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EMGALITY 120 MG PFS 1

  • Manufacturer Name : LILLY ELI & CO
  • MFG # : 00002237711
  • NDC : 00002237711
  • Distributor Name : AmeriSource Bergen
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galcanezumab-gnlm SUBCUT SYRINGE 120 MG/

Product Properties:

Description -
Description S
DESI Drug Ind -
DESI Drug Ind -; -
DESI2 Drug Ind NR
Drug Category USES: This medication is used to help prevent migraine. It is also used to treat a certain type of headache (episodic cluster headache). Galcanezumab belongs to a class of drugs known as monoclonal antibodies. This medication may work by changing the amounts of certain natural substances in the brain. Using this medication can help improve your ability to concentrate and do your usual tasks.
Drug Category -
Drug Type Code COMMON BRAND NAME(S): Emgality
Drug Type Code S
FDA Approval Date 01/23/2019
FDA Therap Equiv ML
HCPCS Unclassified biologics
HCPCS 1
Market Entry Date -
Medical Coverage J3590
Medical Coverage -
Termination Date (GAL-ka-NEZ-ue-mab)
Termination Date 1
Unit 1
Units Per Pkg 09/27/2018
Active Ingredients 17757 galcanezumab-gnlm
Active Ingredients 17757 galcanezumab-gnlm
AHFS Class 28321200 CALCITONIN GENE-RELATED PEPTIDE ANTAG.
AHFS Class 28321200 CALCITONIN GENE-RELATED PEPTIDE ANTAG.
DEA Class NC
DEA Class NC
Dose Form SYRINGE (ML)
Dose Form SYRINGE (ML)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 78997 galcanezumab-gnlm SUBCUT SYRINGE 120 MG/ML
Gen Code and Des 78997 galcanezumab-gnlm SUBCUT SYRINGE 120 MG/ML
Inactive Ingredients 2551 polysorbates 9005645
Inactive Ingredients 2551 polysorbates 9005645
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 120MG
Strength 120MG
Common Brand Name COMMON BRAND NAME(S): Emgality
Common Brand Name J3590
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Allocation Period -
Case Quantity 10
Case Quantity 10
Drug Form Pack Size 1
Drug Form Pack Size 1
Form PRE-FILLED SYRINGE
Form PRE-FILLED SYRINGE
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 30 Refrige./DoNot Freez
Temp Zone 30 Refrige./DoNot Freez
Unit EA
Unit EA
Unit Size -
Unit Size -
How to Use HOW TO USE: Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using galcanezumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Before use, take this medication out of the refrigerator. Remove the syringe/autoinjector from the package and let it warm up to room temperature for at least 30 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not leave in direct sunlight. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into areas of skin that are tender, bruised, red, or hard. Avoid injecting into skin areas with scars or stretch marks. Inject this medication under the skin of the thigh, abdomen, buttocks, or upper arm as directed by your doctor. The dosage is based on your medical condition and response to treatment. For prevention of migraine, usually the first dose is 2 injections, one right after each other. After that, the usual dose is 1 injection once each month. Use this medication regularly to get the most benefit from it. For treatment of episodic cluster headache, the usual dose is 3 injections, one right after each other, at the start of the cluster period. While the cluster period lasts, use this medication monthly. Each monthly dose is usually 3 injections. To help you remember, mark the days on the calendar when you need to receive the medication. Learn how to store and discard medical supplies safely. Tell your doctor if your condition does not get better or if it gets worse.
How to Use -
Missed Dose MISSED DOSE: If you miss a scheduled monthly dose, use it as soon as you remember. Do not double the dose to catch up. Then use your next dose one month later. Continue to use each dose one month apart. Ask your doctor or pharmacist if you have questions about your schedule.
Missed Dose 1
Notes NOTES: Do not share this medication with others.
Notes ML
Overdose NR
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation COVERED WITH CARRIER DISCRETION
Phonetic Pronunciation (GAL-ka-NEZ-ue-mab)
Precautions -
Precautions PRECAUTIONS: Before using galcanezumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Redness, pain, itching, or swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects -
Storage 09/27/2018
Storage STORAGE: Store in the original package in the refrigerator. Do not freeze. After removing from the refrigerator, this medication can be stored at room temperature for up to 7 days. Do not put the medication back in the refrigerator after it has reached room temperature. Do not leave the syringe/autoinjector in direct sunlight. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses Unclassified biologics
Uses USES: This medication is used to help prevent migraine. It is also used to treat a certain type of headache (episodic cluster headache). Galcanezumab belongs to a class of drugs known as monoclonal antibodies. This medication may work by changing the amounts of certain natural substances in the brain. Using this medication can help improve your ability to concentrate and do your usual tasks.

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The cost of EMGALITY 120 MG PFS 1 is available for registerd members only .
EMGALITY 120 MG PFS 1 is manufactured by LILLY ELI & CO.
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