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Sebelipase alfa

Generic name: sebelipase alfa [SE-be-LYE’-LYE-pase’-AL-fa]

The brand name is Kanuma.
Dosage Form: intravenous solution (2 mg/ml)
Drug class: Lysosomal enzymes

What is Sebelipase Alfa?

Sebelipase alfa is a variant of an enzyme naturally produced in your body to reduce fats and prevent them from accumulating inside your cells.

Sebelipase beta is used in the treatment of lysosomal acid lipase deficiency. It is a potentially life-threatening genetic condition that can cause damage to vital organs in the body and cause premature death. Sebelipase alfa replaces the deficient enzyme in the case that the body doesn't have adequate amounts of the enzyme it needs.

Sebelipase alfa can also be used to treat conditions that are not mentioned in this guide.

Side effects of Sebelipase alfa

See a doctor immediately. If you are experiencing symptoms that indicate an allergic reaction, such as symptoms of hives, difficulty breathing, or swelling of your lips, face, or tongue,

There are some side effects that can happen when you inject. Contact your physician immediately whenever you feel itchy, flushed, cold, or shivering, or if you suffer from an irritated nose, eye discomfort, diarrhea, chest discomfort, or breathing difficulties.

Sebelipase alfa may cause serious side effects. Contact your physician immediately if you experience:

  • Extreme skin itching, itching, or swelling;
  • Agitation, irritability;
  • Stomach pain;
  • Low red blood cells (anemia)--pale skin sensation of lightheadedness or sluggish fast heart rate, difficulty concentration

Common negative side effects of sebelipase include:

  • Fever, weakness;
  • Sinus pain, runny nose, sore throat, cough
  • Rash;
  • Diarrhea, constipation;
  • Nausea, vomiting,
  • Headache.

This isn't a complete list of all the side effects. Other side effects could occur. Consult your physician to seek medical advice on the effects. You can report any side effects to the FDA at 1-800-FDA-1088.

Similar/related drugs

Kanuma

Warnings

Follow the instructions on the label of your medication and the package. Be sure to inform your healthcare professionals about your allergies, medical conditions, and any other medications you take.

Prior to use this drug

You shouldn't be treated with sebelipase alfa in case you have an allergy to it.

To ensure sebelipase alfa is not harmful to you, consult your physician if you suffer from:

  • Eggs, or products made from eggs.

It isn't known if sebelipase alfa can harm an unborn baby. Inform your doctor if you are expecting or planning to be pregnant.It isn't known if sebelipase alfa gets into breast milk or if it is harmful to breastfeeding babies. Consult your physician if you are breastfeeding a baby.

Sebelipase alfa isn't approved for use by children younger than one month old.

How to take Sebelipase?

Sebelipase alfa can be injected directly into veins via an IV. Your healthcare provider will provide the injection.

Sebelipase alfa is typically given every two weeks. Infusions via IV must be administered slowly and may take between 1 and 2 hours to finish.You will be closely monitored both before and after taking sebelipase alfa to make sure you don't suffer from an allergic reaction to the medication.

Consult your physician when you notice any weight changes. Sebelipase alfa doses depend on weight (especially for children), and any changes can affect the dose.

Details on dosage

Usual Adult Dose for Wolman's Disease:

The recommended dosage is 1 mg/kg, administered as an IV infusion once a week.
Patients with a suboptimal response to treatment:
Increase the dose to 3 mg/kg once a week.
Comments:
Suboptimal clinical response can be defined as one of the following indicators: slow growth, declining biochemical markers like Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or the parameters of lipid metabolism, like low-density lipoprotein cholesterol (LDL-c) and triglycerides (TG).
Use: To treat lysosomal acid lipase (LAL) insufficiency

Usual Pediatric Dose for Wolman's Disease:

Infants with rapid progressive deficiency during the first six months of their lives:
Dosage: 1 mg/kg IV, once each week.
Patients with a suboptimal response
Increase the dose to 3 mg/kg IV at least once per week.
Patients who have a persistent suboptimal clinical response
Increase the dosage to 5 mg/kg twice a week.
Comments:
Suboptimal clinical responses are defined as indicators of low growth, degrading biochemical markers, or persistent or worsening organomegaly.
Children over six months of age:
The recommended dosage is 1 mg/kg, administered as an IV infusion once a week.
Patients who have a suboptimal clinical response:
Increase the dose by 3 mg/kg once every week.
Comments:
Suboptimal clinical responses are defined as conditions such as low growth, degrading biochemical indicators like Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or other parameters of lipid metabolism, like low-density lipoprotein cholesterol (LDL-c), as well as triglycerides (TG).
Use: To treat lysosomal acid lipase (LAL) insufficiency

What happens if I miss the dose?

Consult your physician for the proper treatment in the event that you don't make an appointment for sebelipase Alfa injection.

What happens if I overdose?

Get medical attention in an emergency or contact the Poison Help Line toll-free at 1-800-222-1222.

What should be avoided?

Follow the instructions of your physician regarding any limitations on foods, drinks, or any activity.

Interaction with other drugs

Other medications may affect sebelipase alfa, such as prescription and non-prescription drugs, vitamins, and herbal products. Inform your health professionals about any medications you are taking in the present and any medication that you decide to stop or change your use of.