Docetaxel Hikma: detailed information

PACKAGE LEAFLET

Docetaxel Hikma 20 mg/1 ml concentrate for solution for infusion, 80 mg/4 ml concentrate for solution for infusion, 160 mg/8 ml concentrate for solution for infusion

Docetaxel
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, hospital pharmacist, or nurse.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor, hospital pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Docetaxel Hikma is and what it is used for
What you need to know before taking Docetaxel Hikma
How to take Docetaxel Hikma
Possible side effects
How to store Docetaxel Hikma
Contents of the pack and other information

1. What Docetaxel Hikma is and what it is used for

The name of this medicine is Docetaxel Hikma. The common name is docetaxel. Docetaxel
is a substance derived from the needle-like leaves of yew trees.
Docetaxel belongs to a group of anticancer drugs called taxanes.
Docetaxel Hikma has been prescribed by your doctor for the treatment of breast cancer, certain types of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer:

For the treatment of advanced breast cancer, Docetaxel Hikma may be given as monotherapy or in combination with doxorubicin, or trastuzumab or capecitabine.
For the treatment of early-stage breast cancer with or without lymph node involvement, Docetaxel Hikma may be given in combination with doxorubicin and cyclophosphamide.
For the treatment of lung cancer, Docetaxel Hikma may be given as monotherapy or in combination with cisplatin.
For the treatment of prostate cancer, Docetaxel Hikma is given in combination with prednisone or prednisolone.
For the treatment of metastatic gastric cancer, Docetaxel Hikma is given in combination with cisplatin and 5-fluorouracil.
For the treatment of head and neck cancer, Docetaxel Hikma is given in combination with cisplatin and 5-fluorouracil.

2. Before taking Docetaxel Hikma

Do not take Docetaxel Hikma:

If you are allergic (hypersensitive) to docetaxel or to any of the other ingredients of this medicine (listed in section 6).
If your white blood cell count is too low.
If you have severe liver disease.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Docetaxel Hikma.
Before each treatment with Docetaxel Hikma, you will undergo a blood test to check that your blood cell levels and liver function are adequate for receiving Docetaxel Hikma. If you have abnormalities in your white blood cells, you may develop fever or infections.
Immediately inform your doctor, hospital pharmacist, or nurse if you experience abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in the stools, or fever. These symptoms may be the first signs of severe gastrointestinal toxicity, which could be fatal. Your doctor should address this immediately.
Tell your doctor, hospital pharmacist, or nurse if you have vision problems. If you experience vision problems, especially blurred vision, you must immediately have an eye and vision examination.
Inform your doctor, hospital pharmacist, or nurse if you have had allergic reactions to previous treatments with paclitaxel.
Inform your doctor, hospital pharmacist, or nurse if you have heart problems.
If acute lung problems occur or if your existing lung problems worsen (fever, shortness of breath, or cough), inform your doctor, hospital pharmacist, or nurse immediately. Your doctor may immediately discontinue your treatment.
One day before administration of Docetaxel Hikma and for one or two days after completion of treatment, you will be asked to undergo premedication with an oral corticosteroid such as dexamethasone, to minimize certain adverse effects that may occur after infusion of Docetaxel Hikma, particularly allergic reactions and fluid retention (swelling of hands, feet, legs, or weight gain).
During treatment, you may be given medications to maintain stable blood cell counts.
Docetaxel Hikma contains alcohol. Discuss with your doctor if you suffer from alcohol dependence or liver insufficiency. See also the section “Docetaxel Hikma contains ethanol (alcohol)” below.
For individuals engaged in sports, the use of medicinal products containing ethyl alcohol may result in a positive doping test, depending on the blood alcohol concentration limits set by certain sports federations.

