Patient leaflet - Ciambra
1. What CIAMBRA is and what it is used for
CIAMBRA is a medicine used in the treatment of cancer.
CIAMBRA is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
CIAMBRA is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
CIAMBRA can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.
CIAMBRA is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
2. What you need to know before you use CIAMBRA
Do not use CIAMBRA
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– if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of CIAMBRA (listed in section 6).
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– if you are breast-feeding; you must discontinue breast-feeding during treatment with CIAMBRA.
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– if you have recently received or are about to receive a vaccine against yellow fever.
Warnings and precautions
Talk to your doctor or pharmacist before receiving CIAMBRA.
If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive CIAMBRA.
Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive CIAMBRA. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. If you are also receiving cisplatin, your doctor will make sure that you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting.
If you have had or are going to have radiation therapy, please tell your doctor, as there may be an early or late radiation reaction with CIAMBRA.
If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with CIAMBRA.
If you have heart disease or a history of heart disease, please tell your doctor.
If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you CIAMBRA.
Children and adolescents
CIAMBRA is not to be given to children and adolescents because no studies were performed in these groups.
Other medicines and CIAMBRA
Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor’s prescription (such as ibuprofen). There are many sorts of NSAIDs with different durations of activity. Based on the planned date of your infusion of CIAMBRA and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them. If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. The use of CIAMBRA should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking CIAMBRA during pregnancy. Women must use effective contraception during treatment with CIAMBRA.
Breast-feeding
If you are breast-feeding, tell your doctor.
Breast-feeding must be discontinued during treatment with CIAMBRA.
Fertility
Men are advised not to father a child during and up to 6 months following treatment with CIAMBRA and should therefore use effective contraception during treatment with CIAMBRA and for up to 6 months afterwards. If you would like to father a child during the treatment or in the 6 months following receipt of treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy.
Driving and using machines
CIAMBRA may make you feel tired. Be careful when driving a car or using machines.
CIAMBRA contains sodium
CIAMBRA 100 mg contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
CIAMBRA 500 mg contains 54 mg sodium (main component of cooking salt) in each vial. This is equivalent to 2,7% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to use CIAMBRA
The dose of CIAMBRA is 500 mg for every square metre of your body’s surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dose may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition. A hospital pharmacist, nurse or doctor will have mixed the CIAMBRA powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
You will always receive CIAMBRA by infusion into one of your veins. The infusion will last approximately 10 minutes.
When using CIAMBRA in combination with cisplatin:
The doctor or hospital pharmacist will work out the dose you need based on your height and weight. Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of CIAMBRA has finished. The infusion of cisplatin will last approximately 2 hours.
You should usually receive your infusion once every 3 weeks.
Additional medicines:
Corticosteroids: your doctor will prescribe you steroid tablets (equivalent to 4 mg of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after CIAMBRA treatment. This medicine is given to you to reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.
Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking CIAMBRA. You must take at least 5 doses during the seven days before the first dose of CIAMBRA. You must continue taking the folic acid for 21 days after the last dose of CIAMBRA. You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of CIAMBRA and then approximately every 9 weeks (corresponding to 3 courses of CIAMBRA treatment). Vitamin B12 and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must contact your doctor immediately if you notice any of the following:
Fever or infection: if you have a temperature of 38°C or greater, sweating or other
signs of infection (since you might have less white blood cells than normal). Infection (sepsis) may be severe and could lead to death.
If you start feeling chest pain or having a fast heart rate.
If you have pain, redness, swelling or sores in your mouth.
Allergic reaction: if you develop skin rash / burning or prickling sensation, or fever. Rarely, skin reactions may be severe and could lead to death.
Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or toxic epidermal necrolysis).
If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal).
If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal). If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (may indicate a blood clot in the blood vessels of the lungs)
Side effects with CIAMBRA may include:
Very common (may affect more than 1 in 10 people)
Infection
Pharyngitis (a sore throat)
Low number of neutrophil granulocytes (a type of white blood cell)
Low white blood cells
Low haemoglobin level
Pain, redness, swelling or sores in your mouth
Loss of appetite
Vomiting
Diarrhoea
Nausea
Skin rash
Flaking skin
Abnormal blood tests showing reduced functionality of kidneys
Fatigue (tiredness)
Common (may affect up to 1 in 10 people)
Blood infection
Fever with low number of neutrophil granulocytes (a type of white blood cell)
Low platelet count
Allergic reaction
Loss of body fluids
Taste change
Damage to the motor nerves which may cause muscle weakness and atrophy (wasting) primary in the arms and legs)
Damage to the sensory nerves that may cause lost of sensation, burning pain and unsteady gait Dizziness
Inflammation or swelling of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye
Dry eye
Watery eyes
Dryness of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye) and cornea (the clear layer in front of the iris and pupil.
