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Lumizyme

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Lumizyme

Lumizyme Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lumizyme (alglucosidase alfa) for Injection is an enzyme used to treat a glycogen storage disorder called Pompe disease, (also called GAA deficiency) in adults and children who are at least 8 years old. Common side effects include mild skin rash or itching; diarrhea, constipation, upset stomach, vomiting; sore throat, neck pain; pain or swelling in your arms or legs; or pain, swelling, burning, or irritation around the IV needle.

The recommended dosage of Lumizyme is 20 mg/kg body weight administered every 2 weeks as an intravenous infusion. Lumizyme may interact with other drugs. Tell your doctor all medications and supplements you use. Lumizyme is not expected to harm a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Lumizyme (alglucosidase alfa) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lumizyme in Detail - Patient Information: Side Effects

Some people receiving an injection of alglucosidase alfa have had a reaction to the infusion. This type of reaction can occur when the medicine is injected into the vein, or as long as 3 hours after the injection. Tell your caregivers or get emergency medical help right away if you have any of these signs of a severe allergic reaction:

  • feeling like you might pass out, even while lying down;
  • feeling restless, nervous, dizzy, or nauseated;
  • pale skin, redness under your skin, sweating, feeling hot or cold;
  • fast or slow heart rate;
  • pain or tightness in your chest or throat;
  • wheezing, trouble breathing;
  • cold hands, blue lips;
  • back pain;
  • numbness, warmth, redness, or tingly feeling;
  • seizure (convulsions);
  • hives, severe skin rash; or
  • swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • pain or fullness in your ear, problems with hearing;
  • skin ulcers;
  • fast, slow, or uneven heartbeats;
  • urinating less than usual or not at all;
  • weak pulse, fainting, slow breathing (breathing may stop); or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling.

Less serious side effects may include:

  • mild skin rash or itching;
  • diarrhea, constipation, stomach pain or upset, vomiting;
  • sore throat, neck pain;
  • pain or swelling in your arms or legs; or
  • pain, swelling, burning, or irritation around the IV needle.

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.

Read the entire detailed patient monograph for Lumizyme (Alglucosidase Alfa) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lumizyme FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following serious adverse reactions are described below and elsewhere in the labeling:

In clinical trials, the most common adverse reactions ( ≥ 5%) following alglucosidase alfa treatment were hypersensitivity reactions, and included anaphylaxis, rash, pyrexia, flushing/feeling hot, urticaria, headache, hyperhidrosis, nausea, cough, decreased oxygen saturation, tachycardia, tachypnea, chest discomfort, dizziness, muscle twitching, agitation, cyanosis, erythema, hypertension/increased blood pressure, pallor, rigors, tremor, vomiting, fatigue, and myalgia.

Clinical Trials in Infantile-Onset and Juvenile-Onset Pompe Disease

Two multicenter, open-label clinical trials were conducted in 39 infantile-onset Pompe disease patients, ages 1 month to 3.5 years old. Approximately half of the patients (54%) were male. Patients were treated with alglucosidase alfa 20 or 40 mg/kg every other week for periods ranging from 1 to 106 weeks (mean: 61 weeks).

The most serious adverse reactions reported with alglucosidase alfa treatment included anaphylaxis and acute cardiorespiratory failure.

The most common adverse reactions requiring intervention in clinical trials were hypersensitivity reactions, occurring in 20 of 39 (51%) patients treated with alglucosidase alfa, and included rash, pyrexia, urticaria, flushing, decreased oxygen saturation, cough, tachypnea, tachycardia, hypertension/increased blood pressure, pallor, rigors, vomiting, cyanosis, agitation, and tremor. These reactions were more likely to occur with higher infusion rates. Some patients who were pretreated with antihistamines, antipyretics and/or corticosteroids still experienced hypersensitivity reactions.

Table 2 summarizes all adverse reactions occurring in > 5% of patients (2 or more patients) treated with alglucosidase alfa in clinical trials described above.

Table 2: Adverse Reactions that Occurred in At Least 5% of Infantile-Onset Patients Treated with Alglucosidase Alfa in Clinical Trials

  Number of Patients
(N=39) n (%)
Adverse Reaction 20 (51)
  Rash (including rash erythematous, rash macular and maculo-papular) 7 (18)
  Pyrexia 6 (15)
  Urticaria 5 (13)
  Flushing 5 (13)
  Hypertension/Increased Blood Pressure 4 (10)
  Decreased Oxygen Saturation 3 (8)
  Cough 3 (8)
  Tachypnea 3 (8)
  Tachycardia 3 (8)
  Erythema 2 (5)
  Vomiting 2 (5)
  Rigors 2 (5)
  Pallor 2 (5)
  Cyanosis 2 (5)
  Agitation 2 (5)
  Tremor 2 (5)

An open-label, single-center trial was conducted in 18 treatment-naive infantile-onset Pompe disease patients who were treated exclusively with alglucosidase alfa. Adverse reactions observed in these patients were similar to infantile-onset Pompe disease patients who received alglucosidase alfa in other clinical trials.

