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Mepolizumab (Nucala)

Trade Name : Nucala

GlaxoSmithKline LLC

INJECTION, POWDER, FOR SOLUTION

Strength 100 mg/mL

MEPOLIZUMAB Interleukin-5 Antagonist [EPC],Interleukin-5 Antagonists [MoA]

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Mepolizumab (Nucala) which is also known as Nucala and Manufactured by GlaxoSmithKline LLC. It is available in strength of 100 mg/mL per ml. Read more

Mepolizumab (Nucala) 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
  • No data
  • NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for:
  • Limitations of use: Not for relief of acute bronchospasm or status asthmaticus. ()
  • NUCALA is for subcutaneous (SC) use only.
  • For injection: 100 mg white to off-white lyophilized powder in a single-dose vial for reconstitution.
  • Injection: 100 mg/mL as a clear to opalescent, colorless to pale yellow to pale brown solution in a single-dose prefilled autoinjector or a single-dose prefilled glass syringe.
  • For injection: 100 mg of lyophilized powder in a single-dose vial for reconstitution. ()
  • Injection: 100 mg/mL, single-dose, prefilled autoinjector or single-dose prefilled syringe. ()
  • NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation .
  • History of hypersensitivity to mepolizumab or excipients in the formulation. ()
  • No data
  • The following adverse reactions are described in greater detail in other sections:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • Most common adverse reactions (incidence u22655%) include headache, injection site reaction, back pain, and fatigue. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or
  • Formal drug interaction trials have not been performed with NUCALA.
  • No data
  • Single doses of up to 1,500u00a0mg have been administered intravenously to adult subjects in a clinical trial with eosinophilic disease without evidence of dose-related toxicities.
  • There is no specific treatment for an overdose with mepolizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
  • Mepolizumab is a humanized IL-5 antagonist monoclonal antibody. Mepolizumab is produced by recombinant DNA technology in Chinese hamster ovary cells. Mepolizumab has a molecular weight of approximately 149u00a0kDa.
  • NUCALA (mepolizumab) for injection is a sterile, preservative-free, white to off-white, lyophilized powder in a single-dose vial for SC injection after reconstitution. Upon reconstitution with 1.2 mL of Sterile Water for Injection, USP, the resulting concentration is 100 mg/mL and delivers 1 mL . Each vial delivers 100u00a0mg of mepolizumab, polysorbate 80 (0.67u00a0mg), sodium phosphate dibasic heptahydrate (7.14u00a0mg), and sucrose (160u00a0mg), with a pH of 7.0.
  • The vial stopper is not made with natural rubber latex.
  • NUCALA injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brown solution for SC use. It is supplied in a single-dose, 1-mL, prefilled autoinjector with a fixed 29-gauge, half-inch needle or in a single-dose, 1-mL, prefilled syringe with a fixed 29-gauge, half-inch needle with a needle guard. Each 1 mL delivers 100 mg mepolizumab, citric acid monohydrate (0.95 mg), EDTA disodium dihydrate (0.019 mg), polysorbate 80 (0.20 mg), sodium phosphate dibasic heptahydrate (4.16 mg), and sucrose (120 mg), with a pH of 6.3.
  • The prefilled autoinjector and prefilled syringe are not made with natural rubber latex.
  • No data
  • Long-term animal studies have not been performed to evaluate the carcinogenic potential of mepolizumab. Published literature using animal models suggests that IL-5 and eosinophils are part of an early inflammatory reaction at the site of tumorigenesis and can promote tumor rejection. However, other reports indicate that eosinophil infiltration into tumors can promote tumor growth. Therefore, the malignancy risk in humans from an antibody to IL-5 such as mepolizumab is unknown.
