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pegademase bovine

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Overview

What is Adagen?

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The chemical name for (pegademase bovine) Injection is (monomethoxypolyethylene glycol succinimidyl) 11-17-adenosine deaminase. It is a conjugate of numerous strands of monomethoxypolyethylene glycol (PEG), molecular weight 5,000, covalently attached to the enzyme adenosine deaminase (ADA). ADA (adenosine deaminase EC 3.5.4.4) used in the manufacture of (pegademase bovine) Injection is derived from bovine intestine.

The structural formula of (pegademase bovine) Injection is:

Each milliliter of (pegademase bovine) Injection contains:Pegademase bovine                                              250 units*Monobasic sodium phosphate, USP                     1.20 mgDibasic sodium phosphate, USP                           5.58 mgSodium Chloride, USP                                         8.50 mgWater for injection, USP                                      q.s. to 1.0 mL *One unit of activity is defined as the amount of ADA that converts 1μM of adenosine to inosine per minute at 25°C and pH 7.3.



What does Adagen look like?



What are the available doses of Adagen?

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What should I talk to my health care provider before I take Adagen?

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How should I use Adagen?

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Before prescribing (pegademase bovine) Injection the physician should be thoroughly familiar with the details of this prescribing information. For further information concerning the essential monitoring of (pegademase bovine) Injection therapy, the prescribing physician should contact Leadiant Biosciences, Inc., Gaithersburg, MD 20878. Telephone 1-866-792-5172.

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Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

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Dose proportionality has not been established and patients should be closely monitored when the dosage is increased. (pegademase bovine) Injection is not recommended for intravenous administration.

The optimal dosage and schedule of administration should be established for each patient based on monitoring of plasma ADA activity levels (trough levels before maintenance injection) and biochemical markers of ADA deficiency (primarily red cell dATP content). Since improvement in immune function follows correction of metabolic abnormalities, maintenance dosage in individual patients should be aimed at achieving the following biochemical goals: 1) maintain plasma ADA activity (trough levels before maintenance injection) in the range of 15-35 μmol/hr/mL (assayed at 37°C); and 2) decline in erythrocyte dATP to ≤ 0.005-0.015 μmol/mL packed erythrocytes, or ≤ 1% of the total erythrocyte adenine nucleotide (ATP + dATP) content, with a normal ATP level, as measured in a pre-injection sample. In addition, continued monitoring of immune function and clinical status is essential in any patient with a primary immunodeficiency disease and should be continued in patients undergoing treatment with (pegademase bovine) Injection.


What interacts with Adagen?

There is no evidence to support the safety and efficacy of (pegademase bovine) Injection as preparatory or support therapy for bone marrow transplantation. Since (pegademase bovine) Injection is administered by intramuscular injection, it should be used with caution in patients with thrombocytopenia and should not be used if thrombocytopenia is severe.



What are the warnings of Adagen?

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What are the precautions of Adagen?

General

Any laboratory or clinical indication of a decrease in potency of (pegademase bovine) Injection should be reported immediately by telephone to Leadiant Biosciences, Inc. Telephone 1-866-792-5172.

There have been no reports of hypersensitivity reactions in patients who have been treated with (pegademase bovine) Injection.

One of 12 patients showed an enhanced rate of clearance of plasma ADA activity after 5 months of therapy at 15 U/kg/week. Enhanced clearance was correlated with the appearance of an antibody that directly inhibited both unmodified ADA and (pegademase bovine) Injection. Subsequently, the patient was treated with twice weekly intramuscular injections at an increased dose of 20 U/kg, or a total weekly dose of 40 U/kg. No adverse effects were observed at the higher dose and effective levels of plasma ADA were restored. After 4 months, the patient returned to a weekly dosage schedule of 20 U/kg and effective plasma levels have been maintained.

Appropriate care to protect immune deficient patients should be maintained until improvement in immune function has been documented. The degree of immune function improvement may vary from patient to patient and, therefore, each patient will require appropriate care consistent with immunologic status.

Laboratory Tests

The treatment of SCID associated with ADA deficiency with (pegademase bovine) Injection should be monitored by measuring plasma ADA activity and red blood cell dATP levels.

Plasma ADA activity and red cell dATP should be determined prior to treatment. Once treatment with (pegademase bovine) Injection has been initiated, a desirable range of plasma ADA activity (trough level before maintenance injection) should be 15–35 μmol/hr/mL. This minimum trough level will ensure that plasma ADA activity from injection to injection is maintained above the level of total erythrocyte ADA activity in the blood of normal individuals.

Plasma ADA activity (pre-injection) should be determined every 1-2 weeks during the first 8-12 weeks of treatment in order to establish an effective dose of (pegademase bovine) Injection. After 2 months of maintenance treatment with (pegademase bovine) Injection, red cell dATP levels should decrease to a range of ≤ 0.005 to 0.015 μmol/mL. The normal value of dATP is below 0.001 μmol/mL. Once the level of dATP has fallen adequately, it should be measured 2-4 times a year during the remainder of the first year and 2-3 times a year thereafter, assuming no interruption in therapy.

