Inmazeb
- Generic Name: atoltivimab, maftivimab, and odesivimab-ebgn for injection
- Brand Name: Inmazeb
Inmazeb (Atoltivimab, Maftivimab, and Odesivimab-ebgn for Injection) side effects drug center
Inmazeb Side Effects Center
What Is Inmazeb?
Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) is a combination of Zaire ebolavirus glycoprotein-directed human monoclonal antibodies used to treat 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 Inmazeb?
Side effects of Inmazeb include:
- fever,
- chills,
- fast heart rate,
- fast, shallow breathing,
- vomiting,
- low blood pressure (hypotension),
- diarrhea, and
- low blood oxygen (hypoxia)
Dosage for Inmazeb
The recommended dosage of Inmazeb is 50 mg of atoltivimab, 50 mg of maftivimab, and 50 mg of odesivimab per kg diluted and administered as a single intravenous infusion.
Inmazeb In Children
The safety and effectiveness of Inmazeb 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 Inmazeb?
Inmazeb may interact with other medicines such as:
- live vaccines
Tell your doctor all medications and supplements you use.
Inmazeb During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Inmazeb; it is unknown how it would affect a fetus. Zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy. Patients infected with Zaire ebolavirus are advised not to breastfeed due to the potential for Zaire ebolavirus transmission.
Additional Information
Our Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) 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.
Inmazeb 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 may not reflect the rates observed in practice.
Overall, 382 adult and pediatric subjects with Zaire ebolavirus infection received INMAZEB in one clinical trial (the PALM trial) and as part of an expanded access program conducted in the Democratic Republic of Congo during a Zaire ebolavirus outbreak in 2018-2019. In the PALM trial, the safety of INMAZEB was evaluated in a multi-center, open-label, randomized controlled trial, in which 154 subjects (115 adult subjects and 39 pediatric subjects) received INMAZEB [50 mg of atoltivimab, 50 mg of maftivimab, and 50 mg of odesivimab per kg (3 mL/kg)] intravenously as a single infusion and 168 subjects received an investigational control [see Clinical Studies]. All subjects received optimized standard of care treatment. During the same outbreak, INMAZEB [50 mg of atoltivimab, 50 mg of maftivimab, and 50 mg of odesivimab per kg (3 mL/kg)] was given to 228 subjects (190 adult subjects and 38 pediatric subjects) in the expanded access program.
The safety data described below is derived from the PALM trial.
Table 3 summarizes adverse events that were reported during INMAZEB infusion. The evaluation of adverse events in subjects who received INMAZEB may have been confounded by the signs and symptoms of the underlying Zaire ebolavirus infection. The most common adverse events reported in at least 20% of subjects who received INMAZEB were pyrexia (or elevation in fever), chills, tachycardia, tachypnea, and vomiting. The adverse event profile in adult and pediatric subjects treated with INMAZEB was similar.
Table 3: Adverse Events That Occurred during INMAZEB Infusion in ≥10% of Adult and Pediatric Subjects in the PALM Trial
| Adverse Eventa | INMAZEB (N=154) % | Controlc (N=168) % |
| Pyrexia (Elevation in fever) | 54 | 58 |
| Chills | 39 | 33 |
| Tachycardia | 20 | 32 |
| Tachypnea | 19 | 28 |
| Vomitingb | 19 | 23 |
| Hypotension | 15 | 31 |
| Diarrheab | 11 | 18 |
| Hypoxiab | 10 | 11 |
| a Adverse events in this table were reported as preferred terms from a list of pre-defined or other adverse events that occurred on the day of infusion, and included signs and symptoms that occurred during or immediately after infusion b Adverse events that were not pre-specified c Investigational therapy administered as three separate infusions | ||
The following pre-specified symptoms, which were assessed on a daily basis while admitted to the treatment unit, were reported in 40% or more of subjects who received INMAZEB: diarrhea, pyrexia, and vomiting. Evaluation of these symptoms may have been confounded by the underlying Zaire ebolavirus infection.
Discontinuation And Infusion Rate Adjustments In The PALM Trial
Approximately 99% of subjects who received INMAZEB in the PALM trial were able to complete their dose within three hours. Two subjects who received INMAZEB (1%) did not receive their complete infusion. One of the two subjects did not complete their INMAZEB infusion because of fever elevation [see WARNINGS AND PRECAUTIONS].
Selected Laboratory Abnormalities In The PALM Trial
Table 4 presents selected laboratory abnormalities (worsening to Grade 3 or 4 compared to baseline) for adult and pediatric subjects in the PALM trial.
Table 4: Selected Grade 3 and 4 Laboratory Abnormalities, Worsened Grade from Baseline for Adult and Pediatric Subjects in the PALM Trial
| Laboratory Testa | INMAZEB N=154 % | Control N=168 % |
| Sodium, high ≥ 154 mmol/L | 9 | 4 |
| Sodium, low < 125 mmol/L | 7 | 11 |
| Potassium, high ≥ 6.5 mmol/L | 13 | 12 |
| Potassium, low < 2.5 mmol/L | 9 | 8 |
| Creatinine (mg/dL) ≥1.8 x ULNb | 15 | 23 |
| Alanine aminotransferase (U/L) ≥5 x ULN | 10 | 14 |
| Aspartate aminotransferase (U/L) ≥ 5 x ULN | 21 | 18 |
| ULN = upper limit of normal a Graded per Division of AIDS (DAIDS) v2.1 b ULN for creatinine was 1.2 mg/dL. Criterion for increase to ≥ 1.5 x from baseline was applied if the worsening grade was higher. | ||
Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the study described below with the incidence of antibodies in other studies or to other atoltivimab, maftivimab, and odesivimab products may be misleading.
The development of anti-atoltivimab, anti-maftivimab, and anti-odesivimab antibodies was evaluated in 24 healthy adults in a single dose, randomized, double-blind, placebo-controlled, dose escalation study. Immunogenic responses against atoltivimab, maftivimab, and odesivimab were not detected at baseline or through 168 days post-dose in any subjects.
Read the entire FDA prescribing information for Inmazeb (Atoltivimab, Maftivimab, and Odesivimab-ebgn for Injection)
&Copy; Inmazeb Patient Information is supplied by Cerner Multum, Inc. and Inmazeb Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.