Trutakna Autoinjector

Trutakna Autoinjector is used to lower the amount of protein in the urine for adults with primary immunoglobulin A nephropathy, also known as IgAN, who are at risk for their condition getting worse.

It is not known if Trutakna Autoinjector slows down the loss of kidney function over a long period.

Trutakna Autoinjector may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Trutakna Autoinjector is injected under the skin once each week.

Your healthcare provider will show you where to inject Trutakna Autoinjector. Do not inject into the same place two times in a row. Do not give an injection into skin that is hard, red, bruised, or tender.

Inject Trutakna Autoinjector under the skin in your stomach area at least 2 inches away from your belly button, or in the front of your thigh. Choose a different injection site each time you use this medicine.

Ask your doctor or pharmacist if you don't understand how to use an injection.

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.

Each Trutakna Autoinjector autoinjector is for one use only. Throw it away after one use, even if there is medicine left inside. Place the used autoinjector in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

You may get infections more easily, even serious infections. Tell your doctor right away if you have any symptoms of an infection.

Store this medicine in the original carton in the refrigerator. Protect from light. Do not freeze or shake the injection. Keep it away from heat.

Take the medicine out of the refrigerator and let it reach room temperature for 15 to 30 minutes before using. Do not warm the medicine with hot water, sunlight, or a microwave.

Trutakna Autoinjector may also be stored in the original carton at room temperature away from heat and light. Do not return the medicine to the refrigerator. Throw the autoinjector away after 3 days if stored at room temperature.

Trutakna Autoinjector weakens your immune system and may increase your risk of infections. Call your doctor right away if you have fever, chills, tiredness, cough, flu-like symptoms, aches and pains, or skin that is warm, red, or painful.

You should not use Trutakna Autoinjector if you are allergic to it.

Tell your doctor if you have or have ever had:

• a recent infection, think you may have an infection, or have infections that keep coming back; or
• recently received a vaccine or are scheduled to receive one.

Make sure you are current on all vaccines before you start using Trutakna Autoinjector.

It is not known if Trutakna Autoinjector will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you become pregnant while using Trutakna Autoinjector. You or your doctor should report the pregnancy to the manufacturer.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Trutakna Autoinjector weakens your immune system and may increase your risk of infections. Call your doctor right away if you have fever, chills, tiredness, cough, flu-like symptoms, aches and pains, or skin that is warm, red, or painful.

Common side effects of Trutakna Autoinjector may include:

• cold symptoms such as stuffy nose, sneezing, sore throat; or
• redness, swelling, itching, or skin irritation where the medicine was injected.

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.

Use the medicine as soon as you remember, and then take your next dose in 1 week. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting a "live" vaccine within 30 days before starting treatment with Trutakna Autoinjector or while you are using this medicine, or you could develop a serious infection.

Using Trutakna Autoinjector with certain medicines may increase your risk of infections.

Other drugs may affect Trutakna Autoinjector, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Find detailed information on biosimilars for this medication.