Nedosiran Injection

WHY is this medicine prescribed?

Nedosiran injection is used is used to lower oxalate levels in urine in certain adults and children 9 years of age and older with primary hyperoxaluria type 1 (PH1; an inherited condition that leads to kidney stones and potentially severe, life-threatening kidney damage). Nedosiran injection is in a class of medications called small interfering RNA (SiRNA) agents. It works by reducing the production of oxalate in the liver, which lowers oxalate levels in the urine and 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?

Nedosiran injection comes as a solution (liquid) to be injected subcutaneously (just under the skin). It is usually injected once a month. Use nedosiran injection at around the same day every month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use nedosiran injection exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.

You may receive your first dose of nedosiran injection in your doctor's office. After that, you can inject nedosiran yourself or have a friend or relative perform the injections at home. Your doctor or nurse will show you or a caregiver how to prepare and inject a dose of nedosiran injection at home. Before you use nedosiran injection yourself the first time, read the manufacturer's instructions for use that comes with the medication. These instructions describe how to prepare and inject a dose of nedosiran. Be sure that you understand these directions. Ask your doctor or pharmacist if you have any questions about when you should use the medication, where on your body you should inject the medication, or how to prepare and give the injection.

Nedosiran injection comes in pre-filled syringes and in vials. If you are using vials of nedosiran injection, your doctor will tell you what type of syringe you should use and how you should draw the medication into the syringe. Do not mix any other medications in the syringe with nedosiran injection.

Take nedosiran injection out of the refrigerator 30 minutes before you plan to inject it to allow the medication to come to room temperature. Keep the syringe or vial in its packaging to protect it from light during this time. Do not try to warm the syringe or vial by heating it in a microwave, placing it in warm water, or through any other method.

Always look at nedosiran solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless to slightly yellow. The liquid should not contain visible particles. Do not use if it is expired or if the liquid is cloudy, discolored, or contains particles.

You may inject nedosiran injection on the front of the thighs or anywhere on your stomach except your navel (belly button) and the area 2 inches around it. Do not inject the medication into skin that is tender, bruised, damaged, or scarred. If your doctor tells you to inject two separate injections one after another, use a different syringe for each injection. If you use the same body site (thigh or stomach) for the two separate injections, make sure the second injection it is not at the exact same spot you used for the first injection.

Each pre-filled syringe or vial only contains enough nedosiran injection for one dose. Do not try to use vials or syringes more than once. Dispose of used syringes in a puncture-resistant container. Talk to your doctor or pharmacist how to dispose of the puncture-resistant container.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using nedosiran injection,

• tell your doctor and pharmacist if you are allergic to nedosiran injection, any other medications, or any of the ingredients in nedosiran injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had kidney or liver problems.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using nedosiran injection, 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 a dose of nedosiran injection, inject the dose as soon as possible. If you miss a dose of nedosiran injection by more than 7 days, inject it as soon as possible and then continue giving your doses a month apart.

What SIDE EFFECTS can this medicine cause?

Nedosiran injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• bruising, pain, redness, rash, or tenderness at the injection site

Nedosiran injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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 a refrigerator, but do not freeze it. If you will not have access to a refrigerator, you can store nedosiran injection at room temperature for up to 4 weeks, but do not expose it to bright light or higher temperatures.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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 OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.