1 mg powder for concentrate for infusion solution
inotuzumab ozogamicin
1. What SPONSOR is and what it is used for
The active substance in BESPONSA is inotuzumab ozogamicin. It belongs to a group of drugs that fight cancer cells. Such drugs are called antineoplastic agents.
BESPONSA is used to treat adults with acute lymphocytic leukemia . Acutelymphocytic leukemia is a cancer of the blood that means you have too many white blood cells . BESPONSA is used for treating acute lymphocytic leukemia in adult patients who have previously received other treatments that have not worked.
BESPONSA works by attaching to cells that have a protein called CD22. The lymphatic leukemia cells have this protein . Once attached to the lymphatic leukemia cells, the drug releases a substance into the cells that disrupts their DNA and eventually kills them.
2. What you need to know before you are given SPONSOR
Do not use SPONSOR
- is allergic to inotuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6)
- have previously been diagnosed with severe venous occlusive disease (a condition in which the blood vessels in the liver are damaged and clogged by blood clots), or have ongoing venous occlusive disease
- have an ongoing severe liver disease, e.g. cirrhosis (cirrhosis of the liver, a condition in which the liver does not function properly due to long-term damage), nodular regenerative hyperplasia (a condition with symptoms of high blood pressure in the portal veins that can be caused by long-term use of drugs), or active hepatitis ( inflammation of the liver ).
Warnings and cautions
Talk to your doctor, pharmacist or nurse before receiving SPONSOR if you:
- have had liver problems or liver diseases in the past or if you have symptoms of a serious disease called hepatic venous occlusive disease, which is a condition in which the blood vessels in the liver are damaged and clogged by blood clots. Venous occlusive disease can be fatal and the symptoms are rapid weight gain, pain in the upper right side of the abdomen, enlarged liver, fluid accumulation in the abdomen leading to bloating, and elevated bilirubin and / or liver enzyme levels in the blood (something that can manifest itself as yellowing of the skin or the whites of the eyes). The condition can occur during treatment with BESPONSA or during subsequent stem cell transplantation . A stem cell transplant involves transplanting a stem cellyou (cells that develop into new blood cells ) from another person in your blood. Transplantation may be necessary if your disease responds completely to treatment.
- have symptoms of low blood cell types of the types neutrophils (sometimes accompanied by fever), red blood cells, white blood cells, lymphocytes, or platelets. Symptoms of this are that you easily get infection , fever or bruising, or often get nosebleeds.
- have symptoms of a reaction in connection with infusion , such as fever and chills or breathing problems during or shortly after an infusion with BESPONSA.
- have symptoms of tumor lysis syndrome, which can cause symptoms in the stomach and intestines (for example, nausea, vomiting and diarrhea), the heart (for example, altered heart rhythm), the kidneys (for example, decreased urine output, blood in the urine), and nerves and muscles (for example muscle spasms, weakness and cramps), during or shortly after an infusion of BESPONSA.
- have previously had or tend to have prolonged QT intervals (a change in the electrical activity of the heart that can lead to severe irregular heartbeat), take drugs that are known to prolong the QT interval, and/or have abnormal electrolyte levels (e.g. calcium , magnesium , potassium ).
- have an increased amount of the enzymes amylase or lipase in the blood, which can be a sign of problems with the pancreas or liver and gallbladder or bile ducts.
Tell your doctor, pharmacist or nurse immediately if you become pregnant during treatment with BESPONSA and for up to 8 months after stopping treatment.
Your doctor will take blood samples at regular intervals to check your blood levels during treatment with BESPONSA. See also section 4.
During treatment, especially in the very first days after starting treatment, the number of white blood cells can drop sharply ( neutropenia ), which may be accompanied by fever (febrile neutropenia ).
During treatment, especially in the very first days after starting treatment, you may have elevated liver enzymes. Your doctor will take blood samples at regular intervals to check your liver enzymes during treatment with BESPONSA.
Treatment with BESPONSA may prolong the QT interval (a change in the electrical activity of the heart that can cause severe irregular heartbeats). Your doctor will take an electrocardiogram ( ECG ) and blood tests to measure electrolytes (eg calcium , magnesium , potassium ) before the first dose of BESPONSA and then repeat these tests during treatment. See also section 4.
Your doctor will also check the symptoms of tumor lysis syndrome after you have BEEN SPONSORED. See also section 4.
