Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Interferon gamma-1b may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
IMMUKIN contains a substance called recombinant human interferon gamma-1b. Interferons are socalled immunomodulators. These are small proteins that can stimulate the body's immune system defences. They protect against micro-organisms (e.g. bacteria, viruses and fungi) that can cause diseases. IMMUKIN is for use by patients with chronic granulomatous disease (CGD). CGD is a defect in the metabolism of neutrophils, a type of white blood cell. These normally kill invading bacteria or fungi. The defect with CGD makes neutrophils less able to prevent infections. IMMUKIN is used to reduce the number of serious infections that may occur with this disease. IMMUKIN is also used in patients with severe, progressive marble bone disease (osteopetrosis). This is an inherited defect in bone cells, which leads to excessive, abnormal bone growth. It also affects the bone marrow and the blood cells that are usually formed in it. As a result, patients with osteopetrosis are also at risk of serious infections. 2.
e IMMUKIN
Do not use IMMUKIN • if you are allergic to interferon gamma or to other related interferons or any of the other ingredients of this medicine (listed in section 6). Ask your doctor or pharmacist if you are unsure about whether you are allergic to interferons. Warnings and precautions Talk to you doctor or pharmacist before using IMMUKIN. Take special care with IMMUKIN 1
• • • • • •
if you have heart disease, because higher than usual doses can make your heart condition worse (see section 3 for dosage information) if you have seizure disorder and/or compromised central nervous system function if your liver does not function as effectively as normal (hepatic insufficiency) if your kidneys do not function as effectively as normal (renal insufficiency) if your bone marrow does not produce as many blood cells as normal (myelosuppression) if you are allergic to Latex, because the stopper of the glass vial contains natural rubber (a derivative of latex) which may cause allergic reactions.
Consult your doctor if one of the warnings above applies to you now or if it did in the past. You should avoid using IMMUKIN at the same time as other types of protein-based medicines. You should also avoid taking IMMUKIN at the same time as you are given a vaccine. If you have any questions about this, ask your doctor. You should continue to have the tests used in the management of CGD and severe, progressive osteopetrosis. Your blood count, urine, kidney and liver function should be carefully checked, both before and during the treatment. High interferon gamma-1b levels in the body may possibly harm the fertility of men and women. Other medicines and IMMUKIN Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may also require antibiotics to treat infections that still occur while you are taking IMMUKIN for the treatment of CGD. There is no evidence that IMMUKIN affects the efficacy of antibiotics or corticosteroids, commonly used medications in CGD and severe, malignant osteopetrosis patients. Medicines that affect the liver or the kidneys may affect the excretion of IMMUKIN from the body. It is possible that IMMUKIN might prolong the activity of other medicines that are broken down and removed from the body by the liver. If you use IMMUKIN at the same time as medicines or vaccines that have effects upon the heart, blood, bone marrow, nervous system or immune system, the risk of side effects may be increased. Pregnancy, breast-feeding and fertility If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Based on the information available, effects on fertility are not known but cannot be excluded. You should not use IMMUKIN during pregnancy, unless your doctor thinks it is essential. You are recommended not to breast-feed while using IMMUKIN. Ask your doctor or pharmacist for advice before using any medicine. Driving and using machines IMMUKIN can cause fatigue, fits (seizures), confusion, disorientation or distorted or imaginary sensations (hallucinations). These side effects can reduce the ability to respond and can thus have a negative effect upon the ability to drive and use machines. Do not drive or use machines if you realise reduced responsiveness. IMMUKIN contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml vial, i.e. it is 'sodiumfree'. This may be important for people with high blood pressure and others wishing to maintain a low sodium diet.
IMMUKIN
2
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. IMMUKIN is for injection under the skin (subcutaneous use) and can be administered by a doctor or nurse. You or a family member could also administer IMMUKIN. You or your family member should be trained by a doctor or nurse in giving this type of injection. The recommended dosage of IMMUKIN for the treatment of patients with CGD or severe, malignant osteopetrosis is 50 mcg/m2 for patients whose body surface area is greater than 0.5 m2 and 1.5 mcg/kg for patients whose body surface area is equal to or less than 0.5 m2. Your doctor will decide how much IMMUKIN you need to take to treat CGD or severe, progressive osteopetrosis. You should inject (or should have injected) under your skin the exact amount of IMMUKIN your doctor has told you that you need. You should give the injections three times per week (for example, Monday, Wednesday and Friday), preferably in the evening. The recommended injection sites are the upper arm or the top of the thigh.
Do not use IMMUKIN if you can see small particles or discolouration of the solution.
•
Do not mix IMMUKIN with other medicines.
•
Do not strongly shake IMMUKIN vials.
