Hizentra Special Precautions

Route of administration: Hizentra is for subcutaneous use only. Hizentra must not be given intravascularly. If Hizentra is accidentally administered into a blood vessel, patients could develop shock.
The recommended infusion rate given in Infusion rate under Dosage & Administration should be adhered to. Patients should be closely monitored during their first supervised infusions with regard to any adverse events during the infusion period and for at least 20 minutes thereafter.
Hypersensitivity/Anaphylaxis: True allergic reactions are rare. They can particularly occur in patients with anti-IgA antibodies who should be treated with particular caution. Patients with anti-IgA antibodies, in whom treatment with subcutaneous IgG products remains the only option, should be switched to Hizentra only under close medical supervision.
Rarely, human immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human immunoglobulin.
Certain adverse reactions may occur more frequently in patients who receive human immunoglobulin for the first time or, in rare cases, when the human immunoglobulin product is switched or when treatment has been stopped for more than eight weeks.
Potential complications can often be avoided by ensuring that patients: are not sensitive to human immunoglobulin, by initially injecting the product slowly (≤ 15 ml/hour/site); are carefully monitored for any symptoms throughout the infusion period and for at least 20 minutes after administration. In particular, patients naive to human immunoglobulin, patients switched from an alternative product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment should be administered.
Thromboembolism: Arterial and venous thromboembolic events such as myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been associated with the use of immunoglobulins. Particular caution should be therefore exercised in patients with pre-existing risk factors for thrombotic events such as advanced age, oestrogen use, in-dwelling vascular catheters, history of vascular disease or thrombotic episodes, cardiovascular risk factors (including history of atherosclerosis and/or impaired cardiac output), acquired or inherited hypercoagulable states, prolonged periods of immobilization, severe hypovolemia, and diseases which increase blood viscosity.
Patients should be informed about first symptoms of thromboembolic events including shortness of breath, chest pain, pain and swelling of limbs, focal neurological deficits and should be advised to contact their physician immediately upon onset of symptoms. Patients should be sufficiently hydrated before use of immunoglobulins.
Aseptic Meningitis Syndrome (AMS): AMS cases have occurred with use of intravenous or subcutaneous immunoglobulin. The syndrome usually begins within several hours to 2 days following immune globulin treatment. AMS is characterised by the following signs and symptoms: severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting. Patients exhibiting signs and symptoms of AMS should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis. Discontinuation of immunoglobulin treatment may result in remission of AMS within several days without sequelae.
Information on safety with respect to transmissible agents: Hizentra is made from human plasma. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses (see Pharmacology under Actions). 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 or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
It is recommended that every time Hizentra is administered to a patient, the name and batch number of the medicinal product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Effects on ability to drive and use machines: There is no indication that immunoglobulins adversely affect the ability to drive or to use machines.