Children and young people
BESPONSA should not be used for children and young people under 18 years of age. No data are available on treatment in this patient group.
Other drugs and SPONSOR
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines.
Pregnancy, breastfeeding, 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 nurse for advice before taking this medicine.
Contraceptive
You need to avoid getting pregnant or becoming a father. Women must use effective contraception during treatment and for at least 8 months after the last dose . Men must use effective contraception during treatment and for at least 5 months after the last dose .
Pregnancy
The effect of BESPONSA in pregnant women is not known, but given its mechanism of action, BESPONSA could harm an unborn baby. You should not use BESPONSA during pregnancy unless your doctor thinks it is the best medicine for you.
Contact your doctor immediately if you or your partner becomes pregnant during treatment with this medicine.
Fertility
Men and women should seek fertility counseling advice before treatment.
Breast-feeding
If you are to be treated with BESPONSA, you must stop breast-feeding during the treatment period and for at least 2 months after the treatment. Talk to your doctor.
Driving and using machines
If you feel unusually tired (a very common side effect of BESPONSA), do not drive or use machines.
SPONSOR contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per 1 mg inotuzumab ozogamicin, ie it is essentially ‘sodium-free’.
3. How SPONSORS are given
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist or nurse.
How SPONSORS are given
- Your doctor will determine the correct dose for you.
- A doctor or nurse will give you SPONSOR by drip into a vein ( intravenous infusion) lasting 1 hour.
- You receive one dose each week and each treatment cycle consists of 3 doses .
- If the medicine works well and you are going to have a stem cell transplant (see section 2), you can receive 2 or a maximum of 3 rounds of treatment (cycles).
- If the medicine works well but you are not going to have a stem cell transplant(see section 2), you can have a maximum of 6 treatment cycles.
- If the medicine has not worked well after 3 cycles, treatment is stopped.
- Your doctor may change your dose , suspend or stop treatment with BESPONSA if you experience any side effects .
- Your doctor may reduce your dose depending on how you respond to treatment.
- Your doctor will take blood samples during treatment to check for any side effectsand to see how you respond to treatment.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
Medicines given before treatment with BESPONSA
Before treatment with BESPONSA, you will be given other medicines (premedication) to reduce infusion reactions and other possible side effects . These can be corticosteroids ( cortisone such as dexamethasone), antipyretics and antihistamines(medicines to reduce allergic reactions).
Before treatment with BESPONSA, you can receive medication and fluid therapy to prevent the development of tumor lysis syndrome. Tumor light syndrome can cause several different symptoms from the stomach and intestines (eg, nausea, vomiting, and diarrhea), the heart (such as changes in heart rhythm), kidneys (such as decreased urine output, blood in the urine), and nerves and muscles. (eg muscle twitching, weakness and cramps).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious.
Tell your doctor immediately if you get symptoms of any of the following serious side effects:
- reaction associated with infusion one (see section 2): symptoms may include fever and chills or breathing problems during or shortly after BESPONSA infusion one.
- venous occlusive liver disease (see section 2): symptoms may include rapid weight gain, upper abdominal pain, enlarged liver, abdominal fluid accumulation leading to bloating and elevated bilirubin and / or liver enzyme levels in the blood (which may manifest as yellowing of the skin or whites of the eyes).
- low blood cell count of the types neutrophils (sometimes accompanied by fever), red blood cells , white blood cells , lymphocytes or platelets (see section 2): symptoms of this may include that you easily get infections , fever or bruising, or often get nosebleeds.
- Tumor light syndrome (see section 2): this condition may be accompanied by several different symptoms from the stomach and intestines (eg nausea, vomiting, and diarrhea), the heart (eg altered heart rhythm), kidneys (eg decreased urine output, blood in the urine), and nerves and muscles (eg muscle twitching, weakness, and cramps).
- prolonged QT interval (see section 2): symptoms of this may include a change in the electrical activity of the heart which may lead to severe irregular heartbeat. Tell your doctor if you have symptoms such as dizziness, dizziness or fainting.
Other side effects can be:
Very common : may affect more than 1 in 10 people
- infection is
- decreased number of white blood cells , which can lead to general weakness and a tendency to get infections you
- decreased number of lymphocytes s (a type of white blood cells ), which can lead to a tendency to infection s
- decreased number of red blood cells , which can lead to fatigue and shortness of breath
- reduced appetite
- headache
- bleeding
- abdominal pain
- vomiting
- diarrhea
- nausea
- inflammation of the mouth
- constipation
- elevated bilirubin in the blood, which can cause yellowing of the skin, eyes and other tissues s
- fever
- overindulge
- fatigue
- high level of liver enzymes in the blood (may indicate liver damage).
