Trade Name: GAMIFANT

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Swedish Orphan Biovitrum AB (publ)

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 10 mg/2mL

Storage and handling

EMAPALUMAB

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.
  • GAMIFANT is an interferon gamma (IFNu03b3) blocking antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. ()
  • For intravenous infusion only:
  • Recommended starting dosage: 1 mg/kg as an intravenous infusion over 1 hour twice per week. ()
  • Administer dexamethasone concomitantly with GAMIFANT. ()
  • GAMIFANT is a clear to slightly opalescent, colorless to slightly yellow preservative-free solution available as:
  • Injection:
  • Injection:
  • 10 mg/2 mL (5 mg/mL) solution in a single-dose vial ()
  • 50 mg/10 mL (5 mg/mL) solution in a single-dose vial ()
  • 100 mg/20 mL (5 mg/mL) solution in a single-dose vial ()
  • None.
  • None. ()
  • No data
  • Infections: Monitor patients for signs and symptoms and treat promptly. Test for latent tuberculosis. Administer prophylactic treatment against Herpes Zoster, and fungal infections. ()
  • Live Vaccines: Do not administer live or live attenuated vaccines to patients receiving GAMIFANT. ()
  • Infusion-Related Reactions: Monitor patients for infusion-related reactions. Interrupt infusion for severe infusion reactions and institute appropriate medical management. ()
  • The following adverse reactions are described elsewhere in the labeling:
  • n n The most common adverse reactions (u2265 20%) were: infections, hypertension, infusion-related reactions, and pyrexia. ()
  • The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (such as IFNu03b3) during chronic inflammation. By neutralizing IFNu03b3, use of GAMIFANT may normalize CYP450 activities which may reduce the efficacy of drugs that are CYP450 substrates due to increased metabolism.
  • Upon initiation or discontinuation of concomitant GAMIFANT, monitor for reduced efficacy and adjust dosage of CYP450 substrate drugs as appropriate.
  • No data
  • Emapalumab-lzsg is an interferon gamma (IFNu03b3) blocking antibody. Emapalumab-lzsg is produced in Chinese Hamster Ovary cells by recombinant DNA technology. Emapalumab-lzsg is an IgG1 immunoglobulin with a molecular weight of approximately 148 kDa.
  • GAMIFANT (emapalumab-lzsg) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution provided in single-dose vials that require dilution prior to intravenous infusion.
  • Each vial contains 10 mg/2 mL, 50 mg/10 mL, or 100 mg/20 mL emapalumab-lzsg at a concentration of 5 mg/mL. Each mL also contains the following inactive ingredients: L-Histidine (1.55 mg), L-Histidine monohydrochloride, monohydrate (3.14 mg), Polysorbate 80 (0.05 mg), sodium chloride (7.30 mg), and Water for Injection, USP.
  • No data
  • No carcinogenicity or genotoxicity studies have been conducted with emapalumab-lzsg.
  • No studies have been conducted to evaluate the effects of emapalumab-lzsg on fertility; however, no adverse effects on male or female reproductive organs were observed in the 8- or 13-week repeat-dose toxicity studies in cynomolgus monkeys.
  • The efficacy of GAMIFANT was evaluated in a multicenter, open-label, single-arm trial NI-0501-04 (NCT01818492) in 27 pediatric patients with suspected or confirmed primary HLH with either refractory, recurrent, or progressive disease during conventional HLH therapy or who were intolerant of conventional HLH therapy.
  • Patients were required to fulfill the following criteria for enrollment: primary HLH based on a molecular diagnosis or family history consistent with primary HLH or five out of the 8 criteria fulfilled: fever, splenomegaly, cytopenias affecting 2 of 3 lineages in the peripheral blood (hemoglobin < 9 , platelets < 100 x 10/L, neutrophils < 1 x 10/L), hypertriglyceridemia (fasting triglycerides > 3 mmol/L or u2265 265 mg/dL) and/or hypofibrinogenemia (u2264 1.5 g/L), hemophagocytosis in bone marrow, spleen, or lymph nodes with no evidence of malignancy, low or absent NK-cell activity, ferritin u2265 500 mcg/L, soluble CD25 u2265 2400 U/mL. Patients had to have evidence of active disease as assessed by treating physician. Patients had to fulfill one of the following criteria as assessed by the treating physician: having not responded or not achieved a satisfactory response or not maintained a satisfactory response to conventional HLH therapy, or intolerance to conventional HLH treatments. Patients with active infections caused by specific pathogens favored by IFNu03b3 neutralization were excluded from the trial (e.g., mycobacteria and ). Patients received prophylaxis for Herpes Zoster, , and fungal infections.
  • Twenty-seven patients enrolled and received treatment in the study and twenty patients (74%) completed the study. Seven patients (26%) were prematurely withdrawn. Twenty-two patients (81%) enrolled onto the open-label extension study which monitored patients for up to 1 year after HSCT or after the last GAMIFANT infusion (NI-0501-05; NCT02069899).
  • The study treatment duration was up to 8 weeks after which patients could continue treatment on the extension study. All patients received an initial starting dose of GAMIFANT of 1 mg/kg every 3 days. Subsequent doses could be increased to a maximum of 10 mg/kg based on clinical and laboratory parameters interpreted as unsatisfactory response. Forty-four percent of patients remained at a dose of 1 mg/kg, 30% of patients increased to 3-4 mg/kg and 26% of patients increased to 6-10 mg/kg. The median time to dose increase was 27 days (range: 3-31 days) with 22% of patients requiring a dose increase in the first week of treatment.
