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205, Al Qaizi Building, Al Muteena Street, Deira , AE
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61b0560507a1173b2771442e FABRAZYME 35 MG 1 VIAL https://cdn1.storehippo.com/s/6052eead9e1cf8aa024c48c8/61b0552999cadf2325ae3615/webp/fabrazyme-35-mg-1-vial.jpg

What is Fabrazyme and how is it used?

Fabrazyme is a prescription medicine used to treat the symptoms of Fabry Disease. Fabrazyme may be used alone or with other medications.

Fabrazyme belongs to a class of drugs called Enzymes, Metabolic.

It is not known if Fabrazyme is safe and effective in children younger than 2 years of age.

What are the possible side effects of Fabrazyme?

Fabrazyme may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • skin rash,
  • flushing (warmth, redness, or tingly feeling),
  • trouble swallowing,
  • chest discomfort,
  • lightheadedness,
  • fever,
  • headache,
  • chills,
  • stuffy nose,
  • muscle pain,
  • back pain,
  • dizziness,
  • drowsiness,
  • tiredness,
  • pale skin,
  • feeling hot or cold,
  • itching,
  • numbness or tingly feeling,
  • swelling in your hands or feet,
  • nausea,
  • vomiting,
  • tight feeling in your throat,
  • stomach pain,
  • diarrhea,
  • chest pain,
  • fast or slow heart rate, and
  • shortness of breath

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Fabrazyme include:

  • fever,
  • chills,
  • cough,
  • dizziness,
  • swelling in your hands or feet,
  • numbness or tingling,
  • tiredness,
  • rash,
  • stuffy nose,
  • sneezing, and
  • sore throat

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Fabrazyme. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

INDICATIONS

Fabrazyme® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.

DOSAGE AND ADMINISTRATION

Recommended Dosage

  • The recommended dosage of Fabrazyme is 1 mg/kg body weight infused every two weeks as an intravenous infusion.
  • Infusion rate:
    • The initial intravenous infusion rate is 0.25 mg/min (15 mg/hour). Slow the infusion rate in the event of infusion-associated reactions [see WARNINGS AND PRECAUTIONS].
    • For patients > 30 kg, after patient tolerance to the infusion is well established, increase the infusion rate in increments of 0.05 to 0.08 mg/min (increments of 3 to 5 mg/hour) with each subsequent infusion. The minimum infusion duration is 1.5 hours (based on individual patient tolerability).
    • For patients weighing < 30 kg, the maximum infusion rate is 0.25 mg/minute (15 mg/hour).
  • Because of the potential for severe infusion-associated reactions, appropriate medical support measures should be readily available when Fabrazyme is administered [see WARNINGS AND PRECAUTIONS].
  • Administer antipyretics prior to infusion of Fabrazyme [see WARNINGS AND PRECAUTIONS].
  • Rechallenge: Patients who have had a positive skin test to Fabrazyme or who have tested positive for anti-Fabrazyme IgE may be successfully rechallenged with Fabrazyme. The initial rechallenge administration should be a low dose at a lower infusion rate, e.g., ½ the therapeutic dose (0.5 mg/kg) at 1/25 of the initial standard recommended rate (0.01 mg/min). Once a patient tolerates the infusion, the dose may be increased to reach the approved dose of 1 mg/kg and the infusion rate may be increased by slowly titrating upwards (doubled every 30 minutes up to a maximum rate of 0.25 mg/minute), as tolerated [see ADVERSE REACTIONS].

Preparation And Administration Instructions

Fabrazyme does not contain any preservatives. Vials are for single use only. Discard any unused product.

Avoid shaking or agitating this product. Do not use filter needles during the preparation of the infusion.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Anaphylaxis And Hypersensitivity Reactions

In clinical trials and postmarketing safety experience with Fabrazyme, approximately 1% of patients developed anaphylactic or severe hypersensitivity reactions during Fabrazyme infusion.

In clinical trials with Fabrazyme, 10 of 238 patients developed IgE antibodies or skin test reactivity specific to Fabrazyme. Two of six patients in the rechallenge study discontinued treatment with Fabrazyme prematurely due to recurrent infusion-associated reactions. Four serious infusion-associated reactions occurred in three patients during Fabrazyme infusions, including bronchospasm, urticaria, hypotension, and development of Fabrazyme-specific antibodies. Other infusion-associated reactions occurring in more than one patient during the study included rigors, hypertension, nausea, vomiting, and pruritus.