Between 3 and 9 months, plasma ADA should be determined twice a month, then monthly until after 18-24 months of treatment with (pegademase bovine) Injection.

Patients who have successfully been maintained on therapy for two years should continue to have plasma ADA measured every 2-4 months and red cell dATP measured twice yearly. More frequent monitoring would be necessary if therapy were interrupted or if an enhanced rate of clearance of plasma ADA activity develops.

Once effective ADA plasma levels have been established, should a patient’s plasma ADA activity level fall below 10 μmol/hr/mL (which cannot be attributed to improper dosing, sample handling or antibody development) then the patients receiving this lot of (pegademase bovine) Injection should be requested to have a blood sample for plasma ADA determination taken prior to their next injection of (pegademase bovine) Injection.

Immune function, including the ability to produce antibodies, generally improves after 2-6 months of therapy, and matures over a longer period. Compared with the natural history of combined immunodeficiency disease due to ADA deficiency, a trend toward diminished frequency of opportunistic infections and fewer complications of infections has occurred in patients receiving (pegademase bovine) Injection. However, the lag between the correction of the metabolic abnormalities and improved immune function with a trend toward diminished frequency of infections and complications of infection is variable, and has ranged from a few weeks to approximately 6 months. Improvement in the general clinical status of the patient may be gradual (as evidenced by improvement in various clinical parameters) but should be apparent by the end of the first year of therapy. Antibody to (pegademase bovine) Injection may develop in patients and may result in more rapid clearance of (pegademase bovine) Injection. Antibody to (pegademase bovine) Injection should be suspected if a persistent fall in pre-injection levels of plasma ADA to < 10 μmol/hr/mL occurs. If other causes for a decline in plasma ADA levels can be ruled out [such as improper storage of (pegademase bovine) Injection vials (freezing or prolonged storage at temperatures above 8°C), or improper handling of plasma samples (e.g., repeated freezing and thawing during transport to laboratory)], then a specific assay for antibody to ADA and (pegademase bovine) Injection (ELISA, enzyme inhibition) should be performed.

In patients undergoing treatment with (pegademase bovine) Injection, a decline in immune function, with increased risk of opportunistic infections and complications of infection, will result from failure to maintain adequate levels of plasma ADA activity [whether due to the development of antibody to (pegademase bovine) Injection, to improper calculation of (pegademase bovine) Injection dosage, to interruption of treatment or to improper storage of (pegademase bovine) Injection with subsequent loss of activity]. If a persistent decline in plasma ADA activity occurs, immune function and clinical status should be monitored closely and precautions should be taken to minimize the risk of infection. If antibody to ADA or (pegademase bovine) Injection is found to be the cause of a persistent fall in plasma ADA activity, then adjustment in the dosage of (pegademase bovine) Injection and other measures may be taken to induce tolerance and restore adequate ADA activity.

Drug Interactions

There are no known drug interactions with (pegademase bovine) Injection. However, Vidarabine is a substrate for ADA and 2′-deoxycoformycin is a potent inhibitor of ADA. Thus, the activities of these drugs and (pegademase bovine) Injection could be substantially altered if they are used in combination with one another.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenic studies in animals have not been performed with (pegademase bovine) Injection nor have studies been performed on impairment of fertility.

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Pregnancy

Animal reproduction studies have not been conducted with (pegademase bovine) Injection. It is also not known whether (pegademase bovine) Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. (pegademase bovine) Injection should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether (pegademase bovine) Injection is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when (pegademase bovine) Injection is administered to a nursing woman.


What are the side effects of Adagen?

Clinical experience with (pegademase bovine) Injection has been limited. The following adverse reactions were reported: headache in one patient and pain at the injection site in two patients. The following adverse reactions have been identified during post-approval use of (pegademase bovine) Injection. Because these reactions are reported voluntarily from a very small population, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematologic events: hemolytic anemia, auto-immune hemolytic anemia, thrombocythemia, thrombocytopenia and autoimmune thrombocytopenia.

Dermatological events: injection site erythema, urticaria. Lymphomas

To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or by email at or contact the FDA at 1-800-FDA-1088 or .


What should I look out for while using Adagen?

There is no evidence to support the safety and efficacy of (pegademase bovine) Injection as preparatory or support therapy for bone marrow transplantation. Since (pegademase bovine) Injection is administered by intramuscular injection, it should be used with caution in patients with thrombocytopenia and should not be used if thrombocytopenia is severe.


What might happen if I take too much Adagen?

There is no documented experience with (pegademase bovine) Injection overdosage. An intraperitoneal dose of 50,000 U/kg of (pegademase bovine) Injection in mice resulted in weight loss up to 9%.


