Gohibic

Package leaflet: Information for the user

Gohibic 200 mg concentrate for solution for infusion

Vilobelimab

This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before you are given this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

1. What Gohibic is and what it is used for
2. What you need to know before you are given Gohibic
3. How Gohibic will be administered
4. Possible side effects
5. How to store Gohibic
6. Contents of the pack and other information

1. What Gohibic is and what it is used for

Gohibic contains the active substance vilobelimab, which belongs to a class of medicines known as monoclonal antibodies.
Gohibic is used to treat adults with acute respiratory failure caused by SARS-CoV-2 (the virus that causes COVID-19), who are receiving mechanical ventilation (a machine that helps the patient to breathe), with or without ECMO (a life support system that can assist a person whose lungs and heart are not functioning properly). Gohibic is used in patients who are already being treated with corticosteroid medicines.
Monoclonal antibodies such as vilobelimab are types of proteins that can bind to specific targets in the body. Vilobelimab binds to a protein called C5a, blocking its activity. C5a is part of the so-called complement system, a component of the immune system (the body’s natural defences). High levels of C5a can cause damage to lung tissue, as seen in patients with severe COVID-19. By blocking the C5a protein, Gohibic helps prevent such damage, allowing the lungs to deliver oxygen into the blood.

2. What you need to know before taking Gohibic

Do not take Gohibic

• if you are allergic to vilobelimab or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Your doctor or nurse will monitor you during treatment with Gohibic to check whether you develop:

• allergic reactions or infusion-related reactions. Your doctor may need to stop treatment with Gohibic if you experience symptoms such as:
• low or high blood pressure
• fast or slow heartbeat
• breathing difficulties
• lack of oxygen in body tissues
• wheezing
• fever
• chills
• severe allergic reactions causing swelling of the face or throat
• skin rash
• nausea
• vomiting
• excessive sweating
• a new infection. Your doctor may need to perform further tests and treat the new infection if you experience symptoms such as:
• fever
• fatigue
• congestion
• cough
• body aches
• headache
• chills
• nausea, vomiting, diarrhea
• local swelling, redness, warmth

Children and adolescents
Gohibic is not recommended in children and adolescents under 18 years of age, as studies have not been conducted in this age group.

Other medicines and Gohibic
Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor.
Gohibic is not recommended for pregnant women, as it has not been tested in this group.
It is not known whether vilobelimab is excreted in breast milk, and a risk to the newborn cannot be ruled out. Your doctor will decide whether breastfeeding must be discontinued during treatment with Gohibic.

Driving and using machines
Gohibic is not expected to have any effect on your ability to drive or operate machinery.

Gohibic contains sodium
This medicine contains 296.8 mg of sodium (the main component of table salt) in each dose of 4 vials, equivalent to 15% of the maximum daily recommended sodium intake for an adult.

3. How Gohibic will be administered

Gohibic will be administered by intravenous infusion (drip) over 30–60 minutes by a doctor or nurse.
The recommended dose of this medicine is 800 mg (4 vials), diluted in infusion solution. Treatment should begin (Day 1) within 48 hours of receiving mechanical ventilation. If still hospitalised, further doses are administered on Days 2, 4, 8, 15, and 22.
If you have any questions about how this medicine is used, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people)

• severe lung infection which may be caused by bacteria, viruses or fungi (pneumonia)

Common (may affect up to 1 in 10 people)

• potentially life-threatening condition in which the body damages its own tissues and organs in response to an infection (sepsis)
• fungal infection of the lungs (bronchopulmonary aspergillosis)
• painful blisters or sores in the mouth or on the genitals caused by a virus (herpes simplex)
• decrease in the number of cells that help blood to clot (thrombocytopenia)
• sudden, very fast heartbeat affecting the upper chambers of the heart (supraventricular tachycardia)
• rash.

