41/20. Atoitivimab- (IMMAZEB)- (Oct 2020)- To treat Ebola Virus
Drug Name:41/20. Atoitivimab- (IMMAZEB)- (Oct 2020)- To treat Ebola Virus
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
DRUG INTERACTIONS-(summary)
Interaction with live vaccine indicated for prevention of Zaire ebolavirus infection: No vaccine interaction studies have been performed.
INMAZEB may reduce the efficacy of the live vaccine. The interval between live vaccination following initiation of INMAZEB therapy should be in accordance with current vaccination guidelines.
DRUG INTERACTIONS -(details)
1. Vaccine Interactions No vaccine-therapeutic interaction studies have been performed in human subjects using INMAZEB. However, because of the potential for INMAZEB to inhibit replication of a live vaccine virus indicated for prevention of Zaire ebolavirus infection and possibly reduce the efficacy of the vaccine, avoid the concurrent administration of a live vaccine during treatment with INMAZEB.
The interval between live vaccination following initiation of INMAZEB therapy should be in accordance with current vaccination guidelines.
The efficacy of INMAZEB among subjects who reported receipt of a recombinant live vaccine prior to their enrollment in the PALM clinical trial was similar to subjects who did not receive a vaccine.
Indication:
U.S. FDA APPROVED DRUGS DURING 2020
Sr.No- 41
Adverse Reaction:
ADVERSE REACTIONS-
The most common adverse events (incidence =20%) were pyrexia, chills, tachycardia, tachypnea, and vomiting.
Contra-Indications:
CONTRAINDICATIONS-
None.
WARNINGS AND PRECAUTIONS-
Hypersensitivity Reactions Including Infusion-Associated Events: Hypersensitivity reactions including infusion-associated events have been reported during and post-infusion with INMAZEB.
These may include acute, life-threatening reactions during and after the infusion. Monitor patients and in the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of INMAZEB immediately and administer appropriate emergency care.
Dosages/ Overdosage Etc:
Patient Information:
PATIENT COUNSELING INFORMATION
Hypersensitivity Reactions Including Infusion-Associated Events Inform patients that hypersensitivity reactions including infusion-associated events have been reported during and post-infusion with INMAZEB and to immediately report if they experience any symptoms of systemic hypersensitivity reactions.
Lactation- Instruct patients with Zaire ebolavirus infection not to breastfeed because of the risk of passing Zaire ebolavirus to the baby.
Manufactured by: Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, NY 10591-6707 U.S. License No. 1760 INMAZEB trademark is owned by Regeneron Pharmaceuticals, Inc. ©2020 Regeneron Pharmaceuticals, Inc. All rights reserved.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action-
INMAZEB is an antiviral drug combination of three recombinant human IgG1? monoclonal antibodies (atoltivimab, maftivimab, and odesivimab) that inhibit Zaire ebolavirus.
2. Pharmacodynamics - Atoltivimab, maftivimab, and odesivimab exposure-response relationships and the time course of pharmacodynamic response are unknown.
3. Pharmacokinetics- No pharmacokinetic data are available in patients with Zaire ebolavirus infection.
Distribution at Steady State, mL/kg 58.2 (2.66) 57.6 (3.89) 56.0 (3.16)
Elimination Mean (SD)- Elimination Half-Life (days) 21.2 (3.36) 22.3 (3.09) 25.3 (3.86) Mean (SD) Clearance (mL/day/kg) 3.08 (0.719) 2.78 (0.558) 2.02 (0.374) a INMAZEB was administered at a total dose of 50 mg of atoltivimab, 50 mg of maftivimab, and 50 mg of odesivimab per kg in a 1:1:1 ratio.
Specific Populations- The effect of age (< 21 or > 60), renal impairment, or hepatic impairment on the pharmacokinetics of atoltivimab, maftivimab, and odesivimab is unknown.
Microbiology- Mechanism of Action INMAZEB is a combination of three recombinant human IgG1? monoclonal antibodies each targeting the Zaire ebolavirus glycoprotein (GP).
Zaire ebolavirus encodes a sole envelope protein, the glycoprotein, which mediates virus attachment and membrane fusion with the host cell membranes.
Pregnancy and lactation:
8 USE IN SPECIFIC POPULATIONS
1. Pregnancy Risk Summary-
Zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy (see Clinical Considerations).
Available data from the PALM trial and an expanded access program in which pregnant women with Zaire ebolavirus infection were treated with INMAZEB demonstrate the high rate of maternal and fetal/neonatal morbidity consistent with published literature regarding the risk associated with underlying maternal Zaire ebolavirus infection.
These data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal/fetal outcome.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Maternal, fetal and neonatal outcomes are poor among pregnant women infected with Zaire ebolavirus.
The majority of such pregnancies result in maternal death with miscarriage, stillbirth, or neonatal death. Treatment should not be withheld due to pregnancy.
2 Lactation Risk Summary- The Centers for Disease Control and Prevention recommend that patients with confirmed Zaire ebolavirus not breastfeed their infants to reduce the risk of postnatal transmission of Zaire ebolavirus infection.
There are no data on the presence of atoltivimab, maftivimab, and odesivimab-ebgn in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk.
The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to atoltivimab, maftivimab, or odesivimab-ebgn are unknown.
3.Pediatric Use- 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.
4.Geriatric Use- Clinical studies of INMAZEB did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.