  • Male and female fertility were unaffected based upon no adverse histopathological findings in the reproductive organs from cynomolgus monkeys receiving mepolizumab for 6 months at IV dosages up to 100 mg/kg once every 4 weeks (approximately 20 times the MRHD of 300 mg on an AUC basis). Mating and reproductive performance were unaffected in male and female CD-1 mice receiving an analogous antibody, which inhibits the activity of murine IL-5, at an IV dosage of 50u00a0mg/kg once per week.
  • No data
  • NUCALA for Injection
  • NUCALA (mepolizumab) for injection is a sterile, preservative-free, white to off-white, lyophilized powder for reconstitution and SC injection in a single-dose glass vial with a flip-off seal. The vial stopper is not made with natural rubber latex.
  • NUCALA for injection is supplied as:
  • 100-mg single-dose vials in cartons of 1 (NDC 0173-0881-01).
  • Store vials below 77u00b0F (25u00b0C). Do not freeze. Store in the original carton to protect from light.
  • NUCALA Injection
  • NUCALA (mepolizumab) injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brown solution for SC use. Each single-dose prefilled autoinjector or single-dose prefilled syringe is designed to deliver 100 mg of mepolizumab in 1 mL of solution. The autoinjectors and syringes are not made with natural rubber latex.
  • NUCALA injection is supplied as:
  • 100 mg/mL, single-dose, prefilled autoinjector with attached 29-gauge, half-inch needle in cartons of 1 (NDC 0173-0892-01).
  • 100 mg/mL, single-dose, prefilled glass syringe with attached 29-gauge, half-inch needle in cartons of 1 (NDC 0173-0892-42).
  • Prior to Dispensing:
  • Following Dispensing:
  • If necessary, an unopened carton can be stored outside the refrigerator at up to 86u00b0F (30u00b0C) for up to 7 days. Discard if left out of the refrigerator for more than 7 days.
  • NUCALA injection must be administered within 8 hours after removal from the carton. Discard if not administered within 8 hours.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Hypersensitivity Reactions
  • Inform patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of NUCALA. Instruct patients to contact their physicians if such reactions occur.
  • Not for Acute Symptoms or Deteriorating Disease
  • Inform patients that NUCALA does not treat acute asthma symptoms or acute exacerbations. Inform patients to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with NUCALA.
  • Opportunistic Infections: Herpes Zoster
  • Inform patients that herpes zoster infections have occurred in patients receiving NUCALA and where medically appropriate, inform patients that vaccination should be considered.
  • Reduction of Corticosteroid Dosage
  • Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a physician. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
  • Pregnancy Exposure Registry
  • Inform women there is a pregnancy exposure registry that monitors pregnancy outcomes in women with asthma exposed to NUCALA during pregnancy and that they can enroll in the Pregnancy Exposure Registry by calling 1-877-311-8972 or by visiting n .
  • Trademarks are owned by or licensed to the GSK group of companies.
  • Manufactured by
  • GlaxoSmithKline LLC
  • Philadelphia, PA 19112
  • U.S. License Number 1727
  • Distributed by
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92019 GSK group of companies or its licensor.
  • NCL:5PI
  • No data
  • No data
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0881-01
  • Nucala
  • (mepolizumab)
  • for Injection
  • 100 mg/vial
  • Rx Only
  • For subcutaneous injection after reconstitution.
  • Reconstituted solution contains 100mg/mL.
  • Single-dose vial. Discard unused portion.
  • Contents:
  • No preservative.
  • No U.S. standard of potency.
  • 1 vial
  • Do not accept if plastic overseal is missing or not securely fitted.
  • u00a92019 GSK group of companies or its licensor.
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0892-01
  • Nucala
  • (mepolizumab)
  • 100 mg/mL
  • Rx Only
  • Prefilled Autoinjector
  • For subcutaneous use only.
  • Contents:
  • -1 Single-Dose 1-mL. Prefilled Autoinjector
  • -Instructions for Use
  • -Prescribing Information
  • -Patient Information
  • u00a92019 GSK group of companies or its licensor.
  • Do not accept if security seal is missing or broken.

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