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Sebelipase alfa Side Effects

In Summary

Commonly reported side effects of sebelipase alfa include: diarrhea, fever, vomiting, hypersensitivity reaction, and urticaria. Other side effects include: nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to sebelipase alfa: intravenous solution

As well as its needed effects, sebelipase alfa may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sebelipase alfa, check with your doctor or nurse immediately:

More common:
  • Abdominal or stomach pain
  • anxiety or agitation
  • blurred vision
  • chills
  • coughing
  • diarrhea
  • difficulty with breathing or swallowing
  • dizziness
  • dry mouth
  • fever
  • headache
  • hives, itching, or rash
  • hoarseness
  • hyperventilation
  • irregular heartbeats
  • irritability
  • nausea
  • nervousness
  • paleness of the skin
  • pounding in the ears
  • reddening of the skin, especially around the ears
  • restlessness
  • shaking
  • skin rash, encrusted, scaly, and oozing
  • slow or fast heartbeat
  • slow or irregular breathing
  • swelling of the eyes, face, inside of the nose, or throat
  • tightness in the chest
  • vomiting
  • trouble sleeping
  • unusual tiredness or weakness
Less common:
  • Chest discomfort
  • fast, pounding, or irregular heartbeat or pulse
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid shallow breathing
  • redness of the skin
  • redness of the white part of the eyes
  • swelling of the eyelids

Minor Side Effects

Some sebelipase alfa side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Difficulty having a bowel movement (stool)
  • muscle aches
  • pale skin
  • sneezing
  • sore throat
  • stuffy or runny nose
  • troubled breathing with exertion
  • unusual bleeding or bruising

For Healthcare Professionals

Applies to sebelipase alfa: intravenous solution

Cardiovascular

Common (1% to 10%): Tachycardia, hyperemia, hypotension

Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Tachycardia, hypertension, pallor, increased blood pressure, increased heart rate[Ref]

Dermatologic

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[Ref]

Gastrointestinal

Constipation and nausea were each reported in 8% of pediatric and adult patients receiving this drug, compared to 3% and 7% of those receiving placebo, respectively.[Ref]

Common (1% to 10%): Nausea, diarrhea, abdominal pain, abdominal distention, constipation

Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Diarrhea (67%), vomiting (67%), gastroesophageal reflux disease, retching[Ref]

General

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).[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, menorrhagia[Ref]

Hematologic

Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Anemia (44%)[Ref]

Hypersensitivity

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[Ref]

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.[Ref]

Immunologic

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.[Ref]

Very common (10% or more): Antidrug antibody development
Common (1% to 10%): Neutralizing antibody development

Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Development of antidrug antibodies (ADA), positive for neutralizing antibodies[Ref]

Metabolic

Very common (10% or more): Increased low-density lipoprotein (LDL) cholesterol, increased triglycerides
Common (1% to 10%): Transient hypercholesterolemia, transient hypertriglyceridemia

Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Decreased oxygen saturation[Ref]

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. These increases generally improved within an additional 8 weeks of therapy.[Ref]

Nervous system

Very common (10% or more): Headache (28%)
Common (1% to 10%): Dizziness

Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Hypotonia[Ref]

Ocular

Common (1% to 10%): Eyelid edema

Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Eyelid edema[Ref]

Other

Very common (10% or more): Fever/pyrexia (25%)
Common (1% to 10%): Chills, chest discomfort, edema, fatigue, increased body temperature, infusion site induration, infusion related reaction, asthenia

Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Fever/pyrexia (56%), increased body temperature, decreased oxygen saturation, chills, edema, hyperthermia, irritability, decreased growth velocity[Ref]

Psychiatric

Common (1% to 10%): Anxiety, insomnia

Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Agitation[Ref]

Respiratory

Very common (10% or more): Oropharyngeal pain (17%), nasopharyngitis (11%)
Common (1% to 10%): Laryngeal edema, dyspnea

Rapidly Progressive LAL Deficiency:
-Very common (10% or more): Rhinitis (56%), Nasopharyngitis (33%), Cough (33%), respiratory distress, wheezing, nasal congestion, sneezing, increased respiratory rate[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Kanuma (sebelipase alfa)." Alexion Pharmaceuticals Inc, Cheshire, CT.

It is possible that some side effects of sebelipase alfa may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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