4.5 mg / ml concentrate for solution for infusion dinutuximab
beta
What Qarziba is and what it is used for
Qarziba contains dinutuximab beta, which belongs to a group of medicines called “monoclonal antibodies”. These are proteins that you specifically recognize and bind to other unique proteins in your body. Dinutuximab beta binds to a molecule found on cancer cells called disialoganglioside 2 (GD2). This activates the body’s immune system so that it attacks the cancer cells.
Qarziba is used to treat neuroblastoma (a type of cancer) with a high risk of recurrence after a series of treatments, which include stem cell transplantation to rebuild the immune system. It is also used to treat recurrent neuroblastoma ( recurrence ) or which could not be completely treated with previous treatments.
Before treating a recurrence of neuroblastoma, the treating physician will stabilize the disease activity using other appropriate methods.
Your doctor will also decide if co-administration of a second drug, interleukin ‑2, is necessary to treat your cancer.
Neuroblastoma is a type of cancer that occurs in abnormal nerve cells in the body, especially in the glands above the kidneys. It is one of the most common cancers in children.
The drug is used in patients from 12 months of age.
What you need to know before using Qarziba
Do not use Qarziba
- if you are allergic to dinutuximab beta or any of the other ingredients of this medicine (listed in section 6)
- if you have acute severe (grade 3 or 4) or long-term extensive graft-versus-host disease this disease is a reaction in which the cells in the transplanted tissue attack the recipient’s cells.
Warnings and cautions
Before you receive Qarziba, you will be given blood tests to check the function of your liver, lungs, kidneys, and bone marrow.
You may notice any of the following when you start treatment with Qarziba and during treatment:
- maintain is one of the most common side effects of Qarziba. It usually occurs at the beginning of infusion one. Your doctor will therefore give you an appropriate pain relief treatment that starts 3 days before the start of treatment and continues while you are using Qarziba.
- allergic reactions or other infusion-related reactions tell your doctor or nurse if you get any kind of reaction during or after infusion one, such as
- fever, tremors and/or low blood pressure,
- difficulty breathing,
- skin rash, or hives.
You will receive appropriate treatment to prevent these reactions and you will be closely monitored for these symptoms while receiving the infusion with Qarziba. - leakage from small blood vessels (capillary leakage syndrome)Leakage of blood components from the small blood vessels can lead to rapid swelling in the arms, legs, and other parts of the body. The rapid drop in blood pressure, dizziness, and difficulty breathing are other signs.
- eye problemsYou may notice vision changes.
- problems with the nerves you may notice numbness, tingling, or a burning sensation in your hands, feet, legs, or arms; impaired sensation or weakness in movement.
Tell your doctor immediately if you notice any of these symptoms.
Your doctor will take blood samples and possibly perform an eye examination while you are taking this medicine.
Children
This medicine should not be given to children under 12 months of age due to insufficient experience in this age group.
Other medicines and Qarziba
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Do not use medicines that inhibit the immune system from 2 weeks before the first dose of one with Qarziba and up to 1 week after the last course of treatment, unless prescribed by a doctor. Examples of drugs that inhibit the immune system are corticosteroids, which reduce inflammation or prevent the rejection of organ transplants.
Avoid vaccinations during treatment with Qarziba and 10 weeks thereafter.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Talk to your doctor before receiving Qarziba if you may have children (are of childbearing potential ). It is recommended to use contraception for 6 months after stopping treatment with Qarziba. You should only use Qarziba if your doctor considers that the benefits outweigh the risks to the fetus.
Tell your doctor if you are breastfeeding. You must not breastfeed during treatment with Qarziba and for 6 months after the last dose. It is not known if the drug can pass into breast milk.
Driving and using machines
Qarziba has several side effects that may affect your ability to drive and use machines. Do not perform these activities if your ability to concentrate and react has been affected.
