Atacicept
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation and Administration Instructions TRUTAKNA autoinjector is intended for SC administration by patients/caregivers at home. The TRUTAKNA “Instructions for Use” contains more detailed instructions on the preparation and administration of TRUTAKNA [see Instructions for Use ] . Remove TRUTAKNA autoinjector from the refrigerator and allow it to sit for 15 to 30 minutes at room temperature between 15°C to 25°C (60°F to 77°F) prior to injecting.
Do not use an external heat source to heat TRUTAKNA, because heat may damage the product. If needed, TRUTAKNA autoinjector may be stored at room temperature up to 25°C (77°F), for a single period of 3 days (72 hours). Once TRUTAKNA has been stored at room temperature, it should not be placed back into the refrigerator. Discard the autoinjector if not used within this 72‑hour period.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. TRUTAKNA should appear as a clear to slightly opalescent, brownish-yellow solution. Do not use if the liquid contains particles or is cloudy. Administer each injection at a different location than the previous injection.
Sites for injections include the abdomen and thigh.
Contraindications
4 CONTRAINDICATIONS TRUTAKNA is contraindicated in patients with serious hypersensitivity to atacicept-vymj or any excipients of TRUTAKNA. Serious hypersensitivity to any of the ingredients in TRUTAKNA. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for atacicept. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data on TRUTAKNA use in pregnant women exposed during clinical trials are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on mechanism of action, TRUTAKNA may cause immunosuppression in the in utero-exposed infant [see Warnings and Precautions ( 5.1 and 5.2 ), Clinical Pharmacology ( 12.1 ) and Clinical Considerations ] . There are risks to the mother and infant with untreated IgAN nephropathy in pregnancy (see Clinical Considerations ) .
In animal reproduction studies, no treatment-related malformations were observed in mice and rabbits at atacicept-vymj exposures approximately up to 12 times and 4 times, respectively, the clinical exposure at the recommended human dose (RHD) (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Pregnant women exposed to TRUTAKNA, or their healthcare providers, should report TRUTAKNA exposure by calling 1-833-633-8372. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk IgAN in pregnancy is associated with adverse maternal outcomes, including increased rates of cesarean section, pregnancy-induced hypertension, pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including stillbirth and low birth weight. Fetal/Neonatal Adverse Reactions Based on mechanism of action, TRUTAKNA may cause immunosuppression in the in utero exposed infant. The potential clinical impact of TRUTAKNA exposure in infants exposed in utero should be considered.
Data Animal Data In pregnant mice, SC administration of atacicept-vymj once every two days (0, 5, 20, and 80 mg/kg) throughout organogenesis from gestation day (GD) 6 to 15 did not result in any adverse effects on embryofetal development at up to 80 mg/kg, approximately 12 times the clinical exposure at the RHD based on area under the concentration curve (AUC). In pregnant rabbits, SC administration of atacicept-vymj once every two days (0, 5, 20, and 80 mg/kg) throughout organogenesis from GD 6 to 18 resulted in early and late resorptions, reduced number of live fetuses, and decreased mean fetal weight at ≥20 mg/kg, doses that resulted in maternal toxicity (reduced body weight gain).…
Breastfeeding (LactMed)
No information is available on the clinical use of atacicept during breastfeeding. Because atacicept is a large protein molecule with a molecular weight of 73,500 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant’s gastrointestinal tract and absorption by the infant is probably minimal. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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