What is Emgality (galcanezumab-gnlm) and how is it used?
Emgality is indicated for the preventive treatment of migraine in adults.
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.
Emgality (galcanezumab-gnlm) injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution, for subcutaneous use available in a single-dose prefilled pen or a single-dose prefilled syringe to deliver 120 mg galcanezumab-gnlm. Each mL is composed of 120 mg galcanezumab-gnlm; L-histidine, USP (0.5 mg); L-histidine hydrochloride monohydrate (1.5 mg); Polysorbate 80, USP (0.5 mg); Sodium Chloride, USP (8.8 mg); Water for Injection, USP. The pH range is 5.3 – 6.3.
What are the side effects of Emgality (galcanezumab-gnlm)?
Emgality may cause serious side effects, including: Allergic reactions
Allergic reactions, including itching, rash, hives, and trouble breathing, can happen after receiving Emgality. This can happen days after using Emgality. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, which may be part of an allergic reaction:
- swelling of the face, mouth, tongue, or throat
- trouble breathing
The most common side effects of Emgality include:
- injection site reactions
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Emgality. For more information, ask your healthcare provider or pharmacist.
What is the dosage of Emgality (galcanezumab-gnlm)?
The recommended dosage of Emgality is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously. If a dose of Emgality is missed, administer as soon as possible. Thereafter, Emgality can be scheduled monthly from the date of the last dose.
For subcutaneous injection only. Before you use the Emgality prefilled syringe, read and carefully follow all the step-by-step instructions. Important Information
- Your healthcare provider or nurse should show you how to prepare and inject Emgality using the prefilled syringe. Do not inject yourself or someone else until you have been shown how to inject Emgality.
- Keep these Instructions for Use and refer to them as needed.
- Each Emgality prefilled syringe is for one-time use only. Do not share or reuse your Emgality prefilled syringe. You may give or get an infection.
- Your healthcare provider may help you decide where on your body to inject your dose. You can also read the “Choose your injection site” section of these instructions to help you choose which area can work best for you.
- If you have vision problems, do not use Emgality prefilled syringe without help from a caregiver.
What drugs interact with Emgality (galcanezumab-gnlm)?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.
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Is Emgality (galcanezumab-gnlm) safe to use while pregnant or breastfeeding?
There are no adequate data on the developmental risk associated with the use of Emgality in pregnant women. Administration of galcanezumab-gnlm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at plasma exposures greater than that expected clinically did not result in adverse effects on development (see Animal Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively. The estimated rate of major birth defects (2.2% – 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.
There are no data on the presence of galcanezumab-gnlm in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Emgality and any potential adverse effects on the breastfed infant from Emgality or from the underlying maternal condition.