PEMETREXED 100 mg Порошок Для Приготовления Раствора Для Инфузий

Содержание инструкции

1. Pemetrexed Glenmark 100 mg powder for concentrate for solution for infusion, 500 mg powder for concentrate for solution for infusion
   1. What is Pemetrexed Glenmark and what is it used for
   2. What you need to know before you take Pemetrexed Glenmark
   3. How to take Pemetrexed Glenmark
   4. Possible side effects
   5. How to store Pemetrexed Glenmark
   6. Package Contents and Other Information

Pemetrexed Glenmark 100 mg powder for concentrate for solution for infusion, 500 mg powder for concentrate for solution for infusion

pemetrexed disodium heptahydrate

Generic medicine

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, see your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Pemetrexed Glenmark is and what it is used for
• 2. What you need to know before you use Pemetrexed Glenmark
• 3. How to use Pemetrexed Glenmark
• 4. Possible side effects
• 5. How to store Pemetrexed Glenmark
• 6. Contents of the pack and other information

1. What is Pemetrexed Glenmark and what is it used for

Pemetrexed Glenmark is a medicine used in the treatment of tumors.
Pemetrexed Glenmark is administered in association with cisplatin, another anticancer drug,
as treatment for malignant pleural mesothelioma, a form of tumor that affects the tissue
lining the lungs, to patients who have not received previous chemotherapy.
Furthermore Pemetrexed Glenmark, in association with cisplatin, is administered for first-line therapy in
patients affected by advanced stage lung cancer.
Pemetrexed Glenmark may be prescribed in case of advanced stage lung cancer if the
disease has responded to treatment or if it remains mostly unchanged after initial chemotherapy.
Furthermore Pemetrexed Glenmark is a treatment for patients affected by advanced stage lung
cancer whose disease has progressed after a previous initial chemotherapeutic treatment.

2. What you need to know before you take Pemetrexed Glenmark

Do not take Pemetrexed Glenmark

• if you are allergic (hypersensitive) to pemetrexed or to any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding; you must stop breastfeeding during treatment with Pemetrexed Glenmark.
• if you have recently had or are about to have the vaccination for yellow fever.

Warnings and precautions
Talk to your doctor or hospital pharmacist or nurse before using Pemetrexed Glenmark.
If you have or have had kidney problems, tell your doctor or hospital pharmacist as you may not
be able to receive Pemetrexed Glenmark.
Before each infusion, blood tests will be performed to assess whether you have sufficient
liver and kidney function and to check that you have enough cells in your blood to receive
Pemetrexed Glenmark. The doctor may decide to change the dose or delay treatment depending on
your general condition and if the blood test (white blood cells and platelets) is inadequate (too low). Also, if you are receiving cisplatin, the doctor must ensure that you are
adequately hydrated and that you receive appropriate treatment before and after receiving cisplatin
to prevent vomiting.
If you have had or will be undergoing radiotherapy, tell your doctor, as Pemetrexed Glenmark may cause an early or delayed reaction due to radiation treatment.
If you have been vaccinated recently, tell your doctor, as Pemetrexed Glenmark may
cause adverse effects.
If you have heart disease or a history of heart disease, tell your doctor.
If you have fluid buildup around your lungs, the doctor may decide to remove the
fluid before administering Pemetrexed Glenmark.

Children and adolescents
This medicine should not be used in children and adolescents because there is no experience in
children and adolescents under 18 years of age.

Other medicines and Pemetrexed Glenmark
Tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “non-steroidal anti-inflammatory drugs”
(NSAIDs), including over-the-counter medicines (such as ibuprofen). There are many
types of NSAIDs with different durations of activity. Based on the planned pemetrexed infusion date and/or
your kidney function, your doctor will 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.
Tell your doctor or hospital pharmacist if you are taking or have recently taken any other
medicines, even those available without a prescription.

Pregnancy
If you are pregnant, if you suspect you are pregnant or are planning a pregnancy, ask your doctor
or pharmacist for advice before taking this medicine.
The use of Pemetrexed Glenmark during pregnancy should be avoided. Your doctor will discuss with you the
potential risks of taking Pemetrexed Glenmark during pregnancy. Women must use
an effective method of contraception during treatment with Pemetrexed Glenmark and for 6 months
after receiving the last dose.

