Ebanga
- Generic Name: ansuvimab-zykl for injection, for intravenous use
- Brand Name: Ebanga
Ebanga (Ansuvimab-zykl for Injection, for Intravenous Use) side effects drug center
Ebanga Side Effects Center
What Is Ebanga?
Ebanga (ansuvimab-zykl) is a Zaire ebolavirus glycoprotein (EBOV GP)-directed human monoclonal antibody indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.
What Are Side Effects of Ebanga?
Side effects of Ebanga include:
- fever,
- fast heart rate,
- diarrhea,
- vomiting,
- low blood pressure (hypotension),
- fast, shallow breathing,
- chills, and
- low blood oxygen
Dosage for Ebanga
The recommended dose of Ebanga for adult and pediatric patients is 50 mg/kg reconstituted, further diluted, and administered as a single intravenous infusion over 60 minutes.
Ebanga In Children
The safety and effectiveness of Ebanga for the treatment of infection caused by Zaire ebolavirus have been established in pediatric patients from birth to less than 18 years of age.
What Drugs, Substances, or Supplements Interact with Ebanga?
Ebanga may interact with other medicines such as:
- live vaccines
Tell your doctor all medications and supplements you use and all vaccines you recently received.
Ebanga During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Ebanga; Zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy. It is unknown if Ebanga passes into breast milk. The Centers for Disease Control and Prevention recommend that mothers with confirmed Zaire ebolavirus not breastfeed their infants to reduce the risk of postnatal transmission of Zaire ebolavirus infection.
Additional Information
Our Ebanga (ansuvimab-zykl) for Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
Ebanga Professional Information
SIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions Including Infusion-Associated Events [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice.
Overall, 424 adult and pediatric subjects with Zaire ebolavirus infection received EBANGA in one clinical trial and as part of an expanded access program during the 2018 Zaire ebolavirus outbreak in the Democratic Republic of Congo (DRC).
In the PALM trial, the safety of EBANGA was evaluated in a multi-center, open-label, randomized controlled trial, in which 173 subjects (119 adults and 54 pediatric subjects) with confirmed Zaire ebolavirus infection received EBANGA as a single 50 mg/kg IV infusion and 168 subjects received an investigational control [see Clinical Studies]. All subjects received optimized standard of care treatment (oSOC). The median age of the study population that received EBANGA was 26 years (range: 1 day to 85 years). Fifty-five percent (55%) of enrolled subjects were female and 45% were male.
During the same outbreak, 251 subjects (173 adults and 78 pediatric subjects) with laboratory-confirmed Zaire ebolavirus infection received EBANGA under an expanded access program; 57% of whom were female and 43% of whom were male. Ages ranged from 6 days to 80 years, with a median age of 25 years.
Common Adverse Events
Table 2 summarizes the adverse events that were reported in the PALM trial from a pre-defined list of signs and symptoms that occurred during EBANGA infusion. The evaluation of adverse events in subjects who received EBANGA may have been confounded by the signs and symptoms of the underlying Zaire ebolavirus infection. Twenty nine percent (n=51) of subjects who received EBANGA in the PALM Trial experienced a pre-specified infusion-related adverse event. The most common prespecified infusion-related adverse event reported in at least 10% of subjects who received EBANGA was fever (Table 2). The adverse event profile in adult and pediatric subjects treated with EBANGA was similar.
Table 2: Adverse Events That Occurred During Infusion in >10% of Adult and Pediatric Subjects in the PALM Trial
| Adverse Eventa | EBANGA (N=173) % | Controlb (N=168) % |
| Pyrexia | 17 | 58 |
| Tachycardia | 9 | 32 |
| Diarrheac | 9 | 18 |
| Vomitingc | 8 | 23 |
| Hypotension | 8 | 31 |
| Tachypnea | 6 | 28 |
| Chillsd | 5 | 33 |
| Hypoxiac, | 3 | 11 |
| a Adverse events in this table were reported on the day of infusion, and included signs and symptoms that occurred during or immediately after infusion b Investigational therapy administered as three separate infusions c Adverse events that occurred during infusion but were not pre-specified. d The term chills includes other similar adverse events including rigors and tremors | ||
The following pre-specified symptoms, which were assessed on a daily basis during admission while admitted to the treatment unit, were reported in ≥40% of subjects who received EBANGA: diarrhea, pyrexia, abdominal pain, and vomiting. Evaluation of these symptoms may have been confounded by the underlying Zaire ebolavirus infection.
Discontinuation And Infusion Rate Adjustments
Approximately 99% of subjects who received EBANGA in the PALM trial were able to complete their dose within one hour. Two subjects who received EBANGA (1%) did not receive their complete infusion. In eight subjects (5%) the EBANGA infusion rate was decreased due to an AE [see WARNINGS AND PRECAUTIONS].
Selected Laboratory Abnormalities In The PALM Trial
Table 3 presents selected laboratory abnormalities (worsening to Grade 3 or 4 compared to baseline) in the PALM trial.
Table 3: Selected Grade 3 and 4 Laboratory Abnormalitiesa, Worsened Grade from Baseline in the PALM Trial
| Laboratory Testa | EBANGA N=173 % | Control N=168 % |
| Sodium, high ≥ 154 mmol/L | 5 | 4 |
| Sodium, low < 125 mmol/L | 7 | 11 |
| Potassium, high ≥ 6.5 mmol/L | 15 | 12 |
| Potassium, low < 2.5 mmol/L | 6 | 8 |
| Creatinine (mg/dL) > 1.8 x ULN or ≥ 1.5 x baselineb | 27 | 23 |
| Alanine aminotransferase (U/L) ≥ 5 x ULNc | 12 | 14 |
| Aspartate aminotransferase (U/L) ≥ 5 x ULNd | 13 | 18 |
| ULN= upper limit of normal a Graded per Division of AIDS (DAIDS) v2.1 b Based on a ULN of 1.2 mg/dL. c Based on a ULN of 47U/L. d Based on a ULN of 38 U/L. | ||
Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity from using ansuvimab-zykl. There are no data to assess the effects of potential immunogenicity on efficacy and safety in subjects with Zaire ebolavirus infection.
Read the entire FDA prescribing information for Ebanga (Ansuvimab-zykl for Injection, for Intravenous Use)
&Copy; Ebanga Patient Information is supplied by Cerner Multum, Inc. and Ebanga Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.