Other medicines and Docetaxel Hikma
Inform your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. This is because Docetaxel Hikma or the other medicine may become less effective, and you may experience adverse effects.
The amount of alcohol in this medicine may alter the effects of other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Ask your doctor for advice before taking any medicine.
Docetaxel Hikma must NOT be administered during pregnancy unless specifically indicated by your doctor.
During treatment with this medicine, you must not become pregnant and should use an effective method of contraception, as Docetaxel Hikma may harm the unborn baby. Inform your doctor immediately if you become pregnant during treatment.
You must not breastfeed during treatment with Docetaxel Hikma.
If you are a man being treated with Docetaxel Hikma, you are advised not to father a child during treatment and for 6 months after the last dose of the medicine, and to seek advice regarding sperm preservation, as the medicine may impair male fertility.

Driving and using machines
The amount of alcohol in this medicine may impair your ability to drive or use machinery.
This medicine may cause adverse effects that could affect your ability to drive, use tools, or operate machinery (see section 4 Possible side effects). In such cases, do not drive or use tools or machinery before speaking with your doctor, nurse, or hospital pharmacist.

Docetaxel Hikma contains ethanol (alcohol)
This medicinal product contains 50% by volume of ethanol (alcohol), i.e.:
395 mg (0.5 ml) per vial, equivalent to 10 ml of beer or 4 ml of wine per vial
1580 mg (2 ml) per vial, equivalent to 40 ml of beer or 17 ml of wine per vial
3160 mg (4 ml) per vial, equivalent to 80 ml of beer or 33 ml of wine per vial.
Potentially dangerous for individuals suffering from alcoholism.
This should be taken into account if you are pregnant or breastfeeding, in children, and in high-risk groups such as patients with liver disease or epilepsy.
The alcohol content in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).

3. HOW TO TAKE DOCETAXEL HIKMA

Docetaxel Hikma will be administered to you by a healthcare professional.
Recommended dose
The dose will depend on your body weight and general health condition. Your doctor will calculate your body surface area in square meters (m²) and determine the dose of medication you should receive.
Method and route of administration
Docetaxel Hikma will be given by intravenous infusion (into one of your veins).
The infusion will last approximately 1 hour and will be administered in a hospital setting.
Frequency of administration
Normally, you will receive an infusion every 3 weeks.
Your doctor may decide to adjust the dose and frequency of treatment based on the results of your blood tests, your general health condition, and your response to Docetaxel Hikma. In particular, inform your doctor if you experience diarrhea, mouth ulcers, fever, numbness or tingling sensations, and provide the results of your blood tests. This information will allow your doctor to determine whether the dose needs to be reduced. If you have any further questions about the use of this medicine, ask your doctor or hospital pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Your doctor will discuss this with you and explain the potential risks and benefits of your treatment.
The most commonly reported adverse reactions with Docetaxel Hikma as monotherapy are: reduction in red blood cells or white blood cells, hair loss, nausea, vomiting, mouth ulcers, diarrhoea, and fatigue.
The severity of adverse events associated with Docetaxel Hikma treatment may increase when Docetaxel Hikma is administered in combination with other chemotherapeutic agents.
The following allergic reactions may occur during the infusion in hospital (reported in more than 1 patient in 10):

flushing, skin reactions, itching
chest tightness; breathing difficulties
fever or chills
back pain
low blood pressure. Sometimes more severe reactions may also occur.

If you have had an allergic reaction to paclitaxel, you may also have an allergic reaction to docetaxel, which could be more severe.
Hospital staff will closely monitor your health during treatment.
Inform hospital staff immediately if you notice any adverse effect.
Between two Docetaxel infusions, the following adverse effects may occur, and their frequency may vary depending on the concomitant medications you are taking:

