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Kanuma is a copy of an enzyme that is normally produced in the body to help break down fats and keep them from building up in your cells.
Kanuma is used to treat lysosomal acid lipase deficiency. This is a life-threatening genetic disorder that can damage major organs in the body and lead to early death. This medicine replaces the missing enzyme when the body does not have enough of its own.
Kanuma may also be used for purposes not listed in this medication guide.
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
You should not be treated with Kanuma if you are allergic to it.
To make sure Kanuma is safe for you, tell your doctor if you have:
an allergy to eggs or egg products.
It is not known whether Kanuma will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether sebelipase alfa passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Kanuma is not approved for use by anyone younger than 1 month old.
Kanuma is injected into a vein through an IV. A healthcare provider will give you this injection.
Kanuma is usually given once every other week. The IV infusion must be given slowly and can take 1 to 2 hours to complete.
You will be watched closely during and after receiving Kanuma, to make sure you do not have an allergic reaction to the medication.
Tell your doctor if you have any changes in weight. Kanuma doses are based on weight (especially in children), and any changes may affect the dose.
Call your doctor for instructions if you miss an appointment for your Kanuma.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
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 occur during the injection. Tell your caregiver right away if you feel itchy, flushed, chilled or feverish, or if you have a runny nose, eye irritation, diarrhea, chest discomfort, or trouble breathing.
Call your doctor at once if you have:
severe skin rash, itching, or swelling;
agitation, irritability;
stomach pain; or
low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.
Common side effects may include:
fever, weakness;
runny nose, sinus pain, sore throat, cough;
rash;
diarrhea, constipation;
nausea, vomiting; or
headache.
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.
Other drugs may interact with sebelipase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Kanuma (www.drugs.com/mtm/kanuma.html).
Note: This document contains side effect information about sebelipase alfa. Some of the dosage forms listed on this page may not apply to the brand name Kanuma.
Common side effects of Kanuma include: diarrhea, fever, vomiting, hypersensitivity reaction, and urticaria. Other side effects include: nausea. See below for a comprehensive list of adverse effects.
Applies to sebelipase alfa: intravenous solution
Along with its needed effects, sebelipase alfa (the active ingredient contained in Kanuma) 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 while taking sebelipase alfa:
More common
Less common
Some side effects of sebelipase alfa 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
Applies to sebelipase alfa: intravenous solution
Common (1% to 10%): Tachycardia, hyperemia, hypotension
Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Hypertension, pallor, increased blood pressure, increased heart rate
-Frequency not reported: Tachycardia
Common (1% to 10%): Urticaria, rash, pruritus, eczema, papular rash, pruritic rash
Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Urticaria (33%), rash, eczema, pruritus, maculopapular rash
Common (1% to 10%): Nausea, diarrhea, abdominal pain, abdominal distention, constipation
Frequency not reported: Retching
Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Diarrhea (67%), vomiting (67%), gastroesophageal reflux disease, retching
In clinical trials, 106 patients (total) were treated with this drug. In 66 pediatric and adult patients with lysosomal acid lipase (LAL) deficiency, 36 patients received this drug (1 mg/kg IV every other week) while 30 patients received placebo during the double-blind period of the trial; age at first dose was 4 to 58 years. Infants with evidence of rapidly progressive LAL deficiency before 6 months of age (n=9) received up to 3 mg/kg IV once a week; age at first dose was 1 to 6 months.
The most serious side effects reported in clinical studies were signs/symptoms consistent with anaphylaxis (including chest discomfort, conjunctival injection, dyspnea, generalized and itchy rash, hyperemia, mild eyelid edema, rhinorrhea, severe respiratory distress, tachycardia, tachypnea, urticaria).
Common (1% to 10%): Urinary tract infection, menorrhagia
Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Anemia (44%)
Very common (10% or more): Hypersensitivity reaction
Common (1% to 10%): Anaphylactic reaction
Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Hypersensitivity reaction, anaphylaxis
In clinical trials, signs/symptoms of anaphylaxis were reported in 3 of 106 patients treated with this drug (including 2 of 92 children and adults and 1 of 14 infants). Anaphylaxis was reported during infusion up to 1 year after the start of therapy.
In clinical trials, signs/symptoms of hypersensitivity reaction were reported in 21 of 106 patients treated with this drug (including 12 of 92 children and adults and 9 of 14 infants); such signs/symptoms occurred in at least 2 patients and included abdominal pain, agitation, chills, diarrhea, eczema, hypertension, irritability, laryngeal edema, nausea, edema, pallor, pruritus, pyrexia/increased body temperature, rash, tachycardia, urticaria, and vomiting. Most reactions occurred during or within 4 hours of completing the infusion.
Very common (10% or more): Antidrug antibodies (ADA) developed (14%)
Common (1% to 10%): Neutralizing antibody development
Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Antidrug antibodies developed (57%), positive for neutralizing antibodies
During a double-blind study, 5 out of 35 pediatric and adult patients treated with this drug developed ADA. During the open-label extension, 2 patients developed in vitro neutralizing antibodies.
ADA developed in 4 of 7 patients with rapidly progressive LAL deficiency presenting with the first 6 months of life; 2 of the 4 ADA-positive patients were positive for neutralizing antibodies. Hypersensitivity reactions were reported in all 4 ADA-positive patients compared to 1 of the 3 ADA-negative patients. Decreased growth velocity (in a setting of neutralizing antibodies to this drug) was reported in 1 patient.
There was no clear association between the development of ADA and decreased efficacy of this drug.
Very common (10% or more): Increased low-density lipoprotein (LDL) cholesterol (81%), increased triglycerides (58%)
Common (1% to 10%): Transient hypercholesterolemia, transient hypertriglyceridemia
Frequency not reported: Oxygen saturation decreased
Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Oxygen saturation decreased
Increases in LDL cholesterol (LDL-c) and triglycerides above pretreatment levels were observed in 29 of 36 and 21 of 36 patients, respectively, at 2 and 4 weeks following initiation of this drug. The maximum mean percentage increase for LDL-c at week 2 was 18% and 5% for triglycerides at week 4.
Very common (10% or more): Headache (28%), hypotonia
Common (1% to 10%): Dizziness
Rapidly Progressive LAL Deficiency:
-Frequency not reported: Hypotonia
Common (1% to 10%): Eyelid edema, conjunctival injection
Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Eyelid edema
Very common (10% or more): Fever/pyrexia (25%), oxygen saturation decreased
Common (1% to 10%): Chills, chest discomfort, edema, fatigue, body temperature increased, infusion site induration, infusion related reaction, asthenia
Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Fever/pyrexia (56%), catheter site/device related infection (33%), increased body temperature, chills, edema, hyperthermia, irritability, decreased growth velocity, oxygen saturation decreased
Common (1% to 10%): Anxiety, insomnia
Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Agitation, irritability
Very common (10% or more): Oropharyngeal pain (17%), nasopharyngitis (11%), sneezing
Common (1% to 10%): Laryngeal edema, dyspnea, rhinorrhea, severe respiratory distress, tachypnea
Frequency not reported: Nasal congestion, sneezing, wheezing
Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Rhinitis (56%), nasopharyngitis (33%), cough (33%), respiratory distress, wheezing, nasal congestion, increased respiratory rate, nasal congestion, sneezing
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Kanuma (www.drugs.com/mtm/kanuma.html).
March 28, 2020
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