Velmanase alfa

Velmanase alfa is used to treat certain symptoms of alpha-mannosidosis (a genetic condition where the body cannot break down complex sugars) in adults and children.

Velmanase alfa may also be used for reasons not mentioned in this medication guide.

Velmanase alfa is given through an injection into a vein by a healthcare provider over a certain period of time.

Doses depend on your weight. Your dose may change if you gain or lose weight.

You may receive other medications to help prevent serious side effects or allergic reactions. Continue taking these medicines for as long as your doctor has prescribed.

Store at room temperature, away from moisture, heat, and light. Do not freeze.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

You may need to take a pregnancy test that shows a negative result before starting this treatment.

May harm an unborn baby. Use effective birth control while using velmanase alfa and for at least 14 days after your last dose. Inform your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using velmanase alfa.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may happen during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Common side effects of velmanase alfa may include:

• fever;
• headache;
• joint pain;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• hives, difficult breathing, swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Mannosidosis:

1 mg/kg (actual weight) via IV infusion once a week Comments:-Consider pre-treatment with antihistamines, antipyretics, and/or corticosteroids. -See Other Comments/Administration Advice for recommended dilution volume, infusion rates, and recommendations for hypersensitivity reactions.Use: For the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients

Usual Pediatric Dose for Mannosidosis:

1 mg/kg (actual weight) via IV infusion once a week Comments:-Consider pre-treatment with antihistamines, antipyretics, and/or corticosteroids. -See Other Comments/Administration Advice for recommended dilution volume, infusion rates, and recommendations for hypersensitivity reactions.Use: For the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients

Call your doctor for instructions if you miss an appointment for your Velmanase alfa injection.

In a medical setting, an overdose would be handled promptly.

Follow your doctor’s instructions regarding any restrictions on food, drinks, or activities.

Other drugs may affect velmanase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.