Patient leaflet - Treprostinil 2.5 mg / ml solution for infusion
1. What Trepr
ostinil is and what it is used use Treprostinil
for
2. Before you
3. How to use
Treprostinil
4. Possible si
de effects re Treprostinil f the pack and other informa
5. How to sto
6. Contents o
tion
- 1.
What Tr used fo
eprostinil is and what it r
is
What Trepro
stinil is
The active ing For Infusion is
redient of Treprostinil Solution treprostinil.
Treprostinil be which work in occurring pro hormone-like pressure by re them to wide more easily. P influence in p
longs to a group of medicines a similar way to the naturally stacyclins. Prostacyclins are substances which reduce bloo laxing blood vessels, causing n, which allows the blood to flo rostacyclins can also have an reventing blood from clotting.
d
w
What Trepro
stinil is used to treat
Treprostinil is heritable pulm in patients wi symptoms. Pu condition whe
used to treat idiopathic or onary arterial hypertension (P th moderate severity of the lmonary arterial hypertension re your blood pressure is too h
AH)
is a
igh
in the blood v lungs, causing tiredness, fain heartbeat, dry ankles or legs
essels between the heart and shortness of breath, dizzines ting, palpitations or abnormal cough, chest pain and swolle .
the
s,
n
Treprostinil is continuous su infusion. Som tolerate this b swelling. Your Treprostinil ca intravenous (d instead. This central venou
initially administered as a bcutaneous (under the skin) e patients may become unable ecause of local site pain and doctor will decide whether n be administered by continu irectly into a vein) infusion will require the insertion of a s tube (catheter) that is usuall
to
ous
y
located in you
r neck, chest or groin.
How Trepro
stinil works
Treprostinil lo pulmonary art reducing the a Improved bloo supply of oxyg on the heart, effectively. Tr associated wi in patients wh
wers blood pressure within th ery, by improving blood flow a mount of work for the heart. d flow leads to an improved en to the body and reduced st causing it to function more eprostinil improves the sympto th PAH and the ability to exerc
e
nd
rain
ms
ise
o are limited in terms of activi
ty.
- 2.
Before y
ou use Treprostinil
Do not use T
reprostinil
if you are al treprostinil this medici
lergic (hypersensitive) to or any of the other ingredients ne listed in section 6
of
if you have called “pul This is a dis that carry b swollen and pressure in heart and t
been diagnosed with a disease monary veno-occlusive disea
se”.
ease in which the blood vessel lood through your lungs becom clogged resulting in a higher the blood vessels between the he lungs
s
e
if you have
severe liver disease
if you have
a heart problem, for example: dial infarction (heart attack) e last six months
- a myocar within th
severe ch
anges in heart rate ronary heart disease or unst
severe co angina
able
a heart d as a fault heart to
efect has been diagnosed, su y heart valve that causes the work poorly
ch
any disea treated o observati
se of the heart which is not be r not under close medical on
ing
if you have a birth d which affects the w through it
efect in your heart ay your blood flows
if you are on a low s
odium diet.
During your treatment your doctor:
with Treprostinil, tell
if your blood pressu (hypotension)
re decreases
if you experience a breathing difficultie can be related to co asthma or other con doctor immediatel
rapid increase in
s or persistent cough (this ngestion in the lungs or dition), consult your y
if you have excessiv
e bleeding as treprostinil k, by preventing your
may increase the ris blood from clotting
if you develop a fev intravenous Trepros infusion site becom painful to the touch infection.
er whilst receiving
tinil or the intravenous es red, swollen and / or , as this could be a sign of
Other medicines an
d Treprostinil
Please tell your doctor recently taken, might
if you are taking or have use any other medicines.
Please tell your doctor
if you are taking:
medicines used to t (antihypertensive dr
reat high blood pressure ugs or other vasodilators) ase the rate of urination furosemide
drugs used to incre
(diuretics) including
medicines that stop (anticoagulants) suc nitric oxide based p
blood clotting
h as warfarin, heparin or roducts
any non-steroidal a drugs (e.g. acetylsal
nti-inflammatory (NSAID) icylic acid, ibuprofen) increase or decrease the l (e.g. gemfibrozil,
medicines that may effect of Treprostini rifampicin, trimetho phenytoin, carbama St John’s Wort) as y adjust your dose of
prim, deferasirox,
zepine, phenobarbital, our doctor may need to Treprostinil.
Pregnancy and bre
astfeeding
If you are pregnant or
breast-feeding, think you e planning to have a baby, vice before taking this
may be pregnant or ar ask your doctor for ad medicine.
