Patient leaflet - Pemetrexed DR. Reddys 1000 mg powder for concentrate for solution for infusion
1. What Pemetrexed i for
2. What you need to k
Pemetrexed
3. How to use Pemetr
- 4. Possible side effec
- 5.
How to store Peme
t s and what it is used now before you use exed ts trexed
Pregnancy
If you are pregnant, or think you may be pregnant, or are planning to have a baby, tell your doctor. The use of Pemetrexed should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Pemetrexed during pregnancy. Women must use effective contraception during treatment
- 6.
Contents of the pa information
ck and other ed is and what it is ne used in the combination with ancer medicine, as pleural mesothelioma,
with Pemetrexed.
Breastfeeding
If you are breastfeeding, tell your doctor. Breast-feeding must be discontinued during Pemetrexed treatment.
Fertility
Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed and should therefore use effective contraception during treatment with
- 1. What Pemetrex used for
Pemetrexed is a medici treatment of cancer. Pemetrexed is given in cisplatin, another anti-c treatment for malignant a form of cancer that af lung, to patients who ha chemotherapy.
Pemetrexed is also give cisplatin for the initial tr advanced stage of lung Pemetrexed can be pre have lung cancer at an disease has responded remains largely unchan
fects the lining of the ve not received prior n in combination with eatment of patients with cancer.
scribed to you if you advanced stage if your to treatment or it ged after initial
Pemetrexed and for up to 6 months afterwards. If you would like to father a child during the treatment or in the 6 months after 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
Pemetrexed may make you feel tired. Be careful when driving a car or using machines.
- 3. How to use Pemetrexed
chemotherapy.
Pemetrexed is also a tr advanced stage of lung has progressed after ot has been used.
eatment for patients with cancer whose disease her initial chemotherapy to know before exed xed if you:
trexed or any of the
The dose of Pemetrexed is 500 milligrams 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.
- 2. What you need you use Pemetr
Do not use Pemetre
- are allergic to peme other ingredients of section 6)
are breast-feeding;
breast-feeding durin Pemetrexed
have recently receiv receive a vaccine a Warnings and Preca Talk to your doctor pharmacist before r
this medicine (listed in you must discontinue g treatment with ed or are about to gainst yellow fever. utions or hospital eceiving
A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed powder with 9 mg/ml (0.9%) sodium chloride solution for injection or glucose 50 mg/ml (5%) solution for infusion before it is given to you.
You will always receive Pemetrexed by infusion into one of your veins. The infusion will last approximately 10 minutes.
When using Pemetrexed in combination
Pemetrexed if you:
- currently have or ha problems with you doctor or hospital ph not be able to receiv
- have had or are goin therapy, as there m radiation reaction wi
have been recently possibly cause bad
ve previously had r kidneys, talk to your armacist as you may e Pemetrexed g to have radiation ay be an early or late th Pemetrexed vaccinated, as this can effects with Pemetrexed
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 Pemetrexed has finished. The infusion of cisplatin will last approximately 2 hours.
You should usually receive your infusion once every 3 weeks.
- have heart disease disease
- have an accumulatio lungs; your doctor the fluid before givin Blood tests
Before each infusion yo your blood taken to che kidney and liver functio have enough blood cell
or a history of heart n of fluid around your may decide to remove g you Pemetrexed.
u will have samples of ck you have sufficient n and to check that you s to receive
Additional medicines:
Corticosteriods: Your doctor will prescribe you steroid tablets (equivalent to 4 milligrams of dexamethasone twice a day) to take on the day before, on the day of, and the day after Pemetrexed treatment. This will reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.
Vitamin supplements: Your doctor will
Pemetrexed. Your doct the dose or delay treati your general condition counts are too low. If you are also receiving will make sure that you and receive appropriate after receiving cisplatin Children and adolesc
This medicine should n
or may decide to change ng you depending on and if your blood cell cisplatin, your doctor are properly hydrated treatment before and to prevent vomiting. ents ot be used in children or
prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) to take once a day while you are taking Pemetrexed. You must also take at least five doses of folic acid during the seven days before the first dose of Pemetrexed and must continue taking folic acid for 21 days after the last dose of Pemetrexed.
You will also have an injection of vitamin B12 (1000 micrograms) in the week before receiving adolescents, since ther this medicine in childre 18 years of age.
