20 mg / mL concentrate for infusion solution 
Cabazitaxel

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cabazitaxel Accord is and what it is used for 
2. What you need to know before you get Cabazitaxel Accord 
3. How to use Cabazitaxel Accord 
4. Possible side effects 
5. How to store Cabazitaxel Accord 
6. Contents of the packaging and other information 

1. What Cabazitaxel Accord is and what it is used for

Your medicine is called Cabazitaxel Accord. The active substance is cabazitaxel. It belongs to a group of drugs called “taxanes” used in cancer treatment.

Cabazitaxel Accord is used to treat adults with prostate cancer who have progressed after receiving other chemotherapy . It works by inhibiting cell growth and cell division.

As part of your treatment, you will also take corticosteroids (prednisone or prednisolone ) by mouth every day. Ask your doctor to inform you about this medicine as well.

2. What you need to know before you get Cabazitaxel Accord

Do not use Cabazitaxel Accord

  • if you are allergic (hypersensitive) to cabazitaxel, other taxanes, polysorbate 80, or any of the other ingredients of this medicine (listed in section 6).
  • if the white blood cell count is too low ( neutrophils lower than or equal to 1500 / mm 3 ),
  • if you have severe hepatic impairment,
  • if you have recently received or are about to receive the yellow fever vaccine.

You should not use Cabazitaxel Accord if any of these apply to you. If you are not sure, talk to your doctor before taking Cabazitaxel Accord.

Warnings and cautions

Before each treatment with Cabazitaxel Accord, you will have blood tests to check that you have enough blood cells and sufficient liver and kidney function to obtain Cabazitaxel Accord.

Immediately inform your doctor about:

  • you have a fever. During treatment with Cabazitaxel Accord, your white blood cells are likely to be reduced. Your doctor will monitor your blood count and general condition for signs of infection. Your doctor may give you other medicines to maintain your blood levels. People with low blood counts can develop life-threatening infections . The earliest sign of infection may be a fever, so contact your doctor immediately if you develop a fever.
  • you have or have had any allergies. Serious allergic reactions may occur during treatment with Cabazitaxel Accord.
  • you have severe or prolonged diarrhea, feeling unwell, or vomiting. Each of these conditions can cause severe dehydration. Your doctor may need to give you care.
  • you have numbness, tingling, burning sensation, or decreased sensation in your hands and feet.
  • you have problems with bleeding from the intestines or a change in the color of your stools or stomach pain. If the bleeding or pain is severe, your doctor will stop your treatment with Cabazitaxel Accord. This is because Cabazitaxel Accord may increase the risk of bleeding or developing holes in the intestinal wall.
  • you have kidney problems.
  • liver problems occur during treatment.
  • you experience a significant increase or decrease in the volume of daily urine.
  • you have blood in your urine

If any of these occur to you, tell your doctor immediately. Your doctor may reduce the dose of Cabazitaxel Accord or stop the treatment.

Use of other medicines and Cabazitaxel Accord

Tell your doctor, nurse, or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because some medicines may affect the way Cabazitaxel Accord works or Cabazitaxel Accord may affect the way these medicines work. These medications are:

  • ketoconazole , rifampicin (for infections );
  • carbamazepine, phenobarbital or phenytoin (for seizures);
  • St. John’s wort (Hypericum perforatum) (herbal medicine for depression and other conditions);
  • statins (such as simvastatin , lovastatin, atorvastatin, rosuvastatin or pravastatin) (lowers blood cholesterol );
  • valsartan (for high blood pressure );
  • repaglinide (in diabetes ).

Talk to your doctor before taking any vaccination while you are being treated with Cabazitaxel Accord.

Pregnancy, breastfeeding, and fertility

Cabazitaxel Accord should not be used by pregnant women or women of childbearing potential without the use of contraceptives.

Cabazitaxel Accord should not be used during breast-feeding.

Use a condom during intercourse if your partner is or may become pregnant. Cabazitaxel Accord may be present in semen and may affect the fetus. You will be advised not to get pregnant during and up to 6 months after treatment and to seek advice on sperm preservation before treatment, as Cabazitaxel Accord may affect male fertility.

Driving and using machines

You may feel tired or dizzy while taking this medicine. If this happens, do not drive or use any tools or machines until you feel better

Cabazitaxel Accord contains ethanol (alcohol)

This medicine contains 1,185 mg of alcohol ( ethanol ) per vial corresponding to 16.33% by volume. The amount in dose one of this medicine corresponds to 30 ml of beer or 12 ml of wine.

The amount of alcohol in this medicine is unlikely to have any effects on adults.

The alcohol in this medicine may affect the effectiveness of other medicines. Tell your doctor or pharmacist if you are taking any other medicines.

If you are or have been addicted to alcohol, consult your doctor or pharmacist before using this medicine.

3. How to use Cabazitaxel Accord

User instructions

Allergy medicines will be given to you by a doctor or nurse before you receive Cabazitaxel Accord to reduce the risk of allergic reactions.