If you use more IMMUKIN than you should Immediately consult your doctor if you have administered more IMMUKIN than your doctor has told you. Symptoms after having administered too much IMMUKIN can include the following: central nervous system side effects such as difficulty in thinking, difficulty in walking, and dizziness. if you have heart disease, this may get worse for a short time. blood disorders can occur during treatment with IMMUKIN. These include:
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The risk of side effects occurring depends on the dose and the dosing schedule you have been given. The most common side effects are flu-like symptoms such as fever, headache, cold chills, and fatigue. 3
These may become less severe over time as the treatment is continued. Some of these symptoms can be reduced by administering IMMUKIN just before going to sleep. A medicine such as paracetamol can be used to reduce some of these side effects. Some people who take IMMUKIN may develop short-term skin problems, such as a temporary skin rash, spotty skin rash, the sudden formation of blisters on the skin, and reddening of the skin at the injection site. However, these are rarely severe enough to stop treatment with IMMUKIN. The side effects listed below are grouped by how likely they are to happen. Very common side effects (more than 1 in 10 patients treated) are:
have also been seen in patients with conditions other than CGD or malignant osteopetrosis. These events have not been seen in clinical trials involving CGD or osteopetrosis. The following side effects have been reported in clinical trials with patients suffering from other diseases/conditions than CGD or osteopetrosis. Often the doses used in these studies were higher than the recommended dose for CGD and osteopetrosis. For this reason it is not possible to say accurately how often they occurred. Not known (cannot be estimated from the available data): –
low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits or coma (hyponatraemia) high levels of a sugar called glucose (hyperglycaemia) fatty acids called triglycerides (hypertriglyceridaemia) in the blood
The following nervous system disorders have been observed:
bleeding in the digestive system inflammation of the pancreas, which can lead to death damage to the liver that affects its function (liver failure) damage to the kidneys that affect their function but can be treated effectively (reversible kidney failure) pains in the chest worsening of a skin condition called dermatomyositis (seen as a skin rash accompanying muscle weakness) development of the long-term disease called systemic lupus erythematosus (i.e. the patient's own immune system attacks various parts of the body) autoimmune reaction (Autoantibody response)
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
IMMUKIN
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and vial, after `EXP ́. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze. IMMUKIN solution for injection vials are for single use only. IMMUKIN contains no preservatives. Once opened, you should use the contents of a vial immediately. Dispose of any unused contents of the vial. Do not use this medicine if you notice particles or discolouration in it before use.
5
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. 6.
What IMMUKIN contains –
The active substance is recombinant human interferon gamma-1b. Each vial (0.5 ml) contains 2 x 106 IU (0.1 mg) recombinant human interferon gamma-1b. This is a substance produced using E. coli bacteria modified by gene technology.
–
The other ingredients are D-mannitol, disodium succinate hexahydrate, polysorbate 20, succinic acid and water for injections.
The stopper of the glass vial contains natural rubber (a derivative of latex). What IMMUKIN looks like and contents of the pack IMMUKIN is a clear, colourless solution for injection. IMMUKIN is available in 4 ml vials containing 0.5 ml solution for injection. Pack sizes: 1, 3, 5, 6 and 12 vial(s) in one folding box. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Clinigen Healthcare Limited Pitcairn House Crown Square, First Avenue Burton‐on‐Trent Staffordshire DE14 2WW United Kingdom Manufacturer Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk Co. Louth A91 P9KD Ireland Alternatively: Almac Pharma Services Limited Almac House 20 Seagoe Industrial Estate Craigavon BT63 5QD Northern Ireland, United Kingdom This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom under the following names: 6
Austria, France, Germany, Italy, Norway, Spain
IMUKIN
Netherlands
Immukine
United Kingdom
Immukin
This leaflet was last approved in 09/2022.
7
IMMUKIN 2 x 106 IU (0.1 mg) solution for injection comes as injection containing 106iu / 0.1mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in IMMUKIN 2 x 106 IU (0.1 mg) solution for injection is interferon gamma-1b.
This leaflet reproduces the patient information leaflet approved for IMMUKIN 2 x 106 IU (0.1 mg) solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
IMMUKIN is indicated for the reduction of the frequency of serious infections in patients with chronic granulomatous disease (CGD) (see also section 4.4).
IMMUKIN is indicated for the reduction in frequency of serious infections in patients with severe, malignant osteopetrosis (see also section 4.4 and 5.1).
Posology
The recommended dosage of IMMUKIN for the treatment of patients with CGD or severe, malignant osteopetrosis is 50 mcg / m2 for patients whose body surface area is greater than 0.5 m2 and 1.5 mcg / kg / dose for patients whose body surface area is equal to or less than 0.5 m2. The actually drawn volume has to be controlled before injection. Injections should be administered subcutaneously preferably in the evening three times weekly (for example, Monday, Wednesday, Friday). The optimum sites of injection are the right and the left deltoid and anterior thigh. IMMUKIN can be administered by a physician, nurse, family member or patient when trained in the administration of subcutaneous injections.
