Qarziba is a cancer medicine use to treat neuroblastoma, a cancer of nerve cells, in patients over 1 year of age.

It is use in 2 groups of patients who have high-risk neuroblastoma (which has a high chance of coming back):

• Patients who have had some improvement with previous treatments, which included blood stem-cell transplantation (a transplant of blood-producing cells);
• Patients whose neuroblastoma has not improved with other cancer treatments or has come back.

If the neuroblastoma has come back after previous treatment, it should be Stabilised (stopped from getting worse) before treatment with Qarziba is start. Qarziba is used together with another medicine called interleukin-2 (Aldesleukin) in some cases where previous treatments have not worked well enough.

Because the number of patients with neuroblastoma is low, the disease is considered ‘rare’, and Qarziba was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 November 2012.

The medicine contains the active substance Dinutuximab beta.

How is Qarziba use?

• Qarziba is given as an infusion (drip) into a vein. Qarziba 4.5 mg/ml Each course of treatment with the medicine is give  for 5 or 10 days every 35 days. It is given for a total of 5 courses. The recommended dose depends on the patient’s weight and height.
• The doctor may need to reduce or delay doses if certain side effects occur or stop treatment altogether if side effects are severe.
• Treatment with Qarziba should not start unless the patient has satisfactory results in certain blood tests of liver, lung, kidney and bone marrow function.
• Treatment must be supervise by a doctor experience in the treatment of cancer. It must be give in hospital by a doctor or nurse who can manage severe allergic reactions and who has full resuscitation services immediately available if need. The medicine can only be obtained with a prescription.
• For further information, see the summary of product characteristics (also part of the EPAR)

How does Qarziba work?

Qarziba 4.5 mg/ml is a monoclonal antibody Qarziba 4.5 mg price (a type of protein) that has been designed to recognize and attach to a structure called GD2 that is present in high amounts on the surface of neuroblastoma cells, but not normal cells.

When Qarziba attaches to the neuroblastoma cells, it makes them a target for the body’s immune system (the body’s natural defenses), which then kills the cancer cells.

What benefits of Qarziba have been shown in studies?

• Studies have shown that Qarziba is effective at increasing survival in patients with neuroblastoma.
• Two studies analyzed data from 88 children and adults with neuroblastoma that had not improved with other cancer treatments or had come back. Patients were treated with Qarziba plus interleukin-2 and another medicine called isotretinoin. In these studies, 70% and 78% of the patients whose neuroblastoma had not improved with other treatments were still alive 2 years after treatment. Of the patients with neuroblastoma that had come back, 42% and 69% were still alive 2 years after treatment.
• In a third study, 370 children with high-risk neuroblastoma that had improved after other treatments were given Qarziba and isotretinoin with or without interleukin 2. At the start of treatment some of these patients had no sign of neuroblastoma and some still had some sign of the disease. Of the patients who had no sign of neuroblastoma, 71% were still alive 3 years after treatment and the results were similar whether the treatment included interleukin-2 or not. Of the patients who had some sign of neuroblastoma, 63% of those given interleukin-2 were still alive 3 years after treatment compared with 54% of patients who did not receive interleukin-2.
• In these studies, outcomes with Qarziba compared favorably with those previously seen in patients treated for neuroblastoma without Qarziba.
• What are the risks associate with Qarziba?

Why is Qarziba approve?

• The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted the lack of treatment options to prevent high-risk neuroblastoma from coming back.
• Taken together, data on outcomes with Qarziba show that the medicine is effective. However, more data are need to fully understand the medicine’s effectiveness.
• Although treatment with Qarziba can cause serious side effects, Dinutuximab Price the safety of the medicine is consider acceptable.
• Therefore the CHMP decided that Qarziba benefits are greater than its risks and recommended that it be approve for use in the EU.
• Qarziba has authorize under ‘exceptional circumstances. This is because it has not possible to obtain complete information about Qarziba for ethical reasons. As Dinutuximab is a recommend treatment for high-risk neuroblastoma, it would not ethical to carry out a trial in which some patients were give placebo (a dummy treatment). Every year, the European Medicines Agency will review any new information that becomes available, and this summary will be update as necessary.

Dinutuximab side effects

Get emergency medical help if your child has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Some side effects may occur during the injection or up to 24 hours afterward. Qarziba 4.5 mg/ml Tell your child’s caregiver if the child seems dizzy or light-headed, or has a skin rash, chest tightness, wheezing, trouble breathing, or swelling in the face.

Capillary leak syndrome is a rare but serious side effect. Qarziba 4.5 mg/ml Call your doctor right away if your child has signs of this condition: stuffy or runny nose followed by tiredness, thirst, decreased urination, trouble breathing, and sudden swelling or weight gain.

Dinutuximab can damage red blood cells, which may cause irreversible kidney failure. Call Dinutuximab Price your doctor right away if your child has unusual bruising or bleeding, pale skin, confusion, tiredness or irritability, stomach pain, bloody diarrhea, red or pink urine, swelling, rapid weight gain, and little or no urination.

Also call your doctor at once if the child has:

• Sudden vision loss or vision changes
• Headache, confusion, thinking problems, Seizure
• Severe dizziness or Fainting;
• Vomiting, diarrhea, feeling very ill
• Nerve problems–sharp or shooting pain, numbness or tingling, burning or cold feeling, Dinutuximab Price weakness, loss of movement, problems with walking or daily activities, loss of bladder or bowel control
• Low blood cell counts–fever, chills, Dinutuximab Price tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• Signs of an electrolyte imbalance–increased thirst or urination, constipation, muscle pain or weakness, leg cramps, numbness or tingling, feeling jittery, irregular heartbeats, fluttering in your chest, or a choking feeling.

