side effects of Lamzede (velmanase alfa)?
Common Side Effects
- Upper respiratory symptoms (66%)
- Fever (40%)
- Headache (33%)
- Joint pain (20%)
Other Side Effects
- Swollen tonsils
- Eye itching
- Ear infection
- Flu infection
- Stomach flu
- Urinary tract infection
- Feeling faint or fainting
- Toothache
- Back pain
- Allergic reactions
Serious Side Effects
- Serious allergic reaction (e.g., anaphylaxis): difficulty breathing, tightness in the throat, hives, itching, fast heartbeat, nausea, stomach pain, dizziness, lightheadedness, swelling in the face or tongue
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Fever
- Headache
- Joint pain
- Sore throat
Pros and cons of Lamzede (velmanase alfa)
Pros
The first and only approved treatment for alpha-mannosidase
Given once per week
Cons
Only used for treating certain symptoms and isn't a cure for alpha-mannosidase
Can cause allergic and infusion reactions
Needs to be given by a healthcare professional
Pharmacist tips for Lamzede (velmanase alfa)
Make sure to mark your appointments on your calendar for when you need to see your provider and get your Lamzede (velmanase alfa) doses. This helps you keep track of your appointments so you don't miss any doses. You'll typically receive an infusion every week.
Each Lamzede (velmanase alfa) infusion will take at least 1 hour. It might take longer if you experience infusion reactions and your provider needs to temporarily stop or slow down the infusion. You can bring a book, something to work on, or an electronic device to keep yourself occupied while you receive Lamzede (velmanase alfa).
If you accidentally miss an appointment for your Lamzede (velmanase alfa) dose, talk with your provider right away about rescheduling it. You can usually make up the missed dose as long as there are at least 3 days until your next scheduled dose.
You might experience infusion-related reactions when you're treated with Lamzede (velmanase alfa). Let your provider know right away if you experience fever, chills, vomiting, cough, or rash during the infusion or even when you're already home. You might need more medical attention.
Lamzede (velmanase alfa) can cause serious allergic reactions. This can happen even if you've safely received this medication before. If you experience any allergic reaction, such as hives, tightness in your throat, or trouble breathing, let your nurse know right away. They'll stop the Lamzede (velmanase alfa) infusion and give you medical attention right away.
If you're a female who's able to have children, it's recommended that you use birth control during treatment with Lamzede (velmanase alfa) and for at least 2 weeks after your last dose. Let your provider know right away if you get pregnant while taking this medication. Lamzede (velmanase alfa) can potentially harm an unborn baby.
Frequently asked questions about Lamzede (velmanase alfa)
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What are the risks and warnings for Lamzede (velmanase alfa)?
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.
Severe allergic reactions
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.
Infusion-related reactions
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.
Risk of harm to unborn baby when taken during pregnancy
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.
Lamzede (velmanase alfa) dosage forms
Typical dosing for Lamzede (velmanase alfa)
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.
Lamzede (velmanase alfa) images
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References
Best studies we foundChiesi USA, Inc. (2023). Lamzede- velmanase alfa-tycv injection, powder, lyophilized, for solution [package insert]. DailyMed.
MedlinePlus. (2014). Alpha-mannosidosis.
National Organization for Rare Disorders. (2023). Alpha-mannosidosis.
U.S. Food and Drug Administration. (2023). FDA approves first enzyme replacement therapy for rare alpha-mannosidosis.
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