Qarziba 4.5 mg/mL concentrate for solution for infusion

Qarziba 4.5 mg/mL concentrate for solution for infusion

dinutuximab beta

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Qarziba contains dinutuximab beta, which belongs to a group of medicines called ‘monoclonal antibodies’. These are proteins, which specifically recognise and bind to other unique proteins in the body. Dinutuximab beta binds to the molecule known as disialoganglioside 2 (GD2), which is present on cancer cells, and this activates the body’s immune system, causing it to attack the cancer cells.

Qarziba is used to treat neuroblastoma that has a high risk of coming back after a series of treatments, which include a stem cell transplantation for rebuilding the immune system. It is also used to treat neuroblastoma that has come back (relapsed) or could not be completely treated with previous therapies.

Prior to the treatment of relapsed neuroblastoma, your treating physician will stabilise any actively progressing disease by other suitable measures.

Your doctor will further decide whether the co-administration of a second medicine, interleukin-2, is necessary for the treatment of your cancer.

Neuroblastoma is a type of cancer that grows from abnormal nerve cells in the body, in particular in the glands above the kidneys. It is one of the most common cancers in infancy.

It is used for patients aged 12 months and above.

A doctor experienced in the use of medicines to treat cancer will supervise your treatment. It will be given to you by a doctor or nurse while you are in hospital. It is given into one of your veins (intravenous infusion) usually by using special tubes (catheters) and a pump. During and after the infusion, you will be checked regularly for infusion-related side effects.

Qarziba will be given to you in five treatment courses of 35 days and the infusion will last 5 or 10 days in the beginning of each course. The recommended dose is 100 mg dinutuximab beta per square metre of body surface per treatment course. The doctor will calculate your body surface area from your height and weight.

If your doctor considers co-administration of interleukin-2, it will be given twice, by injection under the skin, each time for 5 consecutive days (before and during treatment with Qarziba).

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you have any of the following:

Very common (may affect more than 1 in 10 people):

• rapid swelling of arms, legs and other body parts, rapid drop in blood pressure, light-headedness and breathing difficulties (capillary leak syndrome)
• pain in the stomach, throat, chest, face, hands, feet, legs, arms, back, neck, joint, or muscles
• allergic reactions and cytokine release syndrome with symptoms such as face or throat swelling, breathing difficulties, dizziness, hives, rapid or noticeable heartbeat, low blood pressure, hives, rash, fever, or nausea

Other side effects and their frequencies include:

Very common (may affect more than 1 in 10 people):

• fever, chills
• vomiting, diarrhoea, constipation
• inflammation of the mouth and lips (stomatitis)
• cough
• itching, rash
• low blood pressure, increased heartbeat
• oxygen deficiency
• tissue swelling (in the face, lip, around the eye, in the lower limbs)
• increased weight
• infection, in particular infection associated with the catheter that delivers the medicine
• headache
• dilated pupils or abnormal pupil reactions
• abnormal blood or urine tests (blood cells and other components, liver function, renal function)

Common (may affect up to 1 in 10 people):

• life-threatening infection (sepsis)
• fits
• agitation, anxiety
• nerve disorder in the arms and/or legs (with abnormal sensations or weakness), light-headedness, trembling, muscle spasms
• paralysis of eye muscles, blurred vision, light sensitivity, swelling in the retina
• high blood pressure
• cardiac failure, fluid around the heart
• respiratory failure, fluid in the lungs
• sudden constriction of the airways (bronchospasm, laryngospasm), rapid breathing
• decreased appetite, nausea, abdominal distension, accumulation of fluid in the abdominal cavity
• injection-site reactions, skin problems such as reddening, dry skin, eczema, excessive sweating, reaction to light
• unable to pass urine or passing reduced urine volume
• decreased weight, loss of fluids (dehydration)

Uncommon (may affect up to 1 in 100 people):

• shock due to decreased body fluid volume
• formation of blood clots in the small blood vessels (disseminated intravascular coagulation)
• a type of allergy (serum sickness) with fever, rash, joint inflammation
• a brain disorder characterised by headache, confusion, seizures and loss of vision (posterior reversible encephalopathy syndrome)
• inflammation of the intestine, injury to the liver
• kidney failure
• a condition in which some of the small veins in the liver are obstructed (veno-occlusive disease)

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

• extreme tiredness and shortness of breath (which may be due to a low number of red blood cells), bleeding and bruising (which may be due to a low number of blood platelets) and kidney disease where you pass little or no urine (atypical haemolytic uraemic syndrome)

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 label and the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8 °C). Keep the vial in the outer carton in order to protect from light.

Once opened, Qarziba is intended for immediate use.

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