Additional hypersensitivity reactions observed in infantile-onset Pompe disease patients treated in other clinical trials and expanded access programs with alglucosidase alfa included livedo reticularis, irritability, retching, increased lacrimation, ventricular extrasystoles, nodal rhythm, rales, respiratory tract irritation, and cold sweat.

Safety was also evaluated in 99 patients (51 male, 48 females) with Pompe disease in an ongoing, open-label, prospective study in patients 12 months of age and older who were previously treated with the 160 L scale of alglucosidase alfa and switched to the 4000 L scale of alglucosidase alfa. Patients were aged 1 to 18 years with a median duration of treatment of 437 days (range 13 to 466 days). No new safety findings were observed following the switch to 4000 L scale of alglucosidase alfa.

Clinical Trials in Late-Onset Pompe Disease

Assessment of adverse reactions in patients with late-onset Pompe disease is based on the exposure of 90 patients (45 male, 45 female), aged 10 to 70 years, to 20 mg/kg alglucosidase alfa or placebo in a randomized, double-blind, placebo-controlled trial. The youngest alglucosidase alfa-treated patient was 16 years of age, and the youngest placebo-treated patient was 10 years of age. All patients were naive to enzyme replacement therapy. Patients were randomized in a 2:1 ratio and received alglucosidase alfa or placebo every other week for 78 weeks (18 months). The study population included 34 males and 26 females (n=60) in the alglucosidase alfa group and 11 males and 19 females (n=30) in the placebo group. Two patients receiving alglucosidase alfa discontinued the trial due to anaphylactic reactions.

Serious adverse reactions reported with alglucosidase alfa included anaphylaxis, which presented as angioedema, throat tightness and chest pain/discomfort. One patient with a history of Wolff-Parkinson-White syndrome experienced a serious adverse reaction of supraventricular tachycardia.

The most common adverse reactions ( ≥ 3%; 2 or more patients) observed in alglucosidase alfatreated patients were hypersensitivity reactions and included anaphylaxis, headache, nausea, urticaria, dizziness, chest discomfort, vomiting, hyperhidrosis, flushing/feeling hot, increased blood pressure, paresthesia, pyrexia, local swelling, diarrhea, pruritus, rash, and throat tightness.

Delayed-onset reactions, defined as adverse reactions occurring 2 - 48 hours after completion of alglucosidase alfa infusion, that were observed in ≥ 3% more patients in the alglucosidase alfatreated group compared to patients in the placebo-treated group in the controlled trial, included hyperhidrosis. Additional delayed-onset reactions occurring in alglucosidase alfa-treated patients included fatigue, myalgia, and nausea. Patients should be counseled about the possibility of delayed-onset hypersensitivity reactions and given proper follow-up instructions.

Table 3 summarizes the most common adverse reactions that occurred in at least 3% of alglucosidase alfa-treated patients and with a higher incidence than the placebo-treated patients during the randomized, double-blind, placebo-controlled study described above.

Table 3: Adverse Reactions Occurring in at Least 3% of Alglucosidase Alfa-Treated Late- Onset Patients and with a Higher Incidence than the Placebo-Treated Patients

Adverse Reaction Alglucosidase Alfa
n=60 N (%)
Placebo
n=30 N (%)
Hyperhidrosis 5 (8.3) 0 (0)
Urticaria 5 (8.3) 0 (0)
Anaphylaxis 4 (6.7) 0 (0)
Chest Discomfort 4 (6.7) 1 (3.3)
Muscle Twitching 4 (6.7) 1 (3.3)
Myalgia 3 (5.0) 1 (3.3)
Flushing/Feeling Hot 3 (5.0) 0 (0)
Increased Blood Pressure 3 (5.0) 0 (0)
Vomiting 3 (5.0) 0 (0)
Edema, Peripheral 2 (3.3) 0 (0)
Pruritus 2 (3.3) 0 (0)
Rash Papular 2 (3.3) 0 (0)
Throat Tightness 2 (3.3) 0 (0)

In clinical trials, anaphylaxis and hypersensitivity reactions were managed with infusion interruption, decreased infusion rate, administration of antihistamines, corticosteroids, intravenous fluids, and/or oxygen, when clinically indicated. In some cases of anaphylactic reactions, epinephrine was administered. Patients who have experienced anaphylaxis or hypersensitivity reactions should be treated with caution when they are re-administered alglucosidase alfa.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The data reflect the percentage of patients whose test results were considered positive for antibodies to alglucosidase alfa using an enzyme-linked immunosorbent assay (ELISA) and confirmed by a radioimmunoprecipitation (RIP) assay for alglucosidase alfa-specific IgG antibodies.

