Immunoglobulins, normal human, IV interacts in the following cases:
Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella. After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year. Therefore patients receiving measles vaccine should have their antibody status checked.
Avoidance of concomitant use of loop diuretics.
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore it should only be given with caution to pregnant women. IVIg products have been shown to cross the placenta, increasingly during the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry. No negative effects on the breastfed newborn/infants are anticipated.
Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
The ability to drive and operate machines may be impaired by some adverse reactions associated with human normal immunoglobulin. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions (including cutaneous lupus erythematosus – frequency unknown) have been observed with human normal immunoglobulin. Reversible haemolytic reactions have been observed in patients, especially those with blood groups A, B, and AB. Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment).
Increase in serum creatinine level and/or acute renal failure have been observed.
Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thromboses.
Cases of Transfusion Related Acute Lung Injury (TRALI).
The tables presented below are according to the MedDRA system organ classification (SOC and Preferred Term Level). Table 1 shows the adverse reactions from clinical trials and Table 2 shows the post-marketing ARs.
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 available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1. Frequency of Adverse Reactions (ADRs) in clinical studies with human normal immunoglobulin (IVIg):
| MedDRA System Organ Class (SOC) | Adverse reaction | Frequency |
|---|---|---|
| Infections and infestations | Bronchitis, nasopharyngitis | Common |
| Chronic sinusitis, fungal infection, infection, kidney infection, sinusitis, upper respiratory tract infection, urinary tract infection, bacterial urinary tract infection, meningitis aseptic | Uncommon | |
| Blood and lymphatic system disorders | Anaemia, lymphadenopathy | Common |
| Immune system disorders | Hypersensitivity, anaphylactic reaction | Uncommon |
| Endocrine disorders | Thyroid disorder | Uncommon |
| Metabolism and nutrition disorders | Decreased appetite | Common |
| Psychiatric disorders | Insomnia, anxiety | Common |
| Irritability | Uncommon | |
| Nervous system disorders | Headache | Very common |
| Dizziness, migraine, paresthesia, hypoesthesia | Common | |
| Amnesia, dysarthria, dysgeusia, balance disorder, tremor | Uncommon | |
| Eye disorders | Conjunctivitis | Common |
| Eye pain, eye swelling | Uncommon | |
| Ear and labyrinth disorders | Vertigo, fluid in middle ear | Uncommon |
| Cardiac disorders | Tachycardia | Common |
| Vascular disorders | Hypertension | Very common |
| Flushing | Common | |
| Peripheral coldness, phlebitis | Uncommon | |
| Respiratory, thoracic and mediastinal disorders | Cough, rhinorrhoea, asthma, nasal congestion, oropharyngeal pain, dyspnea | Common |
| Oropharyngeal swelling | Uncommon | |
| Gastrointestinal disorders | Nausea | Very common |
| Diarrhoea, vomiting, abdominal pain, dyspepsia | Common | |
| Abdominal distension | Uncommon | |
| Skin and subcutaneous tissue disorders | Rash | Very common |
| Contusion, pruritus, urticaria, dermatitis, erythema | Common | |
| Angioedema, acute urticaria, cold sweat, photosensitivity reaction, night sweats, hyperhidrosis | Uncommon | |
| Musculoskeletal and connective tissue disorders | Back pain, arthralgia, pain in extremity, myalgia, muscle spasms, muscular weakness | Common |
| Muscle twitching | Uncommon | |
| Renal and urinary disorders | Proteinuria | Uncommon |
| General disorders and administration site conditions | Local reactions (e.g. infusion site pain/swelling/reaction/pruritus), pyrexia, fatigue | Very common |
| Chills, edema, influenza-like illness, chest discomfort, chest pain, asthenia, malaise, rigors | Common | |
| Chest tightness, feeling hot, burning sensation, swelling | Uncommon | |
| Investigations | Blood cholesterol increased, blood creatinine increased, blood urea increased, white blood cell count decreased, alanine aminotransferase increased, haematocrit decreased, red blood cell count decreased, respiratory rate increased | Uncommon |
Table 2. Post-Marketing Adverse Reactions (ARs):
| MedDRA System Organ Class (SOC) | Adverse reaction | Frequency |
|---|---|---|
| Blood and lymphatic system disorders | Haemolysis | Not known |
| Immune system disorders | Anaphylactic shock | Not known |
| Nervous system disorders | Transient ischemic attack, cerebral vascular accident | Not known |
| Cardiac disorders | Myocardial infarction | Not known |
| Vascular disorders | Hypotension, deep vein thrombosis | Not known |
| Respiratory, thoracic and mediastinal disorders | Pulmonary embolism, pulmonary edema | Not known |
| Investigations | Coombs direct test positive, oxygen saturation decreased | Not known |
| Injury, poisoning and procedural complications | Transfusion-related acute lung injury | Not known |
Muscle twitching and weakness were reported only in patients with MMN.
Frequency, type and severity of adverse reactions in children are the same as in adults.
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