TRUTAKNA safety results
Demonstrated safety
Most side effects were mild or moderate and manageable
In a clinical study of 214 people with IgA nephropathy (IgAN) treated with TRUTAKNA vs 214 people treated with placebo for a median time period of 34 weeks, common side effects (≥5%) included:
Less than 1% (2) of people taking TRUTAKNA left the study due to side effects vs 3.7% (8) taking placebo.
Infection rates were similar to placebo
In the clinical study, the number of infections seen in people taking TRUTAKNA was similar to those taking placebo. No one taking TRUTAKNA experienced a serious infection or stopped treatment due to an infection.
Define:
IgA=immunoglobulin A.
Talk to your healthcare provider if you experience any side effects while taking TRUTAKNA
Once-weekly, at-home dosing with TRUTAKNA
Learn about the TRUTAKNA autoinjector, instructions for using it, and tips for adding treatment to your weekly routine
INDICATION AND IMPORTANT SAFETY INFORMATION
What is TRUTAKNA?
TRUTAKNA (atacicept-vymj) is a prescription medicine used to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease getting worse.
It is not known if TRUTAKNA is safe and effective in children.
TRUTAKNA is approved based on reduction of proteinuria. Continued approval may depend on results from an ongoing study to determine whether TRUTAKNA slows decline in kidney function.
IMPORTANT SAFETY INFORMATION
Who should not take TRUTAKNA?
Do not take TRUTAKNA if you are allergic to atacicept-vymj or any of the ingredients in TRUTAKNA. Get emergency help if you develop signs and symptoms of an allergic reaction, including:
breathing problems
swelling of the face, eyes, lips, tongue, or throat
dizziness or lightheadedness
itching
hives
skin rash
Before using TRUTAKNA, tell your doctor about all your medical conditions, including if you:
have or think you have an infection or have infections that keep coming back.
have recently received or are scheduled to receive an immunization (vaccine). TRUTAKNA may affect your immune system response to vaccines and increase your risk of an infection from live vaccines.
You should be brought up to date with all vaccines before starting treatment with TRUTAKNA.
You should not receive live vaccines within 30 days before starting or during treatment with TRUTAKNA.
are pregnant or plan to become pregnant. It is not known if TRUTAKNA will harm your unborn baby. If you become pregnant during treatment with TRUTAKNA, you and your healthcare provider should call 1-833-633-8372.
are breastfeeding or plan to breastfeed. It is not known if TRUTAKNA passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you take TRUTAKNA.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using TRUTAKNA with certain medicines may increase your risk of infections.
What are the possible side effects of TRUTAKNA?
TRUTAKNA can cause serious side effects, including:
Immunosuppression and increased risk of infections: TRUTAKNA weakens your immune system, which may increase your risk of infections. Your healthcare provider will check you for signs and symptoms of infections before you start and during treatment with TRUTAKNA. Tell your healthcare provider right away if you develop any signs or symptoms of infection, including:
fever
chills
feeling tired
cough
flu-like symptoms
aches and pains
warm, red, or painful skin
The most common side effects of TRUTAKNA include: upper respiratory tract infection and injection site reactions, such as redness, swelling, itching or skin irritation at the injection site. Your healthcare provider may interrupt treatment with TRUTAKNA if you have serious side effects.
These are not all the possible side effects of TRUTAKNA. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Vera Therapeutics at 1-833-MED-VERA or medinfo@veratx.com.
Please see Full Prescribing Information, including Patient Information.
