Nedosiran (ned-oh-SIR-an)

Lowers oxalate levels in the urine.

Brand Name(s):

Rivfloza

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the upper thighs or stomach.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are scarred or bruised.
• This medicine is available in 2 forms: vial and prefilled syringe.
• Allow 30 minutes for the medicine to warm up to room temperature. Do not warm it by using a heat source (including hot water, microwave) or in any other way.
• Prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Check the liquid in the syringe. It should be colorless to yellow. Do not use the syringe if it is cloudy, discolored, or has particles in it. Do not use the prefilled syringe if it has been broken or damaged.
  • Remove the needle cap. Hold the syringe with one hand and the needle pointed away from you. Pull the needle cap straight off with your other hand.
  • Do not touch or recap the needle. Do not touch the plunger rod until you are ready to inject.
  • Pinch the skin around the injection site with one hand. Grasp the finger grip of the prefilled syringe with your other hand and fully insert the needle into the skin at a 45 degree angle.
  • Gently push the rod all the way down until empty.
• Vial:
  • Wash your hands with soap and water before and after using this medicine.
  • Check the liquid in the vial. It should be colorless to yellow. Do not use the vial if it is cloudy, discolored, or has particles in it. Do not use the vial if it looks broken or damaged.
  • Remove the cap from the vial. Clean the top of the grey rubber stopper. Do not remove the stopper from the vial.
  • Remove the needle cap by pulling it straight off and away from your body.
  • If your child's dose is 0.5 milliliters (mL) or less, insert the needle into the grey rubber stopper on top of the vial. Turn the vial and syringe upside down. Keep the tip of the needle in the medicine. Hold the syringe and vial in one hand. With the other hand, slowly pull back on the plunger rod to withdraw the needed dose.
  • If your child's dose is 0.6 milliliters (mL) or more, you will need to withdraw from 2 vials using 2 syringes. Insert the needle into the grey rubber stopper on top of the vial. Turn the vial and syringe upside down. Keep the tip of the needle in the medicine. Hold the syringe and vial in one hand. With the other hand, slowly pull back on the plunger rod to withdraw the needed dose.
  • If you see large air bubbles in the syringe, tap the side of the syringe to move any air bubbles to the top of the syringe.
  • Push the plunger rod up to push the air bubbles back into the vial. If the syringe does not contain the correct dose after the large air bubbles are removed, you will need to pull back on the plunger rod again to fill the syringe with the needed dose.
  • Turn the vial and syringe back upright and remove the needle from the vial.
  • Pinch the skin around the injection site with one hand. With the other hand, insert the needle into the skin at a 45 degree angle. If you are giving 2 injections, inject each syringe in a different location.
  • Gently push the plunger rod all the way down until empty.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, inject as soon as possible. If it is more than 7 days, use it as soon as possible and go back to the monthly dosing from the most recent injected dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. If needed, you may store prefilled syringe or vial at room temperature for up to 28 days. Throw the medicine away if not used within 28 days.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, of if you have kidney disease.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088