How should I store and handle Adagen?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. FOR YOUR PROTECTION:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. FOR YOUR PROTECTION:ADAGEN ADAGEN Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.Refrigerate. Store between +2°C and +8°C (36°F and 46°F). DO NOT FREEZE. (pegademase bovine) Injection should not be stored at room temperature. This product should not be used if there are any indications that it may have been frozen.Manufactured by Exelead, Inc., Indianapolis, IN 46268.Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878.ADAGEN ADAGEN Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.Refrigerate. Store between +2°C and +8°C (36°F and 46°F). DO NOT FREEZE. (pegademase bovine) Injection should not be stored at room temperature. This product should not be used if there are any indications that it may have been frozen.Manufactured by Exelead, Inc., Indianapolis, IN 46268.Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878.ADAGEN ADAGEN Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.Refrigerate. Store between +2°C and +8°C (36°F and 46°F). DO NOT FREEZE. (pegademase bovine) Injection should not be stored at room temperature. This product should not be used if there are any indications that it may have been frozen.Manufactured by Exelead, Inc., Indianapolis, IN 46268.Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878.ADAGEN ADAGEN Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.Refrigerate. Store between +2°C and +8°C (36°F and 46°F). DO NOT FREEZE. (pegademase bovine) Injection should not be stored at room temperature. This product should not be used if there are any indications that it may have been frozen.Manufactured by Exelead, Inc., Indianapolis, IN 46268.Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878.ADAGEN ADAGEN Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.Refrigerate. Store between +2°C and +8°C (36°F and 46°F). DO NOT FREEZE. (pegademase bovine) Injection should not be stored at room temperature. This product should not be used if there are any indications that it may have been frozen.Manufactured by Exelead, Inc., Indianapolis, IN 46268.Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Severe combined immunodeficiency disease (SCID) associated with a deficiency of ADA is a rare, inherited, and often fatal disease. In the absence of the ADA enzyme, the purine substrates adenosine and 2′-deoxyadenosine accumulate, causing metabolic abnormalities that are directly toxic to lymphocytes.

The immune deficiency can be cured by bone marrow transplantation. When a suitable bone marrow donor is unavailable or when bone marrow transplantation fails, non-selective replacement of the ADA enzyme has been provided by periodic irradiated red blood cell transfusions. However, transmission of viral infections and iron overload are serious risks associated with irradiated red blood cell transfusions, and relatively few ADA deficient patients have benefitted from chronic transfusion therapy.

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In patients with ADA deficiency, rigorous adherence to a schedule of (pegademase bovine) Injection administration can eliminate the toxic metabolites of ADA deficiency and result in improved immune function. It is imperative that treatment with (pegademase bovine) Injection be carefully monitored by measurement of the level of ADA activity in plasma. Monitoring of the level of deoxyadenosine triphosphate (dATP) in erythrocytes is also helpful in determining that the dose of (pegademase bovine) Injection is adequate.

Non-Clinical Toxicology
There is no evidence to support the safety and efficacy of (pegademase bovine) Injection as preparatory or support therapy for bone marrow transplantation. Since (pegademase bovine) Injection is administered by intramuscular injection, it should be used with caution in patients with thrombocytopenia and should not be used if thrombocytopenia is severe.

There are no known drug interactions with (pegademase bovine) Injection. However, Vidarabine is a substrate for ADA and 2′-deoxycoformycin is a potent inhibitor of ADA. Thus, the activities of these drugs and (pegademase bovine) Injection could be substantially altered if they are used in combination with one another.

Any laboratory or clinical indication of a decrease in potency of (pegademase bovine) Injection should be reported immediately by telephone to Leadiant Biosciences, Inc. Telephone 1-866-792-5172.

There have been no reports of hypersensitivity reactions in patients who have been treated with (pegademase bovine) Injection.

One of 12 patients showed an enhanced rate of clearance of plasma ADA activity after 5 months of therapy at 15 U/kg/week. Enhanced clearance was correlated with the appearance of an antibody that directly inhibited both unmodified ADA and (pegademase bovine) Injection. Subsequently, the patient was treated with twice weekly intramuscular injections at an increased dose of 20 U/kg, or a total weekly dose of 40 U/kg. No adverse effects were observed at the higher dose and effective levels of plasma ADA were restored. After 4 months, the patient returned to a weekly dosage schedule of 20 U/kg and effective plasma levels have been maintained.

Appropriate care to protect immune deficient patients should be maintained until improvement in immune function has been documented. The degree of immune function improvement may vary from patient to patient and, therefore, each patient will require appropriate care consistent with immunologic status.

Clinical experience with (pegademase bovine) Injection has been limited. The following adverse reactions were reported: headache in one patient and pain at the injection site in two patients. The following adverse reactions have been identified during post-approval use of (pegademase bovine) Injection. Because these reactions are reported voluntarily from a very small population, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematologic events: hemolytic anemia, auto-immune hemolytic anemia, thrombocythemia, thrombocytopenia and autoimmune thrombocytopenia.

Dermatological events: injection site erythema, urticaria. Lymphomas

To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or by email at or contact the FDA at 1-800-FDA-1088 or .

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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