Common: may affect up to 1 in 10 people
- reduced the number of different types of blood cell s
- excess uric acid in the blood
- accumulation of fluid in the abdomen
- swelling of the abdomen
- altered heart rhythm (can be seen on ECG )
- abnormally high levels of amylase in the blood (an enzyme required for digestion and the conversion of starch into sugars)
- Abnormally high levels of lipase in the blood (an enzyme needed to break down fat in food)
- hypersensitivity.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to Store SPONSOR
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 vial label and on the carton after EXP. The expiry date will be the last day of that month.
Unopened vial
Store in a refrigerator (2 ° C – 8 ° C).
– Store in the original box. Sensitive to light.
– Do not freeze.
Ready-made solution
– Should be used immediately or stored in a refrigerator (2 ° C – 8 ° C) for a maximum of 4 hours.
– Sensitive to light.
– Do not freeze.
Diluted solution
– To be used immediately or stored at room temperature (20 ° C – 25 ° C) or in a refrigerator
(2 ° C – 8 ° C). The maximum permitted time from preparation and until the drug has been given is 8 hours, of which a maximum of 4 hours between preparation and dilution.
– Sensitive to light.
– Do not freeze.
The drug should be inspected visually for particulate matter and discoloration prior to use. If the medicine contains particles or is discolored, it should not be used.
Medicines should not be disposed of via wastewater or household waste. Ask your doctor how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is inotuzumab ozogamicin. Each vial contains 1 mg of inotuzumab ozogamicin. After reconstitution , 1 ml of the solution contains 0.25 mg of inotuzumab ozogamicin.
- The other ingredients are sucrose, polysorbate 80, sodium chloride and tromethamine (see section 2).
What the medicine looks like and the contents of the pack
BESPONSA is a powder for solution for infusion solution
Each pack of BESPONSA contains:
- 1 glass vial containing a white to off-white lyophilised cake or powder.
Marketing Authorization Holder and Manufacturer
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Service Company BVBA
High Way 10
B-1930, Zaventem
Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgique / België / BelgienPfizer SA / NVTel: +32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel: +370 52 51 4000 |
| BulgariaPfizer Luxembourg SAARЛ, Clone of BulgariaTel: +359 2 970 4333 | Luxembourg / LuxemburgPfizer SATel: +32 (0) 2 554 62 11 |
| Czech RepublicPfizer, spol. s roTel: +420 283 004 111 | HungaryPfizer Kft.Tel: + 36-1-488-37-00 |
| DenmarkPfizer ApSTel: +45 44 20 11 00 | MaltaVivian Corporation Ltd.Tel: +356 21344610 |
| GermanyPfizer Pharma GmbHTel: +49 (0) 30 550055 51000 | The NetherlandsPfizer bvTel: +31 (0) 10 406 43 01 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | NorwayPfizer ASTel: +47 67 52 61 00 |
| GreecePfizer Aλλάς AE:Ηλ: +30 210 6785 800 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| SpainPfizer SLTel: +34 91 490 99 00 | PolandPfizer Polska Sp.zooTel: +48 22 335 61 00 |
| FrancePfizerTel: +33 (0) 1 58 07 34 40 | PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500 |
| CroatiaPfizer Croatia dooTel: + 385 1 3908 777 | RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | SloveniaPfizer Luxembourg SARLPfizer, underwriting and dryingpharmacevtske dejavnosti, LjubljanaTel: + 386 (0) 1 52 11 400 |
| IcelandIcepharma hf.Phone: +354 540 8000 | Slovak RepublicPfizer Luxembourg SARL, organizerTel: + 421 2 3355 5500 |
| ItalyPfizer Italia SrlTel: +39 06 33 18 21 | Finland / FinlandPfizer OyPuh / Tel: +358 (0) 9 43 00 40 |
| ΚύπροςPfizer Αλλάς Α.Ε. (Cyprus Branch):Ηλ: +357 22 817690 | |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel: + 371 670 35 775 | United KingdomPfizer LimitedTel: +44 (0) 1304 616161 |