Description
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 or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of velmanase alfa-tycv injection in children. Safety and efficacy have been established.
Geriatric
Alpha-mannosidosis is a disease that usually affects children and young adults. Appropriate studies on the relationship of age to the effects of velmanase alfa-tycv injection have not been performed in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
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.
Precautions
It is very important that your doctor check your or your child's progress closely and at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
Using this medicine could harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure 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 keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have 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. Tell your doctor right away if you start to have fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness, or fainting after receiving this medicine.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need 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. Also, your health care professional may 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 or 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.
CON-XXXXXXXX
