Pegzilarginase-nbln injection may cause serious or life-threatening allergic reactions. These reactions may occur with the first few doses or at any time during your treatment. You will first receive your medication in a healthcare setting. Your doctor will watch you carefully during and after the injection. Your doctor may give you certain medications before you receive pegzilarginase-nbln injection to help to prevent a reaction. Tell your doctor if you experience difficulty swallowing or breathing, shortness of breath, wheezing, hoarseness, hives, rash, itching, redness of the skin, sudden redness of the face, neck or upper chest or swelling of the face, throat, tongue or lips.
Why is this medicine prescribed?
Pegzilarginase-nbln is used to treat Arinase 1 Deficiency (ARG 1-D; an inherited condition with a partial or complete lack of the enzyme arginase in the body). Pegzilarginase-nbln is in a class of medications called enzymes. It works by reducing the amount of arginine in the body.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Pegzilarginase-nbln comes as a solution to be injected intravenously (into a vein) or subcutaneously (just under the skin) by a doctor or a nurse in a hospital or clinic. You will receive pegzilarginase-nbln intravenously once weekly over 30 minutes for 8 weeks. After that time you may receive it subcutaneously once weekly into your abdomen, thigh, or upper arms.
If you tolerate receiving the medication subcutaneously, your doctor may allow you or a caregiver to perform the injections at home. If you using pegzilarginase-nbln injection at home, your healthcare provider will show you or a caregiver how to prepare and inject a dose of the medication. Also read the manufacturer's information for the patient that comes with it. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about how to prepare or inject the medication or how to dispose of used needles and syringes after you inject the medication.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
What special precautions should I follow?
Before recieving pegzilarginase-nbln,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- tell your doctor if you have or have ever had any other medical conditions.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving pegzilarginase-nbln, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
If you miss an appointment to receive a dose, contact your healthcare provider as soon as possible. If you are using pegzilarginase-nbln at home and miss a dose, contact your healthcare provider as you may need to receive the next doses in a healthcare setting.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Pegzilarginase-nbln may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- vomiting, constipation
- pain, redness, swelling, irritation, or rash at the site of injection
- fever
Some side effects can be serious. If you experience those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment.
Pegzilarginase-nbln may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in refrigerator and protect from light. Do not freeze or shake.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to pegzilarginase-nbln.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.