Velmanase alfa-tycv (Intravenous)

Velmanase alfa-tycv injection is used to treat non-central nervous system (CNS) symptoms of alpha-mannosidosis. Alpha-mannosidosis is a rare genetic disease caused by a deficiency of an enzyme called alpha-mannosidase.

This medicine is to be given only by your doctor or under their direct supervision.

It is very important for your doctor to monitor your or your child's progress closely and during regular visits to ensure this medicine is working properly and to determine if you should continue receiving it. Blood tests may be needed to check for side effects.

Using this medicine could harm your unborn baby. If you are a woman who can get pregnant, your doctor may perform tests to confirm you are not pregnant before starting this treatment. Use an effective form of birth control during treatment with this medicine and for 14 days after the last dose to prevent pregnancy. Inform your doctor immediately if you think you may be pregnant.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Inform your doctor right away if you experience a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Inform your doctor right away if you experience fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness, or fainting after receiving this medicine.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine compared to the benefits it provides. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies so far have not shown any specific problems in children that would limit the usefulness of velmanase alfa-tycv injection. Its safety and effectiveness have been confirmed.

Geriatric

Alpha-mannosidosis is a disease that typically affects children and young adults. There have not been appropriate studies on how age affects the results of velmanase alfa-tycv injection in elderly patients.

Breast Feeding

There are no adequate studies in women to assess the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the possible risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines can be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may require medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Back pain
• bladder pain
• bloody or cloudy urine
• change in hearing
• chest tightness
• chills
• cough
• diarrhea
• difficult, burning, or painful urination
• ear drainage or pain
• fainting
• fast heartbeat
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• hives, itching, skin rash
• irritation
• joint pain, stiffness, or swelling
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea
• redness of the skin
• shivering
• sore throat
• stomach pain
• stuffy or runny nose
• sweating
• swelling of the eyelids, face, lips, hands, or feet
• trouble breathing
• unusual tiredness or weakness
• vomiting

Less common

• Agitation
• coma
• confusion
• decreased urine output
• depression
• dizziness
• hostility
• lethargy
• muscle twitching
• rapid weight gain
• seizures
• stupor
• swelling of the face, ankles, or hands

Incidence not known

• Blurred vision
• chest pain or discomfort
• deafness
• delusions
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, irregular, pounding, or racing heartbeat or pulse
• hallucinations
• heart murmur
• shakiness and unsteady walk
• sleepiness or unusual drowsiness
• unsteadiness, trembling, or other problems with muscle control or coordination

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Difficulty in moving
• joint pain
• toothache

Incidence not known

• Decreased appetite
• joint swelling or warmth
• lack or loss of strength
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• watering of the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Lamzede

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Enzyme Replacement

Pharmacologic Class: Velmanase Alfa

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. It is usually given once every week.

Your doctor will give you other medicines (eg, allergy medicine, fever medicine, or steroid medicine) before you receive this medicine to help prevent unwanted effects.

Missed Dose

Call your doctor or pharmacist for instructions.