Higher incidences of hypersensitivity reactions were observed in adult patients with persistent anti-Fabrazyme antibodies and in adult patients with high antibody titer compared to that in antibody negative adult patients [see ADVERSE REACTIONS].

Life-threatening anaphylactic and severe hypersensitivity reactions have been observed in patients during Fabrazyme infusions. Reactions have included localized angioedema (including swelling of the face, mouth, and throat), bronchospasm, hypotension, generalized urticaria, dysphagia, rash, dyspnea, flushing, chest discomfort, pruritus, and nasal congestion. Interventions have included cardiopulmonary resuscitation, oxygen supplementation, intravenous fluids, hospitalization, and treatment with inhaled beta-adrenergic agonists, epinephrine, and intravenous corticosteroids.

If anaphylactic or severe hypersensitivity reactions occur, immediately discontinue the administration of Fabrazyme and initiate necessary emergency treatment. Because of the potential for severe hypersensitivity reactions, appropriate medical support measures should be readily available when Fabrazyme is administered.

The risks and benefits of readministering Fabrazyme following an anaphylactic or severe hypersensitivity reaction should be considered. If a decision is made to readminister the product, ensure that appropriate medical emergency support is available [see DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS].

Physicians should consider testing for IgE antibodies in patients who experienced suspected hypersensitivity reactions and consider the risks and benefits of continued treatment in patients with anti-Fabrazyme IgE antibodies. There are no marketed tests for antibodies against Fabrazyme. If testing is warranted, contact Genzyme Corporation at 1-800-745-4447.

Patients who have had a positive skin test to Fabrazyme or who have tested positive for Fabrazyme-specific IgE antibody have been rechallenged with Fabrazyme using a rechallenge protocol. Rechallenge of these patients should only occur under the direct supervision of qualified personnel, with appropriate medical support measures readily available [see DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS].

Infusion-Associated Reactions

In clinical trials of Fabrazyme, 59% of patients experienced infusion-associated reactions during Fabrazyme administration, some of which were severe. Infusion-associated reactions are defined as adverse reactions occurring on the same day as the infusion. The incidence of infusionassociated reactions was higher in patients who were positive for anti-Fabrazyme antibodies than in patients who were negative for anti-Fabrazyme antibodies [see ADVERSE REACTIONS].

Severe infusion-associated reactions experienced by more than one patient in clinical trials of Fabrazyme included chills, vomiting, hypotension, and paresthesia. Other infusion-associated reactions included pyrexia, feeling hot or cold, dyspnea, nausea, flushing, headache, fatigue, pruritus, pain in extremity, hypertension, chest pain, throat tightness, abdominal pain, dizziness, tachycardia, nasal congestion, diarrhea, edema peripheral, myalgia, urticaria, bradycardia, and somnolence [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].

Most patients in clinical trials were pretreated with acetaminophen. In patients experiencing infusion-associated reactions, pretreatment with an antipyretic and antihistamine is recommended. Infusion-associated reactions occurred in some patients after receiving pretreatment with antipyretics, antihistamines, and oral steroids. Infusion-associated reactions tended to decline in frequency with continued use of Fabrazyme. However, infusion-associated reactions may still occur despite extended duration of Fabrazyme treatment. If an infusionassociated reaction occurs, decrease the infusion rate, temporarily stop the infusion, and consider administrating additional antipyretics, antihistamines, and/or steroids. If severe infusionassociated reactions occur, discontinue administration of Fabrazyme immediately and initiate appropriate medical treatment. Severe reactions are generally managed with administration of antihistamines, corticosteroids, intravenous fluids, and/or oxygen, when clinically indicated.

Because of the potential for severe infusion-associated reactions, ensure appropriate medical support measures are readily available when Fabrazyme is administered. Monitor closely patients who have experienced infusion-associated reactions when readministering Fabrazyme. Patients with advanced Fabry disease may have compromised cardiac function, which may predispose them to a higher risk of severe complications from infusion-associated reactions. Monitor closely patients with compromised cardiac function if Fabrazyme is administered to these patients [see WARNINGS AND PRECAUTIONS].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

There are no animal or human studies to assess the carcinogenic or mutagenic potential of Fabrazyme. A study to evaluate the effects of agalsidase beta on fertility and general reproduction was performed in male and female rats at doses up to 10 mg/kg/day (23 times the human dose, on a body surface area basis). There were no adverse effects of agalsidase beta on fertility and early embryonic development in rats.

