DRUG INTERACTIONS-(summary)

 Interaction with live vaccine indicated for prevent

EBANGA may reduce the efficacy of the live vaccine. The interval between administration of EBANGA therapy and live vaccination 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 EBANGA.

However, because of the potential for EBANGA 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 EBANGA.

The interval between administration of EBANGA therapy and live vaccination should be in accordance with current vaccination guidelines. The efficacy of EBANGA among subjects who reported receipt of a recombinant live vaccine prior to their enrollment in the PALM trial was similar to subjects who did not report receiving a vaccine prior to enrollment. 

U.S. FDA APPROVED  DRUGS DURING 2020

Sr.No-  52

 ADVERSE REACTIONS-

clinically significant adverse reactions are :

• Hypersensitivity Reactions Including Infusion-Associated Events [see Warnings and Precautions 

CONTRAINDICATIONS-

 None.

WARNINGS AND PRECAUTIONS-

 Hypersensitivity Reactions Including Infusion-Associated Events:                   Hypersensitivity reactions including infusion-associated events have been reported with EBANGA. These may include acute, lifethreatening reactions during and after the infusion.

Monitor patients and in the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of EBANGA immediately and administer appropriate emergency care.

DOSAGE AND ADMINISTRATION-

 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.

 See Full Prescribing Information for instructions on preparation, dilution and administration of EBANGA injection.

DOSAGE FORMS AND STRENGTHS-

 For injection: 400 mg lyophilized powder in a single-dose vial for reconstitution and further dilution. 

7 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 EBANGA and to immediately report if they experience any symptoms of systemic hypersensitivity reactions.

Lactation. Instruct patients with Zaire ebolavirus not to breastfeed because of the risk of passing Zaire ebolavirus to the baby.

Manufactured by: Ridgeback Biotherapeutics, LP 3480 Main Highway, Unit 402 Miami, FL 33133 U.S. License number 2162 [EBANGA™ is a trademark of Ridgeback Biotherapeutics, LP] © 2020 Ridgeback Biotherapeutics, LP. All rights reserved

17 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 EBANGA and to immediately report if they experience any symptoms of systemic hypersensitivity reactions [see Warnings and Precautions (5.1)]. Lactation Instruct patients with Zaire ebolavirus not to breastfeed because of the risk of passing Zaire ebolavirus to the baby [see Use in Specific Populations (8.2)]. Manufactured by: Ridgeback Biotherapeutics, LP 3480 Main Highway, Unit 402 Miami, FL 33133 U.S. License number 2162 [EBANGA™ is a trademark of Ridgeback Biotherapeutics, LP]

 CLINICAL PHARMACOLOGY-

1. Mechanism of Action-

Ansuvimab-zykl is a recombinant human monoclonal antibody with antiviral activity against Zaire ebolavirus.

2. Pharmacodynamics -                                                                                            Ansuvimab-zykl exposure-response relationship and the time course of pharmacodynamic response is unknown.

Specific Populations-                                                                                                   The effect of age, renal impairment or hepatic impairment on the pharmacokinetics of ansuvimab-zykl is unknown.

3. Microbiology -Mechanism of Action-

EBANGA (ansuvimab-zykl) is a recombinant, human IgG1? monoclonal antibody that binds to the glycan cap and inner chalice of the EBOV GP1 subunit.

 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 in which pregnant women with Zaire ebolavirus infection were treated with EBANGA 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.

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 mothers with confirmed Zaire ebolavirus not breastfeed their infants to reduce the risk of postnatal transmission of Zaire ebolavirus infection.

The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to ansuvimab-zykl are unknown.

3. Pediatric Use -                                                                                                          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.

Use of EBANGA for this indication is supported by evidence from a multi-center, open label, randomized controlled trial of EBANGA in adults and pediatric subjects that included 54 pediatric subjects birth to less than 18 years of age, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.

An additional 78 (31%) pediatric subjects from birth to less than 18 years of age received EBANGA in an expanded access program. 8 Reference ID: 4720395

5.Geriatric Use-                                                                                                              Clinical trials of EBANGA did not include sufficient numbers of subjects aged 65 and over to determine whether the safety profile of EBANGA is different in this population compared to younger subjects. Of the total number of subjects administered EBANGA in the PALM trial, 6 subjects (3%) were 65 years or older.

The limited clinical experience has not identified differences in responses between the elderly and younger subjects.