  • All patients received dexamethasone as background HLH treatment with doses between 5 to 10 mg/m/day. Cyclosporine A was continued if administered prior to screening. Patients receiving methotrexate and glucocorticoids administered intrathecally at baseline could continue these treatments.
  • In Study NI-0501-04, the median patient age was 1 year (0.2 to 13). Fifty-nine percent of the patients were female, 63% were Caucasian, 11% were Asian, and 11% were Black.
  • A genetic mutation known to cause HLH was present in 82% of patients. The most frequent causative mutations were FHL3-UNC13D (MUNC 13-4) (26%), FHL2-PRF1 (19%), and Griscelli Syndrome type 2 (19%).
  • The HLH mutations in the population enrolled are described in .
  • All patients received previous HLH treatments. Patients received a median of 3 prior agents before enrollment into the trial. Prior regimens included combinations of the following agents: dexamethasone, etoposide, cyclosporine A, and anti-thymocyte globulin.
  • At baseline entry into the study, 78% of patients had elevated ferritin levels, thrombocytopenia (70% with platelet count of < 100 x 10cells/L), hypertriglyceridemia (67%) with triglyceride level > 3 mmol/L. Central nervous system findings were present in 37% of patients. Forty-one percent of patients had active infections not due to specific pathogens favored by IFNu03b3 neutralization at the time of GAMIFANT initiation.
  • The efficacy of GAMIFANT was based upon overall response rate (ORR) at the end of treatment, defined as achievement of either a complete or partial response or HLH improvement. ORR was evaluated using an algorithm that included the following objective clinical and laboratory parameters: fever, splenomegaly, central nervous system symptoms, complete blood count, fibrinogen and/or D-dimer, ferritin, and soluble CD25 (also referred to as soluble interleukin-2 receptor) levels. Complete response was defined as normalization of all HLH abnormalities (i.e., no fever, no splenomegaly, neutrophils > 1x10/L, platelets > 100x10/L, ferritin < 2,000 u03bcg/L, fibrinogen > 1.50 g/L, D-dimer < 500 u03bcg/L, normal CNS symptoms, no worsening of sCD25 > 2-fold baseline). Partial response was defined as normalization of u2265 3 HLH abnormalities. HLH improvement was defined as u2265 3 HLH abnormalities improved by at least 50% from baseline.
  • The median duration of first response, defined as time from achievement of first response to loss of first response, is not reached (range: 4-56+ days). Seventy percent (19/27) of patients proceeded to HSCT.
  • GAMIFANT (emapalumab-lzsg) injection is a sterile, clear to slightly opalescent, colorless to slightly yellow solution supplied in the following packaging configuration:
  • NDC 66658-501-01 u2013 containing one 10 mg/2 mL (5 mg/mL) single-dose vial
  • NDC 66658-505-01 u2013 containing one 50 mg/10 mL (5 mg/mL) single-dose vial
  • NDC 66658-510-01 u2013 containing one 100 mg/20 mL (5 mg/mL) single-dose vial
  • Store GAMIFANT in a refrigerator at 2u00b0C to 8u00baC (36u00b0F to 46u00b0F) in original carton to protect from light. Do not freeze or shake. This product contains no preservative.
  • Advise the patient to read the FDA-approved patient labeling ().
  • Infections
  • Inform patients and their caregivers of the risk of developing infections during treatment with GAMIFANT, and to report any symptoms of infection .
  • Vaccinations
  • Advise patients and their caregivers that the patient should not receive live or live attenuated vaccines during GAMIFANT treatment .
  • Infusion-Related Reactions
  • Advise patients and their caregivers of the potential for developing infusion-related reactions during treatment with GAMIFANT .
  • Manufactured by:
  • Swedish Orphan Biovitrum AB (publ)Stockholm, SwedenU.S. License Number 1859
  • Distributed by:
  • Sobi Inc.890 Winter StreetWaltham, MA 02451
  • Manufactured at:
  • Patheon Italia S.p.A2u00b0 Trav. SX Via Morolense, 503013-Ferentino Italy
  • Product of the United Kingdom
  • No data
  • Package Label - Carton - 10mg/2mL Single-use Vial
  • PRINCIPAL DISPLAY PANEL
  • NDC 66658-501-01
  • Gamifantn
  • (emapalumab-lzsg)
  • Injection
  • 10 mg/2 mL
  • (5 mg/mL)
  • For intravenous infusion only.
  • Requires dilution prior to administration.
  • Single-dose vial. Discard unused portion.
  • Rx only
  • Dispense with Medication Guide providedseparately.
  • Package Label - Carton - 50mg/10mL Single-use Vial
  • PRINCIPAL DISPLAY PANEL
  • NDC 66658-505-01
  • Gamifantn
  • (emapalumab-lzsg)
  • Injection
  • 50 mg/10 mL
  • (5 mg/mL)
  • For intravenous infusion only.
  • Requires dilution prior to administration.
  • Single-dose vial. Discard unused portion.
  • Rx only
  • Dispense with Medication Guide providedseparately.
  • Package Label - Carton - 100mg/20mL Single-use Vial
  • PRINCIPAL DISPLAY PANEL
  • NDC 66658-510-01
  • Gamifantn
  • (emapalumab-lzsg)
  • Injection
  • 100 mg/20 mL
  • (5 mg/mL)
  • For intravenous infusion only.
  • Requires dilution prior to administration.
  • Single-dose vial. Discard unused portion.
  • Rx only
  • Dispense with Medication Guide providedseparately.

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of (emapalumab-lzsg) (GAMIFANT) which is also known as GAMIFANT and Manufactured by Swedish Orphan Biovitrum AB (publ). It is available in strength of 10 mg/2mL.

(emapalumab-lzsg) (GAMIFANT) 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.

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