IMMUKIN 2 x 10⁶ IU (0.1 mg) solution for injection

Recombinant human interferon gamma-1b

IMMUKIN contains a substance called recombinant human interferon gamma-1b. Interferons are so-called 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.

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.

• Always check the amount of IMMUKIN solution before giving the injection.
• 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.

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.

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:

• fever
• headache
• chills
• pain at the injection site
• vomiting
• nausea (feeling sick)
• diarrhoea
• fatigue
• raised levels of liver enzymes
• rash

Common side effects (less than 1 in 10 patients treated) are:

• muscle pain
• joint aching or pain
• back pain
• stomach pain
• depression

Not known (cannot be estimated from the available data):

• shortage of white blood cells (neutropenia)
• shortage of blood platelets (thrombocytopenia) which might be associated with bruises and a tendency towards bleeding
• proteins in the urine

Side effects 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:

• confusion
• disorientation
• effects on ability to walk such as Parkinsonian gait
• trembling
• fits (seizures)
• distorted or imaginary sensations (hallucinations)

The following heart disorders have also been seen to occur:

• additional and irregular heart beats
• disturbance in the heart rate, such as faster or slower heart rate
• heart problems which can cause shortness of breath or ankle swelling (heart failure)
• heart attack

The following blood system disorders have been reported:

• low blood pressure
• fainting
• mild, temporary stroke (transient ischaemic attack)
• blood clot or blockage of a lung artery (deep venous thrombosis and pulmonary embolism); symptoms can include shortness of breath

The following respiratory disorders have occurred:

• rapid breathing
• chest tightness (bronchospasm or interstitial lung disease)

• 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)

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.

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.