Pregnancy & Lactation: Risk data not available
What is Nedosiran?
Nedosiran is used to lower oxalate levels in the urine of adults and children at least 9 years old who have primary hyperoxaluria type 1 (PH1) and still have preserved kidney function.
Nedosiran may also be used for purposes not listed in this medication guide.
Warnings
Tell your doctor before using this medicine if you have other health problems, use other medications, or if you have any allergies.
It is not known if nedosiran will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
How should I use Nedosiran
Use Nedosiran (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Nedosiran is injected under the skin in the stomach or upper thigh once-a-month. Do not inject within 2 inches of your belly button or in areas where the skin is bruised or has scars. Do not inject into the same place two times in a row.
A healthcare provider may give you this injection or may teach you how to properly use the medication by yourself. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it. Ask your doctor or pharmacist if you don't understand how to use an injection.
Doses are based on weight. Your dose may change if you gain or lose weight.
Throw away a prefilled syringe or vial after one use, even if there is still medicine left inside. Do not reuse a needle, vial, or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
Store in the refrigerator in the original container. Protect from light and do not freeze.
Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not heat a syringe with hot water, sunlight, or a microwave.
You may store this medicine at room temperature away from moisture, heat, and light for up to 28 days (4 weeks). Throw the medicine away if not used within 28 days. Do not put it back into the refrigerator.
Use the medicine as soon as you remember, but if you are more than 7 days late for the dose, start a new monthly schedule on the day you remember.
Do not use two doses at one time.
Nedosiran side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Common side effects may include:
- bruising, swelling, warmth, redness, oozing, bleeding, or dimpling where an injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Nedosiran?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.