Other medicines and
Please tell your doctor i medicine for pain or infl such as medicines cal anti-inflammatory dru medicines purchased w prescription (such as ib
e is no experience with n and adolescents under
Pemetrexed f you are taking any ammation (swelling), led “nonsteroidal gs” (NSAIDs), including ithout a doctor’s uprofen). There are
Pemetrexed and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed 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 many sorts of NSAIDs of activity.
Based on the planned d Pemetrexed and/or on t function, your doctor ne which medicines you ca can take them. If you ar doctor or pharmacist if are NSAIDs.
Tell your doctor or hosp
with different durations ate of your infusion of he status of your kidney eds to advise you on n take and when you e unsure, ask your any of your medicines ital pharmacist if you
side effects, although not everybody gets them. You must contact your doctor immediately if you notice any of the following:
- fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection (as this may mean you have less white blood cells than normal which is very common). Infection (sepsis) may be severe and could lead to death
- chest pain (common) or having a fast heart are taking, have recentl any other medicines, in obtained without a pres
y taken or might take cluding medicines cription.
rate (uncommon)
- pain, redness, swelling or sores in your mouth (very common)
P Pemetrexed 10
Read all of this leafle contains important i
- Keep this leaflet. Y
- If you have further
If you get any side
ackage Leaflet: Information for the User
00 mg Powder For Concentrate For Solution For Infusion
Pemetrexed t carefully before you start receiving this medicine because it nformation for you.
ou may need to read it again.
questions, please ask your doctor or pharmacist.
effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.
150 mm
130 mm
Process Black
Brand: Dr Reddy’s
Pemetrexed
1000 mg
Powder For Concentrate For Solution For Infusion
1 Vial
UK
23 MAR 2020
25 SEP 2020
Product Name:
Strength:
Form:
Pack Size:
Leaflet
Country:
Date Created:
Date Modified:
Dr. Reddy’s Laboratories (UK) Ltd 6 Riverview Road, Beverley, HU17 0LD, UK
150 x 535 mm
India
9pt
CC - 1000038873
allergic reactions such as skin ra
common)/ burning or prickling s (common), or fever (common). R reactions may be severe and co death. Contact your doctor if you severe rash, or itching, or blister (Stevens-Johnson Syndrome or epidermal necrolysis)
tiredness, feeling faint, becomin
sh (very ensation
arely, skin uld lead to get a
ing
Toxic
g easily
- inflammation, oedem erosion of the mucos oesophagus caused
- inflammation of the lu therapy
Rare (may affect up to
- destruction of red blo
- anaphylactic shock (s
- inflammatory conditio
breathless or if you look pale (as have less haemoglobin than nor very common)
bleeding from the gums, nose or
any bleeding that will not stop, r pinkish urine, unexpected bruisi might have less platelets than n is very common)
sudden breathlessness, intense
or cough with bloody sputum (un This may indicate a blood clot in
you may mal which is mouth or eddish or ng (as you ormal which chest pain common). the blood
- redness of the skin
- skin rash that develop previously irradiated Very rare (may affect u people)
- infections of skin and
- Stevens-Johnson syn severe skin and muco reaction that may be l
- Toxic epidermal necro vessels of the lungs.
Side effects with Pemetrexed may i Very common (may affect more t people)
- infection
- pharyngitis (sore throat)
low number of neutrophil granul
type of white blood cells)
- low white blood cells
low haemoglobin level
nclude:
han 1 in 10 ocytes (a
skin reaction that ma
- autoimmune disorder rashes and blistering abdomen
- inflammation of the s presence of bullae wh
- skin fragility, blisters a scarring
- redness, pain and sw lower limbs
- inflammation of the s
- loss of appetite
pain, redness, swelling or sores
mouth
- vomiting
- diarrhoea
- nausea
- skin rash
- flaking skin
abnormal blood tests showing re
functionality of kidneys
fatigue (tiredness)
in your
duced
skin (pseudocellulitis)
- inflammation of the s
- skin to became inflam and rough
- intensely itchy spots Not known: frequency from the available data
- form of diabetes prim of the kidney
- disorder of the kidney
Common (may affect up to 1 in 1
- blood infection
fever with low number of neutro
granulocytes (a type of white blo
- low platelet count
- allergic reaction
- loss of body fluids
- taste changes
damage to the motor nerves whi
cause muscle weakness and atr
0 people)
phil
od cells)
ch may ophy
of tubular epithelial ce tubules
You might have any of th conditions. You must te as possible when you any of these side effec
If you are concerned abo talk to your doctor.
