OCTAPLASLG Solution for infusion Ref.[27958] Active ingredients: Human plasma protein fraction

OctaplasLG should not be used:

• As a volume expander.
• In cases of bleeding caused by coagulation factor deficiencies where a specific factor concentrate is available for use.
• To correct hyperfibrinolysis in liver transplantation or other conditions with complex disturbances of haemostasis caused by a deficiency of plasmin inhibitor, also named α2-antiplasmin.

OctaplasLG should be used with caution under the following conditions:

• IgA deficiency.
• Plasma protein allergy.
• Previous reactions to fresh-frozen plasma (FFP) or octaplasLG.
• Manifest or latent cardiac decompensation.
• Pulmonary oedema.

In order to reduce the risk for venous thromboembolism caused by the reduced protein S activity of octaplasLG compared to normal plasma (see section 5.1), caution should be exercised and appropriate measures should be considered in all patients at risk for thrombotic complications.

In intensive plasma exchange procedures, octaplasLG should only be used to correct the coagulation abnormality when abnormal haemorrhage occurs.

Viral safety

Standard measures to prevent infections resulting from the use of medical products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pool for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown and emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV, and HCV. The measures taken may be of limited value against non-enveloped virus such as HAV, HEV and Parvovirus B19.

Parvovirus B19 infection may be serious for pregnant woman (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia). HEV may also seriously affect seronegative pregnant women. Therefore octaplasLG should only be administered to these patients if strongly indicated.

Appropriate vaccination (e.g. against HBV and HAV) for patients in regular receipt of medicinal products derived from human blood or plasma should be considered.

Additionally, a step to remove prions is incorporated.

It is strongly recommended that every time that octaplasLG is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Blood group-specific administration

Administration of octaplasLG must be based on ABO-blood group specificity. In emergency cases, octaplasLG blood group AB can be regarded as universal plasma since it can be given to all patients regardless of blood group.

Patients should be observed for at least 20 minutes after the administration.

Anaphylactic reactions

In case of anaphylactic reaction or shock, the infusion must be stopped immediately. Treatment should follow the guidelines for shock therapy.

Traceability

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

Paediatric population

Some cases of hypocalcaemia, possibly caused by citrate binding, have been observed during therapeutic plasma exchange in the paediatric population (see section 4.8). Monitoring of ionized calcium is recommended during such use of octaplasLG.

Interference with serological testing

Passive transmission of plasma components from octaplasLG (e.g. β-human chorionic gonadotropin; β-HCG) may result in misleading laboratory results in the recipient. For example, a false-positive pregnancy test result has been reported following passive transmission of β-HCG.

This medicinal product contains maximum 920 mg sodium per bag, equivalent to maximum 46% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Interactions

No interactions with other drugs have been identified.

Incompatibilities

• octaplasLG product can be mixed with red blood cells and platelets if ABO compatibility of both preparations is respected.
• octaplasLG must not be mixed with other medicinal products, as inactivation and precipitation may occur.
• To avoid the possibility of clot formation, solutions containing calcium must not be administered by the same intravenous line as octaplasLG.

The safety of octaplasLG for use in human pregnancy has not been established in controlled clinical trials. It is not known whether octaplasLG can affect reproduction capacity. The product should be administered to a pregnant or lactating woman only if alternative therapies are regarded inappropriate.

For potential risk of Parvovirus B19 and HEV transmission, see section 4.4.

After ambulant infusion, the patient should rest for one hour.

OctaplasLG has no or negligible influence on the ability to drive and use machines.

Hypersensitivity reactions may rarely be observed. These are usually mild allergic type reactions consisting of localised or generalised urticaria, erythema, flushing and pruritus. More severe forms can be complicated by hypotension or angioedema of the face or larynx. If other organ systems – cardiovascular, respiratory or gastrointestinal – are involved, the reaction would be considered anaphylactic or anaphylactoid. Anaphylactic reactions may have a rapid onset and may be serious; the symptom complex may include hypotension, tachycardia, bronchospasm, wheezing, coughing, dyspnoea, nausea, vomiting, diarrhoea, abdominal or back pain. Severe reactions may proceed to shock, syncope, respiratory failure and very rarely even death.

High infusion rates may rarely cause cardiovascular effects as a result of citrate toxicity (fall in ionised calcium), especially in patients with liver function disorders. In the course of plasma exchange procedures, symptoms attributable to citrate toxicity such as fatigue, paraesthesia, tremor, and hypocalcemia may be observed rarely.

During clinical trials with octaplasLG’s predecessor product, and its post-approval use, the following adverse reactions have been identified:

Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Table 1. Adverse reactions that have been identified for octaplasLG:

^* This table contains MedDRA Preferred Terms (PTs) unless indicated otherwise.

LLT, MedDRA Lowest Level Term

Paediatric population

In the course of plasma exchange procedures hypocalcemia may be observed in the paediatric population especially in patients with liver function disorders or in case of high infusion rates. Monitoring of ionized calcium (see section 4.4) is recommended during such use of octaplasLG (see section 4.2).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

• OctaplasLG product can be mixed with red blood cells and platelets if ABO compatibility of both preparations is respected.
• OctaplasLG must not be mixed with other medicinal products, as inactivation and precipitation may occur.
• To avoid the possibility of clot formation, solutions containing calcium must not be administered by the same intravenous line as octaplasLG.