Trade Name: EMGALITY

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

Manufacturer: Eli Lilly and Company

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 120 mg/mL

Storage and handling

GALCANEZUMAB

Disclaimer:
  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.
  3. Read more
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  • EMGALITY is a calcitonin-gene related peptide antagonist indicated in adults for the:n
  • preventive treatment of migraine. ()n
  • treatment of episodic cluster headache. ()n
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  • For subcutaneous use only. (, , )n
  • Migraine recommended dosage: 240u00a0mg loading dose (administered as two consecutive injections of 120u00a0mg each), followed by monthly doses of 120u00a0mg. ()n
  • Episodic cluster headache recommended dosage: 300u00a0mg (administered as three consecutive injections of 100u00a0mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. ()n
  • Administer in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously. ()n
  • EMGALITY is a sterile clear to opalescent, colorless to slightly yellow to slightly brown solution available as follows:n
  • Injection: 120u00a0mg/mL solution in a single-dose prefilled pen ()n
  • Injection: 120u00a0mg/mL solution in a single-dose prefilled syringe ()n
  • Injection: 100u00a0mg/mL solution in a single-dose prefilled syringe ()n
  • EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients .n
  • EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. ()n
  • Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration, and may be prolonged. ()n
  • The following clinically significant adverse reactions are described elsewhere in the labeling:n
  • The most common adverse reactions (incidence u22652% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions. ()n
  • To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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  • Galcanezumab-gnlm is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide (CGRP) ligand. Galcanezumab-gnlm is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Galcanezumab-gnlm is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 147u00a0kDa.n
  • EMGALITY (galcanezumab-gnlm) injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution, for subcutaneous use. EMGALITY is supplied in a 1u00a0mL single-dose prefilled pen to deliver 120u00a0mg of galcanezumab-gnlm or a 1u00a0mL single-dose prefilled syringe to deliver 100u00a0mg or 120u00a0mg of galcanezumab-gnlm. Each mL of solution contains 100u00a0mg or 120u00a0mg of galcanezumab-gnlm; L-histidine (0.5u00a0mg); L-histidine hydrochloride monohydrate (1.5u00a0mg); Polysorbate 80 (0.5u00a0mg); Sodium Chloride (8.8u00a0mg); Water for Injection, USP. The pH range is 5.3 - 6.3.n
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  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).n
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  • PACKAGE CARTON u2013 EMGALITY Autoinjector 120 mg
  • NDC 0002-1436-11n
  • EMGALITYn
  • (galcanezumab-gnlm) injectionn
  • 120 mg/mLn
  • 1 x 120 mg/mL Single-Dose prefilled penn
  • For Subcutaneous Use Onlyn
  • Single-Dose Onlyn
  • Rx onlyn
  • Lillyn
  • PACKAGE CARTON u2013 EMGALITY Prefilled Syringe 120 mg
  • NDC 0002-2377-11n
  • EMGALITYn
  • (galcanezumab-gnlm) injectionn
  • 120 mg/mLn
  • 1x 120 mg/mL Single-Dose prefilled syringen
  • For Subcutaneous Use Onlyn
  • Single-Dose Onlyn
  • Rx onlyn
  • Lillyn
  • PACKAGE CARTON u2013 EMGALITY Prefilled Syringe 100 mg
  • NDC 0002-3115-09n
  • EMGALITYn
  • (galcanezumab-gnlm) n
  • 100 mg/mL injectionn
  • All 3 syringes must be administered to receive the 300 mg dose.
  • 3 x 100 mg/mL Single-Dose prefilled syringen
  • For Subcutaneous Use Onlyn
  • Single-Dose Onlyn
  • Rx onlyn
  • Lillyn

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of galcanezumab (EMGALITY) which is also known as EMGALITY and Manufactured by Eli Lilly and Company. It is available in strength of 120 mg/mL.

galcanezumab (EMGALITY) 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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