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LAL-D (lysosomal acid lipase deficiency)

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KANUMA^® (sebelipase alfa) INDICATION AND IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

What is the most important information I should know about KANUMA?

Life-threatening allergic (hypersensitivity) reactions, including anaphylaxis may occur in people who receive enzyme replacement therapies (ERT), including KANUMA. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Seek immediate medical care if you have any of these signs or symptoms that may be related to a severe allergic reaction:

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

Administration of KANUMA should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis.

INDICATION

What is KANUMA^® (sebelipase alfa)?

KANUMA is a prescription medicine that is used to treat people with a diagnosis of lysosomal acid lipase (LAL) deficiency. It is administered as an infusion under the supervision of a healthcare provider.

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 people 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.

These are not all the possible side effects of KANUMA. Call your healthcare provider for medical advice about side effects.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

Tell your doctor about all the medications you take, including prescription and over-the-counter drugs, vitamins, and herbal supplements.

To report SUSPECTED SIDE EFFECTS, contact Alexion at 1-844-259-6783 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for KANUMA (sebelipase alfa), including Boxed WARNING regarding hypersensitivity reactions including anaphylaxis.

What is the most important information I should know about KANUMA?

Life-threatening allergic (hypersensitivity) reactions, including anaphylaxis may occur in people who receive enzyme replacement therapies (ERT), including KANUMA. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Seek immediate medical care if you have any of these signs or symptoms that may be related to a severe allergic reaction:

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

Administration of KANUMA should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis.

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 people 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.

These are not all the possible side effects of KANUMA. Call your healthcare provider for medical advice about side effects.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

Tell your doctor about all the medications you take, including prescription and over-the-counter drugs, vitamins, and herbal supplements.

To report SUSPECTED SIDE EFFECTS, contact Alexion at 1-844-259-6783 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION

What is KANUMA^® (sebelipase alfa)?

KANUMA is a prescription medicine that is used to treat people with a diagnosis of lysosomal acid lipase (LAL) deficiency. It is administered as an infusion under the supervision of a healthcare provider.

Please see full Prescribing Information for KANUMA (sebelipase alfa), including Boxed WARNING regarding hypersensitivity reactions including anaphylaxis.

INDICATION

Expand

What is KANUMA^® (sebelipase alfa)?

KANUMA is a prescription medicine that is used to treat people with a diagnosis of lysosomal acid lipase (LAL) deficiency. It is administered as an infusion under the supervision of a healthcare provider.

KANUMA^® (sebelipase alfa) INDICATION AND IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

Expand

What is the most important information I should know about KANUMA?

Life-threatening allergic (hypersensitivity) reactions, including anaphylaxis may occur in people who receive enzyme replacement therapies (ERT), including KANUMA. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Seek immediate medical care if you have any of these signs or symptoms that may be related to a severe allergic reaction:

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

Administration of KANUMA should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis.

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 people 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.

These are not all the possible side effects of KANUMA. Call your healthcare provider for medical advice about side effects.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

Tell your doctor about all the medications you take, including prescription and over-the-counter drugs, vitamins, and herbal supplements.

To report SUSPECTED SIDE EFFECTS, contact Alexion at 1-844-259-6783 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

KANUMA^® (sebelipase alfa) INDICATION AND IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

Expand

What is the most important information I should know about KANUMA?

Life-threatening allergic (hypersensitivity) reactions, including anaphylaxis may occur in people who receive enzyme replacement therapies (ERT), including KANUMA. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Seek immediate medical care if you have any of these signs or symptoms that may be related to a severe allergic reaction:

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

Administration of KANUMA should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis.

INDICATION

What is KANUMA^® (sebelipase alfa)?

KANUMA is a prescription medicine that is used to treat people with a diagnosis of lysosomal acid lipase (LAL) deficiency. It is administered as an infusion under the supervision of a healthcare provider.