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Equine Thymocyte Immune Globulin (Atgam)

Trade Name : Atgam

Pharmacia and Upjohn Company LLC

INJECTION, SOLUTION, PLASMA DERIVATIVE

Strength 50 mg/mL

EQUINE THYMOCYTE IMMUNE GLOBULIN Immunoglobulin G [EPC],Lymphocyte Function Alteration [PE],Increased T Lymphocyte Destruction [PE],Antibody-Surface Protein Interactions [MoA],Immunoglobulins [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Equine Thymocyte Immune Globulin (Atgam) which is also known as Atgam and Manufactured by Pharmacia and Upjohn Company LLC. It is available in strength of 50 mg/mL per ml. Read more

Equine Thymocyte Immune Globulin (Atgam) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Antithymocyte globulins can cause anaphylaxis when injected intravenously. Although ATGAM is processed to reduce the level of antibodies that will react to non-T cells, physicians should be prepared for the potential risk of anaphylaxis and monitor patients for signs and symptoms during infusion.
  • WARNING: ANAPHYLAXIS
  • Antithymocyte globulins can cause anaphylaxis when injected intravenously. Although ATGAM is processed to reduce the level of antibodies that will react to non-T cells, physicians should be prepared for the potential risk of anaphylaxis and monitor patients for signs and symptoms during infusion.
  • ATGAM is an immunoglobulin G indicated for:
  • Renal transplant rejection. ()
  • Aplastic anemia (moderate to severe) in patients unsuitable for bone marrow transplantation. ()
  • Limitations of Use:
  • ATGAM is intended for intravenous use only.
  • ATGAM is used with concomitant immunosuppressants. During repeat courses of ATGAM, observe patients for signs of allergic reactions .
  • Intravenous use only.
  • ATGAM 50 mg/mL concentrate for solution for infusion
  • ATGAM 50 mg/mL concentrate for solution for infusion. ()
  • Do not administer ATGAM to a patient who has had a systemic reaction (e.g., anaphylactic reaction) during prior administration of ATGAM or any other equine gamma globulin preparation n
  • Systemic reaction (e.g., anaphylactic reaction) during prior administration of ATGAM or any other equine gamma globulin preparation. ()
  • No data
  • Discontinue ATGAM if anaphylaxis occurs. ()
  • Serious immune-mediated reactions, including anaphylaxis, have been reported. To identify those at greatest risk, skin testing before treatment is strongly recommended. ()
  • Monitor patients for concurrent infection, including cytomegalovirus. ()
  • Do not administer live vaccines to patients about to receive, receiving, or after treatment with ATGAM due to a potential of uncontrolled viral replication in the immunosuppressed patient. ()
  • The most clinically significant adverse reactions are anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests.
  • The most common (>10%) adverse reactions are pyrexia, chills, rash, thrombocytopenia, leukopenia and arthralgia. ()n n n
  • Previously masked reactions to ATGAM may appear when the dose of corticosteroids and other immunosuppressants is being reduced.
  • Previously masked reactions to ATGAM may appear following reduced doses of immunosuppressants. ()
  • No data
  • Pregnancy: Use only if the potential benefit justifies the risk. ()
  • Nursing Mothers: Discontinue nursing when administering ATGAM. ()
  • Geriatric: Start dosing at the low end of the dosage range. ()
  • The maximum tolerated dose of ATGAM Sterile Solution would be expected to vary from patient to patient due to the biological nature of the product. The largest single daily dose known to be administered to a patient (renal transplant recipient) was 7,000 mg administered at a concentration of approximately 10 mg/mL Sodium Chloride Injection, USP, seven times the recommended total dose and infusion concentration. In this patient, the administration of ATGAM was not associated with any signs of acute intoxication or late sequelae.
  • A maximum therapeutic dose has not been established therefore the definition of overdose for ATGAM has not been clearly defined. Some renal transplant patients have received up to 50 doses in 4 months, and others have received 28-day courses of 21 doses followed by as many as 3 more courses for the treatment of acute rejection. The incidence of toxicologic manifestations did not increase with any of these regimens; however, close monitoring of the patient is recommended.