Although the most beneficial dose of IMMUKIN is not known yet higher doses are not recommended. Safety and efficacy has not been established for IMMUKIN given in doses greater or less than the recommended dose of 50 mcg / m2. If severe reactions occur, the dosage should be modified (50 % reduction) or therapy should be discontinued until the adverse reaction abates.
Paediatric population
The experience in children is limited (see sections 4.4 and 5.1)
Method of administration
IMMUKIN is for subcutaneous use.
Hypersensitivity to the active substance (interferon gamma-1b) or known hypersensitivity to closely related interferons or to any of the excipients listed in section 6.1.
The use of IMMUKIN does not exclude the need for any additional antimicrobial coverage that might be required for the management of CGD. In the pivotal clinical efficacy study the overwhelming majority of the patients were receiving prophylactic antimicrobial therapy (see section 5.1).
Patients with pre-existing cardiac disease may experience an acute, self-limiting exacerbation of their cardiac condition at doses of 250 mcg / m2 / day or higher, as observed in early clinical trials, although no direct cardiotoxic effect has been demonstrated.
Caution should be exercised when treating patients with known seizure disorders and/or compromised central nervous system function.
Patients with serious hepatic insufficiency and patients with severe renal insufficiency should be treated with caution since the possibility of interferon gamma-1b accumulation exists in those patients.
Elevations of AST and /or ALT (up to 25-fold) have been observed during IMMUKIN therapy. The incidence appeared to be higher in patients less than 1 year of age compared to older children with 6 out of 10 developing elevated enzyme levels. In one case this occurred as early as 7 days after starting therapy. Treatment with IMMUKIN was interrupted in all 6 of these patients and restarted at a reduced dosage in 4. Liver transaminase values returned to baseline in all patients and did not recur with rechallenge except in one patient. Caution should be especially observed in patients with hepatic insufficiency.
Reversible neutropenia and thrombocytopenia that can be severe and may be dose related have been observed during IMMUKIN therapy. Caution should be exercised when administering IMMUKIN to patients with myelosuppression.
Simultaneous administration of interferon gamma-1b with other heterologous serum protein preparations or immunological preparations (e.g. vaccines) should be avoided because of the risk for unexpected amplified immune response (see section 4.5).
In addition to tests normally required for monitoring patients with CGD or severe, malignant osteopetrosis, patients should have performed the following tests before beginning IMMUKIN therapy and at appropriate periods during treatment: haematologic tests, including complete blood counts, differential and platelet counts; blood chemistries, including renal and liver function tests; urinalysis.
Interferon gamma-1b is an exogenous protein, which may lead to the occurrence of antibodies during the course of treatment. Up to now IMMUKIN administered to CGD or severe, malignant osteopetrosis patients in the recommended dose does not seem to be associated with significant risk for the induction of neutralising antibodies to interferon gamma-1b.
The stopper of the glass vial with IMMUKIN contains natural rubber (a derivative of latex) which may cause allergic reactions.
Based on the information available it cannot be excluded that the presence of higher levels of interferon gamma-1b may impair male and female fertility (see section 4.6).
IMMUKIN does not reduce the efficacy of antibiotics or glucocorticoids in CGD or severe, malignant osteopetrosis patients.
Drug interactions seen with IMMUKIN are similar to those seen with other interferons in animal experiments.
It is theoretically possible that hepatotoxic and/or nephrotoxic drugs might have effects on the clearance of IMMUKIN. Also the effects of anti-inflammatory drugs, NSAIDs, theophylline, immunosuppressive and cytostatic drugs on the acute cellular effects of IMMUKIN and its therapeutic effects in CGD or severe, malignant osteopetrosis patients when such drugs are used concomitantly in chronic conditions are not known. The concomitant administration of heterologous serum protein preparations or immunological preparations (e.g. vaccines) may increase the immunogenicity of IMMUKIN (see section 4.4).
IMMUKIN potentially can prolong the half-lives of simultaneously administered drugs, which are metabolised by the cytochrome P-450 system.
Concurrent use of drugs having neurotoxic (including effects on the central nervous system), haemotoxic, myelosuppressive or cardiotoxic effects may increase the toxicity of interferons in these systems.
Paediatric population
Interaction studies have only been performed in adults.
Pregnancy
There are no adequate data from the use of interferon gamma-1b in pregnant women. Higher levels of endogenous interferon gamma were found in women with recurrent first trimester miscarriage compared to women with normal pregnancy. There is no evidence of any clinical relevance for IMMUKIN.
Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. IMMUKIN should not be used during pregnancy unless vitally indicated.
Breastfeeding
It is not known whether interferon gamma-1b is excreted in human milk. Because of the lack of data on neonatal effects, breastfeeding is not recommended.