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Gohibic

Your doctor, pharmacist or nurse is responsible for the storage of this medicinal product and
for the proper disposal of unused medicine. The following information is intended for
healthcare professionals.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the vial and carton after
"EXP.". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze or shake.
Keep in the original packaging to protect the medicine from light.
Use the product immediately after dilution. If not used immediately, the conditions and duration of
storage prior to use are the responsibility of the user; the product should be stored for a period
normally not exceeding 24 hours at a temperature between 2 °C and 8 °C, unless reconstitution/dilution (etc.) has been carried out under aseptic, controlled and validated conditions.

6. Package contents and other information

What Gohibic contains

• The active substance is vilobelimab. Each vial contains 200 mg of vilobelimab in 20 mL (10 mg/mL).
• The other ingredients are sodium chloride, disodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, polysorbate 80, water for injections. See section 2 for further information on sodium.

Description of the appearance of Gohibic and contents of the pack
Gohibic is a concentrate for solution for infusion (sterile concentrate). It is a colourless,
clear to slightly opalescent concentrate in a glass vial.
Each pack contains 4 vials.
Marketing Authorisation Holder
InflaRx GmbH
Winzerlaer Strasse 2
07745 Jena
Germany
Manufacturer
Almac Pharma Services Ltd.
Finnabair Industrial Estate
Dundalk
Co. Louth
A91 P9KD
Ireland
An authorisation has been granted to this medicinal product under "exceptional circumstances". This means that
due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
The European Medicines Agency will review any new information on this medicinal product annually, and this
package leaflet will be updated if necessary.
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly documented.

General handling information

• This medicinal product must be diluted by a healthcare professional using aseptic techniques in a controlled/dedicated area, in accordance with applicable local regulations and requirements for intravenous administration.
• Gohibic must not be diluted or administered with products/single-use devices containing sensitizing compounds such as latex (rubber latex) or silicone oil.

Preparation of the infusion

• To obtain a dose of 800 mg of vilobelimab for intravenous infusion, dilute 80 mL of Gohibic (4 vials) in 170 mL of sodium chloride 9 mg/mL (0.9%) solution for injection at room temperature.
• Use a 250 mL infusion bag of sodium chloride 9 mg/mL (0.9%) solution for injection as follows:
• remove 80 mL of sodium chloride 9 mg/mL (0.9%) solution for injection from the infusion bag and discard it;
• withdraw 80 mL of Gohibic from the 4 vials and slowly add it to the 170 mL of sodium chloride 9 mg/mL (0.9%) solution in the infusion bag;
• to mix the solution, gently invert the bag to avoid foaming.
• Prior to administration, visually inspect the vial for any particles or discoloration. The product must not be used if the solution shows discoloration or contains particles.

Storage conditions of the diluted solution
Chemical and physical in-use stability has been demonstrated for 72 hours at 2 °C–8 °C and for 4 hours at up to 25 °C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user; the product should generally be stored for no longer than 24 hours at 2 °C–8 °C, unless reconstitution/dilution (etc.) has been carried out under aseptic, controlled, and validated conditions.

Instructions for use
Treatment should be initiated within 48 hours of intubation (Day 1), followed by administration on Days 2, 4, 8, 15, and 22, provided the patient remains hospitalized, even if discharged from the ICU.
The infusion should be administered over 30–60 minutes and must be given using an infusion set.
Gohibic must not be infused simultaneously with other medicinal products in the same intravenous line. No physical or biochemical compatibility studies have been conducted to assess co-administration of Gohibic with other medicinal products.

Disposal
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.

ANNEX IV
CONCLUSIONS ON THE GRANTING OF THE MARKETING AUTHORISATION
UNDER EXCEPTIONAL CIRCUMSTANCES
PRESENTED BY THE EUROPEAN MEDICINES AGENCY

Conclusions presented by the European Medicines Agency on:

• Marketing authorisation under exceptional circumstances
  Following the evaluation of the marketing authorisation application, the CHMP considers that the benefit-risk balance is favourable and recommends granting the marketing authorisation under exceptional circumstances, as further described in the European Public Assessment Report (EPAR).