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Lumizyme

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Lumizyme

Lumizyme

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Anaphylaxis And Allergic Reactions

(see BOXED WARNING)

Anaphylaxis and severe allergic reactions have been observed in patients during and up to 3 hours after LUMIZYME infusion. Some of the reactions were life-threatening and included anaphylactic shock, respiratory arrest, apnea, dyspnea, bradycardia, tachycardia, and hypotension. Other accompanying reactions included chest discomfort/pain, throat tightness, bronchospasm, wheezing, tachypnea, cyanosis, decreased oxygen saturation/hypoxia, convulsions, angioedema (including tongue or lip swelling, periorbital edema, and face edema), pruritus, rash, urticaria, hyperhidrosis, nausea, dizziness, hypertension, flushing/erythema, fever, pallor, peripheral coldness, feeling hot, restlessness, nervousness, headache, back pain, and paraesthesia. Some of these reactions were IgE-mediated [see ADVERSE REACTIONS].

If anaphylaxis or other severe allergic reactions occur, immediate discontinuation of the administration of LUMIZYME should be considered, and appropriate medical treatment should be initiated. Severe reactions are generally managed with infusion interruption, administration of antihistamines, corticosteroids, intravenous fluids, and/or oxygen, when clinically indicated. In some cases of anaphylaxis, epinephrine has been administered. Because of the potential for severe allergic reactions, appropriate medical support, including cardiopulmonary resuscitation equipment, should be readily available when LUMIZYME is administered.

The risks and benefits of re-administering LUMIZYME following an anaphylactic or severe allergic reaction should be considered. Some patients have been rechallenged and have continued to receive LUMIZYME under close clinical supervision. Extreme care should be exercised, with appropriate resuscitation measures available, if the decision is made to readminister the product [see ADVERSE REACTIONS].

Immune Mediated Reactions

(see BOXED WARNING)

Severe cutaneous reactions have been reported with alglucosidase alfa including necrotizing skin lesions [see ADVERSE REACTIONS]. Systemic immune mediated reactions, including possible type III immune mediated reactions have been observed with alglucosidase alfa. These reactions occurred several weeks to 3 years after initiation of alglucosidase alfa infusions. Skin biopsy in one patient demonstrated deposition of anti-rhGAA antibodies in the lesion. Another patient developed severe inflammatory arthropathy in association with fever and elevated erythrocyte sedimentation rate. Nephrotic syndrome secondary to membranous glomerulonephritis was observed in a few Pompe patients treated with alglucosidase alfa who had persistently positive anti-rhGAA IgG antibody titers. In these patients renal biopsy was consistent with immune complex deposition. Patients improved following treatment interruption. It is therefore recommended to perform periodic urinalysis [see ADVERSE REACTIONS].

Patients should be monitored for the development of systemic immune mediated reactions involving skin and other organs while receiving LUMIZYME. If immune mediated reactions occur, discontinuation of the administration of LUMIZYME should be considered, and appropriate medical treatment initiated. The risks and benefits of re-administering alglucosidase alfa following an immune mediated reaction should be considered. Some patients have successfully been rechallenged and have continued to receive alglucosidase alfa under close clinical supervision.

Distribution Program For LUMIZYME®

(see BOXED WARNING)

LUMIZYME is available only under a restricted distribution program called the LUMIZYME ACE (Alglucosidase Alfa Control and Education) Program.

The purpose of the program is to ensure that the known risks of anaphylaxis and severe allergic reactions and the potential risks of severe cutaneous and systemic immune mediated reactions associated with the use of LUMIZYME are communicated to patients, caregivers, and prescribers. In addition, the purpose of the program is to mitigate the potential risk of rapid disease progression in infantile-onset Pompe disease patients and late (non-infantile) onset Pompe disease patients less than 8 years of age for whom the safety and effectiveness of LUMIZYME have not been evaluated.

