Feiba® Solution

FEIBA is a preparation made from human plasma which allows haemostasis, even when individual coagulation factors are reduced or lacking.

FEIBA is used:

• To treat spontaneous bleeding episodes in haemophilia A and haemophilia B patients with inhibitors (haemophilia is when your blood does not clot properly)
• In haemophilia A and haemophilia B patients with inhibitors if they need surgery.
• In haemophilia A and haemophilia B patients with inhibitors to prevent frequent bleeding.
• To treat non-haemophiliacs who have developed antibodies in their blood that prevent factor VIII, IX and XII from working.

You should not be given FEIBA:

– In the following situations, your doctor will use FEIBA only if no therapeutic alternatives to FEIBA are available:

• If you are allergic (hypersensitive) to Factor VIII Inhibitor Bypassing Activity or any of the other ingredients of FEIBA.
• Disseminated intravascular coagulation (DIC) (disorder in which the proteins that control blood clotting become overactive and use up the blood's clotting factors, which can lead to massive bleeding in other places).
• Acute thrombosis (presence of a blood clot in a blood vessel) or embolism (an obstruction in a blood vessel due to a blood clot or other foreign matter that gets stuck while traveling through the bloodstream), or in heart attacks.

Warnings and precautions

Talk to your doctor or healthcare professional before being given the injection.

Allergic - Type Hypersensitivity Reactions

Hypersensitivity reactions may occur, as is the case with all intravenously administered plasma products. To be able to recognize an allergic reaction as soon as possible, you should be aware of potential early symptoms of an allergic reaction such as

• redness of the skin
• skin rash
• nettle - rash (urticaria)
• itching
• swelling of lips and tongue
• breathing difficulties/dyspnoea
• wheezing
• tightness of the chest
• dizziness
• sudden drop of blood pressure (dizziness)

If one or more of these symptoms occur, stop the infusion immediately and contact your doctor. The listed symptoms may be early indications of an anaphylactic shock, which is a severe and life - threatening allergic reaction. Severe symptoms require prompt emergency treatment.

Always use FEIBA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You will not be expected to give yourself FEIBA. It will be given to you by a person who is qualified to do so. Your doctor will decide the dose you are to receive and for how long it will be given according to your bleeding rate and body weight. If you have the impression that the effect of FEIBA is too strong or too weak, tell your doctor or pharmacist.

Reconstitute the freeze - dried FEIBA powder with the enclosed solvent and administer the solution intravenously. Taking into consideration the severity of the blood coagulation disorder, the location and extent of the haemorrhage (bleed), and your general condition and response to the preparation, the doctor has determined the dose and dosage intervals required for you personally. Do not change the dosage established by your doctor and do not discontinue the application of the preparation independently.

Warm the product to room or body temperature prior to administration if necessary. FEIBA is to be reconstituted only immediately before administration. The solution should then be used immediately (the preparation does not contain preservatives). Swirl gently until all material is dissolved. Ensure that FEIBA is completely dissolved; otherwise, less FEIBA Units will pass through the device filter. Solutions, which are turbid or have deposits are to be disposed of appropriately. Do not reuse opened containers.

FEIBA can cause side effects

Not all side effects reported for FEIBA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FEIBA, please consult your healthcare provider for advice.

Common side effects

(may affect up to 1 in 10 people):

• Hypersensitivity
• Headache
• Dizziness
• Hypotension
• Rash
• Hepatitis B surface antibody positive.

Side effects with unknown frequency

(the frequency cannot be estimated on the basis of the available data):

• Blood and lymphatic system disorders: Disseminated intravascular coagulation (condition in which blood clots form throughout the body), Increase of inhibitor titer
• Immune system disorders: Anaphylactic reactions, Nettle - rash on the entire body (Urticaria)
• Nervous system disorders: Feeling of numbness in the limbs (hypoesthesia), Abnormal or reduced sensation (Paraesthesia), Stroke (Thrombotic stroke, Embolic stroke), Sleepiness (Somnolence), Altered sense of taste (Dysgeusia)
• Cardiac disorders: Heart attack (Myocardial infarction), Palpitation of the heart (Tachycardia)
• Vascular disorders: Blood clot formation with flushing into the vessels (thromboembolic events, venous and arterial thrombosis), Increase of blood pressure (Hypertension), Flushing
• Respiratory, Thoracic, and Mediastinal disorders: Obstruction of the pulmonary artery (Pulmonary embolism), Constriction of the air passages (Bronchospasm), Wheezing, Cough, Breathlessness (Dyspnoea)
• Gastrointestinal disorders: Vomiting, Diarrhoea, stomach discomfort, Feeling of sickness (Nausea)
• Skin and subcutaneous tissue disorders: Feeling of numbness in the face, Swelling of face, tongue and lips (Angioedema), Nettle - rash on the entire body (Urticaria), Itching (Pruritus)
• General disorders and complaints at the injection site: Pain at injection site, general feeling of being unwell, feeling hot, chills, fever, chest pain, chest discomfort
• Investigations: Drop in blood pressure, increased levels of fibrin D - dimer in blood

Rapid intravenous infusion can cause stabbing pain and a sensation of numbness in face and limbs, as well as a decrease in blood pressure. Myocardial infarctions (heart attack) were observed after the administration of doses above the maximum daily dose and/or prolonged application and/or the presence of risk factors for thromboembolism.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or health care provider. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. Additionally, suspected adverse reactions can be reported to [email protected] or on the 24 hours contact number: 082 525 3040. By reporting side effects, you can help provide more information on the safety of this.

Store all medicines out of reach of children. Store at or below 25 °C. Do not freeze. Discard if frozen. Store in the original package in order to protect from light. FEIBA must not be used beyond the expiry date indicated. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.