Very common (reported in more than 1 patient in 10)

infections, reduction in red blood cells (anaemia) or white blood cells (important for the body's defence against infections), and platelets
fever: inform your doctor immediately
allergic reactions (described above)
loss of appetite (anorexia)
insomnia
numbness or tingling sensation in muscles or at muscle junctions
headache
altered taste
eye inflammation or excessive tearing
swelling due to poor lymphatic drainage
shortness of breath
runny nose; throat and nasal inflammation; cough
nosebleeds
mouth ulcers
stomach problems such as nausea, vomiting, diarrhoea, constipation
abdominal pain
indigestion
hair loss; in most cases, hair regrows. In some cases (frequency not known), permanent hair loss has been observed.
redness and swelling of the palms of the hands or soles of the feet, which may progress to skin peeling (also on arms, face, or body)
nail discoloration and possible nail loss
muscle pain and tenderness; back or bone pain
changes or absence of menstrual cycle
swelling of hands, feet, and legs
fatigue or flu-like symptoms
weight gain or weight loss

Common (may affect up to 1 in 10 patients)

oral candidiasis
dehydration
dizziness
hearing impairment
low blood pressure; irregular or rapid heartbeat
heart failure
oesophagitis
dry mouth
difficulty swallowing or painful swallowing
bleeding
increased liver enzyme levels (regular blood tests are required).

Uncommon (may affect up to 1 in 100 patients)

fainting
skin reactions, phlebitis (vein inflammation), or swelling at injection site
formation of blood clots.

Rare (may affect up to 1 in 1,000 patients)

inflammation of the colon or small intestine, which may be fatal (frequency not known); intestinal perforation

Frequency not known (cannot be estimated from available data):

interstitial lung disease (lung inflammation causing cough and breathing difficulties). Lung inflammation may also develop when docetaxel therapy is used in combination with radiotherapy.
pneumonia (lung infection)
pulmonary fibrosis (scarring and thickening in the lungs causing shortness of breath)
blurred vision due to swelling of the retina inside the eye (cystoid macular edema)
reduction in sodium, potassium, magnesium, and/or calcium in the blood (electrolyte imbalance)
ventricular arrhythmia or ventricular tachycardia (manifested by irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting). Some of these symptoms may be serious. If this occurs, inform your doctor immediately.
injection site reactions at the site of a previous reaction

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report adverse effects directly via the national reporting system at the following address
.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DOCETAXEL HIKMA

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton and label of the
vial after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the original packaging to protect the medicinal product from light.
Use the vial immediately after opening. If not used immediately, storage times and conditions prior to use are the responsibility of the user.
From a microbiological standpoint, reconstitution/dilution must be carried out under controlled and aseptic conditions.
Use the medicinal product immediately after addition to the infusion bag. If not used immediately, storage times and conditions during use are the responsibility of the user and should normally not exceed 8 hours at a temperature not exceeding 25°C, including 1 hour for infusion.
The chemical and physical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags for up to 48 hours when stored at 2°C – 8°C.
Docetaxel infusion solution is supersaturated and may therefore crystallize over time. If crystals appear, the solution must no longer be used and must be discarded.
Do not dispose of any medicinal product via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Docetaxel Hikma contains

The active substance is docetaxel. Each ml of concentrate for solution for infusion contains 20 mg of docetaxel.
The other ingredients are polysorbate 80, anhydrous ethanol and citric acid.

Description of the appearance of Docetaxel Hikma and contents of the pack
Docetaxel Hikma concentrate for solution for infusion is a pale yellow or yellowish-brown solution.
The concentrate is supplied in a 6 ml clear glass vial (type I), closed with a chlorobutyl rubber stopper coated with Teflon, 20 mm in diameter, and sealed with a 20 mm aluminium flip-off cap.
The concentrate is supplied in a 10 ml clear glass vial (type I), closed with a chlorobutyl rubber stopper coated with Teflon, 20 mm in diameter, and sealed with a 20 mm aluminium flip-off cap.
Each carton contains one vial of 1 ml concentrate (20 mg docetaxel).
Each carton contains one vial of 4 ml concentrate (80 mg docetaxel).
Each carton contains one vial of 8 ml concentrate (160 mg docetaxel).