Treprostinil is not reco pregnant, planning to think that you might b considered essential b of this medicine for us not been established.
mmended if you are become pregnant, or e pregnant, unless
y your doctor. The safety e during pregnancy has
Treprostinil is not reco breastfeeding, unless your doctor. You are a breastfeeding if Trepr you, because it is not
mmended for use in considered essential by dvised to stop
ostinil is prescribed for known whether this breast milk.
medicine passes into
Contraception is stron treprostinil treatment
gly recommended during .
Driving and using
machines
Treprostinil may induc dizziness or fainting. I or operate machinery advice.
e low blood pressure with n such a case do not drive and ask your doctor for
Treprostinil contai
ns sodium
This medicine contain (main component of c vial. This is equivalent recommended maxim
s up to 78.4 mg sodium ooking/table salt) in each to 3.9 % of the
um daily dietary intake of
sodium for an adult.
- 3.
How to use Tre
prostinil
Always take this medi doctor has told you. Y doctor if you are not s
cine exactly as your ou should check with your ure.
Treprostinil is adminis infusion, either:
tered as a continuous
if you are at
a specific high risk of bleedi le, active stomach ulcers, injur eding conditions
ng
for examp or other ble
ies,
if you have 3 months, o
had a stroke within the last r any other interruption of blo
od
supply to th
e brain.
subcutaneously (un tube (cannula) whic abdomen or thigh; or,
der the skin) via a small h is located in your
intravenously via a
tube (catheter) that is ur neck, chest or groin.
usually located in yo
Warnings an
d precautions
Before you sta doctor:
rt taking Treprostinil, tell your
if you suffer
from any liver disease from kidney disease
- if you suffer
if you have medically o
been advised that you are bese (BMI greater than 30 kg/ Human Immunodeficiency Vir
m2)
if you have (HIV) infecti
us
on
if you have veins (porta
high blood pressure in your liv l hypertension)
er
For subcutaneous infu be administered undil For intravenous infusi diluted in accordance the prescriber and ma sterile water for inject sodium chloride inject
sion the product should uted.
on the product should be with the instructions of y only be diluted with ion or 0.9% (w/v) or ion.
Brand: Dr Reddy’s
Product Name:
Treprostinil
Strength:
1/2.5/5/10 mg/ml
Form:
Solution for Infusion
Leaflet
Pack Size:
N/A
Country:
UK
Date Created:
10 JAN 2020
Date Modified:
17 SEP 2020
9pt
India
150 x 440 mm Dimensions:
Project:
NPL
Process Black
Dr. Reddy’s Laboratories (UK) Ltd 6 Riverview Road, Beverley, HU17 0LD, UK
FMD Requirements
PC:
00000000000000
SN:
BN:
EXP:
In both cases, Treprostinil the tubing by a portable p Before you leave the hosp doctor will tell you how to and at what rate the pum Treprostinil. Information o pump correctly and what working should also be gi information should also te in an emergency. Flushing of the infusion lin may cause accidental ove Treprostinil is diluted only | luid retention bleeds, urine, n the faeces he legs ncy cannot ata) ls (platelets) ) | |||||||
is pushed through ump. ital or clinic, the prepare Treprostinil p should deliver your n how to use the to do if it stops ven to you. The ll you who to contact e whilst connected rdose. when administered
Oth be e
| welling of feet, ankles, legs or f eeding episodes such as nose oughing up blood, blood in the eeding from the gums, blood i int pain, muscle pain, pain in t nd/or arms er possible side effects (freque | |||||||
| stimated from the available d | ||||||||
| fection at the infusion site bscess at the infusion site decrease of blood clotting cel the blood (thrombocytopenia eeding at the infusion site | ||||||||
intravenously: For intravenous infusion dilute your Treprostinil sol Sterile Water for Injection Chloride Injection (as prov it is being administered as intravenous infusion. Adult patients Treprostinil is available as 5 mg/ml or 10 mg/ml solu doctor will determine the dose appropriate for your Overweight patients If you are overweight (wei | only: You must only ution with either or 0.9% Sodium ided by your doctor) if a continuous 1 mg/ml, 2.5 mg/ml, tion for infusion. Your infusion rate and condition. gh 30% or more than
Add intra
| one pain in rashes with discolouration umps ssue infection under the skin ( o much pumping of blood fro ading to shortness of breath, f welling of the legs and abdome uild-up, persistent cough. itional side effects associated | or raised cellulitis) m the heart atigue, n due to fluid with the n bophlebitis) 3) erial | |||||
| venous route of administratio | ||||||||
| flammation of the vein (throm ood stream bacterial infection acteraemia)* (refer to Section pticaemia (severe blood bact | ||||||||
