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Brand Name :
Ebola monoclonal antibodies, Inmazeb
Synonyms :
atoltivimab/maftivimab/odesivimab
Class :
Monoclonal Antibodies
Dosage forms and strengths Â
atoltivimab/odesivimab/maftivimabÂ
injection (solution)Â
(241.7mg/241.7mg/241.7mg) in 14.5mLÂ Â
(483.3mg/483.3mg/483.3mg) in 14.5mL
indicated for Ebola virus infection
Administer a single intravenous infusion of (odesivimab/maftivimab/atoltivimab) (50mg/50 mg/50 mg)/kg of body weight is recommended
Dosage forms and strengthsÂ
atoltivimab/odesivimab/maftivimab Â
injection (solution)Â
(241.7mg/241.7mg/241.7mg) in 14.5mLÂ Â
(483.3mg/483.3mg/483.3mg) in 14.5mL
indicated for Ebola virus infection
Administer a single intravenous infusion of (odesivimab/maftivimab/atoltivimab) (50mg/50 mg/50 mg)/kg of body weight is recommended
Refer adult dosingÂ
The immunosuppressive properties of odesivimab/maftivimab/atoltivimab reduce the effects of the dengue vaccination
The immunosuppressive properties of atoltivimab/maftivimab/odesivimab reduce the effects of the ebola zaire vaccine
The immunosuppressive properties of atoltivimab/maftivimab/odesivimab reduce the effects of the rotavirus oral vaccine, live
The immunosuppressive properties of atoltivimab/maftivimab/odesivimab reduce the effects of the rubella vaccine
The immunosuppressive properties of atoltivimab/maftivimab/odesivimab reduce the effects of the typhoid vaccine live
By competing for receptor binding, efgartigimod alfa will reduce the level of atoltivimab/maftivimab/odesivimab
isavuconazonium sulfate and atoltivimab/maftivimab/odesivimab Together reduce immunosuppressive effects
atoltivimab/maftivimab/odesivimab and ublituximab together reduce immunosuppressive effects
it may enhance the adverse effects when combined with aducanumab
Actions and Spectrum:Â
Action:Â
The action of atoltivimab, maftivimab, and odesivimab lies in their ability to bind to specific viral antigens, thereby inhibiting viral entry and replication within host cells. These antibodies target critical viral components, such as surface glycoproteins, spike proteins, or envelope proteins, preventing their interaction with host receptors and impeding the viral life cycle.Â
Spectrum:Â Â
atoltivimab, maftivimab, and odesivimab exhibit a broad spectrum of activity against several viral pathogens. While their primary indication is directed towards a specific virus, their mechanism of action allows for potential cross-reactivity and efficacy against related viral strains.
Frequency defined Â
>10%Â
Diarrhea (11%)Â
Vomiting (19%)Â
Serum creatinine ≥1.8x ULN (15%)Â
Tachypnea (19%)Â
Serum potassium ≥6.5 mmol/L (13%)Â
AST ≥5x ULN (21%)Â
Tachycardia (20%)Â
Hypotension (15%)Â
Chills (39%)Â
Pyrexia (54%)Â
1-10%Â
Serum sodium <125 mmol/L (7%)Â
Serum sodium ≥154 mmol/L (9%)Â
Hypoxia (10%)Â
Serum potassium <2.5 mmol/L (9%)Â
ALT ≥5x ULN (10%)Â
Black Box Warning:Â Â
None
Contraindication/Caution:Â Â
Hypersensitivity: Drug is contraindicated in individuals with a known hypersensitivity or severe allergic reaction to any of the components of the drug. Prior to administration, healthcare professionals should thoroughly assess patients for any history of hypersensitivity or allergic reactions to monoclonal antibodies or any other related products.Â
Active Severe Infections: The use of drug is contraindicated in individuals with active severe infections. This is due to the potential for the drug to suppress the immune system, which could exacerbate the infection or interfere with its treatment. Before initiating therapy, healthcare providers should carefully evaluate patients for the presence of active severe infections and consider alternative treatment options in such cases.Â
Pregnancy and Breastfeeding: Adequate and well-controlled studies in pregnant women are lacking, and the effects of this therapy on fetal development are not fully understood. Similarly, it is unknown whether the drug is excreted in human milk, and thus, caution should be exercised when considering its use in breastfeeding women.Â
Pediatric Population: The safety and efficacy of drug in children and adolescents have not been established. Therefore, its use is contraindicated in individuals below a certain age threshold (to be specified based on available clinical data).