Breastfeeding
If you are breastfeeding, tell your doctor.
Breastfeeding must be stopped during treatment with Pemetrexed Glenmark.

Fertility
Men are advised not to father a child during treatment with Pemetrexed Glenmark until
3 months after and therefore to use effective contraception during treatment with Pemetrexed
Glenmark and for 3 months after. If you wish to father a child during treatment or within 3 months
afterwards, ask your doctor or pharmacist for advice. Pemetrexed Glenmark may affect your
ability to have children. Talk to your doctor for advice on storing
sperm before starting therapy.

Driving and operating machinery
Pemetrexed Glenmark can cause fatigue. Be careful when driving a vehicle or operating
machinery.

Pemetrexed Glenmark contains sodium
Pemetrexed Glenmark 100 mg powder concentrate for solution for infusion
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially
“sodium-free”.
Pemetrexed Glenmark 500 mg powder concentrate for solution for infusion
This medicine contains 54 mg of sodium (the main component of table salt) per
vial. This is equivalent to 2.7% of the maximum recommended daily intake of sodium for
an adult.

3. How to take Pemetrexed Glenmark

The dose of Pemetrexed Glenmark is 500 mg per each square meter of body surface area. Your height
and your weight will be measured to calculate your body surface area. The doctor will use this surface
area to calculate the right dose for you. This dosage may be adjusted or treatment may be
delayed depending on your blood tests and your general condition. A hospital pharmacist, a nurse or a doctor will have mixed the powder of Pemetrexed Glenmark with a
solution of sodium chloride 9 mg/ml (0.9 %) for injectable preparations before administering it to you.
You will receive Pemetrexed Glenmark always by infusion into a vein. The infusion will last approximately 10 minutes.
When Pemetrexed Glenmark is used in combination with cisplatin:
The doctor or the hospital pharmacist will calculate the dose you need based on your height and your
weight. Cisplatin is also administered by infusion into a vein, approximately 30 minutes after
the Pemetrexed Glenmark infusion has been completed. The cisplatin infusion will last approximately 2 hours.
Usually you should receive the infusion once every 3 weeks.
Additional medicines:
Corticosteroids: the doctor will prescribe steroid tablets (equivalent to 4 milligrams of
dexamethasone twice a day) that you must take the day before, on the day of and the day after
treatment with Pemetrexed Glenmark. This medicine is given to you to reduce the frequency and severity of skin reactions that may occur during cancer treatment.
Vitamin supplement: the doctor will prescribe folic acid (vitamin) or a multivitamin product
containing folic acid (350-1000 micrograms) orally that you must take once a day
while you are being treated with Pemetrexed Glenmark. You must take at least 5 doses during the seven days
before the first dose of Pemetrexed Glenmark. You must continue to take folic acid for 21
days after the last dose of Pemetrexed Glenmark. You will also receive an injection of vitamin B (1000
micrograms) in the week before the administration of Pemetrexed Glenmark and then approximately every 9
weeks (corresponding to 3 treatment cycles with Pemetrexed Glenmark). Vitamin B and folic acid are administered to you to reduce the possible toxic effects of cancer treatment.
If you have any questions about 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 everyone gets them.
You should immediately contact your doctor if you notice any of the following side effects:

• Fever or infection (common or very common respectively): if you have a body temperature of 38°C or higher, sweating or other signs of infection (as you may have fewer white blood cells than normal, which is very common). Infection (sepsis) can be serious and could lead to death.
• If you begin to feel chest pain (common) or experience an increased heart rate (uncommon).
• If you have pain, redness, swelling or ulcers in your mouth (very common).
• Allergic reaction: if you develop a skin rash (very common)/a burning or tingling sensation (common) or fever (common). Rarely, skin reactions can be severe and could lead to death. Contact your doctor if a severe rash, or itching, or rash with blisters appears (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• If you feel tired, faint, short of breath or pale (as you may have less hemoglobin than normal, which is very common).
• If you experience bleeding from the gums, nose or mouth or any bleeding that does not tend to stop, reddish or slightly pink urine, unexplained bruising (as you may have fewer platelets than normal, which is common).
• If you suddenly experience shortness of breath, severe chest pain or have blood in your sputum (uncommon) (may indicate a blood clot in the pulmonary vessels).