Fertility
Based on the information available it cannot be excluded that the presence of higher levels of interferon gamma-1b may impair male and female fertility. Studies in animals have shown an impact on male fertility at dose levels which are considered not relevant for human use (see section 5.3). In younger patients the long-term effect on fertility is also not known.
No studies on the effect on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as fatigue, convulsion, confusional state, disorientation or hallucination during treatment. Therefore, caution should be recommended when driving a car or operating machinery.
If patients experience any of these events, they should avoid potentially hazardous tasks such as driving or operating machinery.
a) General Description
The clinical and laboratory toxicity associated with multiple-dose IMMUKIN therapy is dose- and schedule-dependent.
The most common adverse events are flu-like symptoms characterised by fever, headache, chills, myalgia or fatigue.
b) Table of Adverse Reactions
Adverse reactions have been ranked under headings of frequency using 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)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and lymphatic system disorders
Not known:
Neutropenia#, thrombocytopenia#
Metabolism and nutrition disorders
Not known:
Hyponatraemia*, hyperglycaemia*, hypertriglyceridaemia*
Psychiatric disorders
Common:
Depression
Not known:
Confusional state*, disorientation*, hallucination*
Nervous system disorders
Not known:
Convulsion*, Parkinsonian gait*, Parkinsonian rest tremor*, gait disturbance*
Cardiac disorders
Not known:
Cardiac failure*, myocardial infarction*, tachyarrhythmia*, atrioventricular block*
Vascular disorders
Not known:
Transient ischemic attack*, deep vein thrombosis*, pulmonary embolism*, hypotension*, syncope*
Respiratory, thoracic and mediastinal disorders
Not known:
Interstitial lung disease*, bronchospasm*, tachypnoea*
Gastrointestinal disorders
Very common:
Nausea, vomiting, diarrhoea
Common:
Abdominal pain
Not known:
Pancreatitis (including fatal outcome)*, gastrointestinal haemorrhage*
Hepatobiliary disorders
Very common:
Hepatic enzymes increased+
Not known:
Hepatic failure*
Skin and subcutaneous tissue disorders
Very common:
Rash
Not known:
(exacerbation of) Dermatomyositis*
Musculoskeletal and connective tissue disorders
Common:
Myalgia, arthralgia, back pain
Not known:
Systemic lupus erythematosus*
Renal and urinary disorders
Not known:
(reversible) Renal failure*, proteinuria#
General disorders and administration site conditions
Very common:
Fever, headache, chills fatigue, injection site pain
Not known:
Chest discomfort*
Investigations
Not known:
Autoantibody positive*
# Cannot be estimated from the available data
+ Frequency higher in placebo group than in verum group
* Undesirable effects seen in clinical trials of conditions other than the registered indications CGD and osteopetrosis. In these trials interferon gamma-1b was usually administered at higher doses than recommended for the registered indications (see also section 4.9) Since these events have not been seen in clinical trials involving CGD or osteopetrosis but are reported in trials of patients with very diverse indications and health statuses, it is not possible to provide meaningful frequencies.
c) Information Characterising Individual Serious and/or Frequently Occurring Adverse Reactions
The flu-like symptoms may decrease in severity as treatment continues. Some of these symptoms can be minimised by bedtime administration. Acetaminophen (paracetamol) may also be used to ameliorate these effects. Vomiting, nausea, arthralgia and injection site tenderness have been reported in some patients.
Transient cutaneous rashes, e.g. dermatitis, maculopapular rash, pustular and vesicular eruptions, and erythema at injection site have occurred in some patients following injection but have rarely necessitated treatment interruption.
The inclusion of autoantibody production and systemic lupus erythematosus is the result of case reports in the literature. The adverse reaction “confusion” is also in the literature as a case report.
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
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
IMMUKIN has been administered at higher doses (>100 mcg / m2) to patients with advanced malignancies by the intravenous or intramuscular route.
Central nervous system adverse reactions including decreased mental status, gait disturbance and dizziness have been observed, particularly in cancer patients receiving doses greater than 100 mcg / m2 / day. These abnormalities were reversible within a few days upon dose reduction or discontinuation of therapy.
Blood disorders including reversible neutropenia and thrombocytopenia as well as the onset of increased hepatic enzymes and of triglycerides have also been observed.
Patients with pre-existing cardiac disease may experience an acute, self-limited exacerbation of their cardiac condition at doses of 250 mcg / m2 / day or higher, as observed in early clinical trials, although no direct cardiotoxic effect has been demonstrated.
Further undesirable effects which may occur as a consequence of overdosing as observed in respective clinical trials in other than the registered indications are outlined in section 4.8 above.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about IMMUKIN 2 x 106 IU (0.1 mg) solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.