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KANUMA® (sebelipase alfa) INDICATION AND IMPORTANT SAFETY INFORMATION
Allergic Reaction
Life-threatening and severe allergic reactions may occur in people who receive KANUMA. These reactions may occur in people who are starting treatment with KANUMA or in people who have previously received KANUMA without having an allergic reaction. You should seek immediate medical care if any of these signs or symptoms that may be related to a severe allergic reaction occur:
Rash such as hives; may also include itching
Difficulty breathing, shortness of breath, tightness in the chest, and wheezing (noises while breathing)
Dizziness or feeling faint
Tingling and swelling around the mouth, in your throat, or eyes
Fast heartbeat
Very low blood pressure
Sweating
Loss of consciousness
Flushing or temporary reddening of the skin (usually on the face)
Agitation or irritability
KANUMA® is indicated for the treatment of people with a diagnosis of lysosomal acid lipase deficiency (LAL-D).
Allergy to Eggs or Egg Products
Tell your doctor if you have had a severe allergic reaction to eggs or egg products, as people with a known history of egg allergies were excluded from clinical trials.
Common Side Effects
The most common side effects in patients treated with KANUMA are:
Infants with rapidly progressive LAL Deficiency presenting within the first 6 months of life (≥30%): diarrhea, vomiting, fever, stuffy or runny nose, anemia, cough, swelling of the nose and throat, and hives.
Pediatric and adult patients with LAL Deficiency (≥8%): headache, fever, sore throat, swelling of the nose and throat, weakness, constipation, and nausea.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.
These are not all the possible side effects of KANUMA. Call your healthcare provider for medical advice about side effects. To report suspected side effects, contact Alexion at 1-844-259-6783 or the FDA at 1-800-FDA-1088.
For additional Important Safety Information, please see the full Prescribing Information for KANUMA at https://alexion.com/Documents/Kanuma_USPI
Allergic Reaction
Life-threatening and severe allergic reactions may occur in people who receive KANUMA. These reactions may occur in people who are starting treatment with KANUMA or in people who have previously received KANUMA without having an allergic reaction. You should seek immediate medical care if any of these signs or symptoms that may be related to a severe allergic reaction occur:
Rash such as hives; may also include itching
Difficulty breathing, shortness of breath, tightness in the chest, and wheezing (noises while breathing)
Dizziness or feeling faint
Tingling and swelling around the mouth, in your throat, or eyes
Fast heartbeat
Very low blood pressure
Sweating
Loss of consciousness
Flushing or temporary reddening of the skin (usually on the face)
Agitation or irritability
Allergy to Eggs or Egg Products
Tell your doctor if you have had a severe allergic reaction to eggs or egg products, as people with a known history of egg allergies were excluded from clinical trials.
Common Side Effects
The most common side effects in patients treated with KANUMA are:
Infants with rapidly progressive LAL Deficiency presenting within the first 6 months of life (≥30%): diarrhea, vomiting, fever, stuffy or runny nose, anemia, cough, swelling of the nose and throat, and hives.
Pediatric and adult patients with LAL Deficiency (≥8%): headache, fever, sore throat, swelling of the nose and throat, weakness, constipation, and nausea.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.
These are not all the possible side effects of KANUMA. Call your healthcare provider for medical advice about side effects. To report suspected side effects, contact Alexion at 1-844-259-6783 or the FDA at 1-800-FDA-1088.
INDICATIONKANUMA® is indicated for the treatment of people with a diagnosis of lysosomal acid lipase deficiency (LAL-D).
For additional Important Safety Information, please see the full Prescribing Information for KANUMA at https://alexion.com/Documents/Kanuma_USPI
INDICATION
KANUMA® is indicated for the treatment of people with a diagnosis of lysosomal acid lipase deficiency (LAL-D).
KANUMA® (sebelipase alfa) INDICATION AND IMPORTANT SAFETY INFORMATION
Allergic Reaction
Life-threatening and severe allergic reactions may occur in people who receive KANUMA. These reactions may occur in people who are starting treatment with KANUMA or in people who have previously received KANUMA without having an allergic reaction. You should seek immediate medical care if any of these signs or symptoms that may be related to a severe allergic reaction occur:
Rash such as hives; may also include itching
Difficulty breathing, shortness of breath, tightness in the chest, and wheezing (noises while breathing)
Dizziness or feeling faint
Tingling and swelling around the mouth, in your throat, or eyes
Fast heartbeat
Very low blood pressure
Sweating
Loss of consciousness
Flushing or temporary reddening of the skin (usually on the face)
Agitation or irritability
Allergy to Eggs or Egg Products
Tell your doctor if you have had a severe allergic reaction to eggs or egg products, as people with a known history of egg allergies were excluded from clinical trials.
Common Side Effects
The most common side effects in patients treated with KANUMA are:
Infants with rapidly progressive LAL Deficiency presenting within the first 6 months of life (≥30%): diarrhea, vomiting, fever, stuffy or runny nose, anemia, cough, swelling of the nose and throat, and hives.
Pediatric and adult patients with LAL Deficiency (≥8%): headache, fever, sore throat, swelling of the nose and throat, weakness, constipation, and nausea.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.
These are not all the possible side effects of KANUMA. Call your healthcare provider for medical advice about side effects. To report suspected side effects, contact Alexion at 1-844-259-6783 or the FDA at 1-800-FDA-1088.
KANUMA® (sebelipase alfa) INDICATION AND IMPORTANT SAFETY INFORMATION
Allergic Reaction
Life-threatening and severe allergic reactions may occur in people who receive KANUMA. These reactions may occur in people who are starting treatment with KANUMA or in people who have previously received KANUMA without having an allergic reaction. You should seek immediate medical care if any of these signs or symptoms that may be related to a severe allergic reaction occur:
Rash such as hives; may also include itching
Difficulty breathing, shortness of breath, tightness in the chest, and wheezing (noises while breathing)
Dizziness or feeling faint
Tingling and swelling around the mouth, in your throat, or eyes
Fast heartbeat
Very low blood pressure
Sweating
Loss of consciousness
Flushing or temporary reddening of the skin (usually on the face)
Agitation or irritability
KANUMA® is indicated for the treatment of people with a diagnosis of lysosomal acid lipase deficiency (LAL-D).