How to use Qarziba
A doctor with experience in the use of cancer drugs will monitor your treatment. The medicine will be given by a doctor or nurse during your hospital stay. It is given into a vein ( intravenous infusion ), usually with the help of special tubes (catheters) and a pump. During and after the infusion, you will be checked regularly to see if you get any infusion-related side effects.
Qarziba will be given through five treatment courses of 35 days and the infusions will last for 5 or 10 days at the beginning of each course. The recommended dose is 100 mg dinutuximab beta per square meter of body surface area for each treatment regimen. Your doctor will calculate your body surface area using your height and weight.
If your doctor is considering co-administration of interleukin ‑2, it will be given twice, as an injection under the skin, each time for 5 consecutive days (before and during treatment with Qarziba).
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to a doctor or nurse immediately if you get any of the following:
Very common (may affect more than 1 user in 10):
- rapid swelling in arms, legs, and other parts of the body; rapid drop in blood pressure; dizziness and difficulty breathing (capillary leakage syndrome)
- pain in the abdomen, neck, chest, face, hands, feet, legs, arms, back, neck, joints, or muscles
- allergic reactions and cytokine release syndrome with symptoms such as swelling of the face or throat, difficulty breathing, dizziness, hives, rapid or noticeable heartbeat, low blood pressure, hives, rash, fever, or nausea.
Other side effects include their frequency:
Very common (may affect more than 1 user in 10):
- fever, chills
- vomiting, diarrhea, constipation
- inflammation of the mouth and lips ( stomatitis )
- cough
- itching, rash
- low blood pressure, faster heartbeat
- acid deficiency
- swelling of tissue (in the face, lips, around the eye, in the legs)
- weight gain
- infection, especially infection associated with the use of the catheter delivering the drug
- headache
- dilated pupil er or abnormal pupil reactions
- abnormal blood or urine levels ( blood cells and other components, liver function, kidney function)
Common (may affect up to 1 in 10 people):
- life-threatening infection (blood poisoning)
- seizures
- anxiety ( agitation ), anxiety
- nerve disorders in the arms and/or legs (with abnormal sensations or weakness), dizziness, tremors, muscle cramps
- paralysis of the eye muscles, blurred vision, photosensitivity, swelling of the retina
- high blood pressure
- heart failure, fluid accumulation around the heart
- impaired respiratory function, fluid accumulation in the lungs
- sudden contraction of the airways ( bronchospasm, laryngospasm ), rapid breathing
- decreased appetite, nausea, swollen abdomen, fluid accumulation in the abdominal cavity
- injection site reactions, skin problems such as redness, dry skin, eczema, heavy sweating, reaction to light
- inability to urinate or decreased amount of urine
- weight loss, fluid loss (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, arthritis
- a brain disease characterized by headache, confusion, seizures, and loss of vision (posterior reversible encephalopathy syndrome)
- inflammation of the intestine, liver damage
- kidney failure
- a condition in which some of the small veins in the liver are blocked (veno-occlusive disease)
How to store Qarziba
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 carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Keep the vial in the outer carton. Sensitive to light.
After opening Qarziba, the product is intended for immediate use.
Contents of the pack and other information
Content declaration
- The active substance is dinutuximab beta.1 ml concentrate contains 4.5 mg dinutuximab beta. Each vial contains 20 mg dinutuximab beta in 4.5 ml.
- The other ingredients are histidine, sucrose, polysorbate 20, water for injections, and hydrochloric acid (for pH adjustment).
What the medicine looks like and the contents of the pack
Qarziba is a colorless or slightly yellowish liquid, supplied in a clear vial with a rubber stopper and aluminum seal.
Each carton contains 1 vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
EUSA Pharma (Netherlands) BV
Beech avenue 54,
1119PW, Schiphol-Rijk
Netherlands
Manufacturer
Millmount Healthcare Ltd
Block 7, City North Business Campus
Stamullen, Co. Meath
K32 YD60
Ireland