Use In Specific Populations

Pregnancy

Pregnancy Exposure Registry

Pregnant women and women of reproductive potential should be encouraged to enroll in the Fabry patient registry. The registry will monitor the effect of Fabrazyme on pregnant women and their offspring. For more information, visit www.registrynxt.com or call 1-800-745-4447, extension 15500.

Risk Summary

Available data from postmarketing case reports and case series with Fabrazyme use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Reproduction studies performed in rats at doses up to 68 times the human dose have revealed no evidence of effects on embryo-fetal development (see Data).

The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

The effects of agalsidase beta on embryo-fetal development in rats were evaluated at doses of 3, 10, and 30 mg/kg/day (up to 68 times the human dose of 1 mg/kg every 2 weeks on a body surface area basis) during gestation days 7 to 17. Hepatocellular necrosis consistent with accumulation of test article was evident in maternal livers in the 10 and 30 mg/kg/day groups (23 and 68 times the human dose on a body surface area basis). There were no adverse effects of agalsidase beta on embryo-fetal development in rats.

Lactation

Risk Summary

There are no data on the presence of agalsidase beta in either human or animal milk, the effects of the drug on the breastfed infant, or on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Fabrazyme and any potential adverse effects on the breastfed child from Fabrazyme or from the underlying maternal condition.

Lactating women with Fabry disease treated with Fabrazyme should be encouraged to enroll in the Fabry registry [see Use In Specific Populations].

Pediatric Use

The safety and effectiveness of Fabrazyme have been established in pediatric patients based on adequate and well-controlled studies in adults, a single-arm, open-label study in 16 pediatric patients with Fabry disease aged 8 to 16 years, and additional data in 24 patients with Fabry disease aged 2 to 7 years [see CLINICAL PHARMACOLOGY and Clinical Studies].

The overall safety profile of Fabrazyme was similar between the pediatric and the adult population [see ADVERSE REACTIONS and Clinical Studies].

Geriatric Use

Clinical studies of Fabrazyme did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

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FABRAZYME 35 MG 1 VIAL

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Description of product

What is Fabrazyme and how is it used?

Fabrazyme is a prescription medicine used to treat the symptoms of Fabry Disease. Fabrazyme may be used alone or with other medications.

Fabrazyme belongs to a class of drugs called Enzymes, Metabolic.

It is not known if Fabrazyme is safe and effective in children younger than 2 years of age.

What are the possible side effects of Fabrazyme?

Fabrazyme may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • skin rash,
  • flushing (warmth, redness, or tingly feeling),
  • trouble swallowing,
  • chest discomfort,
  • lightheadedness,
  • fever,
  • headache,
  • chills,
  • stuffy nose,
  • muscle pain,
  • back pain,
  • dizziness,
  • drowsiness,
  • tiredness,
  • pale skin,
  • feeling hot or cold,
  • itching,
  • numbness or tingly feeling,
  • swelling in your hands or feet,
  • nausea,
  • vomiting,
  • tight feeling in your throat,
  • stomach pain,
  • diarrhea,
  • chest pain,
  • fast or slow heart rate, and
  • shortness of breath

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Fabrazyme include:

  • fever,
  • chills,
  • cough,
  • dizziness,
  • swelling in your hands or feet,
  • numbness or tingling,
  • tiredness,
  • rash,
  • stuffy nose,
  • sneezing, and
  • sore throat

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Fabrazyme. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

INDICATIONS

Fabrazyme® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.

