What is the most important information I should know about LOARGYS®?
Infusion reactions can happen during your infusion of LOARGYS. If you have a reaction while receiving LOARGYS, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe reaction, your doctor may stop treatment completely.
After eight weeks of once weekly intravenous LOARGYS, LOARGYS may be given by an injection under your skin at the doctor’s office or at home under the supervision of a doctor or nurse. Administration of LOARGYS by injection under the skin can cause a reaction. If you have a severe reaction, get medical help immediately.
Serious Allergic Reactions Including Anaphylaxis.
Anaphylaxis is a sudden, severe, and life-threatening allergic reaction that can occur within seconds or minutes of taking LOARGYS.
Tell your doctor or nurse right away if you have any of the following symptoms during or after your treatment with LOARGYS:
- fainting, dizziness, feeling light-headed (low blood pressure)
- swelling of the face, eyelids, lips, mouth, tongue or throat
- severe nausea, vomiting or diarrhea
- trouble breathing, swelling of the throat, or chest tightness
- weak and rapid pulse
- skin rash, hives or itching
Before using LOARGYS, tell your doctor about all of your medical conditions, including if you:
- have any of the symptoms listed in the section “What is the most important information I should know about LOARGYS?”
- are pregnant or plan to become pregnant. It is not known if LOARGYS can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if LOARGYS passes into your breast milk.
Tell your doctor about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of LOARGYS include: vomiting, fever, infusion related reactions (itching, arm swelling, and stomach pain), constipation, and hypersensitivity (facial swelling, rash, flushing, difficulty breathing).
These are not all the possible side effects of LOARGYS. Call your doctor for medical advice about side effects.
LOARGYS is a prescription medicine used to treat high levels of arginine in the blood of adults and children 2 years and older with Arginase 1 Deficiency (ARG1-D), along with limiting the amount of protein in their diet.
Please read the full Prescribing Information for LOARGYS and discuss any questions that you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
Please visit LOARGYS.com for more information.