  • ATGAM Sterile Solution contains lymphocyte immune globulin, anti-thymocyte globulin [equine]. It is the purified, concentrated, and sterile gamma globulin, primarily monomeric IgG, from hyperimmune serum of horses immunized with human thymus lymphocytes. ATGAM is a transparent to slightly opalescent aqueous protein solution. It may appear colorless to faintly pink or brown and is nearly odorless. It may develop a slight granular or flaky deposit during storage .
  • Precise methods of determining the potency of ATGAM have not been established, thus activity may potentially vary from lot to lot. Before release for clinical use, each lot of ATGAM is tested to assure its ability to inhibit rosette formation between human peripheral lymphocytes and sheep red blood cells . In each lot, antibody activity against human red blood cells and platelets is also measured and determined to be within acceptable limits. Only lots that meet the acceptance criteria for pyrogens and test negative for antihuman serum protein antibody and antiglomerular basement membrane antibody are released.
  • Each milliliter of ATGAM contains 50 mg of horse gamma globulin stabilized in 0.3 molar glycine to a pH of approximately 6.8.
  • No data
  • Mutagenicity and carcinogenicity studies have not been conducted on ATGAM.
  • In fertility studies, ATGAM at doses 10, 20 and 40 mg/kg/day was administered to cynomolgus monkeys (Macaca fascicularis) for 14 days either before (male monkeys) or before and after (female monkeys) cohabitation with untreated mates. ATGAM treatment was not associated with male or female hormonal or copulation behavior changes. A decrease in fertility index in female monkeys receiving ATGAM was seen. Female toxicity, including death, was observed with ATGAM doses of u226520 mg/kg/day. While the etiology of this toxicity is uncertain, it may be attributed to hemolytic anemia due to cross-reactivity of ATGAM to a monkey red blood antigen.
  • In embryo-fetal toxicity studies, ATGAM was administered to rats and cynomolgus monkeys for 11 and 16 days, respectively during organogenesis. In rats, hypoplastic cervical vertebrae, a finding consistent with delayed skeletal development, were observed in fetuses whose dams received ATGAM at doses of 100 mg/kg/day during organogenesis. In monkey reproduction studies, maternal toxicity (vaginal bleeding, decreased body weight and loss of appetite) was observed with ATGAM doses u226520 mg/kg/day after 16 days of dosing. Fetal deaths occurred in dams treated with 20 mg/kg/day ATGAM earlier in organogenesis (days 20u201335), but not when treatment was given at a later part of organogenesis (days 35u201350). The maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share. Therefore, this toxicity is not considered relevant to human fetal development.
  • No data
  • No data
  • ATGAM Sterile Solution, containing 50 mg/mL lymphocyte immune globulin, anti-thymocyte globulin [equine], is supplied as follows:
  • Store in a refrigerator at 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F). DO NOT FREEZE.
  • For storage conditions of diluted solution, see .
  • Advise patients receiving ATGAM that they will be monitored in a facility equipped and staffed with adequate laboratory and supportive medical resources.
  • Inform patients that ATGAM may cause serious allergic reactions, infection or abnormal liver or renal function.
  • Healthcare providers should refer to labels.fda.gov or DailyMed for the most updated version of the labeling.
  • This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.
  • U.S. Govt. License No. 1216
  • LAB-0019-8.0
  • NDC 0009-7224-01
  • 5 mL
  • Atgamn
  • lymphocyte immune globulin,anti-thymocyte globulin (equine)
  • 250 mg protein
  • 50 mg/mL For Intravenous use only
  • DOSAGE AND USE: See accompanying prescribing information.
  • ATTENTIONu2014May contain particles; this isnormal. Use 0.2 micron to 1.0 micron in-line filter. See insert.
  • Manufactured by Pharmacia & Upjohn CoDivision of Pfizer Inc, NY, NY 10017
  • U.S. Govt. License No. 1216Rx only
  • PAA111210
  • LOT / EXP
  • NDC 0009-7224-02Contains 5 of NDC 0009-7224-01
  • 5u20135 mL Ampoules(single use containers)
  • Atgamn
  • lymphocyte immune globulin,anti-thymocyte globulin (equine)
  • 250 mg protein
  • 50 mg/mL
  • ATTENTIONu2014This product may contain a granularor flaky deposit; this is normal. See infusioninstructions described in the enclosed product insert.
  • Sterile Solution For Intravenous Use Only
  • Pfizer InjectablesRx only

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