In the two clinical trials in infantile-onset patients, the majority of patients (34 of 38; 89%) tested positive for IgG antibodies to alglucosidase alfa. There is evidence to suggest that some patients who develop high sustained titers of anti-alglucosidase alfa antibodies may experience reduced clinical efficacy to alglucosidase alfa treatment [see WARNINGS AND PRECAUTIONS]. Some IgGpositive patients in clinical trials who were retrospectively evaluated for the presence of inhibitory antibodies tested positive for inhibition of enzyme activity and/or uptake in in vitro assays. Furthermore, CRIM-negative infants have shown reduced clinical effect in the presence of high sustained IgG antibody titers with inhibitory activity. Alglucosidase alfa-treated patients who experience a decrease in motor function should be tested for the presence of inhibitory antibodies that neutralize enzyme uptake or activity.

In the randomized, double-blind, placebo-controlled trial in late-onset patients, all alglucosidase alfa-treated patients with available samples (N=59, 100%) developed IgG antibodies to alglucosidase alfa. Most patients who developed IgG antibodies did so within the first 3 months of exposure (median time to seroconversion was 4 weeks). There was no apparent association between mean or peak IgG antibody titers and the occurrence of adverse reactions.

None of the 59 evaluable patients tested positive for inhibition of enzyme activity. Antibody titers for cellular uptake inhibition were present in 18 of 59 (31%) patients by Week 78. All other patients tested negative for inhibition of cellular uptake. Patients who tested positive for uptake inhibition tended to have higher IgG titers than patients who tested negative for uptake inhibition. Among the 32 patients with evaluable pharmacokinetic (PK) samples, 5 patients tested positive for uptake inhibition. The clinical relevance of this in vitro inhibition is not fully understood. The clearance values for 4 of these 5 patients were approximately 1.2- to 1.8-fold greater in the presence of inhibitory antibodies (Week 52) as compared to in the absence of inhibitory antibodies (Week 0) [see CLINICAL PHARMACOLOGY].

Some patients in the clinical studies or in the postmarketing setting have undergone testing for alglucosidase alfa-specific IgE antibodies. Testing was performed in patients who experienced moderate to severe or recurrent hypersensitivity reactions, for which mast-cell activation was suspected. Some of the patients who tested positive for alglucosidase alfa-specific IgE antibodies experienced anaphylactic reactions [see BOXED WARNING and WARNINGS AND PRECAUTIONS].

Some patients who tested positive for alglucosidase alfa-specific IgE antibodies and experienced hypersensitivity reactions were able to be rechallenged with alglucosidase alfa using a slower infusion rate at lower starting doses and have continued to receive treatment under close clinical supervision [see WARNINGS AND PRECAUTIONS]. Since patients who develop IgE antibodies to alglucosidase alfa appear to be at a higher risk for developing anaphylaxis and hypersensitivity reactions, these patients should be monitored more closely during administration of alglucosidase alfa.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to alglucosidase alfa with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of alglucosidase alfa. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In postmarketing experience with alglucosidase alfa, serious adverse reactions have been reported, including anaphylaxis [see BOXED WARNING and WARNINGS AND PRECAUTIONS]. Acute cardiorespiratory failure, possibly associated with fluid overload, has been reported in infantileonset Pompe disease patients with pre-existing hypertrophic cardiomyopathy [see BOXED WARNING and WARNINGS AND PRECAUTIONS].

Recurrent reactions consisting of flu-like illness or a combination of events such as pyrexia, chills, myalgia, arthralgia, pain, or fatigue occurring after completion of infusions and lasting usually for 1 - 3 days have been observed in some patients treated with alglucosidase alfa. The majority of patients were able to be rechallenged with alglucosidase alfa using lower doses and/or pretreatment with anti-inflammatory drugs and/or corticosteroids and were able to continue treatment under close clinical supervision.

In addition to the hypersensitivity reactions reported in clinical trials, the following hypersensitivity reactions have been reported in at least 2 patients and included: anaphylactic shock, respiratory failure, respiratory arrest, cardiac arrest, hypoxia, dyspnea, wheezing, convulsions, peripheral coldness, restlessness, nervousness, back pain, stridor, pharyngeal edema, abdominal pain, apnea, muscle spasm, and conjunctivitis. In addition, one case of hyperparathyroidism has been reported.

Systemic and cutaneous immune-mediated reactions, including proteinuria and nephrotic syndrome secondary to membranous glomerulonephritis, and necrotizing skin lesions have been reported in postmarketing safety experience with alglucosidase alfa [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Lumizyme (Alglucosidase Alfa) »

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