Side effects with Pemetredex Glenmark may include:

Very common (may affect more than 1 in 10 people)
Infection
Pharyngitis (sore throat)
Low number of neutrophils (a type of white blood cells)
Low number of white blood cells
Low level of hemoglobin
Pain, redness, swelling or ulcers in the mouth
Loss of appetite
Vomiting
Diarrhea
Nausea
Skin rash
Skin peeling
Abnormal blood tests showing reduced kidney function
Fatigue (tiredness)

Common (may affect up to 1 in 10 people)
Bloodstream infection
Fever with low number of neutrophils (a type of white blood cells)
Low platelet count
Allergic reaction
Loss of body fluids
Altered taste
Damage to motor nerves that may cause stiffness and muscle atrophy that can cause muscle weakness and atrophy (wasting) primarily in the arms and legs
Damage to sensory nerves that can cause loss of sensation, burning pain and unsteady gait
Dizziness
Inflammation or swelling of the conjunctiva (the membrane that lines the eyelids and covers the white part of the eye)
Dry eye
Watery eyes
Dryness of the conjunctiva (the membrane that lines the eyelids and covers the white part of the eye) and the cornea (the clear layer in front of the iris and pupil.
Swelling of the eyelids
Eye condition with dryness, tearing, irritation and/or pain
Heart failure (a condition that affects the heart muscle's ability to pump)
Irregular heartbeat
Indigestion
Constipation
Abdominal pain
Liver: increased levels of chemicals produced by the liver in the blood
Increased skin pigmentation
Itchy skin
Widespread red spots
Hair loss
Urticaria (hives)
Kidneys stopping working
Reduced kidney function
Fever
Pain
Excess fluid in body tissues, 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 white and red blood cells and platelets
Stroke
Type of stroke when an artery in 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
Increased heart rate
Poor blood distribution to the limbs
Blockage in the lungs, of one of the pulmonary arteries
Inflammation and scarring of the lining of the lungs, with breathing problems. Fresh red blood from the anus
Bleeding from the gastrointestinal tract
Bowel rupture
Inflammation of the lining of the esophagus
Inflammation of the lining of the large intestine which may be accompanied by intestinal or rectal bleeding (seen only in combination with cisplatin) Inflammation, edema, erythema and erosion of the surface of the mucosa of the esophagus caused by radiation therapy.
Lung inflammation 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
Skin redness
Sudden skin rash that develops in a previously irradiated area.

Very Rare (may affect up to 1 in 10,000 people)
Skin and soft tissue infection
Stevens-Johnson syndrome (a type of severe skin and mucous membrane reaction that could be life-threatening)
Toxic epidermal necrolysis (a type of severe skin reaction that could be life-threatening)
Autoimmune disorders resulting in sudden skin rashes and blisters on the legs, arms and abdomen
Inflammation of the skin characterized by the presence of blisters that fill with fluid
Fragile skin, blisters and erosion and skin scarring
Redness, pain and swelling mainly of the lower limbs
Inflammation of the skin and fat under the skin (pseudocellulitis)
Inflammation of the skin (dermatitis)
Skin that becomes inflamed, itchy, red, cracked and rough
Intensely itchy spots.

Frequency not known: cannot be estimated from the available data
Form of diabetes primarily due to kidney disease
Kidney disorders involving the death of tubular epithelial cells that form the kidney tubules.
You may experience one of these symptoms and/or conditions. You should tell your doctor as soon as possible when you begin to have one of these side effects.
If you have any doubts about any side effect, talk to your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pemetrexed Glenmark

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 package and vial after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Reconstituted and infusion solutions: the product must be used immediately. If prepared as
indicated, the chemical and physical stability during use of reconstituted and infusion solutions of pemetrexed has been demonstrated for 48 hours at refrigerated temperature.
Do not dispose of any medicine in the wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Pemetrexed Glenmark Contains
The active ingredient is pemetrexed.
Pemetrexed Glenmark 100 mg: Each vial contains pemetrexed disodium heptahydrate equivalent to
100 mg of pemetrexed.
Pemetrexed Glenmark 500 mg: Each vial contains pemetrexed disodium heptahydrate equivalent to
500 mg of pemetrexed.
After reconstitution, the solution contains 25 mg/ml of pemetrexed. Further dilution by healthcare
professionals is required before administration.
The other components are mannitol (E421), hydrochloric acid (to adjust the pH) and sodium hydroxide
(to adjust the pH).