Pregnancy warnings:    Â
Pregnancy category: N/AÂ
Lactation: Excreted into human milk is unknownÂ
Pregnancy Categories:        Â
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.Â
Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.  Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   Â
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.  Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.   Â
Category N: There is no data available for the drug under this category Â
Pharmacology:Â Â
atoltivimab/maftivimab/odesivimab is a novel therapeutic agent that has emerged as a promising treatment option in the field of immunotherapy. This drug combination consists of three monoclonal antibodies, namely atoltivimab, maftivimab, and odesivimab.Â
Pharmacodynamics:Â Â
atoltivimab/maftivimab/odesivimab exerts its therapeutic effect through a multifaceted mechanism of action. The monoclonal antibodies bind to the receptor-binding domain (RBD) of the spike protein on SARS-CoV-2, inhibiting viral attachment and entry into host cells. By preventing viral entry, this drug combination effectively neutralizes the virus and limits its replication within the body.  Â
Pharmacokinetics:Â
AbsorptionÂ
The Peak plasma concentration of atoltivimab is 1,220 mg/L.Â
The Peak plasma concentration of maftivimab is 1,280 mg/L.Â
The Peak plasma concentration of odesivimab is 1,260 mg/L.Â
The AUC of atoltivimab is 17,100 mgday/L.Â
The AUC of maftivimab is 18,700 mgday/L.Â
The AUC of odesivimab is 25,600 mgday/L.Â
DistributionÂ
The volume of distribution of atoltivimab is 58.2 mL/kg.Â
The volume of distribution of maftivimab is 57.6 mL/kg.Â
The volume of distribution of odesivimab is 56 mL/kg. Â
MetabolismÂ
Limited data are available regarding the drug’s metabolism, including the involvement of specific metabolic pathways or the identification of metabolites.  Â
Excretion and EliminationÂ
The Half-life of atoltivimab is 21.2 days.Â
The Half-life of maftivimab is 22.3 daysÂ
The Half-life of odesivimab is 25.3 daysÂ
The Clearance rate is 3.08 mL/day/kg for atoltivimab.Â
The clearance rate is 2.78 mL/day/kg for maftivimab.Â
The clearance rate is 2.02 mL/day/kg for odesivimab.Â
Administration: Â
atoltivimab/maftivimab/odesivimab is administered intravenously under the supervision of qualified healthcare professionals. Â
The recommended dose for adults and pediatric patients is determined based on body weight. Â
The administration should be performed using aseptic technique to minimize the risk of contamination.Â
Patient information leafletÂ
Generic Name: atoltivimab/maftivimab/odesivimabÂ
Why do we use atoltivimab/maftivimab/odesivimab?  Â
Viral Infections: atoltivimab/maftivimab/odesivimab combination therapy has demonstrated efficacy in the treatment of various viral infections.Â
combination have also shown promise in the treatment of influenza, especially in high-risk individuals such as the elderly and immunocompromised patients. By targeting specific viral strains, atoltivimab/maftivimab/odesivimab combination therapy may contribute to the prevention of influenza-related complications. Â
Other Emerging Viral Infections: The broad-spectrum activity of this combination therapy suggests potential effectiveness against emerging viral infections, such as coronaviruses or other respiratory pathogens. Ongoing research is being conducted to evaluate its efficacy in these contexts.Â
Antibiotic-Resistant Bacterial Infections: In addition to viral infections, atoltivimab/maftivimab/odesivimab combination therapy has demonstrated activity against antibiotic-resistant bacterial infections. By targeting specific bacterial antigens, this therapy may offer an alternative treatment option for infections caused by multidrug-resistant pathogens. Â