Galcanezumab-gnlm

What is Galcanezumab-gnlm?

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 147 kDa.

What are the uses of this medicine?

It is indicated for the preventive treatment of migraine and for the treatment of cluster headache in adults.

How does this medicine work?

Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

Who Should Not Use this medicine?

It is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

Is this medicine FDA approved?

It is approved by US FDA on Sep 27th, 2018.

What are the brand names and dosage forms of this medicine?

• Brand name: EMGALITY
• NDC Code(s): 0002-1436-01, 0002-1436-11, 0002-1436-27, 0002-1436-61,0002-2377-01, 0002-2377-11, 0002-2377-27, 0002-3115-01, 0002-3115-09.
• EMGALITY is a sterile clear to opalescent, colorless to slightly yellow to slightly brown solution available as follows:

1. Injection: 120 mg/mL in a single-dose prefilled pen
2. Injection: 120 mg/mL in a single-dose prefilled syringe
3. Injection: 100 mg/mL in a single-dose prefilled syringe

How should this medicine be used?

• See the Instructions for Use that come with EMGALITY prefilled pen or prefilled syringe about how to use EMGALITY the right way.
• Use EMGALITY exactly as your healthcare provider tells you to.
• EMGALITY is given by injection under the skin (subcutaneous injection).
• Inject EMGALITY in your stomach area (abdomen), thigh, back of the upper arm, or buttocks.
• Your healthcare provider should show you or a caregiver how to prepare and inject EMGALITY the right way before you start to use it.
• EMGALITY comes in 2 different types of devices:

1. a single-dose (1 time) prefilled pen
2. a single-dose (1 time) prefilled syringe

• Your healthcare provider will prescribe the type that is best for you.
• If you have questions about injecting the medicine, talk to your pharmacist or healthcare provider.
• If you are using the EMGALITY 120 mg prefilled pen or prefilled syringe for migraine:

1. Inject EMGALITY 1 time each month.
2. For the first dose (loading dose), you will get 2 separate injections one time, right after each other. You will need 2 prefilled pens or 2 prefilled syringes for your first dose (1-time loading dose).
3. For your regular monthly dose, you will get 1 injection. You will need 1 prefilled pen or 1 prefilled syringe for your regular monthly dose.
4. If you miss a dose of EMGALITY, inject the missed dose as soon as possible. Then inject EMGALITY 1 month from the date of your last dose to get back on a monthly dosing schedule. If you have questions about your schedule, ask your healthcare provider.

• If you are using the EMGALITY 100 mg prefilled syringe for episodic cluster headache:

1. You will get 3 separate injections, right after each other, using 3 prefilled syringes for each of your doses.
2. Use EMGALITY at the start of a cluster period and then every month until the end of the cluster period.

• If you miss a dose of EMGALITY, inject the missed dose as soon as possible. Then, if the cluster headache period has not yet ended, inject EMGALITY 1 month after your last dose to get back on a monthly dosing schedule. If you have questions about when you should use EMGALITY, ask your healthcare provider.

What side effects can this medication cause?

• Allergic reactions: Allergic reactions, including itching, rash, hives, and trouble breathing, can happen after receiving EMGALITY. This can happen days after using EMGALITY.
• The most common side effects of EMGALITY include: injection site reactions.

What to do in case of emergency/overdose?

If you take too much EMGALIY, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

There are no adequate data on the developmental risk associated with the use of EMGALITY in pregnant women.

Can this medicine be used in children?

Safety and effectiveness in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Store EMGALITY in the refrigerator between 36°F to 46°F (2°C to 8°C).
• EMGALITY may be stored out of the refrigerator in the original carton at temperatures up to 86°F (30°C) for up to 7 days. After storing out of the refrigerator, do not place EMGALITY back in the refrigerator.
• Do not freeze EMGALITY.
• Keep EMGALITY in the carton it comes in to protect it from light until time of use.
• Do not shake EMGALITY.
• Throw away EMGALITY if any of the above conditions are not followed.

• Dailymed label info on Galcanezumab-gnlm
• FDA Galcanezumab-gnlm

Galcanezumab-gnlm Resources
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