Reporting of side effec
If you get any side effect
(wasting) primary in the arms an
damage to the sensory nerves t
cause lost of sensation, burning unsteady gait
- dizziness
inflammation or swelling of the c
(the membrane that lines the ey covers the white of the eye)
- dry eye
- watery eyes
dryness of the conjunctiva (the
d legs
hat may pain and onjunctiva elids and membrane
pharmacist. This include effects not listed in this l report any side effects di Card Scheme, website www.mhra.gov.uk/yellow MHRA Yellow Card in th App Store. By reporting help provide more inform this medicine.
5. How to store Pe
that lines eyelids and covers the eye) and cornea (the clear layer the iris and pupil)
- swelling of the eyelids
eye disorder with dryness, tearin
and/or pain
cardiac failure (condition that aff
pumping power of your heart mu
- irregular heart rhythm
indigestion
white of the in front of g, irritation, ects the
scles)
Keep this medicine out o children.
Do not use this medicine which is stated on the la expiry date refers to the This medicine does not r storage conditions. Chemical and physical in demonstrated for 24 hou
- constipation
- abdominal pain
liver: increases in the chemicals
made by the liver
- increased skin pigmentation
- itchy skin
rash on the body where each m
resembles a bullseye
- hair loss
- hives
kidney stop working
in blood
ark
8°C.
From a microbiological p product should be used i immediately, in-use stora conditions prior to use ar the user and would not b at 2°C to 8°C.
This medicine is for singl unused solution must be accordance with local re
- reduced functionality of kidney
- fever
- pain
- chest pain
- excess fluid in body tissue, caus
inflammation and ulceration of th
membranes lining the digestive t Uncommon (may affect up to 1 in people)
reduction in the number of red,
cells and platelets
- stroke
type of stroke when an artery to
blocked
- bleeding inside the skull
angina (chest pain caused by re
flow to the heart)
- heart attack
narrowing or blockage of the cor
arteries
ing swelling e mucous ract
100
white blood the brain is duced blood onary
6. Contents of the information
What Pemetrexed pow
The active substance is Pemetrexed 1000 mg: E 1000 mg of pemetrexed ditromethamine dihydrat After reconstitution, the s 25 mg/ml of pemetrexed healthcare provider is re administration.
The other ingredients ar and hydrochloric acid (fo What Pemetrexed pow contents of the pack
Pemetrexed is a powder solution for infusion in a either light yellow or gree cake or powder.
- abnormal heart rhythm
- deficient blood distribution to the
blockage in one of the pulmonar
your lungs
inflammation and scarring of the
lungs with breathing problems
- passage of bright red blood from
- bleeding in the gastrointestinal t
- ruptured bowel
- inflammation of the lining of the
inflammation of the lining of the
limbs
y arteries in lining of the the anus ract
oesophagus large bowel,
Each pack of Pemetrexe Pemetrexed vial.
Not all pack sizes may b Marketing Authorisatio Manufacturer
Dr. Reddy’s Laboratories 6 Riverview Road, Bever HU17 0LD, United Kingd Manufacturer betapharm Arzneimittel which may be accompanied by i rectal bleeding (seen only in com with cisplatin)
ntestinal or bination
Augsburg, 86156, Germ This leaflet was last re
a, erythema, and al surface of the by radiation therapy ng caused by radiation
1 in 1,000 people)
od cells evere allergic reaction) n of the liver s throughout a area p to 1 in 10,000 soft tissues drome (a type of us membranes ife threatening)
lysis (a type of severe y be life threatening) that results in skin on the legs, arms and kin characterized by the ich are filled with fluid nd erosions and skin elling mainly of the kin and fat beneath the kin (dermatitis)
ed, itchy, red, cracked, cannot be estimated arily due to pathology s involving the death lls that form the renal ese symptoms and/or ll your doctor as soon start experiencing ts.
ut any side effects, ts s, talk to your doctor or s any possible side eaflet. You can also rectly via the Yellow card or search for e Google Play or Apple side effects you can ation on the safety of metrexed f the sight and reach of after the expiry date bel and carton. The last day of that month. equire any special
-use stability has been rs at 25°C and 2°C to oint of view, the mmediately. If not used ge times and e the responsibility of e longer than 24 hours e use only; any disposed of in quirements.
pack and other der contains pemetrexed.
ach vial contains (as pemetrexed e).
olution contains . Further dilution by a quired prior to e mannitol, trometamol r pH adjustment). der looks like and for concentrate for vial. It is a white to n-yellow lyophilised d consists of one e marketed.
n Holder and
(UK) Ltd., ley, East Yorkshire, om
GmbH, Kobelweg 95, any vised in 09/2020.
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