DOSAGE AND ADMINISTRATION

Recommended Dosage

  • The recommended dosage of Fabrazyme is 1 mg/kg body weight infused every two weeks as an intravenous infusion.
  • Infusion rate:
    • The initial intravenous infusion rate is 0.25 mg/min (15 mg/hour). Slow the infusion rate in the event of infusion-associated reactions [see WARNINGS AND PRECAUTIONS].
    • For patients > 30 kg, after patient tolerance to the infusion is well established, increase the infusion rate in increments of 0.05 to 0.08 mg/min (increments of 3 to 5 mg/hour) with each subsequent infusion. The minimum infusion duration is 1.5 hours (based on individual patient tolerability).
    • For patients weighing < 30 kg, the maximum infusion rate is 0.25 mg/minute (15 mg/hour).
  • Because of the potential for severe infusion-associated reactions, appropriate medical support measures should be readily available when Fabrazyme is administered [see WARNINGS AND PRECAUTIONS].
  • Administer antipyretics prior to infusion of Fabrazyme [see WARNINGS AND PRECAUTIONS].
  • Rechallenge: Patients who have had a positive skin test to Fabrazyme or who have tested positive for anti-Fabrazyme IgE may be successfully rechallenged with Fabrazyme. The initial rechallenge administration should be a low dose at a lower infusion rate, e.g., ½ the therapeutic dose (0.5 mg/kg) at 1/25 of the initial standard recommended rate (0.01 mg/min). Once a patient tolerates the infusion, the dose may be increased to reach the approved dose of 1 mg/kg and the infusion rate may be increased by slowly titrating upwards (doubled every 30 minutes up to a maximum rate of 0.25 mg/minute), as tolerated [see ADVERSE REACTIONS].

Preparation And Administration Instructions

Fabrazyme does not contain any preservatives. Vials are for single use only. Discard any unused product.

Avoid shaking or agitating this product. Do not use filter needles during the preparation of the infusion.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Anaphylaxis And Hypersensitivity Reactions

In clinical trials and postmarketing safety experience with Fabrazyme, approximately 1% of patients developed anaphylactic or severe hypersensitivity reactions during Fabrazyme infusion.

In clinical trials with Fabrazyme, 10 of 238 patients developed IgE antibodies or skin test reactivity specific to Fabrazyme. Two of six patients in the rechallenge study discontinued treatment with Fabrazyme prematurely due to recurrent infusion-associated reactions. Four serious infusion-associated reactions occurred in three patients during Fabrazyme infusions, including bronchospasm, urticaria, hypotension, and development of Fabrazyme-specific antibodies. Other infusion-associated reactions occurring in more than one patient during the study included rigors, hypertension, nausea, vomiting, and pruritus.

Higher incidences of hypersensitivity reactions were observed in adult patients with persistent anti-Fabrazyme antibodies and in adult patients with high antibody titer compared to that in antibody negative adult patients [see ADVERSE REACTIONS].

Life-threatening anaphylactic and severe hypersensitivity reactions have been observed in patients during Fabrazyme infusions. Reactions have included localized angioedema (including swelling of the face, mouth, and throat), bronchospasm, hypotension, generalized urticaria, dysphagia, rash, dyspnea, flushing, chest discomfort, pruritus, and nasal congestion. Interventions have included cardiopulmonary resuscitation, oxygen supplementation, intravenous fluids, hospitalization, and treatment with inhaled beta-adrenergic agonists, epinephrine, and intravenous corticosteroids.

If anaphylactic or severe hypersensitivity reactions occur, immediately discontinue the administration of Fabrazyme and initiate necessary emergency treatment. Because of the potential for severe hypersensitivity reactions, appropriate medical support measures should be readily available when Fabrazyme is administered.

The risks and benefits of readministering Fabrazyme following an anaphylactic or severe hypersensitivity reaction should be considered. If a decision is made to readminister the product, ensure that appropriate medical emergency support is available [see DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS].

Physicians should consider testing for IgE antibodies in patients who experienced suspected hypersensitivity reactions and consider the risks and benefits of continued treatment in patients with anti-Fabrazyme IgE antibodies. There are no marketed tests for antibodies against Fabrazyme. If testing is warranted, contact Genzyme Corporation at 1-800-745-4447.

Patients who have had a positive skin test to Fabrazyme or who have tested positive for Fabrazyme-specific IgE antibody have been rechallenged with Fabrazyme using a rechallenge protocol. Rechallenge of these patients should only occur under the direct supervision of qualified personnel, with appropriate medical support measures readily available [see DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS].

Infusion-Associated Reactions

In clinical trials of Fabrazyme, 59% of patients experienced infusion-associated reactions during Fabrazyme administration, some of which were severe. Infusion-associated reactions are defined as adverse reactions occurring on the same day as the infusion. The incidence of infusionassociated reactions was higher in patients who were positive for anti-Fabrazyme antibodies than in patients who were negative for anti-Fabrazyme antibodies [see ADVERSE REACTIONS].

