Pronunciation:

ned-oh-SIR-an

Brand Names:

• Rivfloza

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Renal-Urologic Agent

Uses of This Medicine:

Nedosiran injection is used to lower urinary oxalate levels in children 9 years of age and older with primary hyperoxaluria type 1 (PH1) and preserved kidney function.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of nedosiran injection in children younger than 9 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nedosiran injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

This medicine is given as a shot under your skin in the upper thighs or stomach. It may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 (eg, hot water, microwave) or in any other way.

Do not inject into skin areas that are scarred or bruised.

To use the 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.

To use the 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 gray 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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For lowering of oxalate levels:
  • For injection dosage form (prefilled syringe):
    • Adults and children 12 years of age and older weighing 50 kilograms (kg) or more—160 milligrams (mg) (1 mL prefilled syringe) injected under the skin once a month.
    • Adults and children 12 years of age and older weighing less than 50 kilograms (kg) —128 mg (0.8 mL prefilled syringe) injected under the skin once a month.
    • Children 9 to 11 years of age weighing 50 kg or more—160 mg (1 mL prefilled syringe) injected under the skin once a month.
    • Children younger than 9 years of age—Use and dose must be determined by your doctor.
  • For injection dosage form (vial):
    • Children 9 to 11 years of age weighing less than 50 kg—Dose is based on body weight and must be determined by your doctor. 3.3 milligrams per kilogram (mg/kg) injected under the skin once a month. Dose is usually not more than 128 mg.
    • Children younger than 9 years of age—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

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.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

If needed, you may store the prefilled syringe and vial at room temperature for up to 28 days. Throw the medicine away if not used within 28 days.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

flushing, redness of the skin

large, flat, blue or purplish patches in the skin

unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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