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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

Along with its needed effects, sebelipase alfa 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

  • 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

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

  • 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): Hypertension, pallor, increased blood pressure, increased heart rate

-Frequency not reported: Tachycardia[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

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[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

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[Ref]

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]

Metabolic

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[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.[Ref]

Nervous system

Very common (10% or more): Headache (28%), hypotonia

Common (1% to 10%): Dizziness

Rapidly Progressive LAL Deficiency:

-Frequency not reported: Hypotonia[Ref]

Ocular

Common (1% to 10%): Eyelid edema, conjunctival injection

Rapidly Progressive LAL Deficiency:

-Very common (10% or more): Eyelid edema[Ref]

Other

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[Ref]

Psychiatric

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

Rapidly Progressive LAL Deficiency:

-Very common (10% or more): Agitation, irritability[Ref]

Respiratory

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[Ref]

References

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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