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Necitumumab (Portrazza)

Trade Name : Portrazza

Eli Lilly and Company

SOLUTION

Strength 16 mg/mL

NECITUMUMAB Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA]

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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 Necitumumab (Portrazza) which is also known as Portrazza and Manufactured by Eli Lilly and Company. It is available in strength of 16 mg/mL per ml. Read more

Necitumumab (Portrazza) 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
  • WARNING: CARDIOPULMONARY ARREST and HYPOMAGNESEMIA
  • See full prescription information for complete boxed warning
  • Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with PORTRAZZA in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after PORTRAZZA administration. (, )
  • Hypomagnesemia occurred in 83% of patients receiving PORTRAZZA in combination with gemcitabine and cisplatin, and was severe in 20%. Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia prior to each dose of PORTRAZZA during treatment and for at least 8 weeks following completion of PORTRAZZA. Withhold PORTRAZZA for Grade 3 or 4 electrolyte abnormalities. Replete electrolytes as medically appropriate. ()
  • PORTRAZZAu2122 is an epidermal growth factor receptor (EGFR) antagonist indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. ()n
  • Limitation of Use: PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer. (, , )n
  • Recommended dose of PORTRAZZA is 800u00a0mg (absolute dose) as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle. ()n
  • Injection: 800u00a0mg/50u00a0mL (16u00a0mg/mL) solution in a single-dose vialn
  • Injection: 800u00a0mg/50u00a0mL (16u00a0mg/mL) solution in a single-dose vial. ()n
  • Nonen
  • None ()n
  • No data
  • Arrayn- Cardiopulmonary Arrest
  • Arrayn- Hypomagnesemia
  • Arrayn- Venous and Arterial Thromboembolic Events (VTE and ATE)
  • Arrayn- Dermatologic Toxicities
  • 2.3n- 5.4
  • Arrayn- Infusion-Related Reactions
  • 2.3n- 5.5
  • Arrayn- Increased Toxicity
  • Arrayn- Embryo-Fetal Toxicity
  • 5.7n- 8.1n- 8.3
  • The following adverse drug reactions are discussed in greater detail in other sections of the label:n
  • The most common adverse reactions (all grades) observed in PORTRAZZA-treated patients at a rate of u226530% and u22652% higher than gemcitabine and cisplatin alone arm were rash and hypomagnesemia. ()n
  • Lactation: Do not breastfeed. ()n
  • There has been limited experience with PORTRAZZA overdose in human clinical trials.n
  • The highest dose of PORTRAZZA studied clinically in a human dose-escalation Phase 1 study was 1000u00a0mg once a week and once every other week. Two out of 9 patients in the every other week cohort experienced dose-limiting toxicities (e.g., a combination of Grade 3 headache, vomiting, and nausea). There is no known antidote for PORTRAZZA overdose.n
  • Necitumumab is an anti-EGFR recombinant human monoclonal antibody of the IgG1 kappa isotype that specifically binds to the ligand binding site of the human EGFR. Necitumumab has an approximate molecular weight of 144.8u00a0kDa. Necitumumab is produced in genetically engineered mammalian NS0 cells.n
  • PORTRAZZA is a sterile, preservative free, clear to slightly opalescent and colorless to slightly yellow solution. PORTRAZZA is available in single-dose vials for intravenous infusion following dilution. Each vial contains 800u00a0mg PORTRAZZA in 50u00a0mL (16u00a0mg/mL).n
  • Each mL contains necitumumab (16u00a0mg), citric acid anhydrous (0.256u00a0mg), glycine (9.984u00a0mg), mannitol (9.109u00a0mg), polysorbate 80 (0.1u00a0mg), sodium chloride (2.338u00a0mg), sodium citrate dihydrate (2.55u00a0mg), and water for injection, pH 6.0.n
  • No data
  • No studies have been performed to assess the potential of necitumumab for carcinogenicity or genotoxicity.n
  • Fertility studies have not been performed with necitumumab.n
  • No data
  • No data
  • Hypomagnesemia
  • Advise patients of risk of decreased blood levels of magnesium, potassium and calcium. Take medicines to replace the electrolytes exactly as advised by the physician. n
  • Venous and Arterial Thromboembolic Events
  • Advise patients of increased risk of venous and arterial thromboembolic events .
  • Skin reactions
  • Advise patients to minimize sun exposure with protective clothing and use of sunscreen while receiving PORTRAZZA n
  • Infusion-Related Reactions
  • Advise patients to report signs and symptoms of infusion reactions such as fever, chills, or breathing problems .
  • Embryo-Fetal Toxicity
  • Advise pregnant women of the potential risk to a fetus .
  • Advise females of reproductive potential to use effective contraception during treatment with PORTRAZZA and for three months following final dose n
  • Lactation
  • Advise women not to breastfeed during treatment with PORTRAZZA and for three months following the final dose .
  • Literature issued November 2015n
  • Manufactured by: Eli Lilly and Company, Indianapolis, IN 46285US License No. 1891Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
  • Copyright u00a9 2015, Eli Lilly and Company. All rights reserved.n
  • POR-0001-USPI-20151124n
  • Rx only
  • NDC 0002-7716-01n
  • Portrazzan
  • (necitumumab) injectionn
  • 800 mg/50 mLn
  • (16 mg/mL)n
  • For Intravenous Infusion Onlyn
  • Must Dilute Prior to Usen
  • Single-Dose Vialn
  • Discard Unused Portionn
  • Keep Refrigeratedn
  • portrazza.comn
  • Lillyn

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