your ideal body weight) yo determine the initial and s based on your ideal body refer to Section 2, “Warnin Older people Your doctor will determine dose appropriate for your Children and adolescents | ur doctor will ubsequent doses weight. Please also gs and precautions”. the infusion rate and condition. for children and educed or increased er medical in * lif b Rep If yo This liste effe web sear or A you safe | fection) e-threatening or fatal cases of acterial infection have been re orting of side effects u get any side effects talk to y includes any possible side eff d in this leaflet. You can also r cts directly via the Yellow Card site www.mhra.gov.uk/yellow ch for MHRA Yellow Card in th pple App Store. By reporting si can help provide more informa ty of this medicine. | blood stream ported our doctor. ects not eport side Scheme card or e Google Play de effects, tion on the | |||||
Limited data are available adolescents. Dosage adjustment The infusion rate can be r on an individual basis und | ||||||||
supervision only. The aim of adjusting the i establish an effective mai improves symptoms of PA any undesirable effects. If your symptoms increase complete rest, or are conf chair, or if any physical ac discomfort and your symp not increase your dose wit Treprostinil may no longer your disease and another required. How can blood stream | nfusion rate is to ntenance rate which H while minimizing or if you need ined to your bed or tivity brings on toms occur at rest, do hout medical advice. be sufficient to treat treatment may be infections during 5. Kee chil This spe Do n that The mon Do n to th dete | How to store Treprostin | il | |||||
p out of the reach and sig dren. medicinal product does not r cial storage conditions. ot use this medicine after the is stated on the carton and vi expiry date refers to the last d th. ot use Treprostinil if you notic e vial, discolouration or other rioration. | ht of equire any expiry date al after “EXP”. ay of that e any damage signs of | |||||||
treatment with intrave be prevented? As with any long-term intr there is a risk of getting bl infections. Your doctor wil avoid this. If you use more Trepro should If you accidentally overdo may experience nausea, v low blood pressure (dizzin or fainting), skin flushes a If any of these effects bec | nous Treprostinil avenous treatment, ood stream l train you on how to stinil than you se on Treprostinil, you omiting, diarrhoea, ess, light-headedness nd/or headaches. ome severe then you A Tr with Duri sing Trep Duri sing mus Any disc For i Sect Do n | eprostinil vial must be used or in 30 days after first opening. ng continuous subcutaneous i le reservoir (syringe) of undilut rostinil must be used within 7 ng continuous intravenous inf le reservoir (syringe) of diluted t be used within 24 hours. remaining diluted solution sho arded. nstructions on use please refe ion 3. “How to use Treprostini ot throw away any medicines | discarded nfusion, a ed 2 hours. usion, a Treprostinil uld be r to l”. via | |||||
should contact your docto immediately. Your doctor discontinue the infusion u have disappeared. Trepros reintroduced at a dose lev your doctor. If you stop using Trepr Always use Treprostinil as d or hospital specialist. Do no Treprostinil unless your doc Abrupt withdrawal or sud dose of Treprostinil may c arterial hypertension to re potential for rapid and sev | r or hospital may reduce or ntil your symptoms tinil will then be el recommended by ostinil irected by your doctor t stop using tor has advised you to. den reductions in the ause the pulmonary turn with the ere deterioration in was pha no l the 6. Wh The 2.5 The are chlo for p | tewater or household waste. A rmacist how to throw away me onger use. These measures wil environment. | sk your dicines you l help protect | |||||
| Contents of the pack an information | d other | |||||||
at Treprostinil Solution co active substance is treprostin mg/ml, 5 mg/ml, 10 mg/ml. other ingredients in Treprostin sodium citrate dehydrate (E33 ride, metacresol, water for inj H adjustment: sodium hydrox | ntains il 1 mg/ml, il Solution 1), sodium ections and ide (E524) | |||||||
your condition. If you have any further qu this product, ask your doc | estions on the use of tor. cts dicine can cause side ybody gets them. (may affect more ls with flushing of nd the infusion site ruising around the and Wh the Trep slig clea and
| hydrochloric acid (E507). at Treprostinil Solution lo contents of the pack rostinil Solution is a clear colo htly yellow solution, available i r glass vial sealed with a rubb a colour coded flip-off seal: eprostinil 1 mg/ml Solution Fo rubber yellow cap. eprostinil, 2.5 mg/ml Solution as a rubber blue cap. eprostinil, 5 mg/ml Solution F as a rubber green cap. eprostinil, 10 mg/ml Solution | oks like and urless to n a 20 ml er stopper r Infusion has For Infusion or Infusion For | |||||
| ||||||||
Like all medicines, this me effects, although not ever Very common side effects | ||||||||
than 1 in 10 people)
| ||||||||
infusion site
Common side effects (may 10 people
| affect up to 1 in ting due to low blood e skin In Eac Ma ma Dr. R Roa Unit This | fusionhas a rubber red cap. h carton contains one vial. rketing Authorisation hold nufacturer: eddy’s Laboratories (UK) Ltd., d, Beverley, East Yorkshire, HU ed Kingdom leaflet was last revised in Se | er and 6 Riverview 17 0LD, p 2020 | |||||