Severe infusion-associated reactions experienced by more than one patient in clinical trials of Fabrazyme included chills, vomiting, hypotension, and paresthesia. Other infusion-associated reactions included pyrexia, feeling hot or cold, dyspnea, nausea, flushing, headache, fatigue, pruritus, pain in extremity, hypertension, chest pain, throat tightness, abdominal pain, dizziness, tachycardia, nasal congestion, diarrhea, edema peripheral, myalgia, urticaria, bradycardia, and somnolence [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].

Most patients in clinical trials were pretreated with acetaminophen. In patients experiencing infusion-associated reactions, pretreatment with an antipyretic and antihistamine is recommended. Infusion-associated reactions occurred in some patients after receiving pretreatment with antipyretics, antihistamines, and oral steroids. Infusion-associated reactions tended to decline in frequency with continued use of Fabrazyme. However, infusion-associated reactions may still occur despite extended duration of Fabrazyme treatment. If an infusionassociated reaction occurs, decrease the infusion rate, temporarily stop the infusion, and consider administrating additional antipyretics, antihistamines, and/or steroids. If severe infusionassociated reactions occur, discontinue administration of Fabrazyme immediately and initiate appropriate medical treatment. Severe reactions are generally managed with administration of antihistamines, corticosteroids, intravenous fluids, and/or oxygen, when clinically indicated.

Because of the potential for severe infusion-associated reactions, ensure appropriate medical support measures are readily available when Fabrazyme is administered. Monitor closely patients who have experienced infusion-associated reactions when readministering Fabrazyme. Patients with advanced Fabry disease may have compromised cardiac function, which may predispose them to a higher risk of severe complications from infusion-associated reactions. Monitor closely patients with compromised cardiac function if Fabrazyme is administered to these patients [see WARNINGS AND PRECAUTIONS].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

There are no animal or human studies to assess the carcinogenic or mutagenic potential of Fabrazyme. A study to evaluate the effects of agalsidase beta on fertility and general reproduction was performed in male and female rats at doses up to 10 mg/kg/day (23 times the human dose, on a body surface area basis). There were no adverse effects of agalsidase beta on fertility and early embryonic development in rats.

Use In Specific Populations

Pregnancy

Pregnancy Exposure Registry

Pregnant women and women of reproductive potential should be encouraged to enroll in the Fabry patient registry. The registry will monitor the effect of Fabrazyme on pregnant women and their offspring. For more information, visit www.registrynxt.com or call 1-800-745-4447, extension 15500.

Risk Summary

Available data from postmarketing case reports and case series with Fabrazyme use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Reproduction studies performed in rats at doses up to 68 times the human dose have revealed no evidence of effects on embryo-fetal development (see Data).

The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

The effects of agalsidase beta on embryo-fetal development in rats were evaluated at doses of 3, 10, and 30 mg/kg/day (up to 68 times the human dose of 1 mg/kg every 2 weeks on a body surface area basis) during gestation days 7 to 17. Hepatocellular necrosis consistent with accumulation of test article was evident in maternal livers in the 10 and 30 mg/kg/day groups (23 and 68 times the human dose on a body surface area basis). There were no adverse effects of agalsidase beta on embryo-fetal development in rats.

Lactation

Risk Summary

There are no data on the presence of agalsidase beta in either human or animal milk, the effects of the drug on the breastfed infant, or on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Fabrazyme and any potential adverse effects on the breastfed child from Fabrazyme or from the underlying maternal condition.

Lactating women with Fabry disease treated with Fabrazyme should be encouraged to enroll in the Fabry registry [see Use In Specific Populations].

Pediatric Use

The safety and effectiveness of Fabrazyme have been established in pediatric patients based on adequate and well-controlled studies in adults, a single-arm, open-label study in 16 pediatric patients with Fabry disease aged 8 to 16 years, and additional data in 24 patients with Fabry disease aged 2 to 7 years [see CLINICAL PHARMACOLOGY and Clinical Studies].

The overall safety profile of Fabrazyme was similar between the pediatric and the adult population [see ADVERSE REACTIONS and Clinical Studies].

Geriatric Use

Clinical studies of Fabrazyme did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

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