Under this program, only trained and certified prescribers, and healthcare facilities enrolled in the program are able to prescribe, dispense or administer LUMIZYME, and only patients who are enrolled in and meet all the conditions of the LUMIZYME ACE Program may receive LUMIZYME.

For information about the ACE Program call 1-800-745-4447.

Risk Of Acute Cardiorespiratory Failure

Patients with acute underlying respiratory illness or compromised cardiac and/or respiratory function may be at risk of serious exacerbation of their cardiac or respiratory compromise during infusions. Appropriate medical support and monitoring measures should be readily available during LUMIZYME infusion, and some patients may require prolonged observation times that should be based on the individual needs of the patient. Acute cardiorespiratory failure has been observed in a few infantileonset Pompe disease patients with underlying cardiac hypertrophy, possibly associated with fluid overload with intravenous administration of alglucosidase alfa [see DOSAGE AND ADMINISTRATION].

Precautions For General/Regional Anesthesia

Administration of general anesthesia can be complicated by the presence of severe cardiac and skeletal (including respiratory) muscle weakness. Therefore, caution should be used when administering general anesthesia.

Monitoring: Laboratory Tests

Patients should be monitored for IgG antibody formation every 3 months for 2 years and then annually thereafter. Testing for IgG titers may also be considered if patients develop allergic or other immune mediated reactions. Patients who experience anaphylactic or allergic reactions may also be tested for IgE antibodies to alglucosidase alfa and other mediators of anaphylaxis [see ADVERSE REACTIONS].

There are currently no marketed tests for antibodies against alglucosidase alfa, however a testing service is provided by Genzyme. Contact your local Genzyme representative or Genzyme Corporation at 1-800-745-4447 for information on testing and to obtain a sample collection box.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with alglucosidase alfa.

Alglucosidase alfa at intravenous doses up to 40 mg/kg, administered every other day (plasma AUC of 64.6 mg•min/mL, 0.4 times the human exposure at the recommended bi-weekly dose) had no effect on fertility and reproductive performance in mice.

Use In Specific Populations

Pregnancy

Teratogenic Effects

Pregnancy Category B. Reproduction studies have been performed in pregnant mice at intravenous doses up to 40 mg/kg/day (plasma AUC of 64.6 mg*min/mL, 0.4 times the human steady-state exposure at the recommended bi-weekly dose) and pregnant rabbits at intravenous doses up to 40 mg/kg/day (plasma AUC of 85 mg*min/mL, 0.5 times the human steady-state exposure at the recommended bi-weekly dose) and have revealed no evidence of impaired fertility or harm to the fetus due to alglucosidase alfa. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Women of childbearing potential are encouraged to enroll in the Pompe Registry [see PATIENT INFORMATION].

Labor And Delivery

Information on the effect of LUMIZYME on labor and delivery is unknown. Pregnant women are encouraged to enroll in the Pompe Registry [see PATIENT INFORMATION].

Nursing Mothers

It is not known whether LUMIZYME is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LUMIZYME is administered to a nursing woman. Nursing women are encouraged to enroll in the Pompe Registry [see PATIENT INFORMATION].

Pediatric Use

LUMIZYME is not for use in patients with infantile-onset Pompe disease or late (non-infantile) onset Pompe disease who are less than 8 years of age. The safety and effectiveness of LUMIZYME in these patients have not been evaluated in clinical trials.

The safety and effectiveness of LUMIZYME was assessed in a randomized, double-blind, placebo-controlled study of 90 patients with late (non-infantile) onset Pompe disease. Patients age 8 to 70 years were eligible for enrollment. The study included 2 patients 16 years of age or less (n=1, age 16 years, LUMIZYME treatment group, n=1, age 10 years, placebo group) [see Clinical Studies].

Geriatric Use

The randomized, double-blind, placebo-controlled study of LUMIZYME did not include sufficient numbers (n=4) of patients aged 65 years and over to determine whether they respond differently from younger patients [see Clinical Studies].

Last reviewed on RxList: 7/14/2014
This monograph has been modified to include the generic and brand name in many instances.

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