Common side effects of Dinutuximab may include:

• Capillary leak Syndrome
• A reaction to the Infusion
• Feeling light-headed.
• Pain
• low blood cell Counts
• An electrolyte imbalance
• Vomiting, Diarrhea
• Rash
• Abnormal liver function tests.

Warnings

Call your doctor at once if your child has severe or worsening pain, numbness. Tingling, weakness, or problems with walking or daily activities.

Some side effects may occur during the injection or up. Qarziba 4.5 mg Dinutuximab Price to 24 hours afterward, including dizziness, skin rash, chest tightness, wheezing, trouble breathing, or swelling in the face.

The most common side effects with Qarziba 4.5 mg price (which may affect more than 7 in 10 people). are pyrexia (fever) and pain. Other side effects (which may affect more than 3 in 10 people) are hypersensitivity (allergy), vomiting, Diarrhoea, capillary leak syndrome (leakage of fluid from blood vessels that can cause swelling and a drop in blood pressure) and hypotension (low blood pressure).

Qarziba must not be use in patients with severe or widespread graft-versus-host disease (when transplanted cells attack the body).

For the full list of all side effects and restrictions with Qarziba, see the package leaflet.

Before taking this medicine

Your child should not treat with Qarziba 4.5 mg/ml Dinutuximab if you are allergic to it.

Tell your doctor if the child has ever had:

• Any type of bacterial, fungal, or viral infection
• An eye disorder or vision Problems
• Dinutuximab Price Bone marrow Suppression
• Low blood Pressure
• An electrolyte imbalance (such as low blood levels of potassium, sodium, or calcium)
• Liver or kidney disease; or
• Urination problems.

How is Dinutuximab give?

• Qarziba 4.5 mg/ml Dinutuximab is inject into a vein.
• Dinutuximab is inject slowly over 10 to 20 hours.
• Qarziba 4.5 mg/ml Dinutuximab is give in a 28-day treatment cycle. Your child will receive this injection only on certain days of the cycle.
• Your doctor will decide how many cycles your child should receive.
• Dinutuximab Price Your child may be give other medicines to help prevent certain side effects.
• Your child will watch for at least 4 hours to make sure he she does not have a reaction to the medicine.
• Your child may need frequent medical tests and treatment may be delay base on the results.

FAQ

What is Qarziba?

Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and older, who have previously received induction chemotherapy and achieved at least partial response, following myeloablative therapy and transplant.

What is Dinutuximab chemotherapy?

Drugs using granulocyte-macrophage colony-stimulating factor (GM-CSF), aldesleukin (IL-2), and 13-cis-retinoic acid treat children with high-risk neuroblastoma. It is used in patients whose disease is treated with other cancer treatments.

Is dinutuximab FDA approved?

The Food and Drug Administration (FDA) approved dinutuximab (Unituxin) for the initial treatment of children with high-risk neuroblastoma - the first approval of a specific treatment for patients with this type of advanced disease.

Can you survive high risk neuroblastoma?

Low-risk group: Children in the low-risk group have a 5-year survival rate that is higher than 95%. Intermediate-risk group: Children in the intermediate-risk group have a 5-year survival rate of around 90% to 95%. High-risk group: Children in the high-risk group have a 5-year survival rate of around 50%.

Does dinutuximab cause pain?

Unituxin causes severe neurological effects, including severe neuropathic pain (nerve pain) and peripheral neuropathy (weakness, pain and/or numbness in the hands, feet, legs or arms). Severe neuropathic pain occurs in many patients.

Dinutuximab dosing information

Usual Pediatric Dose for Neuroblastoma:

Dinutuximab Price 17.5 mg/m2/day IV over 10 to 20 hours for 4 consecutive days for a maximum of 5 cycles:
-Infuse on days 4, 5, 6, and 7 during cycles 1, 3, and 5 (cycles 1, 3, and 5 are 24 days in duration).
-Infuse on days 8, 9, 10, and 11 during cycles 2 and 4 (cycles 2 and 4 are 32 days in duration).

Rate of Infusion:
-Initiate at 0.875 mg/m2/hour for 30 minutes. Gradually increase Qarziba 4.5 mg price as tolerated to a maximum rate of 1.75 mg/m2/hour.

Comments:

REQUIRED PRE-TREATMENT AND GUIDELINES FOR PAIN MANAGEMENT IV HYDRATION:

1) Hydration: –

Administer 0.9% sodium chloride 10 mL/kg IV over one hour just prior to initiating each infusion.

2) Analgesics: –

Administer morphine 50 mcg/kg IV immediately prior to infusion. Dinutuximab Price And then continue as a morphine drip at an infusion. Rate of 20 to 50 mcg/kg/hour during and for 2 hours following completion of therapy.
-Administer additional 25 mcg/kg to 50 mcg/kg IV doses of morphine. Qarziba 4.5 mg price As need for pain up to once every 2 hours. Followed by an increase in the morphine infusion rate in stable patients.
-Consider using fentanyl or hydromorphone if morphine is not tolerate.
-If pain is inadequately manage with opioids. Consider use of gabapentin or lidocaine in conjunction with IV morphine.

3) Antihistamines and Antipyretics:

-Administer an antihistamine such as diphenhydramine (0.5 to 1 mg/kg; maximum dose 50 mg). IV over 10 to 15 minutes starting 20 minutes prior to initiation of therapy. And as tolerate every 4 to 6 hours during therapy.

-Administer acetaminophen (10 to 15 mg/kg; maximum dose 650 mg). 20 minutes prior to each infusion and every 4 to 6 hours as need for fever or pain.

-Administer ibuprofen (5 to 10 mg/kg) every 6 hours as need for control of persistent fever or pain.

Use: In combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). Interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma. Qarziba 4.5 mg price Who achieve at least a partial response to prior first-line multiagent, multimodality therapy.