Description of Pemetrexed Glenmark and Package Contents
Pemetrexed Glenmark is a powder for concentrate for solution for infusion in a vial. It is a
powder or a lyophilized cake of variable color from white to light yellow or yellow-green.
It is available in packs of 1 vial.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Glenmark Arzneimittel GmbH
Industriestrasse 31
82194 Groebenzell
Germany

Manufacturer
Apis labor GmbH
Resslstrasse 9
9065 Ebenthal in Kaernten
Austria

This medicinal product is authorized in the Member States of the European Economic Area with the
following denominations:
Germany Pemetrexed Glenmark 100 mg Pulver für ein Konzentrat zur Herstellung einer
Infusionslösung
Pemetrexed Glenmark 500 mg Pulver für ein Konzentrat zur Herstellung einer
Infusionslösung
Spain Pemetrexed Glenmark 100 mg powder for concentrate for solution for perfusion
Pemetrexed Glenmark 500 mg powder for concentrate for solution for perfusion
Sweden Pemetrexed Glenmark 100 mg powder for concentrate for infusion solution
Pemetrexed Glenmark 500 mg powder for concentrate for infusion solution,
solution
Norway Pemetrexed Glenmark 100 mg powder for concentrate for infusion fluid, solution
Pemetrexed Glenmark 500 mg powder for concentrate for infusion fluid,
solution
Denmark Pemetrexed Glenmark
Finland Pemetrexed Glenmark 100 mg dry powder for intermediate concentrate for infusion fluid,
solution
Pemetrexed Glenmark 500 mg dry powder for intermediate concentrate for infusion fluid,
solution
Poland Pemetrexed Glenmark
Italy Pemetrexed Glenmark 100 mg powder for concentrate for solution for infusion
Pemetrexed Glenmark 500 mg powder for concentrate for solution for infusion
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The following information is intended exclusively for physicians or healthcare professionals:
Instructions for use, handling and disposal

• 1. During the reconstitution and further dilution of pemetrexed for the administration of the intravenous infusion, use aseptic techniques.
• 2. Calculate the dose and the number of vials of pemetrexed needed. Each vial contains an excess of pemetrexed to facilitate dispensing the amount indicated on the label.
• 3. Pemetrexed Glenmark 100 mg: Reconstitute each 100 mg vial with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injections, to obtain a solution containing 25 mg/ml of pemetrexed.

Pemetrexed Glenmark 500 mg:
Reconstitute each 500 mg vial with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for
injections, to obtain a solution containing 25 mg/ml of pemetrexed.
Gently shake each vial until the powder is completely dissolved. The
resulting solution is clear and is variable from colorless to yellow or yellow-green without negatively
affecting the product quality. The pH of the reconstituted solution is between 6.6 and 7.8. Further
dilution is required.

• 4. The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with a sodium chloride 9 mg/ml (0.9 %) solution for injections, without preservatives, and administered by intravenous infusion over 10 minutes.
• 5. Pemetrexed infusion solutions prepared as described above are compatible with polyvinyl chloride and polyolefin coated infusion bags and administration sets. Pemetrexed is incompatible with solvents containing calcium, including Ringer’s lactate solution for injections and Ringer’s solution for injections.
• 6. Before administration, parenteral medicines should be visually inspected for the presence of particles and color changes. Do not administer if particles are observed.
• 7. Pemetrexed solutions are for single use only. Unused product and waste materials derived from this medicine must be disposed of in accordance with local legal requirements.

Precautions for preparation and administration:
As with other potentially toxic antitumor agents, caution should be exercised when handling and
preparing pemetrexed infusion solutions. The use of gloves is recommended. If a pemetrexed solution
comes into contact with the skin, wash immediately and thoroughly with water and soap. If
pemetrexed solutions come into contact with mucous membranes, wash thoroughly with water. Pemetrexed is
not vesicant. There is no specific antidote for pemetrexed extravasation. Some cases of
pemetrexed extravasation have been reported that were not considered serious by the investigator.
Extravasation should be managed according to standard procedures as for other non-vesicant agents.