Swelling of the eyelids
Eye disorder with dryness, tearing, irritation, and/or pain
Cardiac Failure (Condition that affects the pumping power of your heart muscles)
Irregular heart rhythm
Indigestion
Constipation
Abdominal pain
Liver: increases in the chemicals in the blood made by the liver
Increased skin pigmentation
Itchy skin
Rash on the body where each mark resembles a bullseye
Hair loss
Hives
Kidney stop working
Reduced functionality of kidney
Fever
Pain
Excess fluid in body tissue, causing swelling
Chest pain
Inflammation and ulceration of the mucous membranes lining the digestive tract
Uncommon (may affect up to 1 in 100 people)
Reduction in the number of red,white blood cells and platelets
Stroke
Type of stroke when an artery to the brain is blocked
Bleeding inside the skull
Angina (Chest pain caused by reduced blood flow to the heart)
Heart attack
Narrowing or blockage of the coronary arteries
Abnormal heart rythm
Deficient blood distribution to the limbs
Blockage in one of the pulmonary arteries in your lungs
Inflammation and scarring of the lining of the lungs with breathing problems
Passage of bright red blood from the anus
Bleeding in the gastrointestinal tract
Ruptured bowel
Inflammation of the lining of the oesophagus
Inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding (seen only in combination with cisplatin)
Inflammation, edema, erythema, and erosion of the mucosal surface of the esophagus caused by radiation therapy
Inflammation of the lung caused by radiation therapy
Rare (may affect up to 1 in 1,000 people)
Destruction of red blood cells
Anaphylactic shock (severe allergic reaction)
Inflammatory condition of the liver
Redness of the skin
Skin rash that develops throughout a previously irradiated area
Very rare (affect up to 1 of 10 000 people)
Infections of skin and soft tissues
Stevens-Johnson syndrome (a type of severe skin and mucous membranes reaction that may be life threatening)
Toxic epidermal necrolysis (a type of severe skin reaction that may be life threatening) Autoimmune disorder that results in skin rashes and blistering on the legs, arms, and abdomen Inflammation of the skin characterized by the presence of bullae which are filled with fluid Skin fragility, blisters and erosions and skin scarring
Redness, pain and swelling mainly of the lower limbs
Inflammation of the skin and fat beneath the skin (pseudocellulitis)
Inflammation of the skin (dermatitis)
Skin to become inflamed, itchy, red, cracked, and rough
Intensely itchy spots
Not known: frequency cannot be estimated from the available data
Form of diabetes primarily due to pathology of the kidney
Disorder of the kidneys involving the death of tubular epithelial cells that form the renal tubules
You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.
If you are concerned about any side effects, talk to your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store CIAMBRA
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 carton and vial label after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Chemical and physical in-use stability of the infusion solution of pemetrexed was demonstrated for 24 hours at 2°C-8°C or 15–25°C. The reconstituted solution should be used immediately to prepare the infusion solution. From a microbiological point of view, the infusion solution 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 be longer than 24 hours at 2°C to 8°C or 15°C to 25°C.
This medicine is for single use only; any unused solution must be disposed of in accordance with local requirement.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What CIAMBRA contains
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– The active substance is pemetrexed.
CIAMBRA 100 mg: One vial of powder contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
CIAMBRA 500 mg: Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
After reconstitution, the solution contains 25 mg/ml of pemetrexed. Further dilution by a healthcare provider is required prior to administration.
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– The other ingredients are mannitol (E 421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment) (see section 2, “Ciambra contains sodium”).
What CIAMBRA looks like and contents of the pack
CIAMBRA is a powder for concentrate for solution for infusion in a vial. It is a white to almost white lyophilised powder.
Each pack of CIAMBRA consists of one glass vial with rubber stopper and an aluminium seal with flip off cap, and it is covered with a shrink-wrapped plastic sleeve. The vial contains 100 mg or 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Each pack contains 1 vial.
Marketing Authorisation Holder
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.,
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg
Manufacturer:
Oncotec Pharma Produktion GmbH
Am Pharmapark
06861 Dessau-RoBlau
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
AT A. Menarini Pharma GmbH Tel: +43 1 879 95 85–0
BE Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545
BG EepnuH-XeMu/A. MeHapuHu Etnrapua EOOfl Ten.: +359 2 454 0950
CY MENARINI HELLAS AE Tql: +30 210 8316111–13
CZ Berlin-Chemie/A.Menarini Ceska republika s.r.o. Tel: +420 267 199 333
DE Berlin-Chemie AG Tel: +49 (0) 30 67070
DK Berlin-Chemie/A.Menarini Danmark ApS Tlf: +4548 217 110
EE OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001
ES Laboratorios Menarini S.A. Tel: +34–93 462 88 00
FI Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760
FR MENARINI France Tél: +33 (0)1 45 60 77 20
GR MENARINI HELLAS AE Tql: +30 210 8316111–13
HR Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 361
HU Berlin-Chemie/A. Menarini Kft. Tel.: +36 23501301
IE A. Menarini Pharmaceuticals Ltd Tel: +353 1 284 6744
IS Menarini International Operations Luxembourg S.A. Sími: +352 264976
IT A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39–055 56801
LT UAB “BERLIN-CHEMIE MENARINI BALTIC” Tel: +370 52 691 947
LU Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545
LV SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210
MT Menarini International Operations Luxembourg S.A. Tel: +352 264976
NO Menarini International Operations Luxembourg S.A. Tlf: +352 264976
NL Menarini Benelux NV/SA Tel: +32 (0)2 721 4545
PL Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 00
PT A. Menarini Portugal – Farmacéutica, S.A. Tel: +351 210 935 500
RO Berlin-Chemie A.Menarini S.R.L. Tel: +40 21 232 34 32
SE Menarini International Operations Luxembourg S.A. Tel: +352 264976
SK Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 730
SI Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2160
UK A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856400
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: There are also links to other websites about rare diseases and treatments.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
The following information is intended for healthcare professionals only
Instructions for use, handling and disposal.
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1. Use aseptic techniques during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
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2. Calculate the dose and the number of CIAMBRA vials needed. Each vial contains an excess of pemetrexed to facilitate delivery of the label amount.
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3. CIAMBRA 100 mg:
Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
CIAMBRA 500 mg:
Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Gently swirl each vial until the powder is completely dissolved. The resulting solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality. The pH of the reconstituted solution is between 6.6 and 7.8. Further dilution is required.
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4. The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
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5. Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags. Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer’s Injection and Ringer’s Injection.
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6. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
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7. Pemetrexed solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.