FAQs
Frequently asked questions
Find quick answers to some of the most common questions about TRUTAKNA.
About IgAN and TRUTAKNA
What is IgA nephropathy (IgAN)?
IgAN is a rare chronic disease in which B cells (a type of immune cell) produce abnormal antibodies that result in the formation of immune clusters. These clusters build up in the kidneys, causing them to become damaged and stop working properly.
Learn moreDefine:
How is TRUTAKNA designed to work?
TRUTAKNA is the first approved treatment designed to target BAFF and APRIL, the 2 immune signals that activate B cells (a type of immune cell) at the source of IgAN. TRUTAKNA is not a steroid.
TRUTAKNA targets both BAFF and APRIL, blocking them from activating B cells. B cell activity is calmed and fewer abnormal antibodies are made. This helps disrupt the downstream processes that lead to consequences such as proteinuria.
Define:
Taking TRUTAKNA
How do I take TRUTAKNA?
Please read the full Instructions for Use before you use TRUTAKNA and after refilling your prescription, as there may be new information.
Learn more
How do I store or travel with TRUTAKNA?
TRUTAKNA should stay in its original carton in a safe space in your refrigerator between 36 °F and 46 °F (2 °C and 8 °C). A TRUTAKNA autoinjector may be kept at room temperature between 60 °F and 77 °F (15 °C and 25 °C) for a single period of up to 3 days (72 hours). Once TRUTAKNA has been stored at room temperature, it should not be placed back into the refrigerator. Throw away the TRUTAKNA autoinjector if it's not used within these 3 days. Never freeze or shake the autoinjector, and protect it from light. Keep it away from heat and out of reach of children or pets. Safely throw it away if it has expired or is no longer needed.
When traveling, continue to keep the autoinjector between 36 °F and 46 °F (2 °C and 8 °C), away from light, and safely secured. Do not freeze or shake the autoinjector. Medications may require additional security screening. Visit www.tsa.gov/travel/tsa-cares for the latest requirements.
What do I do if I miss a dose?
If you miss a dose of TRUTAKNA on your planned day, inject a dose as soon as possible. Then continue once-weekly dosing based on the new day injected. If you aren’t sure when to inject TRUTAKNA, call your healthcare provider.
Learn moreResults and safety
What results were seen in the clinical study?
In a clinical study, 106 people with IgAN received TRUTAKNA and 97 received placebo for 36 weeks.
After 36 weeks, TRUTAKNA had lowered protein in the urine by an average of 46% in 106 people vs an average of 7% in 97 people taking placebo.
Define:
What are the common side effects of TRUTAKNA?
In a clinical study of 214 people 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.
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.
Can TRUTAKNA be taken with supportive care treatments?
During the clinical study, people taking RASi medications (including ACE inhibitors and ARBs) with or without SGLT2i therapies were able to continue those medications while also taking TRUTAKNA or placebo. Talk to your healthcare provider about adding TRUTAKNA alongside your supportive care treatments.
Learn moreAccess and support
How do I get TRUTAKNA?
TRUTAKNA must be prescribed by your healthcare provider. Talk to your healthcare provider to see if TRUTAKNA is right for you.
Learn more
Is there any financial assistance available for TRUTAKNA?
Subject to annual maximum benefit. Restrictions apply. Please see full Terms and Conditions, including complete eligibility requirements at trutaknatrusupport.com/patient.
Learn more
TRUTAKNA clinical study results
Learn how TRUTAKNA lowered levels of protein in the urine
*
Program is only valid for patients with commercial or private insurance. Patient must be a US resident. Program is not valid for patients insured by a federal or state government-funded health plan, including Medicare, Medicare Advantage, Medicaid, and TRICARE. Program is void where prohibited by law. Program does not cover the costs of any other healthcare provider charges or any other treatment costs. Patients are responsible for non–drug-related out-of-pocket costs. Additional eligibility requirements may apply. Vera Therapeutics reserves the right to terminate or modify this program at any time without notice.
†
To qualify for the Patient Assistance Program, you must complete an application, be a resident of the United States or of a US territory, have a valid prescription for TRUTAKNA, have no coverage/not enough coverage or insurance that doesn’t cover TRUTAKNA, meet annual household income threshold based on household size, and agree to and provide income verification. Not valid for prescriptions reimbursed in whole or in part by any government-funded program including but not limited to Medicare, Medicare Part D, Medicaid, Medigap, Veterans Affairs, Department of Defense, TRICARE, or any state, patient foundation, or other pharmaceutical program.
ACE=angiotensin-converting enzyme; APRIL=A proliferation-inducing ligand; ARBs=angiotensin receptor blockers; BAFF=B-cell activating factor; IgA=immunoglobulin A; RASi=renin-angiotensin system inhibitor; SGLT2i=sodium-glucose cotransporter-2 inhibitor.
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.