Marketing Authorization Holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, nº 8, 8A – 8B
Fervença
2705 – 906 Terrugem SNT
Portugal
Tel.: +351 21 960 84 10
Fax: +351 21 961 51 02
e-mail: [email protected]

Manufacturer
Thymoorgan GmbH Pharmazie
Schiffgraben 23
D-38690 Goslar
Germany

This medicinal product is authorized in the EEA Member States under the following names:
Germany: Docetaxel Ribosepharm 20 mg/1 ml concentrate for solution for infusion
Docetaxel Ribosepharm 80 mg/4 ml concentrate for solution for infusion
Docetaxel Ribosepharm 160 mg/8 ml concentrate for solution for infusion
Italy: Docetaxel Hikma
Portugal: Docetaxel Hikma
Docetaxel Hikma
Docetaxel Hikma

This leaflet was last approved on

The following information is intended exclusively for healthcare professionals.

PREPARATION GUIDE FOR DOCETAXEL HIKMA 20 mg/1 ml
CONCENTRATE FOR INFUSION SOLUTION
It is important that you read the entire content of this guide before preparing Docetaxel Hikma infusion solution.
Safe use recommendations
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, care should be taken when handling and preparing its solution. The use of gloves is recommended.
If Docetaxel Hikma concentrate or infusion solution comes into contact with the skin, wash immediately and thoroughly with soap and water. If contact occurs with mucous membranes, wash immediately and thoroughly with water.

Preparation for intravenous administration
Preparation of infusion solution
DO NOT USE other medicinal products containing docetaxel that consist of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL HIKMA 20 mg/1 ml, 80 mg/4 ml and 160 mg/8 ml concentrate for infusion solution, which contains only 1 vial).
DOCETAXEL HIKMA 20 mg/1 ml, 80 mg/4 ml and 160 mg/8 ml concentrate for infusion solution DOES NOT require prior dilution with a solvent and is ready to be added directly to the infusion solution.
Each vial is for single use only and should be used immediately after opening. If not used immediately, the times and conditions of storage during use are the responsibility of the user. More than one vial of concentrate for infusion solution may be required to achieve the patient's required dose. For example, a docetaxel dose of 140 mg will require 7 ml of docetaxel concentrate for infusion solution.
Aseptically withdraw the required amount of concentrate for infusion solution using a calibrated syringe with a 21G needle.
In DOCETAXEL HIKMA vials of 20 mg/1 ml, 80 mg/4 ml and 160 mg/8 ml, the concentration of docetaxel is 20 mg/ml.
Then, inject the concentrate in a single injection (at one time) into a 250 ml infusion bag or bottle containing either 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion.
If a docetaxel dose greater than 190 mg is required, use a larger volume of infusion solution so that the docetaxel concentration does not exceed 0.74 mg/ml.
Mix the infusion bag or bottle manually by gentle swirling.
From a microbiological standpoint, reconstitution/dilution must be performed under controlled, aseptic conditions and the infusion solution should be used immediately. If not used immediately, the times and conditions of storage during use are the responsibility of the user.
Once added as recommended to the infusion bag, the docetaxel infusion solution is stable for 8 hours when stored below 25°C. It must be used within 8 hours (including 1 hour for intravenous infusion administration).
Furthermore, the chemical and physical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags for up to 48 hours when stored between 2°C and 8°C.
Docetaxel infusion solution is supersaturated and may therefore crystallize over time. If crystals appear, the solution must not be used and should be discarded.
As with all parenteral products, the infusion solution should be inspected visually prior to use; solutions containing precipitate should be discarded.

Disposal
All materials used for dilution and administration must be disposed of according to standard procedures.
Waste materials must be destroyed in accordance with standard hospital procedures applicable to cytotoxic agents, in compliance with current regulations on hazardous waste disposal.
Ask your pharmacist how to dispose of medicines you no longer use. These precautions will help protect the environment.