  • Cabazitaxel Accord will be given to you by a doctor or nurse.
  • Cabazitaxel Accord must be prepared (diluted) before administration. Practical information regarding the handling and administration of Cabazitaxel Accord for doctors, nurses, and pharmacists is included with this leaflet.
  • Cabazitaxel Accord is given by drip ( infusion ) into one of your veins ( intravenously ) for about one hour in the hospital.
  • As part of your treatment, you will also take cortisone medicines (prednisone or prednisolone ) by mouth every day.

How much and how often

  • Dose one is determined by your body surface area. Your doctor will calculate your body area in square meters (m 2 ) and will then decide what dose you should have.
  • You will usually receive an infusion every three weeks.

If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them. Your doctor will discuss these with you and will explain the possible risks and benefits of your treatment.

Contact a doctor immediately if you notice any of the following side effects:

  • fever (high temperature). This is very common (may affect more than 1 in 10 people).
  • severe loss of body fluids (dehydration). This is common (may affect up to 1 in 10 people). This can occur if you have severe or prolonged diarrhea or fever or if you have been nauseous (have had vomiting).
  • severe abdominal pain or persistent abdominal pain that does not go away. This can occur if you have a hole in your stomach, esophagus, or intestine ( gastrointestinal perforation ). This can lead to death.

If any of the above applies to you, contact your doctor immediately.

Other side effects include:

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

  • reduction in the number of red blood cells ( anemia ) or white blood cells (which are important for fighting infections )
  • reduction in the number of platelets (which may increase the risk of bleeding)
  • loss of appetite ( anorexia )
  • taste change
  • shortness of breath
  • cough
  • upset stomach including nausea, vomiting, diarrhea or constipation
  • abdominal pain
  • temporary hair loss (after the end of treatment, normal hair growth should in most cases return)
  • back pain
  • joint pain
  • blood in the urine
  • fatigue, weakness, or lack of energy

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

  • urinary tract infection
  • lack of white blood cells associated with fever and infection
  • numbness or tingling, burning or decreased sensation in hands and feet
  • dizziness
  • headache
  • increased or decreased blood pressure
  • feeling uncomfortable in the stomach, heartburn or belching
  • abdominal pain
  • hemorrhoids
  • muscle spasms
  • painful or frequent urination
  • urinary incontinence
  • kidney disease or kidney problems
  • sores in the mouth or on the lips
  • infection you or a risk of infection s
  • high blood sugar
  • low blood potassium
  • mental confusion
  • anxiety
  • numbness or pain in hands and feet
  • earring
  • balance problem
  • fast or irregular heartbeat
  • a blood clot in bone
  • redness or feeling of warmth in the skin
  • pain in mouth or throat
  • rectal bleeding
  • reddening of the skin
  • muscle aches, aching aches or pains
  • swelling of the feet or legs
  • overindulge

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

  • inflammation of the bladder that can occur when exposed to radiation therapy ( cystitis due to “radiation recall phenomenon”) 

Has been reported (occurs in an unknown number of users):

  • interstitial lung disease ( pneumonia with cough and difficulty breathing).

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 Cabazitaxel Accord

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the inner label of the vial after EXP. The expiration date is the last day of the specified month.

No special temperature instructions.

Store in the original package. Sensitive to light.

After opening

Each vial is for single use only and should be used immediately after opening. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

After final dilution in the infusion bag/bottle

Chemical and physical in-use stability of the infusion solution has been demonstrated for 8 hours at ambient temperature (15 ° C ‑ 30 ° C) including 1 hour infusion time and for 48 hours under cooling conditions (including 1 hour infusion time).

From a microbiological point of view, the infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours at 2‑8 ° C, unless dilution has been performed under controlled and validated aseptic conditions.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements. These measures will help to protect the environment.

6. Contents of the packaging and other information

Cabazitaxel Accord contains

The active substance is cabazitaxel. One ml of concentrate contains 20 mg of cabazitaxel.

Each vial contains 3 ml of concentrate, equivalent to 60 mg cabazitaxel.

The other ingredients are polysorbate 80, citric acid, and anhydrous ethanol (see section 2 “Cabazitaxel Accord contains ethanol (alcohol)”).

What the medicine looks like and contents of the pack

Cabazitaxel Accord is a concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear to light yellow or brownish yellow solution.

It is supplied in a single-use vial with a manageable volume of 3 ml concentrate in a 6 ml clear glass vial.

Pack size:

Each carton contains a single-use vial .

Marketing Authorization Holder and Manufacturer

Accord Healthcare SLU

World Trade Center, Moll de Barcelona s / n,

Estifici Est, 6 a planta, Barcelona,

08039 Barcelona, ​​Spain

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road

Harrow, Middlesex, HA1 4HF

UK

LABORATORI FUNDACIÓ DAU

C / C, 12-14 Pol. Ind. Zona Franca,

Barcelona, ​​08040, Spain

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Accord Healthcare Polska Sp. z oo,

ul. Lutomierska 50, Pabianice, 95-200

Poland

Accord Healthcare BV

Winthontlaan 200, UTRECHT, 3526KV Paola

Netherlands

Muhammad Nadeem

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